PSUSA/00002024/201710 - European Medicines Agency - Europa EU

14 June 2018 EMA/415385/2018 Human Medicines Evaluation Division

List of nationally authorised medicinal products

Active substance(s): methylphenidate

Procedure No.: PSUSA/00002024/201710

30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom Telephone +44 (0)20 3660 6000 Facsimile +44 (0)20 3660 5525 Send a question via our website www.ema.europa.eu/contact

An agency of the European Union

© European Medicines Agency, 2018. Reproduction is authorised provided the source is acknowledged.

Product Name (in

MRP/DCP

authorisation country)

Authorisation

National Authorisation Number

MAH of product in the

Member State where

member state

product is authorised

number Concerta 18 mg comprimate cu eliberare prelungită Concerta 18 mg comprimidos de liberación prolongada. Concerta 18 mg comprimidos de libertação prolongada Concerta 18 mg comprimidos de libertação prolongada. Concerta 18 mg depottabletit Concerta 18 mg depottabletter Concerta 18 mg depottabletter. Concerta 18 mg forðatöflur. Concerta 18 mg ilgstošās darbības tabletes CONCERTA 18 mg pailginto atpalaidavimo tabletės CONCERTA 18 mg pailginto atpalaidavimo tabletės Concerta 18 mg prolonged release tablets

UK/H/0544/001

5339/2013/01-02

JANSSEN PHARMACEUTICA NV

RO

UK/H/0544/001

65.148

JANSSEN-CILAG S.A.

ES

UK/H/0544/ 001

4260881

JANSSEN-CILAG FARMACÊUTICA, LDA.

PT

UK/H/0544/ 001

4260782


PT

UK/H/0544/001

17408

JANSSEN-CILAG OY

FI

UK/H/0544/001

02-1221

JANSSEN-CILAG A/S

NO

UK/H/0544/ 001

18541

JANSSEN-CILAG AB

SE

UK/H/0544/001

IS/1/02/032/01

JANSSEN-CILAG AB

IS

UK/H/0544/001

08-0130

UAB JOHNSON & JOHNSON

LV

UK/H/0544/001

LT/1/08/1152/002


LT

UK/H/0544/001

LT/1/08/1152/001


LT

UK/H/0544/ 001

20060458

BG

Concerta 18 mg prolonged-release tablets Concerta 18 mg Retardtabletten

UK/H/0544/001

MA018/02601

UK/H/0544/001

1-24812

JOHNSON & JOHNSON PRODAJA MEDICINSKIH IN FARMACEVTSKIH IZDELKOV, D.O.O. JANSSEN-CILAG INTERNATIONAL NV JANSSEN-CILAG PHARMA GMBH

List of nationally authorised medicinal products EMA/415385/2018

MT AT

Page 2/68

Product Name (in

MRP/DCP


Authorisation



Member State where

member state


number Concerta 18 mg Retardtabletten Concerta 18 mg Retardtabletten Concerta 18 mg tablete s podaljšanim sproščanjem

UK/H/0544/ 001

BE242681

JANSSEN-CILAG NV

BE

UK/H/0544/001

54861.00.00

JANSSEN-CILAG GMBH

DE

UK/H/0544/ 001

H/08/00411/001

SI

Concerta 18 mg tablete s produljenim oslobađanjem Concerta 18 mg tabletten met verlengde afgifte Concerta 18 mg tabletten met verlengde afgifte. Concerta 18 mg tablety s predĺženým uvoľňovaním Concerta 18 mg tablety s prodlouženým uvolňováním CONCERTA 18 mg δισκία παρατεταμένης αποδέσμευσης Concerta 18 mg δισκία παρατεταμένης αποδέσμευσης. Concerta 18 mg, comprimés à libération prolongée Concerta 18 mg, comprimés à libération prolongée Concerta 18 mg,

not available

HR-H-078951991

JOHNSON & JOHNSON PRODAJA MEDICINSKIH IN FARMACEVTSKIH IZDELKOV, D.O.O. JOHNSON & JOHNSON S.E. D.O.O.

UK/H/0544/ 001

BE242681

JANSSEN-CILAG NV

BE

UK/H/0544/ 001

RVG 28073

JANSSEN-CILAG BV

NL

UK/H/0544/001

78/0126/08-S

SK

UK/H/0544/001

06/407/08-C

JOHNSON & JOHNSON, S.R.O JANSSEN-CILAG S.R.O

UK/H/0544/001

12582

JANSSEN-CILAG PHARMACEUTICAL S.A.C.I.

GR

UK/H/0544/001

20339

JANSSEN-CILAG INTERNATIONAL NV

CY

UK/H/0544/ 001

BE242681

JANSSEN-CILAG NV

BE

UK/H/0544/ 001

2008100010

JANSSEN-CILAG NV

LU

UK/H/0544/ 001

2008100010

JANSSEN-CILAG NV

LU


HR

CZ

Page 3/68

Product Name (in

MRP/DCP


Authorisation



Member State where

member state


number Retardtabletten Concerta 27 mg comprimidos de liberación prolongada. Concerta 27 mg comprimidos de libertação prolongada. Concerta 27 mg comprimidos de libertação prolongada. Concerta 27 mg depottabletit Concerta 27 mg depottabletter Concerta 27 mg depottabletter. Concerta 27 mg forðatöflur. Concerta 27 mg Retardtabletten Concerta 27 mg Retardtabletten Concerta 27 mg Retardtabletten Concerta 27 mg tabletten met verlengde afgifte Concerta 27 mg tabletten met verlengde afgifte. Concerta 27 mg δισκία παρατεταμένης αποδέσμευσης. Concerta 27 mg, comprimés à libération

UK/H/0544/004

69.988

JANSSEN-CILAG S.A.

ES

UK/H/0544/ 004

5205307


PT

UK/H/0544/ 004

5205273


PT

UK/H/0544/004

24631

JANSSEN-CILAG OY

FI

UK/H/0544/004

08-5646

JANSSEN-CILAG A/S

NO

UK/H/0544/ 004

26554

JANSSEN-CILAG AB

SE

UK/H/0544/004

IS/1/08/032/01

JANSSEN-CILAG AB

IS

UK/H/0544/004

1-27727

AT

UK/H/0544/ 004

BE324913

JANSSEN-CILAG PHARMA GMBH JANSSEN-CILAG NV

UK/H/0544/004

72263.00.00

JANSSEN-CILAG GMBH

DE

UK/H/0544/ 004

BE324913

JANSSEN-CILAG NV

BE

UK/H/0544/ 004

RVG 101739

JANSSEN-CILAG BV

NL

UK/H/0544/004

12585/19.02.2015


GR

UK/H/0544/ 004

BE324913

JANSSEN-CILAG NV

BE


BE

Page 4/68

Product Name (in

MRP/DCP


Authorisation



Member State where

member state


number prolongée Concerta 27 mg, comprimés à libération prolongée Concerta 27 mg, Retardtabletten Concerta 36 mg comprimate cu eliberare prelungită Concerta 36 mg comprimate cu eliberare prelungită Concerta 36 mg comprimidos de liberación prolongada. Concerta 36 mg comprimidos de libertação prolongada Concerta 36 mg comprimidos de libertação prolongada Concerta 36 mg depottabletit Concerta 36 mg depottabletter Concerta 36 mg depottabletter. Concerta 36 mg forðatöflur. Concerta 36 mg ilgstošās darbības tabletes CONCERTA 36 mg pailginto atpalaidavimo tabletės CONCERTA 36 mg

UK/H/0544/ 004

2008120051

JANSSEN-CILAG NV

LU

UK/H/0544/ 004

2008120051

JANSSEN-CILAG NV

LU

UK/H/0544/002

5340/2013/02


RO

UK/H/0544/002

5340/2013/01


RO

UK/H/0544/002

65.170

JANSSEN-CILAG S.A.

ES

UK/H/0544/ 002

4260980


PT

UK/H/0544/ 002

4261087


PT

UK/H/0544/002

17409

JANSSEN-CILAG OY

FI

UK/H/0544/002

02-1222

JANSSEN-CILAG A/S

NO

UK/H/0544/ 002

18542

JANSSEN-CILAG AB

SE

UK/H/0544/002

IS/1/02/032/02

JANSSEN-CILAG AB

IS

UK/H/0544/002

08-0131


LV

UK/H/0544/002

LT/1/08/1152/004


LT

UK/H/0544/002

LT/1/08/1152/003


LT


Page 5/68

Product Name (in

MRP/DCP


Authorisation



Member State where

member state


MT

number pailginto atpalaidavimo tabletės Concerta 36 mg prolonged-release tablets Concerta 36 mg Retardtabletten Concerta 36 mg Retardtabletten Concerta 36 mg Retardtabletten Concerta 36 mg tablete s podaljšanim sproščanjem Concerta 36 mg tablete s produljenim oslobađanjem Concerta 36 mg tabletten met verlengde afgifte Concerta 36 mg tabletten met verlengde afgifte Concerta 36 mg tablety s predĺženým uvoľňovaním Concerta 36 mg tablety s prodlouženým uvolňováním CONCERTA 36 mg δισκία παρατεταμένης αποδέσμευσης Concerta 36 mg δισκία παρατεταμένης αποδέσμευσης. Concerta 36 mg,

UK/H/0544/002

MA018/02602

UK/H/0544/002

1-24813

UK/H/0544/ 002

BE242697

JANSSEN-CILAG INTERNATIONAL NV JANSSEN-CILAG PHARMA GMBH JANSSEN-CILAG NV

UK/H/0544/002

54861.01.00

JANSSEN-CILAG GMBH

DE

UK/H/0544/ 002

H/08/00411/005

SI

not available

HR-H-413338677

JOHNSON & JOHNSON PRODAJA MEDICINSKIH IN FARMACEVTSKIH IZDELKOV, D.O.O. JOHNSON & JOHNSON S.E. D.O.O.

UK/H/0544/ 002

BE242697

JANSSEN-CILAG NV

BE

UK/H/0544/002

RVG 28074

JANSSEN-CILAG BV

NL

UK/H/0544/002

78/0127/08-S

SK

UK/H/0544/002

06/408/08-C


UK/H/0544/002

12583


GR

UK/H/0544/002

20340


CY

UK/H/0544/ 002

BE242697

JANSSEN-CILAG NV

BE


AT BE

HR

CZ

Page 6/68

Product Name (in

MRP/DCP


Authorisation



Member State where

member state


number comprimés à libération prolongée Concerta 36 mg, comprimés à libération prolongée Concerta 36 mg, Retardtabletten Concerta 54 mg comprimate cu eliberare prelungită Concerta 54 mg comprimate cu eliberare prelungită Concerta 54 mg comprimidos de liberación prolongada. Concerta 54 mg comprimidos de libertação prolongada Concerta 54 mg comprimidos de libertação prolongada Concerta 54 mg depottabletit Concerta 54 mg depottabletter Concerta 54 mg depottabletter Concerta 54 mg forðatöflur. Concerta 54 mg ilgstošās darbības tabletes CONCERTA 54 mg pailginto atpalaidavimo tabletės

UK/H/0544/ 002

2008100011

JANSSEN-CILAG NV

LU

UK/H/0544/ 002

2008100011

JANSSEN-CILAG NV

LU

UK/H/0544/003

5341/2013/02


RO

UK/H/0544/003

5341/2013/01


RO

UK/H/0544/003

65.171

JANSSEN-CILAG S.A.

