Dec 13, 2017 - number. National Authorisation Number. MAH of product in the member state. Member State where product is
13 December 2017 EMA/789577/2017 Human Medicines Evaluation Division
List of nationally authorised medicinal products
Active substance: lanthanum
Procedure no.: PSUSA/00003175/201703
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 authorisation country)
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
Фосренол 750 mg
SE/H/0481/005
20120594
SHIRE PHARMACEUTICAL
BG
перорален прах Фосренол 1000 mg
CONTRACTS LIMITED SE/H/0481/006
20120595
перорален прах Fosrenol 750 mg oral
SE/H/0481/005
MA593/00105
SE/H/0481/006
MA593/00106 52740 / 19-7-2011
SHIRE PHARMACEUTICAL
SE/H/0481/003
52740 / 19-7-2011
SHIRE PHARMACEUTICAL
SE/H/0481/003
52740 / 19-7-2011
SE/H/0481/001
52738 / 19-7-2011
SE/H/0481/004
52741 / 19-7-2011
SE/H/0481/004
52741 / 19-7-2011
SE/H/0481/004
52741 / 19-7-2011
SE/H/0481/002
52739 / 19-7-2011
GR
SHIRE PHARMACEUTICAL
GR
SHIRE PHARMACEUTICAL
GR
SHIRE PHARMACEUTICAL
GR
CONTRACTS LIMITED SHIRE PHARMACEUTICAL
GR
CONTRACTS LIMITED SE/H/0481/002
52739 / 19-7-2011
μασώμενα δισκία Fosrenol 500 mg
SHIRE PHARMACEUTICAL
CONTRACTS LIMITED
μασώμενα δισκία Fosrenol 500 mg
GR
CONTRACTS LIMITED
μασώμενα δισκία Fosrenol 500 mg
SHIRE PHARMACEUTICAL
CONTRACTS LIMITED
μασώμενα δισκία Fosrenol 1000 mg
GR
CONTRACTS LIMITED
μασώμενα δισκία Fosrenol 1000 mg
GR
CONTRACTS LIMITED
μασώμενα δισκία Fosrenol 1000 mg
MT
CONTRACTS LIMITED
μασώμενα δισκία Fosrenol 250 mg
SHIRE PHARMACEUTICAL
SE/H/0481/003
μασώμενα δισκία Fosrenol 750 mg
MT
CONTRACTS LIMITED
μασώμενα δισκία Fosrenol 750 mg
SHIRE PHARMACEUTICAL CONTRACTS LIMITED
powder Fosrenol 750 mg
BG
CONTRACTS LIMITED
powder Fosrenol 1000 mg oral
SHIRE PHARMACEUTICAL
SHIRE PHARMACEUTICAL
GR
CONTRACTS LIMITED SE/H/0481/002
μασώμενα δισκία
List of nationally authorised medicinal products EMA/789577/2017
52739 / 19-7-2011
SHIRE PHARMACEUTICAL
GR
CONTRACTS LIMITED
Page 2/30
Product Name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
Fosrenol 250 mg
SE/H/0481/001
0403469
SHIRE PHARMACEUTICAL
LU
Kautabletten Fosrenol 500 mg
CONTRACTS LIMITED SE/H/0481/002
0403505
Kautabletten Fosrenol 500 mg
SE/H/0481/002
0403519
SE/H/0481/002
0403522 0403567
SHIRE PHARMACEUTICAL
SE/H/0481/003
0403584
SHIRE PHARMACEUTICAL
SE/H/0481/003
0403603
SE/H/0481/004
0403621
SE/H/0481/004
0403634
SE/H/0481/004
0403655
SE/H/0481/005
2012100115
SE/H/0481/006
2012100116
LU
SHIRE PHARMACEUTICAL
LU
SHIRE PHARMACEUTICAL
LU
SHIRE PHARMACEUTICAL
LU
CONTRACTS LIMITED SHIRE PHARMACEUTICAL
LU
CONTRACTS LIMITED SE/H/0481/001
20223
tuggtabletter FOSRENOL 500 mg
SHIRE PHARMACEUTICAL
CONTRACTS LIMITED
zum Einnehmen Fosrenol 250 mg
LU
CONTRACTS LIMITED
zum Einnehmen Fosrenol 1000 mg Pulver
SHIRE PHARMACEUTICAL
CONTRACTS LIMITED
Kautabletten Fosrenol 750 mg Pulver
LU
CONTRACTS LIMITED
Kautabletten Fosrenol 1000 mg
LU
CONTRACTS LIMITED
Kautabletten Fosrenol 1000 mg
LU
CONTRACTS LIMITED
Kautabletten Fosrenol 1000 mg
SHIRE PHARMACEUTICAL
SE/H/0481/003
Kautabletten Fosrenol 750 mg
LU
CONTRACTS LIMITED
Kautabletten Fosrenol 750 mg
SHIRE PHARMACEUTICAL CONTRACTS LIMITED
Kautabletten Fosrenol 750 mg
LU
CONTRACTS LIMITED
Kautabletten Fosrenol 500 mg
SHIRE PHARMACEUTICAL
SHIRE PHARMACEUTICAL
FI
CONTRACTS LIMITED SE/H/0481/002
tuggtabletter
List of nationally authorised medicinal products EMA/789577/2017
20224
SHIRE PHARMACEUTICAL
FI
CONTRACTS LIMITED
Page 3/30
Product Name (in authorisation country) FOSRENOL 500 mg
MRP/DCP Authorisation number SE/H/0481/002
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
20224
SHIRE PHARMACEUTICAL
FI
tuggtabletter FOSRENOL 500 mg
CONTRACTS LIMITED SE/H/0481/002
20224
tuggtabletter Fosrenol 750 mg
SE/H/0481/003
20225
SE/H/0481/003
20225
SE/H/0481/003
20225
SE/H/0481/004
20226
SE/H/0481/004
20226
SE/H/0481/004
20226
SE/H/481/005
29668
SE/H/0481/006
29669
SE/H/0481/001
BE279754
SE/H/0481/002
BE279763
FI
SHIRE PHARMACEUTICAL
FI
SHIRE PHARMACEUTICAL
FI
SHIRE PHARMACEUTICAL
FI
SHIRE PHARMACEUTICAL
BE
SHIRE PHARMACEUTICAL
BE
CONTRACTS LIMITED SE/H/0481/002
BE279763
Kautabletten FOSRENOL 500 mg
SHIRE PHARMACEUTICAL
CONTRACTS LIMITED
Kautabletten FOSRENOL 500 mg
FI
CONTRACTS LIMITED
Kautabletten FOSRENOL 500 mg
SHIRE PHARMACEUTICAL
CONTRACTS LIMITED
oralt pulver FOSRENOL 250 mg
FI
CONTRACTS LIMITED
pulver FOSRENOL 1 000 mg
SHIRE PHARMACEUTICAL
CONTRACTS LIMITED
tuggtabletter FOSRENOL 750 mg oralt
FI
CONTRACTS LIMITED
tuggtabletter FOSRENOL 1 000 mg
SHIRE PHARMACEUTICAL
CONTRACTS LIMITED
tuggtabletter FOSRENOL 1 000 mg
FI
CONTRACTS LIMITED
tuggtabletter FOSRENOL 1 000 mg
SHIRE PHARMACEUTICAL CONTRACTS LIMITED
tuggtabletter Fosrenol 750 mg
FI
CONTRACTS LIMITED
tuggtabletter Fosrenol 750 mg
SHIRE PHARMACEUTICAL
SHIRE PHARMACEUTICAL
BE
CONTRACTS LIMITED SE/H/0481/002
Kautabletten
List of nationally authorised medicinal products EMA/789577/2017
BE279763
SHIRE PHARMACEUTICAL
BE
CONTRACTS LIMITED
Page 4/30
Product Name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
FOSRENOL 750 mg
SE/H/0481/003
BE279772
SHIRE PHARMACEUTICAL
BE
Kautabletten FOSRENOL 750 mg
CONTRACTS LIMITED SE/H/0481/003
BE279772
Kautabletten FOSRENOL 750 mg
SE/H/0481/003
BE279772
SE/H/0481/004
BE279781 BE279781
SHIRE PHARMACEUTICAL
SE/H/0481/004
BE279781
SHIRE PHARMACEUTICAL
SE/H/0481/004
MA593/00104
SE/H/0481/003
523406
SE/H/0481/001
1-25966
SE/H/0481/004
MA593/00104
SE/H/0481/001
RVG 31927
SE/H/0481/002
34009 369 273 1 5
