30 November 2017 EMA/802792/2017 Human Medicines Evaluation Division
List of nationally authorised medicinal products
Active substance: sertraline
Procedure no.: PSUSA/00002696/201703
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, 2017. Reproduction is authorised provided the source is acknowledged.
Product Name (in authorisation country)
MRP/DCP Authorisation number NL/H/1732/002
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
1-21385
AT
Tresleen® 100 mg Filmtabletten
NL/H/1732/003
1-30163
Tresleen® 50 mg Filmtabletten
NL/H/1732/002
1-21385
Tresleen® 100 mg Filmtabletten
NL/H/1732/003
1-30163
Gladem® 50 mg Filmtabletten Sertralin Pfizer 100 mg Filmtabletten
not available
1-21401
NL/H/1736/002
1-30158
Sertralin Pfizer 50 mg Filmtabletten
NL/H/1736/001
1-30157
Serlain 100 mg Filmtabletten Serlain 50 mg Filmtabletten Serlain 20 mg / ml Konzentrat zur Herstellung einer Lösung zum Einnehmen Serlain 50 mg filmomhulde tabletten Serlain 100 mg filmomhulde tabletten Serlain 20 mg/ml concentraat voor drank Serlain 50 mg comprimés pelliculés
NL/H/1732/003
BE157351
PFIZER CORPORATION AUSTRIA GESELLSCHAFT M.B.H. PFIZER CORPORATION AUSTRIA GESELLSCHAFT M.B.H. PFIZER CORPORATION AUSTRIA GESELLSCHAFT M.B.H. PFIZER CORPORATION AUSTRIA GESELLSCHAFT M.B.H. BOEHRINGER INGELHEIM RCV GMBH & CO KG PFIZER CORPORATION AUSTRIA GESELLSCHAFT M.B.H. PFIZER CORPORATION AUSTRIA GESELLSCHAFT M.B.H. PFIZER S.A. (BELGIUM)
NL/H/1732/002
BE157324
PFIZER S.A. (BELGIUM)
BE
NL/H/1732/004
BE226755
PFIZER S.A. (BELGIUM)
BE
NL/H/1732/002
BE157324
PFIZER S.A. (BELGIUM)
BE
NL/H/1732/003
BE157351
PFIZER S.A. (BELGIUM)
BE
NL/H/1732/004
BE226755
PFIZER S.A. (BELGIUM)
BE
NL/H/1732/002
BE157324
PFIZER S.A. (BELGIUM)
BE
Tresleen® 50 mg Filmtabletten
List of nationally authorised medicinal products
AT AT AT AT AT AT BE
Page 2/24
Product Name (in authorisation country) Serlain 20 mg/ml solution à diluer pour solution buvable Serlain 100 mg comprimés pelliculés Serlain 100 mg Filmtabletten Serlain 50 mg Filmtabletten Serlain 20 mg / ml Konzentrat zur Herstellung einer Lösung zum Einnehmen Serlain 50 mg filmomhulde tabletten Serlain 100 mg filmomhulde tabletten Serlain 20 mg/ml concentraat voor drank Serlain 50 mg comprimés pelliculés Serlain 20 mg/ml solution à diluer pour solution buvable Serlain 100 mg comprimés pelliculés Золофт 50 mg филмирани таблетки Золофт 50 mg филмирани таблетки Zoloft, 50 mg επικαλυμμένα με λεπτό υμένιο δισκία Zoloft, 100 mg επικαλυμμένα με λεπτό υμένιο δισκία
MRP/DCP Authorisation number NL/H/1732/004
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
BE226755
PFIZER S.A. (BELGIUM)
BE
NL/H/1732/003
BE157351
PFIZER S.A. (BELGIUM)
BE
NL/H/1732/003
BE157351
PFIZER S.A. (BELGIUM)
BE
NL/H/1732/002
BE157324
PFIZER S.A. (BELGIUM)
BE
NL/H/1732/004
BE226755
PFIZER S.A. (BELGIUM)
BE
NL/H/1732/002
BE157324
PFIZER S.A. (BELGIUM)
BE
NL/H/1732/003
BE157351
PFIZER S.A. (BELGIUM)
BE
NL/H/1732/004
BE226755
PFIZER S.A. (BELGIUM)
BE
NL/H/1732/002
BE157324
PFIZER S.A. (BELGIUM)
BE
NL/H/1732/004
BE226755
PFIZER S.A. (BELGIUM)
BE
NL/H/1732/003
BE157351
PFIZER S.A. (BELGIUM)
BE
NL/H/1732/002
20000514
PFIZER EUROPE MA EEIG
BG
NL/H/1732/002
20000514
PFIZER EUROPE MA EEIG
BG
NL/H/1732/002
14677/ 5.4.1999
PFIZER HELLAS, A.E.