ES

UK/H/0544/003

4261186


PT

UK/H/0544/003

4261285


PT

UK/H/0544/003

17410

JANSSEN-CILAG OY

FI

UK/H/0544/003

02-1223

JANSSEN-CILAG A/S

NO

UK/H/0544/003

18543

JANSSEN-CILAG AB

SE

UK/H/0544/003

IS/1/02/032/03

JANSSEN-CILAG AB

IS

UK/H/0544/003

08-0132


LV

UK/H/0544/003

LT/1/08/1152/006


LT


Page 7/68

Product Name (in

MRP/DCP


Authorisation



Member State where

member state


number CONCERTA 54 mg pailginto atpalaidavimo tabletės Concerta 54 mg prolonged-release tablets Concerta 54 mg Retardtabletten Concerta 54 mg Retardtabletten Concerta 54 mg Retardtabletten Concerta 54 mg tablete s podaljšanim sproščanjem

UK/H/0544/003

LT/1/08/1152/005


LT

UK/H/0544/003

MA018/02603

MT

UK/H/0544/003

1-24814

UK/H/0544/ 003

BE242706

JANSSEN-CILAG INTERNATIONAL NV JANSSEN-CILAG PHARMA GMBH JANSSEN-CILAG NV

UK/H/0544/003

54861.02.00

JANSSEN-CILAG GMBH

DE

UK/H/0544/ 003

H/08/00411/009

SI

Concerta 54 mg tabletten met verlengde afgifte Concerta 54 mg tabletten met verlengde afgifte Concerta 54 mg tablety s predĺženým uvoľňovaním Concerta 54 mg tablety s prodlouženým uvolňováním CONCERTA 54 mg δισκία παρατεταμένης αποδέσμευσης Concerta 54 mg δισκία παρατεταμένης αποδέσμευσης. Concerta 54 mg, comprimés à libération prolongée

UK/H/0544/ 003

BE242706

JOHNSON & JOHNSON PRODAJA MEDICINSKIH IN FARMACEVTSKIH IZDELKOV, D.O.O. JANSSEN-CILAG NV

UK/H/0544/003

RVG 28075

JANSSEN-CILAG BV

NL

UK/H/0544/003

78/0128/08-S

SK

UK/H/0544/003

06/409/08-C


UK/H/0544/003

12584


GR

UK/H/0544/003

20336


CY

UK/H/0544/ 003

BE242706

JANSSEN-CILAG NV

BE


AT BE

BE

CZ

Page 8/68

Product Name (in

MRP/DCP


Authorisation



Member State where

member state


number Concerta 54 mg, comprimés à libération prolongée Concerta 54 mg, Retardtabletten CONCERTA LP 18 mg, comprimé à libération prolongée CONCERTA LP 36 mg, comprimé à libération prolongée CONCERTA LP 54 mg, comprimé à libération prolongée Concerta XL 18 mg prolonged-release tablets Concerta XL 18 mg prolonged-release tablets Concerta XL 27 mg prolonged-release tablets. Concerta XL 27 mg prolonged-release tablets. Concerta XL 36 mg prolonged-release tablets Concerta XL 36 mg prolonged-release tablets. Concerta XL 54 mg prolonged-release tablets Concerta XL 54 mg prolonged-release tablets. Concerta, 18 mg

UK/H/0544/ 003

2008100012

JANSSEN-CILAG NV

LU

UK/H/0544/ 003

2008100012

JANSSEN-CILAG NV

LU

UK/H/0544/001

34009 361 554 1 1

JANSSEN-CILAG

FR

UK/H/0544/002

34009 361 555 8 9

JANSSEN-CILAG

FR

UK/H/0544/003

34009 361 556 4 0

JANSSEN-CILAG

FR

UK/H/0544/001

PA 0748/049/001

JANSSEN-CILAG LIMITED

IE

UK/H/0544/001

PL 00242/0372


UK

UK/H/0544/004

PA 0748/049/004


IE

UK/H/0544/004

PL 00242/0400


UK

UK/H/0544/002

PA 0748/049/002


IE

UK/H/0544/002

PL 00242/0373


UK

UK/H/0544/003

PA 0748/049/003


IE

UK/H/0544/003

PL 00242/0374


UK

UK/H/0544/001

583608


EE


Page 9/68

Product Name (in

MRP/DCP


Authorisation



Member State where

member state


number toimeainet prolongeeritult vabastavad tabletid Concerta, 18 mg, tabletki o przedłużonym uwalnianiu Concerta, 36 mg toimeainet prolongeeritult vabastavad tabletid Concerta, 36 mg, tabletki o przedłużonym uwalnianiu Concerta, 54 mg toimeainet prolongeeritult vabastavad tabletid Concerta, depottabletter Concerta, depottabletter Concerta, depottabletter Concerta® 18 mg depottabletter Concerta® 27 mg depottabletter Concerta® 36 mg depottabletter Concerta® 54 mg depottabletter DIFUMENIL, 27 MG, TABLETKI O PRZEDŁUŻONYM UWALNIANIU Equasym 10 mg cápsulas duras de liberación modificada

UK/H/0544/001

14751


PL

UK/H/0544/002

583708


EE

UK/H/0544/002

14752


PL

UK/H/0544/003

583808


EE

UK/H/0544/001 UK/H/0544/002 UK/H/0544/003 UK/H/0544/001

42318 42319 42320 17408

JANSSEN-CILAG JANSSEN-CILAG JANSSEN-CILAG JANSSEN-CILAG

DK DK DK FI

UK/H/0544/004

24631

JANSSEN-CILAG OY

FI

UK/H/0544/002

17409

JANSSEN-CILAG OY

FI

UK/H/0544/003

17410

JANSSEN-CILAG OY

FI

DK/H/2138/001

20921

SANDOZ GMBH

PL

UK/H/0819/001

76061

SHIRE PHARMACEUTICALS IRELAND LIMITED

ES


A/S A/S A/S OY

Page 10/68

Product Name (in

MRP/DCP


Authorisation



Member State where

member state


number Equasym 10 mg cápsulas duras de liberación modificada Equasym 10 mg cápsulas duras de liberación modificada Equasym 10 mg cápsulas duras de liberación modificada Equasym 10 mg cápsulas duras de liberación modificada Equasym 10 mg capsule rigide a rilascio modificato Equasym 10 mg capsule rigide a rilascio modificato Equasym 10 mg capsule rigide a rilascio modificato Equasym 10 mg capsule rigide a rilascio modificato Equasym 10 mg capsule rigide a rilascio modificato Equasym 10 mg tablets

UK/H/0819/001

76061


ES

UK/H/0819/001

76061


ES

UK/H/0819/001

76061


ES

UK/H/0819/001

76061


ES

UK/H/0819/001

041889015


IT

UK/H/0819/001

041889039


IT

UK/H/0819/001

041889041


IT

UK/H/0819/001

041889054


IT

UK/H/0819/001

041889066


IT

UK/H/0416/002

PL 27303/0002

UK

Equasym 10 mg tablets

UK/H/0416/002

PL 27303/0002


UK/H/0416/002

PL 27303/0002

Equasym 10 mg Tabletten

UK/H/0416/002

51447.01.00

SHIRE PHARMACEUTICALS IRELAND LIMITED SHIRE PHARMACEUTICALS IRELAND LIMITED SHIRE PHARMACEUTICALS IRELAND LIMITED SHIRE PHARMACEUTICALS IRELAND LIMITED


UK UK DE

Page 11/68

Product Name (in

MRP/DCP


Authorisation



Member State where

member state


SHIRE PHARMACEUTICALS IRELAND LIMITED SHIRE PHARMACEUTICALS IRELAND LIMITED SHIRE PHARMACEUTICALS IRELAND LIMITED SHIRE PHARMACEUTICALS IRELAND LIMITED SHIRE PHARMACEUTICALS IRELAND LIMITED SHIRE PHARMACEUTICALS IRELAND LIMITED SHIRE PHARMACEUTICALS IRELAND LIMITED SHIRE PHARMACEUTICALS IRELAND LIMITED SHIRE PHARMACEUTICALS IRELAND LIMITED SHIRE PHARMACEUTICALS IRELAND LIMITED SHIRE PHARMACEUTICALS IRELAND LIMITED SHIRE PHARMACEUTICALS IRELAND LIMITED SHIRE PHARMACEUTICALS IRELAND LIMITED SHIRE PHARMACEUTICALS IRELAND LIMITED SHIRE PHARMACEUTICALS IRELAND LIMITED

DE


ES

number Equasym 10 Tabletten Equasym 10 Tabletten Equasym 10 Tabletten Equasym 10 Tabletten Equasym 10 Tabletten Equasym 10

mg

UK/H/0416/002

51447.01.00

mg

UK/H/0416/002

51447.01.00

mg

UK/H/0416/002

RVG 26494

mg

UK/H/0416/002

RVG 26494

mg

UK/H/0416/002

RVG 26494

mg tabletter

UK/H/0416/002

35417

Equasym 10 mg tabletter

UK/H/0416/002

35417


UK/H/0416/002

35417

EQUASYM 10 mg tabletter EQUASYM 10 mg tabletter EQUASYM 10 mg tabletter Equasym 10 mg töflur

UK/H/0416/002

03-1987

UK/H/0416/002

03-1987

UK/H/0416/002

03-1987

UK/H/0416/002

IS/1/03/036/02

Equasym 10 mg töflur

UK/H/0416/002

IS/1/03/036/02


UK/H/0416/002

IS/1/03/036/02

Equasym 20 mg cápsulas duras de liberación modificada Equasym 20 mg cápsulas duras de liberación modificada

UK/H/0819/002

76076

UK/H/0819/002

76076


DE NL NL NL DK DK DK NO NO NO IS IS IS ES

Page 12/68

Product Name (in

MRP/DCP


Authorisation



Member State where

member state


number Equasym 20 mg cápsulas duras de liberación modificada Equasym 20 mg cápsulas duras de liberación modificada Equasym 20 mg cápsulas duras de liberación modificada Equasym 20 mg capsule rigide a rilascio modificato Equasym 20 mg capsule rigide a rilascio modificato Equasym 20 mg capsule rigide a rilascio modificato Equasym 20 mg capsule rigide a rilascio modificato Equasym 20 mg capsule rigide a rilascio modificato Equasym 20 mg tablets

UK/H/0819/002

76076


ES

UK/H/0819/002

76076


ES

UK/H/0819/002

76076


ES

UK/H/0819/002

041889080


IT

UK/H/0819/002

041889092


IT

UK/H/0819/002

041889104


IT

UK/H/0819/002

041889116


IT

UK/H/0819/002

041889128


IT

UK/H/0416/003

PL 27303/0003

UK


UK/H/0416/003

PL 27303/0003


UK/H/0416/003

PL 27303/0003

Equasym 20 mg Tabletten Equasym 20 mg Tabletten Equasym 20 mg

UK/H/0416/003

51447.02.00

UK/H/0416/003

51447.02.00

UK/H/0416/003

51447.02.00

SHIRE PHARMACEUTICALS IRELAND LIMITED SHIRE PHARMACEUTICALS IRELAND LIMITED SHIRE PHARMACEUTICALS IRELAND LIMITED SHIRE PHARMACEUTICALS IRELAND LIMITED SHIRE PHARMACEUTICALS IRELAND LIMITED SHIRE PHARMACEUTICALS


UK UK DE DE DE

Page 13/68

Product Name (in

MRP/DCP


Authorisation



Member State where

member state


number Tabletten Equasym 20 mg tabletter

UK/H/0416/003

35418


UK/H/0416/003

35418


UK/H/0416/003

35418

EQUASYM 20 mg tabletter EQUASYM 20 mg tabletter EQUASYM 20 mg tabletter Equasym 20 mg töflur

UK/H/0416/003

03-1988

UK/H/0416/003

03-1988

UK/H/0416/003

03-1988

UK/H/0416/003

IS/1/03/036/03


UK/H/0416/003

IS/1/03/036/03


UK/H/0416/003

IS/1/03/036/03

Equasym 30 mg cápsulas duras de liberación modificada Equasym 30 mg cápsulas duras de liberación modificada Equasym 30 mg cápsulas duras de liberación modificada Equasym 30 mg cápsulas duras de liberación modificada Equasym 30 mg capsule rigide a rilascio modificato Equasym 30 mg capsule

UK/H/0819/003

76060

UK/H/0819/003

76060


ES

UK/H/0819/003

76060


ES

UK/H/0819/003

76060


ES

UK/H/0819/003

041889130


IT

UK/H/0819/003

041889142

SHIRE PHARMACEUTICALS

IT


IRELAND LIMITED SHIRE PHARMACEUTICALS IRELAND LIMITED SHIRE PHARMACEUTICALS IRELAND LIMITED SHIRE PHARMACEUTICALS IRELAND LIMITED SHIRE PHARMACEUTICALS IRELAND LIMITED SHIRE PHARMACEUTICALS IRELAND LIMITED SHIRE PHARMACEUTICALS IRELAND LIMITED SHIRE PHARMACEUTICALS IRELAND LIMITED SHIRE PHARMACEUTICALS IRELAND LIMITED SHIRE PHARMACEUTICALS IRELAND LIMITED SHIRE PHARMACEUTICALS IRELAND LIMITED

DK DK DK NO NO NO IS IS IS ES

Page 14/68

Product Name (in

MRP/DCP


Authorisation



Member State where

member state


number rigide a rilascio modificato Equasym 30 mg capsule rigide a rilascio modificato Equasym 30 mg capsule rigide a rilascio modificato Equasym 40 mg cápsulas duras de liberación modificada Equasym 40 mg cápsulas duras de liberación modificada Equasym 40 mg capsule rigide a rilascio modificato Equasym 40 mg capsule rigide a rilascio modificato Equasym 5 mg tablets

IRELAND LIMITED UK/H/0819/003

041889155


IT

UK/H/0819/003

041889167


IT

UK/H/0819/004

77163


ES

UK/H/0819/004

77163


ES

UK/H/0819/004

041889179


IT

UK/H/0819/004

041889181


IT

UK/H/0416/001

PL 27303/0001

UK


UK/H/0416/001

PL 27303/0001


UK/H/0416/001

PL 27303/0001


UK/H/0416/001

51447.00.00


UK/H/0416/001

51447.00.00


UK/H/0416/001

RVG 26493


UK/H/0416/001

RVG 26493


UK/H/0416/001

RVG 26493

SHIRE PHARMACEUTICALS IRELAND LIMITED SHIRE PHARMACEUTICALS IRELAND LIMITED SHIRE PHARMACEUTICALS IRELAND LIMITED SHIRE PHARMACEUTICALS IRELAND LIMITED SHIRE PHARMACEUTICALS IRELAND LIMITED SHIRE PHARMACEUTICALS IRELAND LIMITED SHIRE PHARMACEUTICALS IRELAND LIMITED SHIRE PHARMACEUTICALS