EE
SHIRE PHARMACEUTICAL
AT
SHIRE PHARMACEUTICAL
MT
SHIRE PHARMACEUTICAL
NL
CONTRACTS LIMITED SHIRE PHARMACEUTICAL
FR
CONTRACTS LIMITED SE/H/0481/004
MA593/00104
chewable tablets Fosrenol 500 mg,
SHIRE PHARMACEUTICAL
CONTRACTS LIMITED
comprimé à croquer Fosrenol 1000 mg
MT
CONTRACTS LIMITED
kauwtabletten FOSRENOL 500 mg,
SHIRE PHARMACEUTICAL
CONTRACTS LIMITED
chewable tablets Fosrenol 250 mg,
BE
CONTRACTS LIMITED
Kautabletten Fosrenol 1000 mg
BE
CONTRACTS LIMITED
närimistabletid Fosrenol 250 mg
BE
CONTRACTS LIMITED
chewable tablets Fosrenol, 750 mg
SHIRE PHARMACEUTICAL
SE/H/0481/004
Kautabletten Fosrenol 1000 mg
BE
CONTRACTS LIMITED
Kautabletten FOSRENOL 1000 mg
SHIRE PHARMACEUTICAL CONTRACTS LIMITED
Kautabletten FOSRENOL 1000 mg
BE
CONTRACTS LIMITED
Kautabletten FOSRENOL 1000 mg
SHIRE PHARMACEUTICAL
SHIRE PHARMACEUTICAL
MT
CONTRACTS LIMITED SE/H/0481/002
kauwtabletten
List of nationally authorised medicinal products EMA/789577/2017
RVG 31928
SHIRE PHARMACEUTICAL
NL
CONTRACTS LIMITED
Page 5/30
Product Name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
FOSRENOL 500 mg,
SE/H/0481/002
34009 369 274 8 3
SHIRE PHARMACEUTICAL
FR
comprimé à croquer FOSRENOL 500 mg,
CONTRACTS LIMITED SE/H/0481/002
34009 369 275 4 4
comprimé à croquer Fosrenol 500 mg,
SE/H/0481/002
RVG 31928
SE/H/0481/002
RVG 31928
SE/H/0481/002
SHIRE PHARMACEUTICAL
523406
SHIRE PHARMACEUTICAL
SE/H/0481/002
12144
SE/H/0481/003
523406
SE/H/0481/003
RVG 31929
SE/H/0481/002
20080280
SE/H/0481/003
34009 369 278 3 4
SE/H/0481/003
RVG 31929
EE
SHIRE PHARMACEUTICAL
NL
SHIRE PHARMACEUTICAL
BG
SHIRE PHARMACEUTICAL
FR
CONTRACTS LIMITED SHIRE PHARMACEUTICAL
NL
CONTRACTS LIMITED SE/H/0481/002
20080280
таблетки за дъвчене FOSRENOL 750 mg,
SHIRE PHARMACEUTICAL
CONTRACTS LIMITED
kauwtabletten Фосренол 500 mg
PL
CONTRACTS LIMITED
comprimé à croquer Fosrenol 750 mg,
SHIRE PHARMACEUTICAL
CONTRACTS LIMITED
таблетки за дъвчене FOSRENOL 750 mg,
EE
CONTRACTS LIMITED
kauwtabletten Фосренол 500 mg
PL
CONTRACTS LIMITED
närimistabletid Fosrenol 750 mg,
NL
CONTRACTS LIMITED SE/H/0481/003
do rozgryzania i zucia Fosrenol, 750 mg
SHIRE PHARMACEUTICAL
12144
närimistabletid Fosrenol 500 mg tabletki
NL
CONTRACTS LIMITED
do rozgryzania i zucia Fosrenol, 750 mg
SHIRE PHARMACEUTICAL CONTRACTS LIMITED
kauwtabletten Fosrenol 500 mg tabletki
FR
CONTRACTS LIMITED
kauwtabletten Fosrenol 500 mg,
SHIRE PHARMACEUTICAL
SHIRE PHARMACEUTICAL
BG
CONTRACTS LIMITED SE/H/0481/003
comprimé à croquer
List of nationally authorised medicinal products EMA/789577/2017
34009 369 281 4 5
SHIRE PHARMACEUTICAL
FR
CONTRACTS LIMITED
Page 6/30
Product Name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
Фосренол 500 mg
SE/H/0481/002
20080280
SHIRE PHARMACEUTICAL
BG
таблетки за дъвчене Fosrenol 500 mg tabletki
CONTRACTS LIMITED SE/H/0481/002
12144
do rozgryzania i zucia FOSRENOL 750 mg,
SE/H/0481/003
34009 369 283 7 4
SE/H/0481/003
RVG 31929
FR
SHIRE PHARMACEUTICAL
NL
CONTRACTS LIMITED SE/H/0481/003
12146
SHIRE PHARMACEUTICAL
SE/H/0481/001
65606.00.00
SHIRE PHARMACEUTICAL
do rozgryzania i zucia Fosrenol 250 mg, 500
SHIRE PHARMACEUTICAL CONTRACTS LIMITED
kauwtabletten Fosrenol 750 mg tabletki
PL
CONTRACTS LIMITED
comprimé à croquer Fosrenol 750 mg,
SHIRE PHARMACEUTICAL
PL
CONTRACTS LIMITED
mg, 750 mg, 1000 mg
DE
CONTRACTS LIMITED
Kautabletten FOSRENOL 1000 mg,
SE/H/0481/004
34009 369 286 6 4
SE/H/0481/004
RVG 31930
SE/H/0481/003
20080281
comprimé à croquer Fosrenol 1000 mg,
SE/H/0481/003
12146
SE/H/0481/004
34009 369 287 2 5
BG
SHIRE PHARMACEUTICAL
PL
SHIRE PHARMACEUTICAL
FR
CONTRACTS LIMITED SE/H/0481/004
RVG 31930
kauwtabletten Фосренол 750 mg
SHIRE PHARMACEUTICAL
CONTRACTS LIMITED
comprimé à croquer Fosrenol 1000 mg,
NL
CONTRACTS LIMITED
do rozgryzania i zucia FOSRENOL 1000 mg,
SHIRE PHARMACEUTICAL CONTRACTS LIMITED
таблетки за дъвчене Fosrenol 750 mg tabletki
FR
CONTRACTS LIMITED
kauwtabletten Фосренол 750 mg
SHIRE PHARMACEUTICAL
SHIRE PHARMACEUTICAL
NL
CONTRACTS LIMITED SE/H/0481/003
таблетки за дъвчене
List of nationally authorised medicinal products EMA/789577/2017
20080281
SHIRE PHARMACEUTICAL
BG
CONTRACTS LIMITED
Page 7/30
Product Name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
Fosrenol 500 mg
SE/H/0481/002
65607.00.00
SHIRE PHARMACEUTICAL
DE
Kautabletten FOSRENOL 1000 mg,
CONTRACTS LIMITED SE/H/0481/004
34009 369 290 3 6
comprimé à croquer Fosrenol 1000 mg,
SE/H/0481/004
RVG 31930
SE/H/0481/003
20080281
SHIRE PHARMACEUTICAL
SE/H/0481/002
65607.00.00
SHIRE PHARMACEUTICAL
SE/H/0481/003
12146
SHIRE PHARMACEUTICAL
BG DE
CONTRACTS LIMITED
do rozgryzania i zucia Fosrenol 1000 mg
NL
CONTRACTS LIMITED
Kautabletten Fosrenol 750 mg tabletki
SHIRE PHARMACEUTICAL CONTRACTS LIMITED
таблетки за дъвчене Fosrenol 500 mg
FR
CONTRACTS LIMITED
kauwtabletten Фосренол 750 mg
SHIRE PHARMACEUTICAL
PL
CONTRACTS LIMITED SE/H/0481/004
12152
tabletki do rozgryzania i
SHIRE PHARMACEUTICAL
PL
CONTRACTS LIMITED
zucia Foznol 750 mg oral
SE/H/0481/005
PA 689/003/005
SE/H/0481/004
20080282
powder Фосренол 1000 mg
IE
CONTRACTS LIMITED
таблетки за дъвчене Fosrenol 1000 mg
SHIRE PHARMACEUTICAL SHIRE PHARMACEUTICAL
BG
CONTRACTS LIMITED SE/H/0481/004
12152
tabletki do rozgryzania i
SHIRE PHARMACEUTICAL
PL
CONTRACTS LIMITED
zucia Fosrenol 500 mg
SE/H/0481/002
65607.00.00
SE/H/0481/006
PA 689/003/006
Kautabletten Foznol 1000 mg oral
DE
CONTRACTS LIMITED
powder Фосренол 1000 mg
SHIRE PHARMACEUTICAL SHIRE PHARMACEUTICAL
