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List of nationally authorised medicinal products - PSUSA/00000294 ...
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List of nationally authorised medicinal products - PSUSA/00000294 ...
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Jun 21, 2017 - Send a question via our website www.ema.europa.eu/contact. © European ... Product Name (in authorisation
21 June 2017 EMA/PRAC/343350/2017
Human Medicines Evaluation Division
List of nationally authorised medicinal products
Active substance(s): baclofen (oral)
Procedure No.: PSUSA/00000294/201609
30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom Telephone +44 (0)20 3660 6000 Facsimile +44 (0)20 3660 5555 Send a question via our website www.ema.europa.eu/contact
An agency of the European Union
© European Medicines Agency, 2017. Reproduction is authorised provided the source is acknowledged.
Product Name (in authorisation
MRP/DCP
National Authorisation
MAH of product in the
Member State where
country)
Authorisation number
Number
member state
product is authorised
Lioresal 10 mg Tabletten Lioresal 25 mg Tabletten LIORESAL 25 MG COMPRIMATE LIORESAL 10 MG COMPRIMATE Lioresal 10 mg tablete Lioresal 25 mg tablete Lioresal 10 mg Tabletten Lioresal 25 mg Tabletten Lioresal® Liquid
not not not not not not not not not
BE051021 BE051012 6381/2014/01 6380/2014/01 UP/I-530-09/11-02/617 UP/I-530-09/11-02/618 0010/93/05/2445 0010/93/05/2446 PL 00101/0503
BE BE RO RO HR HR LU LU UK
LIORESAL 10 mg compresse Lioresal 10 mg comprimidos
not available not available
022999015 9319822
Lioresal 10 mg comprimidos
not available
9319830
LIORESAL 25 mg compresse Lioresal 25 mg comprimidos
not available not available
022999027 9319855
LIORESAL 10 mg comprimidos Lioresal 10 mg tabletter Lioresal 10 mg tabletti LIORESAL 25 mg comprimidos Lioresal 25 mg tabletter Lioresal 25 mg tabletti Lioresal Lioresal Lioresal LIORESAL® 10, 10 MG TABLETTEN Lioresal 10 mg tabletta
not not not not not not not not not not not
available available available available available available available available available available available
52180 6384 6384 52.181 6385 6385 06074 10006 13151 6078226.01.00 OGYI-T-842/01
Lioresal 10, tabletten 10 mg Lioresal® 25, 25 mg Tabletten Lioresal 25 mg tabletta
not available not available not available
RVG 06347 6078226.02.00 OGYI-T-842/02
NOVARTIS PHARMA N.V. NOVARTIS PHARMA N.V. NOVARTIS PHARMA GMBH NOVARTIS PHARMA GMBH NOVARTIS HRVATSKA D.O.O. NOVARTIS HRVATSKA D.O.O. NOVARTIS PHARMA N.V. NOVARTIS PHARMA N.V. NOVARTIS PHARMACEUTICALS UK LIMITED NOVARTIS FARMA S.P.A. NOVARTIS FARMA - PRODUTOS FARMACÊUTICOS S.A. NOVARTIS FARMA - PRODUTOS FARMACÊUTICOS S.A. NOVARTIS FARMA S.P.A. NOVARTIS FARMA - PRODUTOS FARMACÊUTICOS S.A. NOVARTIS FARMACÉUTICA S.A. NOVARTIS FINLAND OY NOVARTIS FINLAND OY NOVARTIS FARMACÉUTICA S.A. NOVARTIS FINLAND OY NOVARTIS FINLAND OY NOVARTIS HEALTHCARE A/S NOVARTIS HEALTHCARE A/S NOVARTIS HEALTHCARE A/S NOVARTIS PHARMA GMBH NOVARTIS HUNGÁRIA KFT. PHARMA NOVARTIS PHARMA B.V. NOVARTIS PHARMA GMBH NOVARTIS HUNGÁRIA KFT. PHARMA
EMA/PRAC/343350/2017
available available available available available available available available available
IT PT PT IT PT ES FI FI ES FI FI DK DK DK DE HU NL DE HU
Page 2/3
Product Name (in authorisation
MRP/DCP
National Authorisation
MAH of product in the
Member State where
country)
Authorisation number
Number
member state
product is authorised
Lioresal 25, tabletten 25 mg Lioresal® 5, 5 mg Tabletten Lioresal 5, tabletten 5 mg Lioresal® Tablets 10mg
not not not not
available available available available
RVG 06348 6078226.00.00 RVG 09086 PL 00101/0504
NL DE NL UK
Lioresal 10 mg - Tabletten Lioresal 10 mg comprimés LIORESAL 10 MG COMPRIMÉS Lioresal 10 mg tabletten Lioresal 10 mg tabletter LIORESAL 10 mg, comprimé sécable Lioresal 25 mg - Tabletten Lioresal 25 mg comprimés Lioresal 25 mg comprimés Lioresal 25 mg tabletten Lioresal 25 mg tabletter LIORESAL 10 MG TABLETS
not not not not not not not not not not not not
available available available available available available available available available available available available
14892 BE051021 0010/93/05/2445 BE051021 8869 3400931716181 14893 BE051012 0010/93/05/2446 BE051012 08870-0 PA 13/58/1
Lioresal 5mg/5ml Oral Solution
not available
PA 13/58/2
Lioresal 25 mg töflur Lioresal 10 mg tabletter Lioresal 25 mg tabletter
not available not available not available
772127 5725 5726
NOVARTIS PHARMA B.V. NOVARTIS PHARMA GMBH NOVARTIS PHARMA B.V. NOVARTIS PHARMACEUTICALS UK LIMITED NOVARTIS PHARMA GMBH NOVARTIS PHARMA N.V. NOVARTIS PHARMA N.V. NOVARTIS PHARMA N.V. NOVARTIS SVERIGE AB NOVARTIS PHARMA S.A.S. NOVARTIS PHARMA GMBH NOVARTIS PHARMA N.V. NOVARTIS PHARMA N.V. NOVARTIS PHARMA N.V. NOVARTIS SVERIGE AB NOVARTIS PHARMACEUTICALS UK LIMITED NOVARTIS PHARMACEUTICALS UK LIMITED NOVARTIS HEALTHCARE A/S NOVARTIS NORGE AS NOVARTIS NORGE AS
BACLOFEN-POLPHARMA 10 mg tablety
not available
63/102/81-A/C
CZ
Baclofen 5mg/5ml Oral Solution
not available
PL 20416/0193
ZAKLADY FARMACEUTYCZNE "POLPHARMA" SPOLKA AKCYJNA CRESCENT PHARMA LIMITED
EMA/PRAC/343350/2017
AT BE LU BE SE FR AT BE LU BE SE IE IE IS NO NO
UK
Page 3/3
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