UK UK DE DE NL NL NL

Page 15/68

Product Name (in

MRP/DCP


Authorisation



Member State where

member state


number IRELAND LIMITED SHIRE PHARMACEUTICALS IRELAND LIMITED SHIRE PHARMACEUTICALS IRELAND LIMITED SHIRE PHARMACEUTICALS IRELAND LIMITED SHIRE PHARMACEUTICALS IRELAND LIMITED SHIRE PHARMACEUTICALS IRELAND LIMITED SHIRE PHARMACEUTICALS IRELAND LIMITED SHIRE PHARMACEUTICALS IRELAND LIMITED SHIRE PHARMACEUTICALS IRELAND LIMITED SHIRE PHARMACEUTICALS IRELAND LIMITED SHIRE PHARMACEUTICALS IRELAND LIMITED SHIRE PHARMACEUTICALS IRELAND LIMITED


UK/H/0416/001

35416


UK/H/0416/001

35416


UK/H/0416/001

35416

EQUASYM 5 mg tabletter

UK/H/0416/001

03-1986


UK/H/0416/001

03-1986


UK/H/0416/001

03-1986


UK/H/0416/001

IS/1/03/036/01


UK/H/0416/001

IS/1/03/036/01


UK/H/0416/001

IS/1/03/036/01


UK/H/0416/001

51447.00.00

Equasym 50 mg cápsulas duras de liberación modificada Equasym 50 mg cápsulas duras de liberación modificada Equasym 50 mg capsule rigide a rilascio modificato Equasym 50 mg capsule rigide a rilascio modificato Equasym 60 mg cápsulas duras de liberación

UK/H/0819/005

77164

UK/H/0819/005

77164


ES

UK/H/0819/005

041889193


IT

UK/H/0819/005

041889205/M


IT

UK/H/0819/006

77165


ES


DK DK DK NO NO NO IS IS IS DE ES

Page 16/68

Product Name (in

MRP/DCP


Authorisation



Member State where

member state


number modificada Equasym 60 mg cápsulas duras de liberación modificada Equasym 60 mg capsule rigide a rilascio modificato Equasym 60 mg capsule rigide a rilascio modificato Equasym Depot 10 mg hörð hylki með breyttan losunarhraða Equasym Depot 10 mg hörð hylki með breyttan losunarhraða Equasym Depot 10 mg hörð hylki með breyttan losunarhraða Equasym Depot 10 mg hörð hylki með breyttan losunarhraða Equasym Depot 10 mg hörð hylki með breyttan losunarhraða Equasym Depot 10 mg kapsler med modifisert frisetting, harde Equasym Depot 10 mg kapsler med modifisert frisetting, harde Equasym Depot 10 mg kapsler med modifisert frisetting, harde Equasym Depot 10 mg

UK/H/0819/006

77165


ES

UK/H/0819/006

041889217


IT

UK/H/0819/006

041889229


IT

UK/H/0819/001

IS/1/06/003/01


IS

UK/H/0819/001

IS/1/06/003/01


IS

UK/H/0819/001

IS/1/06/003/01


IS

UK/H/0819/001

IS/1/06/003/01


IS

UK/H/0819/001

IS/1/06/003/01


IS

UK/H/0819/001

05-3711


NO

UK/H/0819/001

05-3711


NO

UK/H/0819/001

05-3711


NO

UK/H/0819/001

05-3711


NO


Page 17/68

Product Name (in

MRP/DCP


Authorisation



Member State where

member state


number kapsler med modifisert frisetting, harde Equasym Depot 10 mg kapsler med modifisert frisetting, harde Equasym Depot 10 mg hård kapsel med modifierad frisättning Equasym Depot 10 mg hård kapsel med modifierad frisättning Equasym Depot 20 mg hörð hylki með breyttan losunarhraða Equasym Depot 20 mg hörð hylki með breyttan losunarhraða Equasym Depot 20 mg hörð hylki með breyttan losunarhraða Equasym Depot 20 mg hörð hylki með breyttan losunarhraða Equasym Depot 20 mg hörð hylki með breyttan losunarhraða Equasym Depot 20 mg kapsler med modifisert frisetting, harde Equasym Depot 20 mg kapsler med modifisert frisetting, harde Equasym Depot 20 mg kapsler med modifisert frisetting, harde


05-3711


NO

not available

20407


SE

not available

20407


SE

UK/H/0819/002

IS/1/06/003/02


IS

UK/H/0819/002

IS/1/06/003/02


IS

UK/H/0819/002

IS/1/06/003/02


IS

UK/H/0819/002

IS/1/06/003/02


IS

UK/H/0819/002

IS/1/06/003/02


IS

UK/H/0819/002

05-3712


NO

UK/H/0819/002

05-3712


NO

UK/H/0819/002

05-3712


NO


Page 18/68

Product Name (in

MRP/DCP


Authorisation



Member State where

member state


number Equasym Depot 20 mg kapsler med modifisert frisetting, harde Equasym Depot 20 mg kapsler med modifisert frisetting, harde Equasym Depot 20 mg hård kapsel med modifierad frisättning Equasym Depot 20 mg hård kapsel med modifierad frisättning Equasym Depot 30 mg hörð hylki með breyttan losunarhraða Equasym Depot 30 mg hörð hylki með breyttan losunarhraða Equasym Depot 30 mg hörð hylki með breyttan losunarhraða Equasym Depot 30 mg hörð hylki með breyttan losunarhraða Equasym Depot 30 mg kapsler med modifisert frisetting, harde Equasym Depot 30 mg kapsler med modifisert frisetting, harde Equasym Depot 30 mg kapsler med modifisert frisetting, harde Equasym Depot 30 mg kapsler med modifisert

UK/H/0819/002

05-3712


NO

UK/H/0819/002

05-3712


NO

not available

20408


SE

not available

20408


SE

UK/H/0819/003

IS/1/06/003/03


IS

UK/H/0819/003

IS/1/06/003/03


IS

UK/H/0819/003

IS/1/06/003/03


IS

UK/H/0819/003

IS/1/06/003/03


IS

UK/H/0819/003

05-3713


NO

UK/H/0819/003

05-3713


NO

UK/H/0819/003

05-3713


NO

UK/H/0819/003

05-3713


NO


Page 19/68

Product Name (in

MRP/DCP


Authorisation



Member State where

member state


number frisetting, harde Equasym Depot 30 mg hård kapsel med modifierad frisättning Equasym Depot 30 mg hård kapsel med modifierad frisättning Equasym Depot 40 mg kapslar med modifierad frisättning, hårda Equasym Depot 40 mg kapslar med modifierad frisättning, hårda Equasym Depot 40 mg kapsler med modifisert frisetting, harde Equasym Depot 40 mg kapsler med modifisert frisetting, harde Equasym Depot 50 mg kapslar med modifierad frisättning, hårda Equasym Depot 50 mg kapslar med modifierad frisättning, hårda Equasym Depot 50 mg kapsler med modifisert frisetting, harde Equasym Depot 50 mg kapsler med modifisert frisetting, harde Equasym Depot 60 mg kapslar med modifierad frisättning, hårda Equasym Depot 60 mg

not available

20409


SE

not available

20409


SE

not available

47785


SE

not available

47785


SE

UK/H/0819/004

11-8780


NO

UK/H/0819/004

11-8780


NO

not available

47786


SE

not available

47786


SE

UK/H/0819/005

11-8781


NO

UK/H/0819/005

11-8781


NO

not available

47787


SE

not available

47787


SE


Page 20/68

Product Name (in

MRP/DCP


Authorisation



Member State where

member state


number kapslar med modifierad frisättning, hårda Equasym Depot 60 mg kapsler med modifisert frisetting, harde Equasym Depot 60 mg kapsler med modifisert frisetting, harde Equasym Depot, hårde kapsler med modificeret udløsning 10 mg Equasym Depot, hårde kapsler med modificeret udløsning 10 mg Equasym Depot, hårde kapsler med modificeret udløsning 10 mg Equasym Depot, hårde kapsler med modificeret udløsning 10 mg Equasym Depot, hårde kapsler med modificeret udløsning 10 mg Equasym Depot, hårde kapsler med modificeret udløsning 20 mg Equasym Depot, hårde kapsler med modificeret udløsning 20 mg Equasym Depot, hårde kapsler med modificeret udløsning 20 mg Equasym Depot, hårde kapsler med modificeret udløsning 20 mg


11-8782


NO

UK/H/0819/006

11-8782


NO

UK/H/0819/001

38534


DK

UK/H/0819/001

38534


DK

UK/H/0819/001

38534


DK

UK/H/0819/001

38534


DK

UK/H/0819/001

38534


DK

UK/H/0819/002

38535


DK

UK/H/0819/002

38535


DK

UK/H/0819/002

38535


DK

UK/H/0819/002

38535


DK


Page 21/68

Product Name (in

MRP/DCP


Authorisation



Member State where

member state


number Equasym Depot, hårde kapsler med modificeret udløsning 20 mg Equasym Depot, hårde kapsler med modificeret udløsning 30 mg Equasym Depot, hårde kapsler med modificeret udløsning 30 mg Equasym Depot, hårde kapsler med modificeret udløsning 30 mg Equasym Depot, hårde kapsler med modificeret udløsning 30 mg Equasym Depot, hårde kapsler med modificeret udløsning 40 mg Equasym Depot, hårde kapsler med modificeret udløsning 40 mg Equasym Depot, hårde kapsler med modificeret udløsning 50 mg Equasym Depot, hårde kapsler med modificeret udløsning 50 mg Equasym Depot, hårde kapsler med modificeret udløsning 60 mg Equasym Depot, hårde kapsler med modificeret udløsning 60 mg Equasym Retard 10 mg depotkapseli, kova

UK/H/0819/002

38535


DK

UK/H/0819/003

38536


DK

UK/H/0819/003

38536


DK

UK/H/0819/003

38536


DK

UK/H/0819/003

38536


DK

UK/H/0819/004

50037


DK

UK/H/0819/004

50037


DK

UK/H/0819/005

50038


DK

UK/H/0819/005

50038


DK

UK/H/0819/006

50039


DK

UK/H/0819/006

50039


DK

UK/H/0819/001

19257


FI


Page 22/68

Product Name (in

MRP/DCP


Authorisation



Member State where

member state


SHIRE PHARMACEUTICALS IRELAND LIMITED SHIRE PHARMACEUTICALS IRELAND LIMITED SHIRE PHARMACEUTICALS IRELAND LIMITED SHIRE PHARMACEUTICALS IRELAND LIMITED SHIRE PHARMACEUTICALS IRELAND LIMITED

FI

number Equasym Retard 10 mg depotkapseli, kova Equasym Retard 10 mg depotkapseli, kova Equasym Retard 10 mg depotkapseli, kova Equasym Retard 10 mg depotkapseli, kova Equasym Retard 10 mg Hartkapseln mit veränderter Wirkstofffreisetzung Equasym Retard 10 mg Hartkapseln mit veränderter Wirkstofffreisetzung Equasym Retard 10 mg Hartkapseln mit veränderter Wirkstofffreisetzung Equasym Retard 10 mg kapslar med modifierad frisättning, hårda Equasym Retard 10 mg kapslar med modifierad frisättning, hårda Equasym Retard 10 mg kapslar med modifierad frisättning, hårda Equasym Retard 10 mg kapslar med modifierad frisättning, hårda Equasym Retard 10 mg kapslar med modifierad frisättning, hårda

UK/H/0819/001

19257

UK/H/0819/001

19257

UK/H/0819/001

19257

UK/H/0819/001

19257

UK/H/0819/001

64003.00.00

UK/H/0819/001

64003.00.00


DE

UK/H/0819/001

64003.00.00


DE

UK/H/0819/001

19257


FI

UK/H/0819/001

19257


FI

UK/H/0819/001

19257


FI

UK/H/0819/001

19257


FI

UK/H/0819/001

19257


FI


FI FI FI DE

Page 23/68

Product Name (in

MRP/DCP


Authorisation



Member State where

member state


SHIRE PHARMACEUTICALS IRELAND LIMITED SHIRE PHARMACEUTICALS IRELAND LIMITED SHIRE PHARMACEUTICALS IRELAND LIMITED SHIRE PHARMACEUTICALS IRELAND LIMITED SHIRE PHARMACEUTICALS IRELAND LIMITED SHIRE PHARMACEUTICALS IRELAND LIMITED

FI

number Equasym Retard 20 mg depotkapseli, kova Equasym Retard 20 mg depotkapseli, kova Equasym Retard 20 mg depotkapseli, kova Equasym Retard 20 mg depotkapseli, kova Equasym Retard 20 mg depotkapseli, kova Equasym Retard 20 mg Hartkapseln mit veränderter Wirkstofffreisetzung Equasym Retard 20 mg Hartkapseln mit veränderter Wirkstofffreisetzung Equasym Retard 20 mg Hartkapseln mit veränderter Wirkstofffreisetzung Equasym Retard 20 mg kapslar med modifierad frisättning, hårda Equasym Retard 20 mg kapslar med modifierad frisättning, hårda Equasym Retard 20 mg kapslar med modifierad frisättning, hårda Equasym Retard 20 mg kapslar med modifierad frisättning, hårda Equasym Retard 20 mg