IE
CONTRACTS LIMITED SE/H/0481/004
таблетки за дъвчене
List of nationally authorised medicinal products EMA/789577/2017
20080282
SHIRE PHARMACEUTICAL
BG
CONTRACTS LIMITED
Page 8/30
Product Name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
Fosrenol 250 mg
SE/H/0481/001
20045
SHIRE PHARMACEUTICAL
CY
μασώμενα δισκία Фосренол 1000 mg
CONTRACTS LIMITED SE/H/0481/004
20080282
таблетки за дъвчене Fosrenol 750 mg
BG
CONTRACTS LIMITED SE/H/0481/003
65608.00.00
Kautabletten Fosrenol 1000 mg
SHIRE PHARMACEUTICAL SHIRE PHARMACEUTICAL
DE
CONTRACTS LIMITED SE/H/0481/004
12152
tabletki do rozgryzania i
SHIRE PHARMACEUTICAL
PL
CONTRACTS LIMITED
zucia Fosrenol 500 mg
SE/H/0481/002
20046
μασώμενα δισκία Fosrenol 750 mg
SE/H/0481/003
65608.00.00
SE/H/0481/002
20046
SE/H/0481/002
20046
SE/H/0481/006
IS/1/12/031/01
SE/H/0481/003
65608.00.00
SE/H/0481/001
06-4021
CY
SHIRE PHARMACEUTICAL
IS
SHIRE PHARMACEUTICAL
DE
SHIRE PHARMACEUTICAL
NO
CONTRACTS LIMITED SE/H/0481/002
06-4022
tyggetablett Fosrenol 500 mg
SHIRE PHARMACEUTICAL
CONTRACTS LIMITED
tyggetablett Fosrenol 500 mg
CY
CONTRACTS LIMITED
Kautabletten Fosrenol 250 mg
SHIRE PHARMACEUTICAL
CONTRACTS LIMITED
inntöku Fosrenol 750 mg
DE
CONTRACTS LIMITED
μασώμενα δισκία Fosrenol 1000 mg duft til
SHIRE PHARMACEUTICAL CONTRACTS LIMITED
μασώμενα δισκία Fosrenol 500 mg
CY
CONTRACTS LIMITED
Kautabletten Fosrenol 500 mg
SHIRE PHARMACEUTICAL
SHIRE PHARMACEUTICAL
NO
CONTRACTS LIMITED SE/H/0481/002
tyggetablett
List of nationally authorised medicinal products EMA/789577/2017
06-4022
SHIRE PHARMACEUTICAL
NO
CONTRACTS LIMITED
Page 9/30
Product Name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
Fosrenol 500 mg
SE/H/0481/002
06-4022
SHIRE PHARMACEUTICAL
NO
tyggetablett Fosrenol 750 mg duft til
CONTRACTS LIMITED SE/H/481/005
IS/1/12/031/01
inntöku Fosrenol 750 mg pulver
SHIRE PHARMACEUTICAL
IS
CONTRACTS LIMITED SE/H/0481/005
11-8238
SHIRE PHARMACEUTICAL
NO
CONTRACTS LIMITED Fosrenol 250 mg, 500
SE/H/0481/004
65609.00.00
mg, 750 mg, 1000 mg
SHIRE PHARMACEUTICAL
DE
CONTRACTS LIMITED
Kautabletten Fosrenol, 250 mg
SE/H/0481/001
523306
närimistabletid Fosrenol 1000 mg pulver
SHIRE PHARMACEUTICAL
EE
CONTRACTS LIMITED SE/H/0481/006
11-8239
SHIRE PHARMACEUTICAL
NO
CONTRACTS LIMITED Fosrenol 250 mg, 500
SE/H/0481/004
65609.00.00
mg, 750 mg, 1000 mg
SHIRE PHARMACEUTICAL
DE
CONTRACTS LIMITED
Kautabletten Fosrenol 750 mg
SE/H/0481/003
20047
μασώμενα δισκία Fosrenol 750 mg
SE/H/0481/005
87/0175/12-S
SE/H/0481/006
87/0176/12-S
SE/H/0481/003
06-4023
SE/H/0481/002
523606
SHIRE PHARMACEUTICAL
SK
SHIRE PHARMACEUTICAL
NO
CONTRACTS LIMITED
närimistabletid Fosrenol 750 mg
SK
CONTRACTS LIMITED
tyggetablett Fosrenol, 500 mg
SHIRE PHARMACEUTICAL CONTRACTS LIMITED
perorálny prášok Fosrenol 750 mg
CY
CONTRACTS LIMITED
perorálny prášok Fosrenol 1000 mg
SHIRE PHARMACEUTICAL
SHIRE PHARMACEUTICAL
EE
CONTRACTS LIMITED SE/H/0481/003
μασώμενα δισκία
List of nationally authorised medicinal products EMA/789577/2017
20047
SHIRE PHARMACEUTICAL
CY
CONTRACTS LIMITED
Page 10/30
Product Name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
Fosrenol 750 mg oral
SE/H/0481/005
PL 08081/0057
SHIRE PHARMACEUTICAL
UK
powder Fosrenol, 500 mg
CONTRACTS LIMITED SE/H/0481/002
523606
närimistabletid Fosrenol 250 mg, 500
SHIRE PHARMACEUTICAL
EE
CONTRACTS LIMITED SE/H/0481/004
65609.00.00
mg, 750 mg, 1000 mg
SHIRE PHARMACEUTICAL
DE
CONTRACTS LIMITED
Kautabletten Fosrenol, 500 mg
SE/H/0481/002
523606
närimistabletid Fosrenol 750 mg
SE/H/0481/003
20047
SE/H/0481/003
06-4023
SE/H/0481/006
PL 08081/0058
SE/H/0481/002
PL 08081/0042
SE/H/0481/004
20048
SE/H/0481/002
OGYI-T-20336/02
SE/H/0481/003
06-4023
SHIRE PHARMACEUTICAL
UK
SHIRE PHARMACEUTICAL
CY
SHIRE PHARMACEUTICAL
HU
SHIRE PHARMACEUTICAL
NO
CONTRACTS LIMITED SE/H/0481/004
20048
μασώμενα δισκία Fosrenol 500 mg
UK
CONTRACTS LIMITED
tyggetablett Fosrenol 1000 mg
SHIRE PHARMACEUTICAL
CONTRACTS LIMITED
rágótabletta Fosrenol 750 mg
NO
CONTRACTS LIMITED
μασώμενα δισκία Fosrenol 500 mg
SHIRE PHARMACEUTICAL
CONTRACTS LIMITED
chewable tablets Fosrenol 1000 mg
CY
CONTRACTS LIMITED
powder Fosrenol 500 mg
SHIRE PHARMACEUTICAL CONTRACTS LIMITED
tyggetablett Fosrenol 1000 mg oral
EE
CONTRACTS LIMITED
μασώμενα δισκία Fosrenol 750 mg
SHIRE PHARMACEUTICAL
SHIRE PHARMACEUTICAL
CY
CONTRACTS LIMITED SE/H/0481/002
chewable tablets
List of nationally authorised medicinal products EMA/789577/2017
PL 08081/0042
SHIRE PHARMACEUTICAL
UK
CONTRACTS LIMITED
Page 11/30
Product Name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
Fosrenol, 1000 mg
SE/H/0481/004
523506
SHIRE PHARMACEUTICAL
EE
närimistabletid Fosrenol 500 mg
CONTRACTS LIMITED SE/H/0481/002
OGYI-T-20336/02
rágótabletta Fosrenol, 1000 mg
SE/H/0481/004
523506
SE/H/0481/002
PL 08081/0042
SE/H/0481/004
06-4024
SE/H/0481/002
OGYI-T-20336/02
SE/H/0481/004
06-4024
SE/H/0481/004
523506
SE/H/0481/003
PL 08081/0043
SE/H/0481/004
20048
SE/H/0481/004
06-4024
SE/H/0481/003
PL 08081/0043
NO
SHIRE PHARMACEUTICAL
EE
SHIRE PHARMACEUTICAL
UK
SHIRE PHARMACEUTICAL
CY
SHIRE PHARMACEUTICAL
NO
SHIRE PHARMACEUTICAL
UK
CONTRACTS LIMITED SE/H/0481/001
20223
purutabletit Fosrenol 250 mg
SHIRE PHARMACEUTICAL
CONTRACTS LIMITED
chewable tablets Fosrenol 250 mg
HU
CONTRACTS LIMITED
tyggetablett Fosrenol 750 mg
SHIRE PHARMACEUTICAL
CONTRACTS LIMITED
μασώμενα δισκία Fosrenol 1000 mg
NO
CONTRACTS LIMITED
chewable tablets Fosrenol 1000 mg
SHIRE PHARMACEUTICAL
CONTRACTS LIMITED