CY
NL/H/1732/003
14678/ 5.4.1999
PFIZER HELLAS, A.E.
CY
List of nationally authorised medicinal products EMA/173192/2017
Page 3/24
Product Name (in authorisation country) Zoloft, 50 mg επικαλυμμένα με λεπτό υμένιο δισκία Zoloft, 100 mg επικαλυμμένα με λεπτό υμένιο δισκία Zoloft 100 mg potahované tablety Zoloft 50 mg potahované tablety Zoloft 100 mg potahované tablety Zoloft 50 mg potahované tablety Zoloft® 20 mg/ml Konzentrat zur Herstellung einer Lösung zum Einnehmen Zoloft® 50 mg, Filmtabletten Zoloft® 100 mg, Filmtabletten Zoloft® 20 mg/ml Konzentrat zur Herstellung einer Lösung zum Einnehmen Zoloft® 50 mg, Filmtabletten Zoloft® 100 mg, Filmtabletten Zoloft, filmovertrukne tabletter Zoloft, filmovertrukne tabletter Zoloft, filmovertrukne tabletter
MRP/DCP Authorisation number NL/H/1732/002
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
14677/ 5.4.1999
PFIZER HELLAS, A.E.
CY
NL/H/1732/003
14678/ 5.4.1999
PFIZER HELLAS, A.E.
CY
NL/H/1732/003
30/1093/94-B/C
PFIZER, SPOL. S R.O.
CZ
NL/H/1732/002
30/1093/94-A/C
PFIZER, SPOL. S R.O.
CZ
NL/H/1732/003
30/1093/94-B/C
PFIZER, SPOL. S R.O.
CZ
NL/H/1732/002
30/1093/94-A/C
PFIZER, SPOL. S R.O.
CZ
NL/H/1732/004
46312.00.00
PFIZER PHARMA PFE GMBH
DE
NL/H/1732/002
37076.00.00
PFIZER PHARMA PFE GMBH
DE
NL/H/1732/003
37076.01.00
PFIZER PHARMA PFE GMBH
DE
NL/H/1732/004
46312.00.00
PFIZER PHARMA PFE GMBH
DE
NL/H/1732/002
37076.00.00
PFIZER PHARMA PFE GMBH
DE
NL/H/1732/003
37076.01.00
PFIZER PHARMA PFE GMBH
DE
NL/H/1732/001
32146
PFIZER APS
DK
NL/H/1732/002
13471
PFIZER APS
DK
NL/H/1732/003
13472
PFIZER APS
DK
List of nationally authorised medicinal products EMA/173192/2017
Page 4/24
Product Name (in authorisation country) Zoloft, koncentrat til oral opløsning Zoloft, filmovertrukne tabletter Zoloft, filmovertrukne tabletter Zoloft, filmovertrukne tabletter Zoloft, koncentrat til oral opløsning Zoloft, 50 mg õhukese polümeerikattega tabletid Zoloft, 50 mg õhukese polümeerikattega tabletid Besitran 50 mg comprimidos recubiertos con película Besitran 100 mg comprimidos recubiertos con película Besitran 20 mg/ml concentrado para solución oral Besitran 50 mg comprimidos recubiertos con película Besitran 100 mg comprimidos recubiertos con película Besitran 20 mg/ml concentrado para solución oral AREMIS 100 mg comprimidos recubiertos con película
MRP/DCP Authorisation number NL/H/1732/004
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
30610
PFIZER APS
DK
NL/H/1732/001
32146
PFIZER APS
DK
NL/H/1732/002
13471
PFIZER APS
DK
NL/H/1732/003
13472
PFIZER APS
DK
NL/H/1732/004
30610
PFIZER APS
DK
NL/H/1732/002
122095
PFIZER EUROPE MA EEIG
EE
NL/H/1732/002
122095
PFIZER EUROPE MA EEIG
EE
NL/H/1732/002
59.717
PFIZER, S.L.