UK/H/0819/002

19258

UK/H/0819/002

19258

UK/H/0819/002

19258

UK/H/0819/002

19258

UK/H/0819/002

19258

UK/H/0819/002

64004.00.00

UK/H/0819/002

64004.00.00


DE

UK/H/0819/002

64004.00.00


DE

UK/H/0819/002

19258


FI

UK/H/0819/002

19258


FI

UK/H/0819/002

19258


FI

UK/H/0819/002

19258


FI

UK/H/0819/002

19258


FI


FI FI FI FI DE

Page 24/68

Product Name (in

MRP/DCP


Authorisation



Member State where

member state


number kapslar med modifierad frisättning, hårda Equasym Retard 30 mg depotkapseli, kova Equasym Retard 30 mg depotkapseli, kova Equasym Retard 30 mg depotkapseli, kova Equasym Retard 30 mg depotkapseli, kova Equasym Retard 30 mg depotkapseli, kova Equasym Retard 30 mg Hartkapseln mit veränderter Wirkstofffreisetzung Equasym Retard 30 mg Hartkapseln mit veränderter Wirkstofffreisetzung Equasym Retard 30 mg kapslar med modifierad frisättning, hårda Equasym Retard 30 mg kapslar med modifierad frisättning, hårda Equasym Retard 30 mg kapslar med modifierad frisättning, hårda Equasym Retard 30 mg kapslar med modifierad frisättning, hårda Equasym Retard 40 mg depotkapseli, kova Equasym Retard 40 mg


MA 19259

SHIRE PHARMACEUTICALS IRELAND LIMITED SHIRE PHARMACEUTICALS IRELAND LIMITED SHIRE PHARMACEUTICALS IRELAND LIMITED SHIRE PHARMACEUTICALS IRELAND LIMITED SHIRE PHARMACEUTICALS IRELAND LIMITED SHIRE PHARMACEUTICALS IRELAND LIMITED

FI

UK/H/0819/003

19259

UK/H/0819/003

19259

UK/H/0819/003

19259

UK/H/0819/003

19259

UK/H/0819/003

64005.00.00

UK/H/0819/003

64005.00.00


DE

UK/H/0819/003

19259


FI

UK/H/0819/003

19259


FI

UK/H/0819/003

19259


FI

UK/H/0819/003

19259


FI

UK/H/0819/004

30420

FI

UK/H/0819/004

30420

SHIRE PHARMACEUTICALS IRELAND LIMITED SHIRE PHARMACEUTICALS


FI FI FI FI DE

FI

Page 25/68

Product Name (in

MRP/DCP


Authorisation



Member State where

member state


IRELAND LIMITED SHIRE PHARMACEUTICALS IRELAND LIMITED

FI

number depotkapseli, kova Equasym Retard 40 mg kapslar med modifierad frisättning, hårda Equasym Retard 40 mg kapslar med modifierad frisättning, hårda Equasym Retard 50 mg depotkapseli, kova Equasym Retard 50 mg depotkapseli, kova Equasym Retard 50 mg kapslar med modifierad frisättning, hårda Equasym Retard 50 mg kapslar med modifierad frisättning, hårda Equasym Retard 60 mg depotkapseli, kova Equasym Retard 60 mg depotkapseli, kova Equasym Retard 60 mg kapslar med modifierad frisättning, hårda Equasym Retard 60 mg kapslar med modifierad frisättning, hårda Equasym XL 10 mg capsule met gereguleerde afgifte, hard Equasym XL 10 mg capsule met gereguleerde afgifte, hard

UK/H/0819/004

30420

UK/H/0819/004

30420


FI

UK/H/0819/005

30421

FI

UK/H/0819/005

30421

UK/H/0819/005

30421

SHIRE PHARMACEUTICALS IRELAND LIMITED SHIRE PHARMACEUTICALS IRELAND LIMITED SHIRE PHARMACEUTICALS IRELAND LIMITED

UK/H/0819/005

30421


FI

UK/H/0819/006

30422

FI

UK/H/0819/006

30422

UK/H/0819/006

30422

SHIRE PHARMACEUTICALS IRELAND LIMITED SHIRE PHARMACEUTICALS IRELAND LIMITED SHIRE PHARMACEUTICALS IRELAND LIMITED

UK/H/0819/006

30422


FI

UK/H/0819/001

RVG 33227


NL

UK/H/0819/001

RVG 33227


NL


FI FI

FI FI

Page 26/68

Product Name (in

MRP/DCP


Authorisation



Member State where

member state


number Equasym XL 10 mg capsule met gereguleerde afgifte, hard Equasym XL 10 mg capsule met gereguleerde afgifte, hard Equasym XL 10 mg capsule met gereguleerde afgifte, hard Equasym XL 10 mg modified-release capsules, hard Equasym XL 10 mg modified-release capsules, hard Equasym XL 10 mg modified-release capsules, hard Equasym XL 10 mg modified-release capsules, hard Equasym XL 10 mg modified-release capsules, hard Equasym XL 10 mg modified-release capsules, hard Equasym XL 10 mg modified-release capsules, hard Equasym XL 10 mg modified-release

UK/H/0819/001

RVG 33227


NL

UK/H/0819/001

RVG 33227


NL

UK/H/0819/001

RVG 33227


NL

UK/H/0819/001

PA 1575/001/001


IE

UK/H/0819/001

PA 1575/001/001


IE

UK/H/0819/001

PA 1575/001/001


IE

UK/H/0819/001

PA 1575/001/001


IE

UK/H/0819/001

PA 1575/001/001


IE

UK/H/0819/001

PL 27303/0004


UK

UK/H/0819/001

PL 27303/0004


UK

UK/H/0819/001

PL 27303/0004


UK


Page 27/68

Product Name (in

MRP/DCP


Authorisation



Member State where

member state


number capsules, hard Equasym XL 10 mg modified-release capsules, hard Equasym XL 10 mg modified-release capsules, hard Equasym XL 20 mg capsule met gereguleerde afgifte, hard Equasym XL 20 mg capsule met gereguleerde afgifte, hard Equasym XL 20 mg capsule met gereguleerde afgifte, hard Equasym XL 20 mg capsule met gereguleerde afgifte, hard Equasym XL 20 mg capsule met gereguleerde afgifte, hard Equasym XL 20 mg modified-release capsules, hard Equasym XL 20 mg modified-release capsules, hard Equasym XL 20 mg modified-release

UK/H/0819/001

PL 27303/0004


UK

UK/H/0819/001

PL 27303/0004


UK

UK/H/0819/002

RVG 33228


NL

UK/H/0819/002

RVG 33228


NL

UK/H/0819/002

RVG 33228


NL

UK/H/0819/002

RVG 33228


NL

UK/H/0819/002

RVG 33228


NL

UK/H/0819/002

PA 1575/001/002


IE

UK/H/0819/002

PA 1575/001/002


IE

UK/H/0819/002

PA 1575/001/002


IE


Page 28/68

Product Name (in

MRP/DCP


Authorisation



Member State where

member state


number capsules, hard Equasym XL 20 mg modified-release capsules, hard Equasym XL 20 mg modified-release capsules, hard Equasym XL 20 mg modified-release capsules, hard Equasym XL 20 mg modified-release capsules, hard Equasym XL 20 mg modified-release capsules, hard Equasym XL 20 mg modified-release capsules, hard Equasym XL 20 mg modified-release capsules, hard Equasym XL 30 mg capsule met gereguleerde afgifte, hard Equasym XL 30 mg capsule met gereguleerde afgifte, hard Equasym XL 30 mg capsule met gereguleerde afgifte, hard Equasym XL 30 mg

UK/H/0819/002

PA 1575/001/002


IE

UK/H/0819/002

PA 1575/001/002


IE

UK/H/0819/002

PL 27303/0005


UK

UK/H/0819/002

PL 27303/0005


UK

UK/H/0819/002

PL 27303/0005


UK

UK/H/0819/002

PL 27303/0005


UK

UK/H/0819/002

PL 27303/0005


UK

UK/H/0819/003

RVG 33229


NL

UK/H/0819/003

RVG 33229


NL

UK/H/0819/003

RVG 33229


NL

UK/H/0819/003

RVG 33229


NL


Page 29/68

Product Name (in

MRP/DCP


Authorisation



Member State where

member state


number capsule met gereguleerde afgifte, hard Equasym XL 30 mg modified-release capsules, hard Equasym XL 30 mg modified-release capsules, hard Equasym XL 30 mg modified-release capsules, hard Equasym XL 30 mg modified-release capsules, hard Equasym XL 30 mg modified-release capsules, hard Equasym XL 30 mg modified-release capsules, hard Equasym XL 30 mg modified-release capsules, hard Equasym XL 30 mg modified-release capsules, hard Equasym XL 40 mg modified-release capsules, hard Equasym XL 40 mg modified-release capsules, hard Equasym XL 40 mg modified-release


PA 1575/001/003


IE

UK/H/0819/003

PA 1575/001/003


IE

UK/H/0819/003

PA 1575/001/003


IE

UK/H/0819/003

PA 1575/001/003


IE

UK/H/0819/003

PL 27303/0006


UK

UK/H/0819/003

PL 27303/0006


UK

UK/H/0819/003

PL 27303/0006


UK

UK/H/0819/003

PL 27303/0006


UK

UK/H/0819/004

PA 1575/001/007


IE

UK/H/0819/004

PA 1575/001/007


IE

UK/H/0819/04

PL 27303/0007


UK


Page 30/68

Product Name (in

MRP/DCP


Authorisation



Member State where

member state


number capsules, hard Equasym XL 40 mg modified-release capsules, hard Equasym XL 40 mg, capsule met gereguleerde afgifte, hard Equasym XL 40 mg, capsule met gereguleerde afgifte, hard Equasym XL 50 mg modified-release capsules, hard Equasym XL 50 mg modified-release capsules, hard Equasym XL 50 mg modified-release capsules, hard Equasym XL 50 mg modified-release capsules, hard Equasym XL 50 mg, capsule met gereguleerde afgifte, hard Equasym XL 50 mg, capsule met gereguleerde afgifte, hard Equasym XL 60 mg modified-release capsules, hard

UK/H/0819/04

PL 27303/0007


UK

UK/H/0819/004

RVG 111228


NL

UK/H/0819/004

RVG 111228


NL

UK/H/0819/005

PA 1575/001/008


IE

UK/H/0819/005

PA 1575/001/008


IE

UK/H/0819/005

PL 27303/0008


UK

UK/H/0819/005

PL 27303/0008


UK

UK/H/0819/005

RVG 111232


NL

UK/H/0819/005

RVG 111232


NL

UK/H/0819/006

PA 1575/001/009


IE


Page 31/68

Product Name (in

MRP/DCP


Authorisation



Member State where

member state


number Equasym XL 60 mg modified-release capsules, hard Equasym XL 60 mg modified-release capsules, hard Equasym XL 60 mg modified-release capsules, hard Equasym XL 60 mg, capsule met gereguleerde afgifte, hard Equasym XL 60 mg, capsule met gereguleerde afgifte, hard Equasym XR 10 mg capsules met gereguleerde afgifte, hard Equasym XR 10 mg capsules met gereguleerde afgifte, hard Equasym XR 10 mg capsules met gereguleerde afgifte, hard Equasym XR 10 mg capsules met gereguleerde afgifte, hard Equasym XR 10 mg capsules met

UK/H/0819/006

PA 1575/001/009


IE

UK/H/0819/006

PL 27303/0009


UK

UK/H/0819/006

PL 27303/0009


UK

UK/H/0819/006

RVG 111233


NL

UK/H/0819/006

RVG 111233


NL

UK/H/0819/001

BE423586


BE

UK/H/0819/001

BE423586


BE

UK/H/0819/001

BE423586


BE

UK/H/0819/001

BE423586


BE

UK/H/0819/001

BE423586


BE


Page 32/68

Product Name (in

MRP/DCP


Authorisation



Member State where

member state


number gereguleerde afgifte, hard Equasym XR 10 mg gélules à libération modifiée Equasym XR 10 mg gélules à libération modifiée Equasym XR 10 mg gélules à libération modifiée Equasym XR 10 mg gélules à libération modifiée Equasym XR 10 mg gélules à libération modifiée Equasym XR 10 mg gélules à libération modifiée Equasym XR 10 mg gélules à libération modifiée Equasym XR 10 mg gélules à libération modifiée Equasym XR 10 mg gélules à libération modifiée Equasym XR 10 mg gélules à libération modifiée Equasym XR 20 mg capsules met gereguleerde afgifte,