närimistabletid Fosrenol 750 mg
UK
CONTRACTS LIMITED
tyggetablett Fosrenol, 1000 mg
SHIRE PHARMACEUTICAL
CONTRACTS LIMITED
rágótabletta Fosrenol 1000 mg
EE
CONTRACTS LIMITED
tyggetablett Fosrenol 500 mg
SHIRE PHARMACEUTICAL CONTRACTS LIMITED
chewable tablets Fosrenol 1000 mg
HU
CONTRACTS LIMITED
närimistabletid Fosrenol 500 mg
SHIRE PHARMACEUTICAL
SHIRE PHARMACEUTICAL
FI
CONTRACTS LIMITED SE/H/0481/001
tyggetabletter
List of nationally authorised medicinal products EMA/789577/2017
37413
SHIRE PHARMACEUTICAL
DK
CONTRACTS LIMITED
Page 12/30
Product Name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
Fosrenol 750 mg
SE/H/0481/003
PL 08081/0043
SHIRE PHARMACEUTICAL
UK
chewable tablets Fosrenol 250 mg
CONTRACTS LIMITED SE/H/0481/001
OGYI-T-20336/01
rágótabletta Fosrenol 500 mg
SE/H/0481/002
37414
SE/H/0481/003
OGYI-T-20336/03
DK
SHIRE PHARMACEUTICAL
HU
CONTRACTS LIMITED SE/H/0481/004
PL 08081/0044
SE/H/0481/001
5520481
chewable tablets Fosrenol 250 mg
SHIRE PHARMACEUTICAL CONTRACTS LIMITED
rágótabletta Fosrenol 1000 mg
HU
CONTRACTS LIMITED
tyggetabletter Fosrenol 750 mg
SHIRE PHARMACEUTICAL
SHIRE PHARMACEUTICAL
UK
CONTRACTS LIMITED
Comprimidos para
SHIRE PHARMACEUTICAL
PT
CONTRACTS LIMITED
mastigar Fosrenol 1000 mg
SE/H/0481/004
PL 08081/0044
SE/H/0481/003
OGYI-T-20336/03
SHIRE PHARMACEUTICAL
SE/H/0481/002
37414
SHIRE PHARMACEUTICAL
chewable tablets Fosrenol 750 mg
SE/H/0481/001
IS/1/05/033/01
SE/H/0481/002
37414
IS
SHIRE PHARMACEUTICAL
DK
CONTRACTS LIMITED SE/H/0481/004
PL 0081/0044
chewable tablets Fosrenol 750 mg
SHIRE PHARMACEUTICAL CONTRACTS LIMITED
tyggetabletter Fosrenol 1000 mg
DK
CONTRACTS LIMITED
tuggutöflur Fosrenol 500 mg
HU
CONTRACTS LIMITED
tyggetabletter Fosrenol 250 mg
UK
CONTRACTS LIMITED
rágótabletta Fosrenol 500 mg
SHIRE PHARMACEUTICAL
SHIRE PHARMACEUTICAL
UK
CONTRACTS LIMITED SE/H/0481/003
rágótabletta
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OGYI-T-20336/03
SHIRE PHARMACEUTICAL
HU
CONTRACTS LIMITED
Page 13/30
Product Name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
Fosrenol 500 mg
SE/H/0481/002
5520788
SHIRE PHARMACEUTICAL
PT
Comprimidos para
CONTRACTS LIMITED
mastigar Fosrenol 750 mg
SE/H/0481/003
37415
SE/H/0481/002
5520887
tyggetabletter Fosrenol 500 mg
SHIRE PHARMACEUTICAL
DK
CONTRACTS LIMITED
Comprimidos para
SHIRE PHARMACEUTICAL
PT
CONTRACTS LIMITED
mastigar Fosrenol 500 mg
SE/H/0481/002
IS/1/05/033/02
tuggutöflur Foznol 250 mg
IS
CONTRACTS LIMITED SE/H/0481/001
037097033
SE/H/0481/002
5520986
compresse masticabili Fosrenol 500 mg
SHIRE PHARMACEUTICAL SHIRE PHARMACEUTICAL
IT
CONTRACTS LIMITED
Comprimidos para
SHIRE PHARMACEUTICAL
PT
CONTRACTS LIMITED
mastigar Fosrenol 500 mg
SE/H/0481/002
IS/1/05/033/02
SE/H/0481/002
IS/1/05/033/02
SE/H/0481/003
37415
tuggutöflur Fosrenol 500 mg
SE/H/0481/003
37415
SHIRE PHARMACEUTICAL
DK
SHIRE PHARMACEUTICAL
DK
CONTRACTS LIMITED SE/H/0481/003
IS/1/05/033/03
tuggutöflur Fosrenol 250 mg,
IS
CONTRACTS LIMITED
tyggetabletter Fosrenol 750 mg
SHIRE PHARMACEUTICAL CONTRACTS LIMITED
tyggetabletter Fosrenol 750 mg
IS
CONTRACTS LIMITED
tuggutöflur Fosrenol 750 mg
SHIRE PHARMACEUTICAL
SHIRE PHARMACEUTICAL
IS
CONTRACTS LIMITED SE/H/0481/001
comprimés à croquer
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0403469
SHIRE PHARMACEUTICAL
LU
CONTRACTS LIMITED
Page 14/30
Product Name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
Fosrenol 750 mg
SE/H/0481/003
IS/1/05/033/03
SHIRE PHARMACEUTICAL
IS
tuggutöflur Fosrenol 1000mg
CONTRACTS LIMITED SE/H/0481/004
37416
tyggetabletter FOSRENOL 250 mg,
DK
CONTRACTS LIMITED SE/H/0481/001
34009 369 270 2 5
comprimé à croquer Fosrenol 750 mg
SHIRE PHARMACEUTICAL SHIRE PHARMACEUTICAL
FR
CONTRACTS LIMITED SE/H/0481/003
5521281
Comprimidos para
SHIRE PHARMACEUTICAL
PT
CONTRACTS LIMITED
mastigar Fosrenol 1000mg
SE/H/0481/004
37416
tyggetabletter Fosrenol 500 mg,
SE/H/0481/002
0403505
SE/H/0481/004
OGYI-T-20336/04
SE/H/0481/003
IS/1/05/033/03
SHIRE PHARMACEUTICAL
SE/H/0481/002
0403519
SHIRE PHARMACEUTICAL
HU IS LU
CONTRACTS LIMITED SE/H/0481/004
OGYI-T-20336/04
rágótabletta Fosrenol 750 mg
SHIRE PHARMACEUTICAL
CONTRACTS LIMITED
comprimés à croquer Fosrenol 1000 mg
LU
CONTRACTS LIMITED
tuggutöflur Fosrenol 500 mg,
SHIRE PHARMACEUTICAL CONTRACTS LIMITED
rágótabletta Fosrenol 750 mg
DK
CONTRACTS LIMITED
comprimés à croquer Fosrenol 1000 mg
SHIRE PHARMACEUTICAL
SHIRE PHARMACEUTICAL
HU
CONTRACTS LIMITED SE/H/0481/003
5521489
Comprimidos para
SHIRE PHARMACEUTICAL
PT
CONTRACTS LIMITED
mastigar Fosrenol 500 mg,
SE/H/0481/002
0403522
comprimés à croquer Fosrenol 1000mg
SHIRE PHARMACEUTICAL
LU
CONTRACTS LIMITED SE/H/0481/004
tyggetabletter
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37416
SHIRE PHARMACEUTICAL
DK
CONTRACTS LIMITED
Page 15/30
Product Name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
Fosrenol 1000 mg
SE/H/0481/004
IS/1/05/033/04
SHIRE PHARMACEUTICAL
IS
tuggutöflur Fosrenol 1000 mg
CONTRACTS LIMITED IS/1/05/033/04
IS/1/05/033/04
tuggutöflur Fosrenol 1000 mg
IS
CONTRACTS LIMITED SE/H/0481/004
OGYI-T-20336/04
rágótabletta Fosrenol 750 mg
SHIRE PHARMACEUTICAL SHIRE PHARMACEUTICAL
HU
CONTRACTS LIMITED SE/H/0481/003
5521687
Comprimidos para
SHIRE PHARMACEUTICAL
PT
CONTRACTS LIMITED
mastigar Fosrenol 750 mg,
SE/H/0481/003
0403567
comprimés à croquer Fosrenol 1000 mg
SE/H/0481/004
IS/1/05/033/04
SHIRE PHARMACEUTICAL
IS
CONTRACTS LIMITED SE/H/0481/003
0403584
SE/H/0481/004
5521885