ES
NL/H/1732/003
59.718
PFIZER, S.L.
ES
NL/H/1732/004
63.477
PFIZER, S.L.
ES
NL/H/1732/002
59.717
PFIZER, S.L.
ES
NL/H/1732/003
59.718
PFIZER, S.L.
ES
NL/H/1732/004
63.477
PFIZER, S.L.
ES
not available
59.734
LABORATORIOS DR. ESTEVE S.A.
ES
List of nationally authorised medicinal products EMA/173192/2017
Page 5/24
Product Name (in authorisation country)
MRP/DCP Authorisation number not available
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
59.735
LABORATORIOS DR. ESTEVE S.A.
ES
NL/H/1732/002
11557
PFIZER OY
FI
NL/H/1732/003
11558
PFIZER OY
FI
NL/H/1732/003
11558
PFIZER OY
FI
NL/H/1732/002
11557
PFIZER OY
FI
NL/H/1732/002
11557
PFIZER OY
FI
NL/H/1732/003
11558
PFIZER OY
FI
NL/H/1732/003
11558
PFIZER OY
FI
NL/H/1732/002
11557
PFIZER OY
FI
not available
34009 355 621 2 8
ZOLOFT 25 mg, gélule
not available
34009 563 118 8 0
ZOLOFT 25 mg, gélule
not available
34009 563 119 4 1
ZOLOFT 50 mg, gélule
not available
34009 300 379 3 5
PFIZER HOLDING (S.C.A.) PFIZER HOLDING (S.C.A.) PFIZER HOLDING (S.C.A.) PFIZER HOLDING
ZOLOFT 25 mg, gélule
not available
ZOLOFT 50 mg, gélule
AREMIS 50 mg comprimidos recubiertos con película Zoloft 50 mg tabletti, kalvopäällysteinen Zoloft 100 mg tabletti, kalvopäällysteinen Zoloft 100 mg filmdragerade tabletter Zoloft 50 mg filmdragerade tabletter Zoloft 50 mg tabletti, kalvopäällysteinen Zoloft 100 mg tabletti, kalvopäällysteinen Zoloft 100 mg filmdragerade tabletter Zoloft 50 mg filmdragerade tabletter ZOLOFT 25 mg, gélule
FRANCE
FR
FRANCE
FR
FRANCE
FR
FRANCE
FR
34009 355 620 6 7
PFIZER HOLDING FRANCE
FR
not available
34009 340 341 9 0
FR
ZOLOFT 50 mg, gélule
not available
34009 340 344 8 0
ZOLOFT 50 mg, gélule
not available
34009 340 342 5 1
PFIZER HOLDING FRANCE (S.C.A.) PFIZER HOLDING FRANCE (S.C.A.) PFIZER HOLDING FRANCE (S.C.A.)
List of nationally authorised medicinal products EMA/173192/2017
FR FR
Page 6/24
Product Name (in authorisation country)
MRP/DCP Authorisation number not available
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
34009 340 343 1 2
FR
Zoloft, 50 mg επικαλυμμένα με λεπτό υμένιο δισκία Zoloft, 100 mg επικαλυμμένα με λεπτό υμένιο δισκία Sertraline/Generics 100 mg, επικαλυμμένα με λεπτό υμένιο δισκία Zoloft, 50 mg επικαλυμμένα με λεπτό υμένιο δισκία Zoloft, 100 mg επικαλυμμένα με λεπτό υμένιο δισκία ZOLOFT 50 mg filmom obložene tablete Zoloft 50 mg filmtabletta
NL/H/1732/002
43084/23-06-2015
PFIZER HOLDING FRANCE (S.C.A.) PFIZER HELLAS, A.E.
NL/H/1732/003
43085/23-06-2015
PFIZER HELLAS, A.E.