UK/H/0819/001

BE423586


BE

UK/H/0819/001

BE423586


BE

UK/H/0819/001

BE423586


BE

UK/H/0819/001

BE423586


BE

UK/H/0819/001

BE423586


BE

UK/H/0819/001

2013120615


LU

UK/H/0819/001

2013120615


LU

UK/H/0819/001

2013120615


LU

UK/H/0819/001

2013120615


LU

UK/H/0819/001

2013120615


LU

UK/H/0819/002

BE423595


BE


Page 33/68

Product Name (in

MRP/DCP


Authorisation



Member State where

member state


number hard Equasym XR 20 mg capsules met gereguleerde afgifte, hard Equasym XR 20 mg capsules met gereguleerde afgifte, hard Equasym XR 20 mg capsules met gereguleerde afgifte, hard Equasym XR 20 mg capsules met gereguleerde afgifte, hard Equasym XR 20 mg gélules à libération modifiée Equasym XR 20 mg gélules à libération modifiée Equasym XR 20 mg gélules à libération modifiée Equasym XR 20 mg gélules à libération modifiée Equasym XR 20 mg gélules à libération modifiée Equasym XR 20 mg gélules à libération modifiée

UK/H/0819/002

BE423595


BE

UK/H/0819/002

BE423595


BE

UK/H/0819/002

BE423595


BE

UK/H/0819/002

BE423595


BE

UK/H/0819/002

BE423595


BE

UK/H/0819/002

BE423595


BE

UK/H/0819/002

BE423595


BE

UK/H/0819/002

BE423595


BE

UK/H/0819/002

BE423595


BE

UK/H/0819/002

2013120616


LU


Page 34/68

Product Name (in

MRP/DCP


Authorisation



Member State where

member state


number Equasym XR 20 mg gélules à libération modifiée Equasym XR 20 mg gélules à libération modifiée Equasym XR 20 mg gélules à libération modifiée Equasym XR 20 mg gélules à libération modifiée Equasym XR 30 mg capsules met gereguleerde afgifte, hard Equasym XR 30 mg capsules met gereguleerde afgifte, hard Equasym XR 30 mg capsules met gereguleerde afgifte, hard Equasym XR 30 mg capsules met gereguleerde afgifte, hard Equasym XR 30 mg gélules à libération modifiée Equasym XR 30 mg gélules à libération modifiée Equasym XR 30 mg

UK/H/0819/002

2013120616


LU

UK/H/0819/002

2013120616


LU

UK/H/0819/002

2013120616


LU

UK/H/0819/002

2013120616


LU

UK/H/0819/003

BE423604


BE

UK/H/0819/003

BE423604


BE

UK/H/0819/003

BE423604


BE

UK/H/0819/003

BE423604


BE

UK/H/0819/003

BE423604


BE

UK/H/0819/003

BE423604


BE

UK/H/0819/003

BE423604


BE


Page 35/68

Product Name (in

MRP/DCP


Authorisation



Member State where

member state


number gélules à libération modifiée Equasym XR 30 mg gélules à libération modifiée Equasym XR 30 mg gélules à libération modifiée Equasym XR 30 mg gélules à libération modifiée Equasym XR 30 mg gélules à libération modifiée Equasym XR 30 mg gélules à libération modifiée Equasym XR 40 mg capsules met gereguleerde afgifte, hard Equasym XR 40 mg capsules met gereguleerde afgifte, hard Equasym XR 40 mg gélules à libération modifiée Equasym XR 40 mg gélules à libération modifiée Equasym XR 40 mg gélules à libération modifiée Equasym XR 40 mg


BE423604


BE

UK/H/0819/003

2013120617


LU

UK/H/0819/003

2013120617


LU

UK/H/0819/003

2013120617


LU

UK/H/0819/003

2013120617


LU

UK/H/0819/004

BE437595


BE

UK/H/0819/004

BE437595


BE

UK/H/0819/004

BE437595


BE

UK/H/0819/004

BE437595


BE

UK/H/0819/004

2013120618


LU

UK/H/0819/004

2013120618


LU


Page 36/68

Product Name (in

MRP/DCP


Authorisation



Member State where

member state


number gélules à libération modifiée Equasym XR 50 mg capsules met gereguleerde afgifte, hard Equasym XR 50 mg capsules met gereguleerde afgifte, hard Equasym XR 50 mg gélules à libération modifiée Equasym XR 50 mg gélules à libération modifiée Equasym XR 50 mg gélules à libération modifiée Equasym XR 50 mg gélules à libération modifiée Equasym XR 60 mg capsules met gereguleerde afgifte, hard Equasym XR 60 mg capsules met gereguleerde afgifte, hard Equasym XR 60 mg gélules à libération modifiée Equasym XR 60 mg gélules à libération


BE437604


BE

UK/H/0819/005

BE437604


BE

UK/H/0819/005

BE437604


BE

UK/H/0819/005

BE437604


BE

UK/H/0819/005

2013120619


LU

UK/H/0819/005

2013120619


LU

UK/H/0819/006

BE437613


BE

UK/H/0819/006

BE437613


BE

UK/H/0819/006

BE437613


BE

UK/H/0819/006

BE437613


BE


Page 37/68

Product Name (in

MRP/DCP


Authorisation



Member State where

member state


number modifiée Equasym XR 60 mg gélules à libération modifiée Equasym XR 60 mg gélules à libération modifiée Equasym® 10mg, Tablets Equasym® 10mg, Tablets Equasym® 10mg, Tablets Equasym® 20mg Tablets

UK/H/0819/006

2013120620


LU

UK/H/0819/006

2013120620


LU

UK/H/0416/002

PA 1575/1/5

IE

UK/H/0416/002

PA 1575/1/5

UK/H/0416/002

PA 1575/1/5

UK/H/0416/003

PA 1575/1/6

Equasym® 20mg Tablets

UK/H/0416/003

PA 1575/1/6

Equasym® 20mg Tablets

UK/H/0416/003

PA 1575/1/6

Equasym® 5mg, Tablets

UK/H/0416/001

PA 1575/1/4


UK/H/0416/001

PA 1575/1/4


UK/H/0416/001

PA 1575/1/4

Equasym® Retard 40 mg Hartkapseln mit veränderter Wirkstofffreisetzung Equasym® Retard 50 mg Hartkapseln mit veränderter Wirkstofffreisetzung Equasym® Retard 60 mg Hartkapseln mit

UK/H/0819/004

86841.00.00

SHIRE PHARMACEUTICALS IRELAND LIMITED SHIRE PHARMACEUTICALS IRELAND LIMITED SHIRE PHARMACEUTICALS IRELAND LIMITED SHIRE PHARMACEUTICALS IRELAND LIMITED SHIRE PHARMACEUTICALS IRELAND LIMITED SHIRE PHARMACEUTICALS IRELAND LIMITED SHIRE PHARMACEUTICALS IRELAND LIMITED SHIRE PHARMACEUTICALS IRELAND LIMITED SHIRE PHARMACEUTICALS IRELAND LIMITED SHIRE PHARMACEUTICALS IRELAND LIMITED

UK/H/0819/005

86842.00.00


DE

UK/H/0819/006

86843.00.00


DE


IE IE IE IE IE IE IE IE DE

Page 38/68

Product Name (in

MRP/DCP


Authorisation



Member State where

member state


number veränderter Wirkstofffreisetzung Equasym® XR 10 mg Hartkapseln mit veränderter Equasym® XR 10 mg Hartkapseln mit veränderter Equasym® XR 10 mg Hartkapseln mit veränderter Equasym® XR 10 mg Hartkapseln mit veränderter Equasym® XR 10 mg Hartkapseln mit veränderter Equasym® XR 10 mg Hartkapseln mit veränderter Equasym® XR 10 mg Hartkapseln mit veränderter Equasym® XR 10 mg Hartkapseln mit veränderter Equasym® XR 10 mg Hartkapseln mit veränderter Equasym® XR 10 mg Hartkapseln mit veränderter Equasym® XR 20 mg Hartkapseln mit veränderter

UK/H/0819/001

BE423586


BE

UK/H/0819/001

BE423586


BE

UK/H/0819/001

BE423586


BE

UK/H/0819/001

BE423586


BE

UK/H/0819/001

BE423586


BE

UK/H/0819/001

2013120615


LU

UK/H/0819/001

2013120615


LU

UK/H/0819/001

2013120615


LU

UK/H/0819/001

2013120615


LU

UK/H/0819/001

2013120615


LU

UK/H/0819/002

BE423595


BE


Page 39/68

Product Name (in

MRP/DCP


Authorisation



Member State where

member state


number Equasym® XR 20 Hartkapseln mit veränderter Equasym® XR 20 Hartkapseln mit veränderter Equasym® XR 20 Hartkapseln mit veränderter Equasym® XR 20 Hartkapseln mit veränderter Equasym® XR 20 Hartkapseln mit veränderter Equasym® XR 20 Hartkapseln mit veränderter Equasym® XR 20 Hartkapseln mit veränderter Equasym® XR 20 Hartkapseln mit veränderter Equasym® XR 20 Hartkapseln mit veränderter Equasym® XR 30 Hartkapseln mit veränderter Equasym® XR 30 Hartkapseln mit veränderter Equasym® XR 30 Hartkapseln mit

mg

UK/H/0819/002

BE423595


BE

mg

UK/H/0819/002

BE423595


BE

mg

UK/H/0819/002

BE423595


BE

mg

UK/H/0819/002

BE423595


BE

mg

UK/H/0819/002

2013120616


LU

mg

UK/H/0819/002

2013120616


LU

mg

UK/H/0819/002

2013120616


LU

mg

UK/H/0819/002

2013120616


LU

mg

UK/H/0819/002

2013120616


LU

mg

UK/H/0819/003

BE423604


BE

mg

UK/H/0819/003

BE423604


BE

mg

UK/H/0819/003

BE423604


BE


Page 40/68

Product Name (in

MRP/DCP


Authorisation



Member State where

member state


number veränderter Equasym® XR 30 Hartkapseln mit veränderter Equasym® XR 30 Hartkapseln mit veränderter Equasym® XR 30 Hartkapseln mit veränderter Equasym® XR 30 Hartkapseln mit veränderter Equasym® XR 30 Hartkapseln mit veränderter Equasym® XR 40 Hartkapseln mit veränderter Equasym® XR 40 Hartkapseln mit veränderter Equasym® XR 40 Hartkapseln mit veränderter Equasym® XR 50 Hartkapseln mit veränderter Equasym® XR 50 Hartkapseln mit veränderter Equasym® XR 50 Hartkapseln mit veränderter Equasym® XR 50

mg

UK/H/0819/003

BE423604


BE

mg

UK/H/0819/003

2013120617


LU

mg

UK/H/0819/003

2013120617


LU

mg

UK/H/0819/003

2013120617


LU

mg

UK/H/0819/003

2013120617


LU

mg

UK/H/0819/004

BE437595


BE

mg

UK/H/0819/004

BE437595


BE

mg

UK/H/0819/004

2013120618


LU

mg

UK/H/0819/005

BE437604


BE

mg

UK/H/0819/005

BE437604


BE

mg

UK/H/0819/005

2013120619


LU

mg

UK/H/0819/005

2013120619


LU


Page 41/68

Product Name (in

MRP/DCP


Authorisation



Member State where

member state


number Hartkapseln mit veränderter Equasym® XR 60 mg Hartkapseln mit veränderter Equasym® XR 60 mg Hartkapseln mit veränderter Equasym® XR 60 mg Hartkapseln mit veränderter Equasym® XR 60 mg Hartkapseln mit veränderter Medanef 20 mg tabletter Medanef 20 mg tabletter Medanef 5 mg tabletter Medanef 5 mg tabletter Medanef, tabletter Medanef, tabletter Medikinet 10 mg cápsulas de libertação modificada Medikinet 10 mg cápsulas duras de liberación modificada Medikinet 10 mg capsule rigide a rilascio modificato Medikinet 10 mg capsule rigide a rilascio modificato Medikinet 10 mg kapsler med modifisert frisetting, harde


BE437613


BE

UK/H/0819/006

BE437613


BE

UK/H/0819/006

2013120620


LU

UK/H/0819/006

2013120620


LU

UK/H/5833/003 UK/H/5833/003 UK/H/5833/001 UK/H/5833/001 UK/H/5833/001 UK/H/5833/003 DE/H/2223/002

14-10264 51607 14-10262 51605 54633 54635 5361555

MYLAN AB MYLAN AB MYLAN AB MYLAN AB MYLAN AB MYLAN AB MEDICE ARZNEIMITTEL PÜTTER GMBH & CO. KG

NO SE NO SE DK DK PT

DE/H/0690/004

68.542

MEDICE ARZNEIMITTEL PÜTTER GMBH & CO. KG

ES

DE/H/2223/002

041438033


IT

DE/H/2223/002

041438045


IT

DE/H/0690/004

06-4119


NO


Page 42/68

Product Name (in

MRP/DCP


Authorisation



Member State where

member state


number MEDIKINET 10 mg, gélules à libération modifiée Medikinet 10 mg, kapsel med modifierad frisättning, hård Medikinet 20 mg cápsulas de libertação modificada Medikinet 20 mg cápsulas duras de liberación modificada Medikinet 20 mg capsule rigide a rilascio modificato Medikinet 20 mg capsule rigide a rilascio modificato Medikinet 20 mg kapsler med modifisert frisetting, harde MEDIKINET 20 mg, gélules à libération modifiée Medikinet 20 mg, kapsel med modifierad frisättning, hård Medikinet 30 mg cápsulas de libertação modificada Medikinet 30 mg cápsulas duras de liberación modificada Medikinet 30 mg capsule rigide a rilascio