comprimés à croquer Fosrenol 1000 mg
LU
CONTRACTS LIMITED
tuggutöflur Fosrenol 750 mg,
SHIRE PHARMACEUTICAL
SHIRE PHARMACEUTICAL
LU
CONTRACTS LIMITED
Comprimidos para
SHIRE PHARMACEUTICAL
PT
CONTRACTS LIMITED
mastigar Fosrenol 1000 mg
SE/H/0481/004
5521984
Comprimidos para
SHIRE PHARMACEUTICAL
PT
CONTRACTS LIMITED
mastigar Foznol 250 mg chewable
SE/H/0481/001
PA 689/003/001
tablets Fosrenol 750 mg,
IE
CONTRACTS LIMITED SE/H/0481/003
0403603
comprimés à croquer Foznol 750 mg chewable
SHIRE PHARMACEUTICAL SHIRE PHARMACEUTICAL
LU
CONTRACTS LIMITED SE/H/0481/003
tablets
List of nationally authorised medicinal products EMA/789577/2017
PA 689/003/003
SHIRE PHARMACEUTICAL
IE
CONTRACTS LIMITED
Page 16/30
Product Name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
Fosrenol 1000 mg
SE/H/0481/004
H/07/00655/016
SHIRE PHARMACEUTICAL
SI
žvečljive tablete Fosrenol 1000 mg
CONTRACTS LIMITED SE/H/0481/004
5522289
Comprimidos para
SHIRE PHARMACEUTICAL
PT
CONTRACTS LIMITED
mastigar Fosrenol 1000 mg,
SE/H/0481/004
0403621
SE/H/0481/004
0403634
comprimés à croquer Fosrenol 1000 mg,
SE/H/0481/002
PA 689/003/002
SE/H/0481/002
PA 689/003/002 H/07/00655/001
SE/H/0481/004
0403655
SHIRE PHARMACEUTICAL
SE/H/0481/002
PA 689/003/002
SHIRE PHARMACEUTICAL
SE/H/0481/003
PA 689/003/003
SI LU IE
SHIRE PHARMACEUTICAL
IE
CONTRACTS LIMITED SE/H/0481/004
H/07/00655/017
SHIRE PHARMACEUTICAL
SI
CONTRACTS LIMITED SE/H/0481/003
PA 689/003/003
tablets Fosrenol 1000 mg
SHIRE PHARMACEUTICAL
CONTRACTS LIMITED
žvečljive tablete Foznol 750 mg chewable
IE
CONTRACTS LIMITED
tablets Fosrenol 1000 mg
IE
CONTRACTS LIMITED
tablets Foznol 750 mg chewable
SHIRE PHARMACEUTICAL
SE/H/0481/001
comprimés à croquer Foznol 500 mg chewable
SHIRE PHARMACEUTICAL
CONTRACTS LIMITED
tablete Fosrenol 1000 mg,
LU
CONTRACTS LIMITED
tablets Fosrenol 250 mg žvečljive
SHIRE PHARMACEUTICAL CONTRACTS LIMITED
tablets Foznol 500 mg chewable
LU
CONTRACTS LIMITED
comprimés à croquer Foznol 500 mg chewable
SHIRE PHARMACEUTICAL
SHIRE PHARMACEUTICAL
IE
CONTRACTS LIMITED SE/H/0481/004
žvečljive tablete
List of nationally authorised medicinal products EMA/789577/2017
H/07/00655/020
SHIRE PHARMACEUTICAL
SI
CONTRACTS LIMITED
Page 17/30
Product Name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
Fosrenol 500 mg
SE/H/0481/002
07-0025
SHIRE PHARMACEUTICAL
LV
košļājamās tabletes Fosrenol 500 mg
CONTRACTS LIMITED SE/H/0481/002
07-0025
košļājamās tabletes Foznol 1000 mg chewable
SE/H/0481/004
PA 689/003/004
SE/H/0481/004
PA 689/003/004 87/0397/06-S
SHIRE PHARMACEUTICAL
SE/H/0481/002
07-0025
SHIRE PHARMACEUTICAL
SE/H/0481/002
18466
SE/H/0481/002
18466
SE/H/0481/004
PA 689/003/004
SE/H/0481/002
18466
SE/H/0481/004
87/0400/06-S
SE/H/0481/004
07-0027
SE
SHIRE PHARMACEUTICAL
IE
SHIRE PHARMACEUTICAL
SE
SHIRE PHARMACEUTICAL
SK
CONTRACTS LIMITED SHIRE PHARMACEUTICAL
LV
CONTRACTS LIMITED SE/H/0481/004
87/0400/06-S
žuvacie tablety Fosrenol 750 mg
SHIRE PHARMACEUTICAL
CONTRACTS LIMITED
košlajamas tabletes Fosrenol 1000 mg
SE
CONTRACTS LIMITED
žuvacie tablety Fosrenol 1000 mg
SHIRE PHARMACEUTICAL
CONTRACTS LIMITED
tuggtabletter Fosrenol 1000 mg
LV
CONTRACTS LIMITED
tablets Fosrenol 500 mg
SK
CONTRACTS LIMITED
tuggtabletter Foznol 1000 mg chewable
IE
CONTRACTS LIMITED
tuggtabletter Fosrenol 500 mg
SHIRE PHARMACEUTICAL
SE/H/0481/001
košlajamas tabletes Fosrenol 500 mg
IE
CONTRACTS LIMITED
tablety Fosrenol 500 mg
SHIRE PHARMACEUTICAL CONTRACTS LIMITED
tablets Fosrenol 250 mg žuvacie
LV
CONTRACTS LIMITED
tablets Foznol 1000 mg chewable
SHIRE PHARMACEUTICAL
SHIRE PHARMACEUTICAL
SK
CONTRACTS LIMITED SE/H/0481/003
tuggtabletter
List of nationally authorised medicinal products EMA/789577/2017
21073
SHIRE PHARMACEUTICAL
SE
CONTRACTS LIMITED
Page 18/30
Product Name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
Fosrenol 1000 mg
SE/H/0481/004
07-0027
SHIRE PHARMACEUTICAL
LV
košļājamās tabletes Fosrenol 750 mg
CONTRACTS LIMITED SE/H/0481/003
21073
tuggtabletter Fosrenol 250 mg
SE/H/0481/001
MA593/00101
SE/H/0481/003
07-0026 87/0400/06-S
SHIRE PHARMACEUTICAL
SE/H/0481/004
07-0027
SHIRE PHARMACEUTICAL
SE/H/0481/003
07-0026
SE/H/0481/002
MA593/00102
SE/H/0481/003
21073
SE/H/0481/001
17192
SE/H/0481/002
MA593/00102
SE/H/0481/004
21074
MT
SHIRE PHARMACEUTICAL
SE
SHIRE PHARMACEUTICAL
SE
SHIRE PHARMACEUTICAL
MT
CONTRACTS LIMITED SHIRE PHARMACEUTICAL
SE
CONTRACTS LIMITED SE/H/0481/002
20224
purutabletit Fosrenol 1 000 mg
SHIRE PHARMACEUTICAL
CONTRACTS LIMITED
tuggtabletter Fosrenol 500 mg
LV
CONTRACTS LIMITED
chewable tablets Fosrenol 1 000 mg
SHIRE PHARMACEUTICAL
CONTRACTS LIMITED
tuggtabletter Fosrenol 500 mg
LV
CONTRACTS LIMITED
tuggtabletter Fosrenol 250 mg
SK
CONTRACTS LIMITED
chewable tablets Fosrenol 750 mg
LV
CONTRACTS LIMITED
košļājamās tabletes Fosrenol 500 mg
SHIRE PHARMACEUTICAL
SE/H/0481/004
košļājamās tabletes Fosrenol 750 mg
MT
CONTRACTS LIMITED
žuvacie tablety Fosrenol 1000 mg
SHIRE PHARMACEUTICAL CONTRACTS LIMITED
košļājamās tabletes Fosrenol 1000 mg
SE
CONTRACTS LIMITED
chewable tablets Fosrenol 750 mg
SHIRE PHARMACEUTICAL
SHIRE PHARMACEUTICAL
FI
CONTRACTS LIMITED SE/H/0481/004
tuggtabletter
List of nationally authorised medicinal products EMA/789577/2017
21074
SHIRE PHARMACEUTICAL
SE
CONTRACTS LIMITED
Page 19/30
Product Name (in authorisation country) Fosrenol 500 mg
MRP/DCP Authorisation number SE/H/0481/002
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
20224
SHIRE PHARMACEUTICAL
FI
purutabletit Fosrenol 500 mg