GR
EL/H/0177/002
12399/12-02-2013
GENERICS [UK] LIMITED
GR
NL/H/1732/002
43084/23-06-2015
PFIZER HELLAS, A.E.
GR
NL/H/1732/003
43085/23-06-2015
PFIZER HELLAS, A.E.
GR
not available
HR-H-153369585
PFIZER CROATIA D.O.O.
HR
NL/H/1732/002
OGYI-T-4342/01
PFIZER KFT.
HU
Zoloft 20 mg/ml koncentrátum belsőleges oldathoz Zoloft 50 mg filmtabletta
NL/H/1732/004
OGYI-T-4342/02
PFIZER KFT.
HU
NL/H/1732/002
OGYI-T-4342/01
PFIZER KFT.
HU
Zoloft 20 mg/ml koncentrátum belsőleges oldathoz LUSTRAL® 50 mg film coated tablets LUSTRAL® 100 mg film coated tablets LUSTRAL® 50 mg film coated tablets LUSTRAL® 100 mg film coated tablets
NL/H/1732/004
OGYI-T-4342/02
PFIZER KFT.
HU
NL/H/1732/002
PA 822/1/4
IE
NL/H/1732/003
PA 822/1/5
NL/H/1732/002
PA 822/1/4
NL/H/1732/003
PA 822/1/5
PFIZER HEALTHCARE IRELAND PFIZER HEALTHCARE IRELAND PFIZER HEALTHCARE IRELAND PFIZER HEALTHCARE IRELAND
ZOLOFT 50 mg, gélule
List of nationally authorised medicinal products EMA/173192/2017
GR
IE IE IE
Page 7/24
Product Name (in authorisation country) Zoloft 20 mg/ml mixtúruþykkni, lausn Zoloft 100 mg filmuhúðaðar töflur Zoloft 25 mg filmuhúðaðar töflur Zoloft 50 mg filmuhúðaðar töflur Zoloft 20 mg/ml mixtúruþykkni, lausn Zoloft 100 mg filmuhúðaðar töflur Zoloft 25 mg filmuhúðaðar töflur Zoloft 50 mg filmuhúðaðar töflur Zoloft compresse rivestite con film 25 mg Zoloft concentrato per soluzione orale 20 mg/ml Zoloft compresse rivestite con film 50 mg Zoloft compresse rivestite con film 25 mg Zoloft concentrato per soluzione orale 20 mg/ml Zoloft compresse rivestite con film 50 mg Tatig concentrato per soluzione orale 20 mg/ml Tatig compresse rivestite con film 50 mg Tatig compresse rivestite con film 50 mg Tatig compresse rivestite con film 100 mg
MRP/DCP Authorisation number NL/H/1732/004
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
990043 (IS)
PFIZER APS
IS
NL/H/1732/003
990469 (IS)
PFIZER APS
IS
NL/H/1732/001
IS/1/01/102/01
PFIZER APS
IS
NL/H/1732/002
950077 (IS)
PFIZER APS
IS
NL/H/1732/004
990043 (IS)
PFIZER APS
IS
NL/H/1732/003
990469 (IS)
PFIZER APS
IS
NL/H/1732/001
IS/1/01/102/01
PFIZER APS
IS
NL/H/1732/002
950077 (IS)
PFIZER APS
IS
NL/H/1732/001
027753437
PFIZER ITALIA S.R.L.
IT
NL/H/1732/004
027753096
PFIZER ITALIA S.R.L.
IT
NL/H/1732/002
027753108
PFIZER ITALIA S.R.L.
IT
NL/H/1732/001
027753437
PFIZER ITALIA S.R.L.
IT
NL/H/1732/004
027753096
PFIZER ITALIA S.R.L.
IT
NL/H/1732/002
027753108
PFIZER ITALIA S.R.L.
IT
NL/H/1736/003
027754035
PFIZER ITALIA S.R.L.
IT
NL/H/1736/001
027754086
PFIZER ITALIA S.R.L.
IT
NL/H/1736/001
027754047
PFIZER ITALIA S.R.L.
IT
NL/H/1736/002
027754050
PFIZER ITALIA S.R.L.