DE/H/2223/002

CIS: 6 300 053 3


FR

DE/H/0690/004

23840


SE

DE/H/2223/003

5361563


PT

DE/H/0690/005

68.543


ES

DE/H/2223/003

041438058


IT

DE/H/2223/003

041438060


IT

DE/H/0690/005

06-4120


NO

DE/H/2223/003

CIS: 6 365 782 8


FR

DE/H/0690/005

23841


SE

DE/H/2223/004

5361571


PT

DE/H/0690/006

68.544


ES

DE/H/2223/004

041438072


IT


Page 43/68

Product Name (in

MRP/DCP


Authorisation



Member State where

member state


number modificato Medikinet 30 mg capsule rigide a rilascio modificato Medikinet 30 mg kapsler med modifisert frisetting, harde MEDIKINET 30 mg, gélules à libération modifiée Medikinet 30 mg, kapsel med modifierad frisättning, hård Medikinet 40 mg cápsulas de libertação modificada Medikinet 40 mg cápsulas duras de liberación modificada Medikinet 40 mg capsule rigide a rilascio modificato Medikinet 40 mg capsule rigide a rilascio modificato Medikinet 40 mg kapsler med modifisert frisetting, harde MEDIKINET 40 mg, gélules à libération modifiée Medikinet 40 mg, kapsel med modifierad frisättning, hård Medikinet 5 mg cápsulas

DE/H/2223/004

041438084


IT

DE/H/0690/006

06-4121


NO

DE/H/2223/004

CIS: 6 659 298 3


FR

DE/H/0690/006

23842


SE

DE/H/2223/005

5361605


PT

DE/H/0690/007

68.545


ES

DE/H/2223/005

041438096


IT

DE/H/2223/005

041438108


IT

DE/H/0690/007

06-4122


NO

DE/H/2223/005

CIS: 6 421 119 1


FR

DE/H/0690/007

23843


SE

DE/H/2223/001

5361605

MEDICE ARZNEIMITTEL

PT


Page 44/68

Product Name (in

MRP/DCP


Authorisation



Member State where

member state


PÜTTER GMBH & CO. KG MEDICE ARZNEIMITTEL PÜTTER GMBH & CO. KG

ES

number de libertação modificada Medikinet 5 mg cápsulas duras de liberación modificada Medikinet 5 mg capsule rigide a rilascio modificato Medikinet 5 mg capsule rigide a rilascio modificato Medikinet 5 mg capsule rigide a rilascio modificato Medikinet 5 mg kapsler med modifisert frisetting, harde MEDIKINET 5 mg, gélules à libération modifiée Medikinet 5 mg, kapsel med modifierad frisättning, hård Medikinet 50 mg cápsulas duras de liberación modificada Medikinet 50 mg kapsler med modifisert frisetting, harde Medikinet 50 mg, kapsel med modifierad frisättning, hård Medikinet 60 mg cápsulas duras de liberación modificada Medikinet 60 mg kapsler

DE/H/0690/008

73.308

DE/H/2223/001/DC

041438019/M; 041438021/M


IT

DE/H/2223/001

041438019


IT

DE/H/2223/001

041438021


IT

DE/H/0690/008

10/7785


NO

DE/H/2223/001

CIS: 6 114 564 0


FR

DE/H/0690/008

44810


SE

DE/H/0690/009

78.453


ES

DE/H/0690/009

12-9267


NO

DE/H/0690/009

48667


SE

DE/H/0690/010

78.454


ES

DE/H/0690/010

12-9268

MEDICE ARZNEIMITTEL

NO


Page 45/68

Product Name (in

MRP/DCP


Authorisation



Member State where

member state


number med modifisert frisetting, harde Medikinet 60 mg, kapsel med modifierad frisättning, hård Medikinet adult 10 mg Hartkapseln, retardiert Medikinet adult 10 mg Hartkapseln, retardiert Medikinet adult 20 mg Hartkapseln, retardiert Medikinet adult 20 mg Hartkapseln, retardiert Medikinet adult 30 mg Hartkapseln, retardiert Medikinet adult 30 mg Hartkapseln, retardiert Medikinet adult 40 mg Hartkapseln, retardiert Medikinet adult 40 mg Hartkapseln, retardiert Medikinet adult 5 mg Hartkapseln, retardiert Medikinet adult 5 mg Hartkapseln, retardiert Medikinet adult 50 mg Hartkapseln, retardiert Medikinet adult 60 mg Hartkapseln, retardiert Medikinet CR 10 mg hörð hylki með breyttan losunarhraða Medikinet CR 10 mg kapsułki o zmodyfikowanym

PÜTTER GMBH & CO. KG DE/H/0690/010

48668


SE

not available

86182.00.00

DE

not available

63890.00.00

not available

86183.00.00

not available

63891.00.00

not available

65964.00.00

not available

86184.00.00

not available

86185.00.00

not available

65965.00.00

not available

66747.00.00

not available

86181.00.00

not available

88862.00.00

not available

88863.00.00

DE/H/0690/004/E/001

IS/1/14/087/005

MEDICE PHARMA GMBH & CO. KG MEDICE PHARMA GMBH & CO. KG MEDICE PHARMA GMBH & CO. KG MEDICE PHARMA GMBH & CO. KG MEDICE PHARMA GMBH & CO. KG MEDICE PHARMA GMBH & CO. KG MEDICE PHARMA GMBH & CO. KG MEDICE PHARMA GMBH & CO. KG MEDICE PHARMA GMBH & CO. KG MEDICE PHARMA GMBH & CO. KG MEDICE PHARMA GMBH & CO. KG MEDICE PHARMA GMBH & CO. KG MEDICE ARZNEIMITTEL PÜTTER GMBH & CO. KG

DE/H/0690/004

12844


PL


DE DE DE DE DE DE DE DE DE DE DE IS

Page 46/68

Product Name (in

MRP/DCP


Authorisation



Member State where

member state


number uwalnianiu, twarde Medikinet CR 10 mg, capsules met gereguleerde afgifte, hard Medikinet CR 20 mg hörð hylki með breyttan losunarhraða Medikinet CR 20 mg kapsułki o zmodyfikowanym uwalnianiu, twarde Medikinet CR 20 mg säädellysti vapauttava kapseli, kova Medikinet CR 20 mg, capsules met gereguleerde afgifte, hard Medikinet CR 30 mg hörð hylki með breyttan losunarhraða Medikinet CR 30 mg kapsułki o zmodyfikowanym uwalnianiu, twarde Medikinet CR 30 mg säädellysti vapauttava kapseli, kova Medikinet CR 30 mg, capsules met gereguleerde afgifte, hard Medikinet CR 40 mg hörð hylki með breyttan

DE/H/0690/004

RVG 34027


NL

DE/H/0690/005/E/001

IS/1/14/087/006


IS

DE/H/0690/005

12845


PL

DE/H/0690/005

22213


FI

DE/H/0690/005

RVG 34028


NL

DE/H/0690/006/E/001

IS/1/14/087/007


IS

DE/H/0690/006

12846


PL

DE/H/0690/006

22214


FI

DE/H/0690/006

RVG 34029


NL

DE/H/0690/007/E/001

IS/1/14/087/008


IS


Page 47/68

Product Name (in

MRP/DCP


Authorisation



Member State where

member state


number losunarhraða Medikinet CR 40 mg kapsułki o zmodyfikowanym uwalnianiu, twarde Medikinet CR 40 mg säädellysti vapauttava kapseli, kova Medikinet CR 40 mg, capsules met gereguleerde afgifte, hard Medikinet CR 5 mg hörð hylki með breyttan losunarhraða Medikinet CR 5 mg kapsułki o zmodyfikowanym uwalnianiu, twarde Medikinet CR 5 mg säädellysti vapauttava kapseli, kova Medikinet CR 5 mg, capsules met gereguleerde afgifte, hard Medikinet CR 50 mg hörð hylki með breyttan losunarhraða Medikinet CR 50 mg säädellysti vapauttava kapseli, kova Medikinet CR 50 mg, 50 mg, kapsułki o zmodyfikowanym

DE/H/0690/007

12847


PL

DE/H/0690/007

22215


FI

DE/H/0690/007

RVG 34030


NL

DE/H/0690/008/E/001

IS/1/14/087/004


IS

DE/H/0690/008

18355


PL

DE/H/0690/008

28970


FI

DE/H/0690/008

RVG 108026


NL

DE/H/0690/009/E/001

IS/1/14/087/009


IS

DE/H/0690/009

31130


FI

DE/H/0690/009

21934


PL


Page 48/68

Product Name (in

MRP/DCP


Authorisation



Member State where

member state


number uwalnianiu, twarde Medikinet CR 50 mg, capsules met gereguleerde afgifte, hard Medikinet CR 60 mg hörð hylki með breyttan losunarhraða Medikinet CR 60 mg säädellysti vapauttava kapseli, kova Medikinet CR 60 mg, 60 mg, kapsułki o zmodyfikowanym uwalnianiu, twarde Medikinet CR 60 mg, capsules met gereguleerde afgifte, hard Medikinet CR, hårde kapsler med modificeret udløsning Medikinet CR, hårde kapsler med modificeret udløsning Medikinet CR, hårde kapsler med modificeret udløsning Medikinet CR, hårde kapsler med modificeret udløsning Medikinet CR, hårde kapsler med modificeret udløsning 5 mg Medikinet CR, hårde

DE/H/0690/009

RVG 112771


NL

DE/H/0690/010/E/001

IS/1/14/087/010


IS

DE/H/0690/010

31131


FI

DE/H/0690/010

21935


PL

DE/H/0690/010

RVG 112772


NL

DE/H/0690/007

39461


DK

DE/H/0690/006

39460


DK

DE/H/0690/004

39458


DK

DE/H/0690/005

39459


DK

DE/H/0690/008

47393


DK

DE/H/0690/009

51662

MEDICE ARZNEIMITTEL

DK


Page 49/68

Product Name (in

MRP/DCP


Authorisation



Member State where

member state


number kapsler med modificeret udløsning 50 mg Medikinet CR, hårde kapsler med modificeret udløsning 60 mg Medikinet CR10 mg säädellysti vapauttava kapseli, kova Medikinet EM 10 mg capsule cu eliberare modificată Medikinet EM 20 mg capsule cu eliberare modificată Medikinet EM 30 mg capsule cu eliberare modificată Medikinet EM 40 mg capsule cu eliberare modificată Medikinet MR 10 mg modified-release capsules, hard Medikinet MR 20 mg modified-release capsules, hard Medikinet MR 30 mg modified-release capsules, hard Medikinet MR 40 mg modified-release capsules, hard Medikinet MR 5 mg modified-release capsules, hard


51662


DK

DE/H/0690/004

22212


FI

DE/H/2223/002/DC

6241/2014/01, 6241/2014/02


RO

DE/H/2223/003/DC

6242/2014/01, 6242/2014/02


RO

DE/H/2223/004/DC

6243/2014/01, 6243/2014/02


RO

DE/H/2223/005/DC

6244/2014/01, 6244/2014/02


RO

DE/H/2223/002

PA 1555/1/2


IE

DE/H/2223/003

PA1555/001/003


IE

DE/H/2223/004

PA1555/001/004


IE

DE/H/2223/005

PA1555/001/005


IE

DE/H/2223/001

PA1555/001/001


IE


Page 50/68

Product Name (in

MRP/DCP


Authorisation



Member State where

member state


number Medikinet retard 10 mg Hartkapseln mit veränderter Wirkstofffreisetzung Medikinet retard 10 mg Hartkapseln mit veränderter Wirkstofffreisetzung Medikinet retard 10 mg Hartkapseln mit veränderter Wirkstofffreisetzung Medikinet retard 10 mg Hartkapseln mit veränderter Wirkstofffreisetzung Medikinet retard 10 mg, Capsules met gereguleerde afgifte, hard Medikinet retard 20 mg Hartkapseln mit veränderter Wirkstofffreisetzung Medikinet retard 20 mg Hartkapseln mit veränderter Wirkstofffreisetzung Medikinet retard 20 mg Hartkapseln mit veränderter Wirkstofffreisetzung Medikinet retard 20 mg Hartkapseln mit veränderter