CONTRACTS LIMITED SE/H/0481/002
MA593/00102
chewable tablets Fosrenol 1000 mg
SE/H/0481/004
21074
SE/H/0481/003
MA593/00103 7354/2015/01
SHIRE PHARMACEUTICAL
SE/H/0481/003
07-0026
SHIRE PHARMACEUTICAL
SE/H/0481/003
MA593/00103
SE/H/0481/002
7353/2015/01
SE/H/0481/003
20225
SE/H/0481/002
87/104/05-C
SE/H/0481/003
MA593/00103
SE/H/0481/002
7353/2015/02
RO
SHIRE PHARMACEUTICAL
FI
SHIRE PHARMACEUTICAL
CZ
SHIRE PHARMACEUTICAL
MT
CONTRACTS LIMITED SHIRE PHARMACEUTICAL
RO
CONTRACTS LIMITED SE/H/0481/002
87/104/05-C
tablety Fosrenol 750 mg
SHIRE PHARMACEUTICAL
CONTRACTS LIMITED
comprimate masticabile Fosrenol 500 mg žvýkací
MT
CONTRACTS LIMITED
chewable tablets Fosrenol 500 mg
SHIRE PHARMACEUTICAL
CONTRACTS LIMITED
tablety Fosrenol 750 mg
LV
CONTRACTS LIMITED
purutabletit Fosrenol 500 mg žvýkací
RO
CONTRACTS LIMITED
comprimate masticabile Fosrenol 750 mg
MT
CONTRACTS LIMITED
chewable tablets Fosrenol 500 mg
SHIRE PHARMACEUTICAL
SE/H/0481/001
košļājamās tabletes Fosrenol 750 mg
SE
CONTRACTS LIMITED
comprimate masticabile Fosrenol 750 mg
SHIRE PHARMACEUTICAL CONTRACTS LIMITED
chewable tablets Fosrenol 250 mg
MT
CONTRACTS LIMITED
tuggtabletter Fosrenol 750 mg
SHIRE PHARMACEUTICAL
SHIRE PHARMACEUTICAL
CZ
CONTRACTS LIMITED SE/H/0481/003
purutabletit
List of nationally authorised medicinal products EMA/789577/2017
20225
SHIRE PHARMACEUTICAL
FI
CONTRACTS LIMITED
Page 20/30
Product Name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
Fosrenol 500 mg
SE/H/0481/002
7353/2015/03
SHIRE PHARMACEUTICAL
RO
comprimate masticabile Fosrenol 500 mg žvýkací
CONTRACTS LIMITED SE/H/0481/002
87/104/05-C
tablety Fosrenol 500 mg žvečljive
SE/H/0481/002
H/07/00655/005
SE/H/0481/002
H/07/00655/006 20225
SHIRE PHARMACEUTICAL
SE/H/0481/004
20226
SHIRE PHARMACEUTICAL
SE/H/0481/003
H/07/00655/010
SE/H/0481/002
H/07/00655/007
SE/H/0481/004
20226
SE/H/0481/004
87/106/05-C
SE/H/0481/004
87/106/05-C
SE/H/0481/003
H/07/00655/012
SI
SHIRE PHARMACEUTICAL
FI
SHIRE PHARMACEUTICAL
CZ
SHIRE PHARMACEUTICAL
CZ
CONTRACTS LIMITED SHIRE PHARMACEUTICAL
SI
CONTRACTS LIMITED SE/H/0481/003
7354/2015/01
comprimate masticabile Fosrenol 250 mg,
SHIRE PHARMACEUTICAL
CONTRACTS LIMITED
tablete Fosrenol 750 mg
SI
CONTRACTS LIMITED
tablety Fosrenol 750 mg žvečljive
SHIRE PHARMACEUTICAL
CONTRACTS LIMITED
tablety Fosrenol 1000 mg žvýkací
FI
CONTRACTS LIMITED
purutabletit Fosrenol 1000 mg žvýkací
FI
CONTRACTS LIMITED
tablete Fosrenol 1000 mg
SI
CONTRACTS LIMITED
tablete Fosrenol 500 mg žvečljive
SHIRE PHARMACEUTICAL
SE/H/0481/003
purutabletit Fosrenol 750 mg žvečljive
SI
CONTRACTS LIMITED
purutabletit Fosrenol 1000 mg
SHIRE PHARMACEUTICAL CONTRACTS LIMITED
tablete Fosrenol 750 mg
CZ
CONTRACTS LIMITED
tablete Fosrenol 500 mg žvečljive
SHIRE PHARMACEUTICAL
SHIRE PHARMACEUTICAL
RO
CONTRACTS LIMITED SE/H/0481/001
comprimé à croquer
List of nationally authorised medicinal products EMA/789577/2017
BE279754
SHIRE PHARMACEUTICAL
BE
CONTRACTS LIMITED
Page 21/30
Product Name (in authorisation country) Fosrenol 1000 mg
MRP/DCP Authorisation number SE/H/0481/004
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
20226
SHIRE PHARMACEUTICAL
FI
purutabletit Fosrenol 750 mg
CONTRACTS LIMITED SE/H/0481/003
7354/2015/06
comprimate masticabile Fosrenol 750 mg žvečljive
SE/H/0481/003
H/07/00655/014
SE/H/0481/004
87/106/05-C 7354/2015/05
SHIRE PHARMACEUTICAL
SE/H/0481/002
87/0398/06-S
SHIRE PHARMACEUTICAL
SE/H/0481/002
87/0398/06-S
SE/H/0481/002
87/0398/06-S
SE/H/0481/001
BE279754
SE/H/0481/004
7355/2015/01
SE/H/0481/004
7355/2015
SE/H/0481/002
BE279763
SK
SHIRE PHARMACEUTICAL
BE
SHIRE PHARMACEUTICAL
RO
SHIRE PHARMACEUTICAL
RO
CONTRACTS LIMITED SHIRE PHARMACEUTICAL
BE
CONTRACTS LIMITED SE/H/0481/002
037097110
compresse masticabili Fosrenol 500 mg,
SHIRE PHARMACEUTICAL
CONTRACTS LIMITED
comprimé à croquer Foznol 500 mg
SK
CONTRACTS LIMITED
comprimate masticabile Fosrenol 500 mg,
SHIRE PHARMACEUTICAL
CONTRACTS LIMITED
comprimate masticabile Fosrenol 1000 mg
SK
CONTRACTS LIMITED
kauwtabletten Fosrenol 1000 mg
RO
CONTRACTS LIMITED
tablety Fosrenol 250 mg,
CZ
CONTRACTS LIMITED
tablety Fosrenol 500 mg žuvacie
SHIRE PHARMACEUTICAL
SE/H/0481/003
tablety Fosrenol 500 mg žuvacie
SI
CONTRACTS LIMITED
comprimate masticabile Fosrenol 500 mg žuvacie
SHIRE PHARMACEUTICAL CONTRACTS LIMITED
tablety Fosrenol 750 mg
RO
CONTRACTS LIMITED
tablete Fosrenol 1000 mg žvýkací
SHIRE PHARMACEUTICAL
SHIRE PHARMACEUTICAL
IT
CONTRACTS LIMITED SE/H/0481/002
comprimé à croquer
List of nationally authorised medicinal products EMA/789577/2017
BE279763
SHIRE PHARMACEUTICAL
BE
CONTRACTS LIMITED
Page 22/30
Product Name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
Fosrenol 1000 mg
SE/H/0481/004
7355/2015/05
SHIRE PHARMACEUTICAL
RO
comprimate masticabile Foznol 500 mg
CONTRACTS LIMITED SE/H/0481/002
037097122
compresse masticabili Fosrenol 750 mg žuvacie
SE/H/0481/003
87/0399/06-S
SE/H/0481/002
037097134 BE279763
SHIRE PHARMACEUTICAL
SE/H/0481/002
BE279763
SHIRE PHARMACEUTICAL
SE/H/0481/002
BE279763
SE/H/0481/003
037097058
SE/H/0481/003
037097072
SE/H/0481/002
BE279763
SE/H/0481/003
87/0399/06-S
SE/H/0481/003
87/0399/06-S
IT
SHIRE PHARMACEUTICAL
IT
SHIRE PHARMACEUTICAL
BE
SHIRE PHARMACEUTICAL
SK
CONTRACTS LIMITED SHIRE PHARMACEUTICAL
SK
CONTRACTS LIMITED SE/H/0481/003
037097096
compresse masticabili Fosrenol 500 mg
SHIRE PHARMACEUTICAL
CONTRACTS LIMITED
tablety Foznol 750 mg
BE
CONTRACTS LIMITED
tablety Fosrenol 750 mg žuvacie