DE/H/0690/004

1-26725


AT

DE/H/2223/002

75795.00.00


DE

DE/H/0690/004

54569.00.01


DE

DE/H/0690/004

1363/07020042


LU

DE/H/2223/002

BE 381577


BE

DE/H/0690/005

1-26726


AT

DE/H/2223/003

75796.00.00


DE

DE/H/0690/005

54569.01.01


DE

DE/H/0690/005

1363/07020043


LU


Page 51/68

Product Name (in

MRP/DCP


Authorisation



Member State where

member state


number Wirkstofffreisetzung Medikinet retard 20 mg, gélules à libération modifiée Medikinet retard 30 mg Hartkapseln mit veränderter Wirkstofffreisetzung Medikinet retard 30 mg Hartkapseln mit veränderter Wirkstofffreisetzung Medikinet retard 30 mg Hartkapseln mit veränderter Wirkstofffreisetzung Medikinet retard 30 mg Hartkapseln mit veränderter Wirkstofffreisetzung Medikinet retard 30 mg, Capsules met gereguleerde afgifte, hard Medikinet retard 40 mg Hartkapseln mit veränderter Wirkstofffreisetzung Medikinet retard 40 mg Hartkapseln mit veränderter Wirkstofffreisetzung Medikinet retard 40 mg Hartkapseln mit veränderter

DE/H/2223/003

BE 381586


BE

DE/H/0690/006

1-26727


AT

DE/H/2223/004

75797.00.00


DE

DE/H/0690/006

62567.00.00


DE

DE/H/0690/006

1363/07020044


LU

DE/H/2223/004

BE 381595


BE

DE/H/0690/007

1-26728


AT

DE/H/2223/005

75798.00.00


DE

DE/H/0690/007

62568.00.00


DE


Page 52/68

Product Name (in

MRP/DCP


Authorisation



Member State where

member state


number Wirkstofffreisetzung Medikinet retard 40 mg Hartkapseln mit veränderter Wirkstofffreisetzung Medikinet retard 40 mg, Capsules met gereguleerde afgifte, hard Medikinet retard 5 mg Hartkapseln mit veränderter Wirkstofffreisetzung Medikinet retard 5 mg Hartkapseln mit veränderter Wirkstofffreisetzung Medikinet retard 5 mg Hartkapseln mit veränderter Wirkstofffreisetzung Medikinet retard 5 mg Hartkapseln mit veränderter Wirkstofffreisetzung Medikinet retard 5 mg, Capsules met gereguleerde afgifte, hard Medikinet retard 50 mg Hartkapseln mit veränderter Wirkstofffreisetzung Medikinet retard 50 mg Hartkapseln mit

DE/H/0690/007

1363/07020045


LU

DE/H/2223/005

BE381604


BE

DE/H/0690/008

1-30056


AT

DE/H/0690/008

66625.00.00


DE

DE/H/2223/001

75794.00.00


DE

DE/H/0690/008

1754/11030018


LU

DE/H/2223/001

BE 381561


BE

DE/H/0690/009

135358


AT

DE/H/0690/009

88767.00.00


DE


Page 53/68

Product Name (in

MRP/DCP


Authorisation



Member State where

member state


number veränderter Wirkstofffreisetzung Medikinet retard 50 mg Hartkapseln mit veränderter Wirkstofffreisetzung Medikinet retard 50 mg Hartkapseln mit veränderter Wirkstofffreisetzung Medikinet retard 60 mg Hartkapseln mit veränderter Wirkstofffreisetzung Medikinet retard 60 mg Hartkapseln mit veränderter Wirkstofffreisetzung Medikinet retard 60 mg Hartkapseln mit veränderter Wirkstofffreisetzung Medikinet retard 60 mg Hartkapseln mit veränderter Wirkstofffreisetzung Medikinet XL 10 mg ilgstošās darbības cietās kapsulas Medikinet XL 10 mg modified-release capsules, hard Medikinet XL 10 mg modifikuoto atpalaidavimo kietosios

not available

97387.00.00


DE

DE/H/0690/009

2014060146


LU

DE/H/0690/010

135389


AT

not available

97388.00.00


DE

DE/H/0690/010

88768.00.00


DE

DE/H/0690/010

2014060147


LU

DE/H/2223/002

10-0461


LV

DE/H/0690/004

PL 11243/0005


UK

DE/H/2223/002

N28 – LT/1/10/2274/003, N30 – LT/1/10/2274/004


LT


Page 54/68

Product Name (in

MRP/DCP


Authorisation



Member State where

member state


number kapsulės Medikinet XL 20 mg ilgstošās darbības cietās kapsulas Medikinet XL 20 mg modified-release capsules, hard Medikinet XL 20 mg modifikuoto atpalaidavimo kietosios kapsulės Medikinet XL 30 mg ilgstošās darbības cietās kapsulas Medikinet XL 30 mg modified-release capsules, hard Medikinet XL 30 mg modifikuoto atpalaidavimo kietosios kapsulės Medikinet XL 40 mg ilgstošās darbības cietās kapsulas Medikinet XL 40 mg modified-release capsules, hard Medikinet XL 40 mg modifikuoto atpalaidavimo kietosios kapsulės Medikinet XL 5 mg ilgstošās darbības cietās kapsulas Medikinet XL 5 mg

DE/H/2223/003

10-0462


LV

DE/H/0690/005

PL 11243/0006


UK

DE/H/2223/003

N28 – LT/1/10/2274/005, N30 – LT/1/10/2274/006


LT

DE/H/2223/004

10-0463


LV

DE/H/0690/006

PL 11243/0007


UK

DE/H/2223/004

N28 – LT/1/10/2274/007, N30 – LT/1/10/2274/008


LT

DE/H/2223/005

10-0464


LV

DE/H/0690/007

PL 11243/0008


UK

DE/H/2223/005

N28 – LT/1/10/2274/009, N30 – LT/1/10/2274/010


LT

DE/H/2223/001

10-0448


LV

DE/H/0690/008

PL 11243/0010

MEDICE ARZNEIMITTEL

UK


Page 55/68

Product Name (in

MRP/DCP


Authorisation



Member State where

member state


number modified-release capsules, hard Medikinet XL 5 mg modifikuoto atpalaidavimo kietosios kapsulės Medikinet XL 5 mg, toimeainet modifitseeritult vabastavad kõvakapslid Medikinet XL 50 mg modified-release capsules, hard Medikinet XL 60 mg modified-release capsules, hard Medikinet XL10 mg, toimeainet modifitseeritult vabastavad kõvakapslid Medikinet XL20 mg, toimeainet modifitseeritult vabastavad kõvakapslid Medikinet XL30 mg, toimeainet modifitseeritult vabastavad kõvakapslid Medikinet XL40 mg, toimeainet modifitseeritult vabastavad kõvakapslid Methylfenidaat HCl Mylan 5 mg, tabletten Methylphenidat


N28 – LT/1/10/2274/001, N30 – LT/1/10/2274/002


LT

DE/H/2223/001

705610


EE

DE/H/0690/009

PL 11243/0011


UK

DE/H/0690/010

PL 11243/0012


UK

DE/H/2223/002

705110


EE

DE/H/2223/003

705010


EE

DE/H/2223/004

705310


EE

DE/H/2223/005

705710


EE

UK/H/5833/001

RVG 116232

MYLAN B.V.

NL

not available

54924

ALTERNOVA A/S

DK


Page 56/68

Product Name (in

MRP/DCP


Authorisation



Member State where

member state


number "Alternova", tabletter Methylphenidat "Alternova", tabletter Methylphenidate ”Sandoz”, depottabletter 27 mg Methylphenidate Hydrochloride 20 mg Tablets Methylphenidate Hydrochloride 5 mg Tablets Methylphenidate Mylan 20 mg tabletten Methylphenidate Mylan 5 mg tabletten Quasym 10 mg cápsulas de libertação modificada Quasym 10 mg cápsulas de libertação modificada Quasym 10 mg cápsulas de libertação modificada Quasym 10 mg cápsulas de libertação modificada Quasym 10 mg cápsulas de libertação modificada Quasym 20 mg cápsulas de libertação modificada Quasym 20 mg cápsulas de libertação modificada Quasym 20 mg cápsulas de libertação modificada Quasym 20 mg cápsulas de libertação modificada

not available

54926

ALTERNOVA A/S

DK

DK/H/2138/001

49666

SANDOZ A/S

DK

UK/H/5833/003

PL 04569/1498

GENERICS [UK] LIMITED

UK

UK/H/5833/001

PL 04569/1496

GENERICS [UK] LIMITED

UK

UK/H/5833/003

BE489413

MYLAN BVBA/SPRL

BE

UK/H/5833/001

BE489395

MYLAN BVBA/SPRL

BE

UK/H/0819/001

5436563

PT

UK/H/0819/001

5436563

UK/H/0819/001

5436563

UK/H/0819/001

5436563

UK/H/0819/001

5436563

UK/H/0819/002

5436571

UK/H/0819/002

5436571

UK/H/0819/002

5436571

UK/H/0819/002

5436571

SHIRE PHARMACEUTICALS IRELAND LIMITED SHIRE PHARMACEUTICALS IRELAND LIMITED SHIRE PHARMACEUTICALS IRELAND LIMITED SHIRE PHARMACEUTICALS IRELAND LIMITED SHIRE PHARMACEUTICALS IRELAND LIMITED SHIRE PHARMACEUTICALS IRELAND LIMITED SHIRE PHARMACEUTICALS IRELAND LIMITED SHIRE PHARMACEUTICALS IRELAND LIMITED SHIRE PHARMACEUTICALS IRELAND LIMITED


PT PT PT PT PT PT PT PT

Page 57/68

Product Name (in

MRP/DCP


Authorisation



Member State where

member state


SHIRE PHARMACEUTICALS IRELAND LIMITED SHIRE PHARMACEUTICALS IRELAND LIMITED SHIRE PHARMACEUTICALS IRELAND LIMITED SHIRE PHARMACEUTICALS IRELAND LIMITED SHIRE PHARMACEUTICALS IRELAND LIMITED SHIRE PHARMACEUTICALS IRELAND LIMITED SHIRE PHARMACEUTICALS IRELAND LIMITED SHIRE PHARMACEUTICALS IRELAND LIMITED SHIRE PHARMACEUTICALS IRELAND LIMITED SHIRE PHARMACEUTICALS IRELAND LIMITED SHIRE PHARMACEUTICALS IRELAND LIMITED SHIRE PHARMACEUTICALS IRELAND LIMITED SHIRE PHARMACEUTICALS IRELAND LIMITED SHIRE PHARMACEUTICALS IRELAND LIMITED SHIRE PHARMACEUTICALS IRELAND LIMITED

PT


FR

number Quasym 20 mg cápsulas de libertação modificada Quasym 30 mg cápsulas de libertação modificada Quasym 30 mg cápsulas de libertação modificada Quasym 30 mg cápsulas de libertação modificada Quasym 30 mg cápsulas de libertação modificada Quasym 40 mg cápsulas de libertação modificada Quasym 40 mg cápsulas de libertação modificada QUASYM 40 mg, gélule à libération modifiée Quasym 50 mg cápsulas de libertação modificada Quasym 50 mg cápsulas de libertação modificada QUASYM 50 mg, gélule à libération modifiée Quasym 60 mg cápsulas de libertação modificada Quasym 60 mg cápsulas de libertação modificada QUASYM 60 mg, gélule à libération modifiée QUASYM L.P. 10 mg, gélule à libération modifiée QUASYM L.P. 10 mg, gélule à libération modifiée

UK/H/0819/002

5436571

UK/H/0819/003

5436605

UK/H/0819/003

5436605

UK/H/0819/003

5436605

UK/H/0819/003

5436605

UK/H/0819/004

5550462

UK/H/0819/004

5550462

UK/H/0819/004

585 147-0

UK/H/0819/005

5550454

UK/H/0819/005

5550454

UK/H/0819/005

585 149-3

UK/H/0819/006

5550470

UK/H/0819/006

5550470

UK/H/0819/006

585 151-8

UK/H/0819/001

377 617-8

UK/H/0819/001

497 261-6


PT PT PT PT PT PT FR PT PT FR PT PT FR FR

Page 58/68

Product Name (in

MRP/DCP


Authorisation



Member State where

member state


number QUASYM L.P. 10 mg, gélule à libération modifiée QUASYM L.P. 10 mg, gélule à libération modifiée QUASYM L.P. 10 mg, gélule à libération modifiée QUASYM L.P. 20 mg, gélule à libération modifiée QUASYM L.P. 20 mg, gélule à libération modifiée QUASYM L.P. 20 mg, gélule à libération modifiée QUASYM L.P. 20 mg, gélule à libération modifiée QUASYM L.P. 20 mg, gélule à libération modifiée QUASYM L.P. 30 mg, gélule à libération modifiée QUASYM L.P. 30 mg, gélule à libération modifiée QUASYM L.P. 30 mg, gélule à libération modifiée QUASYM L.P. 30 mg, gélule à libération

UK/H/0819/001

377 618-4


FR

UK/H/0819/001

570 268-1


FR

UK/H/0819/001

570 269-8


FR

UK/H/0819/002

377 620-9


FR

UK/H/0819/002

377 619-0


FR

UK/H/0819/002

497 262-2


FR

UK/H/0819/002

378 313-2


FR

UK/H/0819/002

570 271-2


FR

UK/H/0819/003

377 621-5


FR

UK/H/0819/003

497 267-4


FR

UK/H/0819/003

377 622-1


FR

UK/H/0819/003

378 314-9


FR


Page 59/68

Product Name (in

MRP/DCP


Authorisation



Member State where

member state


number modifiée Rilatine 10 mg comprimés RILATINE 10 mg tabletten Rilatine 10 mg Tabletten Rilatine 10 mg Tabletten Rilatine 10 mg, comprimés Rilatine Modified Release 10 mg Hartkapseln mit veränderter Wirkstofffreisetzung Rilatine Modified Release 10 mg Hartkapseln mit veränderter Wirkstofffreisetzung RILATINE Modified Release 10 mg, capsules met gereguleerde afgifte, hard Rilatine Modified Release 10 mg, gélules à libération modifiée Rilatine Modified Release 10 mg, gélules à libération modifiée Rilatine Modified Release 20 mg Hartkapseln mit veränderter Wirkstofffreisetzung Rilatine Modified Release 20 mg Hartkapseln mit veränderter Wirkstofffreisetzung

not available

2002096657

NOVARTIS PHARMA N.V.