SHIRE PHARMACEUTICAL
CONTRACTS LIMITED
kauwtabletten Fosrenol 750 mg žuvacie
BE
CONTRACTS LIMITED
compresse masticabili Fosrenol 500 mg,
BE
CONTRACTS LIMITED
compresse masticabili Foznol 750 mg
IT
CONTRACTS LIMITED
kauwtabletten Foznol 750 mg
SHIRE PHARMACEUTICAL
SE/H/0481/002
comprimé à croquer Fosrenol 500 mg,
SK
CONTRACTS LIMITED
kauwtabletten Fosrenol 500 mg,
SHIRE PHARMACEUTICAL CONTRACTS LIMITED
compresse masticabili Fosrenol 500 mg,
IT
CONTRACTS LIMITED
tablety Foznol 500 mg
SHIRE PHARMACEUTICAL
SHIRE PHARMACEUTICAL
IT
CONTRACTS LIMITED SE/H/0481/002
Kautabletten
List of nationally authorised medicinal products EMA/789577/2017
1-25967
SHIRE PHARMACEUTICAL
AT
CONTRACTS LIMITED
Page 23/30
Product Name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
Fosrenol 500 mg
SE/H/0481/002
1-25967
SHIRE PHARMACEUTICAL
AT
Kautabletten Fosrenol 500 mg
CONTRACTS LIMITED SE/H/0481/002
1-25967
Kautabletten Foznol 1000 mg
SE/H/0481/004
037097161
SE/H/0481/004
037097173 037097209
SHIRE PHARMACEUTICAL
SE/H/0481/003
1-25968
SHIRE PHARMACEUTICAL
SE/H/0481/003
1-25968
SE/H/0481/003
BE279772
SE/H/0481/003
1-25968
SE/H/0481/03
BE279772
SE/H/0481/004
1-25969
SE/H/0481/004
1-25969
BE
SHIRE PHARMACEUTICAL
AT
SHIRE PHARMACEUTICAL
BE
SHIRE PHARMACEUTICAL
AT
CONTRACTS LIMITED SHIRE PHARMACEUTICAL
AT
CONTRACTS LIMITED SE/H/0481/003
BE279772
comprimé à croquer Fosrenol 750 mg,
SHIRE PHARMACEUTICAL
CONTRACTS LIMITED
Kautabletten Fosrenol 750 mg,
AT
CONTRACTS LIMITED
Kautabletten Fosrenol 1000 mg
SHIRE PHARMACEUTICAL
CONTRACTS LIMITED
comprimé à croquer Fosrenol 1000 mg
AT
CONTRACTS LIMITED
Kautabletten Fosrenol 750 mg,
IT
CONTRACTS LIMITED
comprimé à croquer Fosrenol 750 mg
IT
CONTRACTS LIMITED
Kautabletten Fosrenol 750 mg,
SHIRE PHARMACEUTICAL
SE/H/0481/004
Kautabletten Fosrenol 750 mg
IT
CONTRACTS LIMITED
compresse masticabili Fosrenol 750 mg
SHIRE PHARMACEUTICAL CONTRACTS LIMITED
compresse masticabili Foznol 1000 mg
AT
CONTRACTS LIMITED
compresse masticabili Foznol 1000 mg
SHIRE PHARMACEUTICAL
SHIRE PHARMACEUTICAL
BE
CONTRACTS LIMITED SE/H/0481/003
kauwtabletten
List of nationally authorised medicinal products EMA/789577/2017
BE279772
SHIRE PHARMACEUTICAL
BE
CONTRACTS LIMITED
Page 24/30
Product Name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
Fosrenol 1000 mg
SE/H/0481/004
1-25969
SHIRE PHARMACEUTICAL
AT
Kautabletten Fosrenol 750 mg,
CONTRACTS LIMITED SE/H/0481/003
BE279772
kauwtabletten Fosrenol 750 mg,
SE/H/0481/003
BE279772
SE/H/0481/004
BE279781
SE/H/0481/002
68438
SE/H/0481/002
68438
SE/H/0481/002
68438
SE/H/0481/003
68439
SE/H/0481/004
BE279781
SE/H/0481/003
68439
SE/H/0481/003
68439
SE/H/0481/004
BE279781
ES
SHIRE PHARMACEUTICAL
ES
SHIRE PHARMACEUTICAL
BE
SHIRE PHARMACEUTICAL
ES
SHIRE PHARMACEUTICAL
ES
SHIRE PHARMACEUTICAL
BE
CONTRACTS LIMITED SE/H/0481/004
BE279781
kauwtabletten Fosrenol 1000 mg,
SHIRE PHARMACEUTICAL
CONTRACTS LIMITED
comprimé à croquer Fosrenol 1000 mg,
ES
CONTRACTS LIMITED
comprimidos masticables Fosrenol 1 000 mg,
SHIRE PHARMACEUTICAL
CONTRACTS LIMITED
comprimidos masticables Fosrenol 750 mg
ES
CONTRACTS LIMITED
comprimé à croquer Fosrenol 750 mg
SHIRE PHARMACEUTICAL
CONTRACTS LIMITED
comprimidos masticables Fosrenol 1 000 mg,
BE
CONTRACTS LIMITED
comprimidos masticables Fosrenol 750 mg
SHIRE PHARMACEUTICAL
CONTRACTS LIMITED
comprimidos masticables Fosrenol 500 mg
BE
CONTRACTS LIMITED
comprimidos masticables Fosrenol 500 mg
SHIRE PHARMACEUTICAL CONTRACTS LIMITED
comprimé à croquer Fosrenol 500 mg
BE
CONTRACTS LIMITED
kauwtabletten Fosrenol 1 000 mg,
SHIRE PHARMACEUTICAL
SHIRE PHARMACEUTICAL
BE
CONTRACTS LIMITED SE/H/0481/004
kauwtabletten
List of nationally authorised medicinal products EMA/789577/2017
BE279781
SHIRE PHARMACEUTICAL
BE
CONTRACTS LIMITED
Page 25/30
Product Name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
Fosrenol 1000 mg,
SE/H/0481/004
BE279781
SHIRE PHARMACEUTICAL
BE
kauwtabletten Fosrenol 1000 mg
CONTRACTS LIMITED SE/H/0481/004
68434
comprimidos masticables Fosrenol 1000 mg
SE/H/0481/004
68434
SE/H/0481/004
68434 786812
SHIRE PHARMACEUTICAL
SE/H/0481/006
48687
SHIRE PHARMACEUTICAL
SE/H/0481/005
48686
SE/H/0481/006
786912
SE/H/0481/005
OGYI-T-20336/05
SE/H/0481/006
OGYI-T-20336/06
SE/H/0481/005
76054
SE/H/0481/006
76053
EE
SHIRE PHARMACEUTICAL
HU
SHIRE PHARMACEUTICAL
HU
SHIRE PHARMACEUTICAL
ES
CONTRACTS LIMITED SHIRE PHARMACEUTICAL
ES
CONTRACTS LIMITED SE/H/0481/002
20224
purutabletit FOSRENOL 250 mg
SHIRE PHARMACEUTICAL
CONTRACTS LIMITED
oral Fosrenol 500 mg
DK
CONTRACTS LIMITED
oral Fosrenol 1000 mg polvo
SHIRE PHARMACEUTICAL
CONTRACTS LIMITED
belsőleges por Fosrenol 750 mg polvo
DK
CONTRACTS LIMITED
belsőleges por Fosrenol 1000 mg
EE
CONTRACTS LIMITED
suukaudne pulber Fosrenol 750 mg
ES
CONTRACTS LIMITED
pulver Fosrenol 1000 mg
SHIRE PHARMACEUTICAL
SE/H/0481/005
pulver Fosrenol 750 mg oralt
ES
CONTRACTS LIMITED
suukaudne pulber Fosrenol 1000 mg oralt
SHIRE PHARMACEUTICAL CONTRACTS LIMITED
comprimidos masticables Fosrenol 750 mg
ES
CONTRACTS LIMITED
comprimidos masticables. Fosrenol 1000 mg
SHIRE PHARMACEUTICAL
SHIRE PHARMACEUTICAL
FI
CONTRACTS LIMITED SE/H/0481/001
kramtomosios tabletės
List of nationally authorised medicinal products EMA/789577/2017
LT/1/07/0776/002
SHIRE PHARMACEUTICAL
LT
CONTRACTS LIMITED
Page 26/30
Product Name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
FOSRENOL 500 mg
SE/H/0481/002
LT/1/07/0776/005
SHIRE PHARMACEUTICAL
LT
kramtomosios tabletės FOSRENOL 500 mg
CONTRACTS LIMITED SE/H/0481/002
LT/1/07/0776/006
kramtomosios tabletės FOSRENOL 500 mg
SE/H/0481/002
LT/1/07/0776/007
SE/H/0481/003
LT/1/07/0776/010
SE/H/0481/003
LT/1/07/0776/012
SE/H/0481/003
LT/1/07/0776/014
SE/H/0481/004
LT/1/07/0776/016
SE/H/0481/004
LT/1/07/0776/017
SE/H/0481/004
LT/1/07/0776/020
SE/H/0481/005
45908
SE/H/0481/006
45909
LT
SHIRE PHARMACEUTICAL
LT
SHIRE PHARMACEUTICAL
LT
SHIRE PHARMACEUTICAL
LT
SE/H/0481/005
29668
SHIRE PHARMACEUTICAL
SE
CONTRACTS LIMITED
pulver Fosrenol 750 mg jauhe
SHIRE PHARMACEUTICAL
CONTRACTS LIMITED
pulver Fosrenol 1 000 mg oralt
LT
CONTRACTS LIMITED
kramtomosios tabletės Fosrenol 750 mg oralt
SHIRE PHARMACEUTICAL
CONTRACTS LIMITED
kramtomosios tabletės FOSRENOL 1000 mg
LT
CONTRACTS LIMITED
kramtomosios tabletes FOSRENOL 1000 mg
SHIRE PHARMACEUTICAL
CONTRACTS LIMITED
kramtomosios tabletės FOSRENOL 1000 mg
LT
CONTRACTS LIMITED
kramtomosios tabletės FOSRENOL 750 mg
SHIRE PHARMACEUTICAL CONTRACTS LIMITED
kramtomosios tabletės FOSRENOL 750 mg
LT
CONTRACTS LIMITED
kramtomosios tabletės FOSRENOL 750 mg
SHIRE PHARMACEUTICAL
SHIRE PHARMACEUTICAL
SE
CONTRACTS LIMITED SHIRE PHARMACEUTICAL
FI
CONTRACTS LIMITED Fosrenol 1000 mg jauhe
SE/H/0481/006
29669
SHIRE PHARMACEUTICAL
FI
CONTRACTS LIMITED Fosrenol 750 mg Pulver
SE/H/0481/005
zum Einnehmen
List of nationally authorised medicinal products EMA/789577/2017
84928.00.00
SHIRE PHARMACEUTICAL
DE
CONTRACTS LIMITED
Page 27/30
Product Name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
Fosrenol 1000 mg Pulver
SE/H/0481/006
84929.00.00
SHIRE PHARMACEUTICAL
DE
zum Einnehmen FOSRENOL 1000 mg
CONTRACTS LIMITED SE/H/0481/006
34009 223 620 9 0
poudre orale FOSRENOL 750 mg
SE/H/0481/005
34009 223 619 0 1
SE/H/0481/006
RVG 109379
SE/H/0481/005
RVG 109377
SE/H/0481/005
87/468/12-C
SE/H/0481/006
87/469/12-C
SE/H/0481/005
1-31665
SE/H/0481/006
1-31666
SE/H/0481/005
2012100115
SE/H/0481/006
2012100116
SE/H/0481/005
2012100115
CZ
SHIRE PHARMACEUTICAL
AT
SHIRE PHARMACEUTICAL
AT
SHIRE PHARMACEUTICAL
LU
SHIRE PHARMACEUTICAL
LU
SHIRE PHARMACEUTICAL
LU
CONTRACTS LIMITED SE/H/0481/006
2012100116
voor oraal gebruik Fosrenol 750 mg pulveris
SHIRE PHARMACEUTICAL
CONTRACTS LIMITED
voor oraal gebruik Fosrenol 1000 mg poeder
CZ
CONTRACTS LIMITED
orale Fosrenol 750 mg poeder
SHIRE PHARMACEUTICAL
CONTRACTS LIMITED
orale Fosrenol 1000 mg poudre
NL
CONTRACTS LIMITED
zum Einnehmen Fosrenol 750 mg poudre
SHIRE PHARMACEUTICAL
CONTRACTS LIMITED
zum Einnehmen Fosrenol 1000 mg Pulver
NL
CONTRACTS LIMITED
perorální prášek Fosrenol 750 mg Pulver
SHIRE PHARMACEUTICAL
CONTRACTS LIMITED
perorální prášek Fosrenol 1000 mg
FR
CONTRACTS LIMITED
voor oraal gebruik Fosrenol 750 mg
SHIRE PHARMACEUTICAL CONTRACTS LIMITED
poeder voor oraal gebruik Fosrenol 750 mg, poeder
FR
CONTRACTS LIMITED
poudre orale Fosrenol 1000 mg,
SHIRE PHARMACEUTICAL
SHIRE PHARMACEUTICAL
LU
CONTRACTS LIMITED SE/H/0481/005
iekšķīgai lietošanai
List of nationally authorised medicinal products EMA/789577/2017
12-0285
SHIRE PHARMACEUTICAL
LV
CONTRACTS LIMITED
Page 28/30
Product Name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
Fosrenol 1000 mg
SE/H/0481/006
12-0286
SHIRE PHARMACEUTICAL
LV
pulveris iekšķīgai
CONTRACTS LIMITED
lietošanai Fosrenol 750 mg pulbere
SE/H/0481/005
7356/2015/01
SE/H/0481/006
7357/2015/01
SE/H/0481/006
H/07/00655/023
orală Fosrenol 1000 mg
SE/H/0481/005
H/07/00655/022
SE/H/0481/005
BE433684
SE/H/0481/006
BE433693
SHIRE PHARMACEUTICAL
SE/H/0481/006
BE433693
SHIRE PHARMACEUTICAL
SHIRE PHARMACEUTICAL
BE BE BE
CONTRACTS LIMITED SE/H/0481/005
BE433684
SHIRE PHARMACEUTICAL
BE
CONTRACTS LIMITED SE/H/0481/006
BE433693
SHIRE PHARMACEUTICAL
BE
CONTRACTS LIMITED SE/H/0481/005
20967
doustny Fosrenol 1000 mg,
BE
CONTRACTS LIMITED
voor oraal gebruik Fosrenol 750 mg, proszek
SI
CONTRACTS LIMITED
voor oraal gebruik Fosrenol 1000 mg poeder
SHIRE PHARMACEUTICAL
BE433684
poudre orale Fosrenol 750 mg poeder
SHIRE PHARMACEUTICAL
SE/H/0481/005
zum Einnehmen Fosrenol 1 000 mg
SI
CONTRACTS LIMITED
orale Fosrenol 1000 mg Pulver
SHIRE PHARMACEUTICAL
CONTRACTS LIMITED
zum Einnehmen Fosrenol 750 mg poudre
RO
CONTRACTS LIMITED
peroralni prašek Fosrenol 750 mg Pulver
SHIRE PHARMACEUTICAL CONTRACTS LIMITED
peroralni prašek Fosrenol 750 mg
RO
CONTRACTS LIMITED
pulbere orală Fosrenol 1000 mg
SHIRE PHARMACEUTICAL
SHIRE PHARMACEUTICAL
PL
CONTRACTS LIMITED SE/H/0481/006
proszek doustny
List of nationally authorised medicinal products EMA/789577/2017
20968
SHIRE PHARMACEUTICAL
PL
CONTRACTS LIMITED
Page 29/30
Product Name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
Foznol 750 mg polvere
SE/H/0481/005
37097223
SHIRE PHARMACEUTICAL
IT
orale Foznol 1000 mg polvere
CONTRACTS LIMITED SE/H/0481/006
37097235
orale Fosrenol 750 mg πόσιμη
IT
CONTRACTS LIMITED SE/H/0481/005
51693/1-7-2013
κόνις Fosrenol 1000 mg πόσιμη
SHIRE PHARMACEUTICAL SHIRE PHARMACEUTICAL
GR
CONTRACTS LIMITED SE/H/0481/006
51694/1-7-2013
κόνις
SHIRE PHARMACEUTICAL
GR
CONTRACTS LIMITED
Fosrenol 750 mg pó oral
SE/H/0481/005
5579321
Fosrenol 1000 mg pó oral
SE/H/0481/006
5579313
SHIRE PHARMACEUTICAL
PT
CONTRACTS LIMITED SHIRE PHARMACEUTICAL
PT
CONTRACTS LIMITED Fosrenol 750 mg πόσιμη
SE/H/0481/005
21928
κόνις Fosrenol 1000 mg πόσιμη
SHIRE PHARMACEUTICAL
CY
CONTRACTS LIMITED SE/H/0481/006
κόνις
List of nationally authorised medicinal products EMA/789577/2017
21929
SHIRE PHARMACEUTICAL
CY
CONTRACTS LIMITED
Page 30/30