LU

not available

BE051597


BE

not available not available not available

BE051597 2002096657 BE051597

NOVARTIS PHARMA N.V. NOVARTIS PHARMA N.V. NOVARTIS PHARMA N.V.

BE LU BE

not available

BE426413


BE

not available

2014060160


LU

not available

BE426413


BE

not available

BE426413


BE

not available

2014060160


LU

not available

BE241534


BE

not available

0010/10/03/0097


LU


Page 60/68

Product Name (in

MRP/DCP


Authorisation



Member State where

member state


number RILATINE Modified Release 20 mg, capsules met gereguleerde afgifte, hard Rilatine Modified Release 20 mg, gélules à libération modifiée Rilatine Modified Release 20 mg, gélules à libération modifiée Rilatine Modified Release 30 mg Hartkapseln mit veränderter Wirkstofffreisetzung Rilatine Modified Release 30 mg Hartkapseln mit veränderter Wirkstofffreisetzung RILATINE Modified Release 30 mg, capsules met gereguleerde afgifte, hard Rilatine Modified Release 30 mg, gélules à libération modifiée Rilatine Modified Release 30 mg, gélules à libération modifiée Rilatine Modified Release 40 mg Hartkapseln mit veränderter Wirkstofffreisetzung Rilatine Modified Release 40 mg Hartkapseln mit veränderter

not available

BE241534


BE

not available

BE241534


BE

not available

0010/10/03/0097


LU

not available

BE241543


BE

not available

0010/10/03/0098


LU

not available

BE241543


BE

not available

BE241543


BE

not available

0010/10/03/0098


LU

not available

BE241552


BE

not available

0010/10/08/0034


LU


Page 61/68

Product Name (in

MRP/DCP


Authorisation



Member State where

member state


number WirkstofffreisetzungMeth ylphenidat RILATINE Modified Release 40 mg, capsules met gereguleerde afgifte, hard Rilatine Modified Release 40 mg, gélules à libération modifiée Rilatine Modified Release 40 mg, gélules à libération modifiée Ritalin Ritalin 10 mg - Tabletten RITALIN 10 mg compresse Ritalin 10 mg hårda kapslar med modifierad frisättning Ritalin 10 mg kapsler med modifisert frisetting, harde Ritalin 10 mg tabletta

not available

BE241552


BE

not available

BE241552


BE

not available

0010/10/08/0034


LU

not available not available Not Applicable

01870 1-22028 035040017

NOVARTIS HEALTHCARE A/S NOVARTIS PHARMA GMBH Novartis Farma S.p.A.

DK AT IT

not available

41556

NOVARTIS SVERIGE AB

SE

not available

09-6501

NOVARTIS NORGE AS

NO

not available

OGYI-T-6954/01

HU

Ritalin 10 mg tabletter Ritalin 10 mg tabletter Ritalin 10 mg tablety Ritalin 10 mg töflur RITALIN 10MG TABLETS

not not not not not

3449 20606 06/1179/97-C 640044 PA 13/66/1

Ritalin 20 mg hårda kapslar med modifierad frisättning

not available

NOVARTIS HUNGÁRIA KFT. PHARMA NOVARTIS NORGE AS NOVARTIS SVERIGE AB NOVARTIS, S.R.O. NOVARTIS HEALTHCARE A/S NOVARTIS PHARMACEUTICALS UK LIMITED NOVARTIS SVERIGE AB

available available available available available


20607

NO SE CZ IS IE SE

Page 62/68

Product Name (in

MRP/DCP


Authorisation



Member State where

member state


number Ritalin 20 mg kapsler med modifisert frisetting, harde Ritalin 30 mg hårda kapslar med modifierad frisättning Ritalin 30 mg kapsler med modifisert frisetting, harde Ritalin 40 mg hårda kapslar med modifierad frisättning Ritalin 40 mg kapsler med modifisert frisetting, harde Ritalin 60 mg hårda kapslar med modifierad frisättning Ritalin 60 mg kapsel med modifiert frisetting, hard Ritalin LA 10 mg Kapseln Ritalin LA 10 mg, harde capsules met gereguleerde afgifte Ritalin LA 20 mg Kapseln Ritalin LA 20 mg módosított hatóanyagleadású kemény kapszula Ritalin LA 20 mg, harde capsules met gereguleerde afgifte Ritalin LA 30 mg -

not available

04-2876

NOVARTIS NORGE AS

NO

not available

20608

NOVARTIS SVERIGE AB

SE

not available

05-3197

NOVARTIS NORGE AS

NO

not available

20609

NOVARTIS SVERIGE AB

SE

not available

05-3198

NOVARTIS NORGE AS

NO

not available

50408

NOVARTIS SVERIGE AB

SE

not available

13-9867

NOVARTIS NORGE AS

NO

not available

1-31212

NOVARTIS PHARMA GMBH

AT

not available

RVG 116377

NOVARTIS PHARMA B.V.

NL

not available

1-24270


AT

not available

OGYI-T-6954/02

NOVARTIS HUNGÁRIA KFT. PHARMA

HU

not available

RVG 116379


NL

not available

1-24271


AT


Page 63/68

Product Name (in

MRP/DCP


Authorisation



Member State where

member state


number Kapseln Ritalin LA 30 mg módosított hatóanyagleadású kemény kapszula Ritalin LA 30 mg, harde capsules met gereguleerde afgifte Ritalin LA 40 mg Kapseln Ritalin LA 40 mg módosított hatóanyagleadású kemény kapszula Ritalin LA 40 mg, harde capsules met gereguleerde afgifte Ritalin LA 60 mg módosított hatóanyagleadású kemény kapszula Ritalin LA 60 mg, harde capsules met gereguleerde afgifte Ritalin Uno Ritalin Uno Ritalin Uno Ritalin Uno Ritalin Uno Ritalin Uno 10 mg hylki með breyttan losunarhraða, hart Ritalin Uno 20 mg hylki með breyttan losunarhraða, hart

not available

OGYI-T-6954/03


HU

not available

RVG 116380


NL

not available

1-24272


AT

not available

OGYI-T-6954/04


HU

not available

RVG 116381


NL

not available

OGYI-T-6954/05


HU

not available

RVG 116382


NL

not not not not not not

available available available available available available

34357 34355 53335 34356 44662 IS/1/10/133/01

NOVARTIS NOVARTIS NOVARTIS NOVARTIS NOVARTIS NOVARTIS

not available

IS/1/02/127/01

NOVARTIS HEALTHCARE A/S


HEALTHCARE HEALTHCARE HEALTHCARE HEALTHCARE HEALTHCARE HEALTHCARE

A/S A/S A/S A/S A/S A/S

DK DK DK DK DK IS IS

Page 64/68

Product Name (in

MRP/DCP


Authorisation



Member State where

member state


number Ritalin Uno 30 mg hylki með breyttan losunarhraða, hart Ritalin Uno 40 mg hylki með breyttan losunarhraða, hart Ritalin Uno 60 mg hylki með breyttan losunarhraða, hart Ritalin, tabletten 10 mg Ritalin®

not available

IS/1/02/127/02


IS

not available

IS/1/02/127/03


IS

not available

IS/1/15/020/01


IS

not available not available

RVG 03957 PL 00101/0539

NL UK

RITALIN® 10 MG TABLETES RITALIN® 10 mg Tablets

not available

00-0118

NOVARTIS PHARMA B.V. NOVARTIS PHARMACEUTICALS UK LIMITED NOVARTIS FINLAND OY

not available

088/03101

MT

Ritalin® 10 mg Tabletten Ritalin® Adult 10 mg Hartkapseln mit veränderter Wirkstofffreisetzung Ritalin® Adult 20 mg Hartkapseln mit veränderter Wirkstofffreisetzung Ritalin® Adult 30 mg Hartkapseln mit veränderter Wirkstofffreisetzung Ritalin® Adult 40 mg Hartkapseln mit veränderter Wirkstofffreisetzung

not available not available

6094573.00.00 77240.00.00

NOVARTIS PHARMACEUTICALS UK LIMITED NOVARTIS PHARMA GMBH NOVARTIS PHARMA GMBH

not available

67252.00.00


DE

not available

67253.00.00


DE

not available

67254.00.00


DE


LV

DE DE

Page 65/68

Product Name (in

MRP/DCP


Authorisation



Member State where

member state


number Ritalin® Adult 60 mg Hartkapseln mit veränderter Wirkstofffreisetzung Ritalin® LA 10 mg Hartkapseln mit veränderter Wirkstofffreisetzung Ritalin® LA 20 mg Hartkapseln mit veränderter Wirkstofffreisetzung Ritalin® LA 30 mg Hartkapseln mit veränderter Wirkstofffreisetzung Ritalin® LA 40 mg Hartkapseln mit veränderter Wirkstofffreisetzung Ritalin® LA 60 mg Hartkapseln mit veränderter Wirkstofffreisetzung RITALIN®LA 20MG, PROLONGED-RELEASE CAPSULES RITALIN®LA 30MG, PROLONGED-RELEASE CAPSULES RITALIN®LA 40MG, PROLONGED-RELEASE CAPSULES Ritalina LA 20 mg cápsulas de libertação

not available

91388.00.00


DE

not available

77239.00.00


DE

not available

67249.00.00


DE

not available

67250.00.00


DE

not available

67251.00.00


DE

not available

91387.00.00


DE

not available

PA 13/66/2

IE

not available

PA 13/66/3

not available

PA 13/66/4

Not Applicable

3761780

NOVARTIS PHARMACEUTICALS UK LIMITED NOVARTIS PHARMACEUTICALS UK LIMITED NOVARTIS PHARMACEUTICALS UK LIMITED Novartis Farma - Produtos Farmaceuticos S.A.


IE IE PT

Page 66/68

Product Name (in

MRP/DCP


Authorisation



Member State where

member state


number modificada Ritalina LA 20 mg cápsulas de libertação modificada Ritalina LA 30 mg cápsulas de libertação modificada Ritalina LA 30 mg cápsulas de libertação modificada Ritalina LA 30 mg cápsulas de libertação modificada Ritalina LA 40 mg cápsulas de libertação modificada Ritalina LA 60 mg cápsulas de libertação modificada Ritalina LA 60 mg cápsulas de libertação modificada RITALINE 10 mg comprimé RITALINE 10 mg comprimé RITALINE 10 mg comprimé RITALINE L.P. 10 mg, gélule à libération prolongée RITALINE L.P. 10 mg, gélule à libération prolongée RITALINE L.P. 10 mg,

Not Applicable

3761889

Novartis Farma - Produtos Farmaceuticos S.A.

PT

Not Applicable

3761988


PT

Not Applicable

3762085


PT

Not Applicable

3762084


PT

Not Applicable

3762283


PT

Not Applicable

5635115


PT

Not Applicable

5635123


PT

not available

3400933929404

NOVARTIS PHARMA S.A.S.

FR

not available

3400933942410


FR

not available

3400933942649


FR

not available

3400941686764


FR

not available

3400957974572


FR

not available

3400941686535


FR


Page 67/68

Product Name (in

MRP/DCP


Authorisation



Member State where

member state


number gélule à libération prolongée RITALINE L.P. 20 mg gélule à libération prolongée RITALINE L.P. 20 mg gélule à libération prolongée RITALINE L.P. 20 mg gélule à libération prolongée RITALINE L.P. 30 mg, gélule à libération prolongée RITALINE L.P. 30 mg, gélule à libération prolongée RITALINE L.P. 30 mg, gélule à libération prolongée RITALINE L.P. 40 mg, gélule à libération prolongée RITALINE L.P. 40 mg, gélule à libération prolongée RITALINE L.P. 40 mg, gélule à libération prolongée

not available

3400936231382


FR

not available

3400956496914


FR

not available

3400936534933


FR

not available

3400936535015


FR

not available

3400936231504


FR

not available

3400956497164


FR

not available

3400956497225


FR

not available

3400936535183


FR

not available

3400936231733


FR


Page 68/68