IT
List of nationally authorised medicinal products EMA/173192/2017
Page 8/24
Product Name (in authorisation country) Tatig compresse rivestite con film 100 mg Zoloft 50 mg plėvele dengtos tabletės Zoloft 50 mg plėvele dengtos tabletės Zoloft 50 mg plėvele dengtos tabletės Zoloft 50 mg plėvele dengtos tabletės Zoloft 50 mg plėvele dengtos tabletės Zoloft 50 mg plėvele dengtos tabletės Zoloft 50 mg plėvele dengtos tabletės Zoloft 50 mg plėvele dengtos tabletės Zoloft 50 mg plėvele dengtos tabletės Zoloft 50 mg plėvele dengtos tabletės Zoloft 50 mg plėvele dengtos tabletės Zoloft 50 mg plėvele dengtos tabletės Zoloft 50 mg plėvele dengtos tabletės Zoloft 50 mg plėvele dengtos tabletės Zoloft 50 mg plėvele dengtos tabletės Zoloft 50 mg plėvele dengtos tabletės Zoloft 50 mg plėvele dengtos tabletės
MRP/DCP Authorisation number NL/H/1736/002
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
027754098
PFIZER ITALIA S.R.L.
IT
NL/H/1732/002
LT/1/96/2037/005
PFIZER LIMITED
LT
NL/H/1732/002
LT/1/96/2037/004
PFIZER LIMITED
LT
NL/H/1732/002
LT/1/96/2037/008
PFIZER LIMITED
LT
NL/H/1732/002
LT/1/96/2037/006
PFIZER LIMITED
LT
NL/H/1732/002
LT/1/96/2037/010
PFIZER LIMITED
LT
NL/H/1732/002
LT/1/96/2037/013
PFIZER LIMITED
LT
NL/H/1732/002
LT/1/96/2037/012
PFIZER LIMITED
LT
NL/H/1732/002
LT/1/96/2037/002
PFIZER LIMITED
LT
NL/H/1732/002
LT/1/96/2037/016
PFIZER LIMITED
LT
NL/H/1732/002
LT/1/96/2037/009
PFIZER LIMITED
LT
NL/H/1732/002
LT/1/96/2037/001
PFIZER LIMITED
LT
NL/H/1732/002
LT/1/96/2037/014
PFIZER LIMITED
LT
NL/H/1732/002
LT/1/96/2037/003
PFIZER LIMITED
LT
NL/H/1732/002
LT/1/96/2037/007
PFIZER LIMITED
LT
NL/H/1732/002
LT/1/96/2037/015
PFIZER LIMITED
LT
NL/H/1732/002
LT/1/96/2037/011
PFIZER LIMITED
LT
NL/H/1732/002
LT/1/96/2037/005
PFIZER LIMITED
LT
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Product Name (in authorisation country) Zoloft 50 mg plėvele dengtos tabletės Zoloft 50 mg plėvele dengtos tabletės Zoloft 50 mg plėvele dengtos tabletės Zoloft 50 mg plėvele dengtos tabletės Zoloft 50 mg plėvele dengtos tabletės Zoloft 50 mg plėvele dengtos tabletės Zoloft 50 mg plėvele dengtos tabletės Zoloft 50 mg plėvele dengtos tabletės Zoloft 50 mg plėvele dengtos tabletės Zoloft 50 mg plėvele dengtos tabletės Zoloft 50 mg plėvele dengtos tabletės Zoloft 50 mg plėvele dengtos tabletės Zoloft 50 mg plėvele dengtos tabletės Zoloft 50 mg plėvele dengtos tabletės Zoloft 50 mg plėvele dengtos tabletės Serlain 100 mg Filmtabletten Serlain 50 mg Filmtabletten
MRP/DCP Authorisation number NL/H/1732/002
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
LT/1/96/2037/004
PFIZER LIMITED
LT
NL/H/1732/002
LT/1/96/2037/008
PFIZER LIMITED
LT
NL/H/1732/002
LT/1/96/2037/006
PFIZER LIMITED
LT
NL/H/1732/002
LT/1/96/2037/010
PFIZER LIMITED
LT
NL/H/1732/002
LT/1/96/2037/013
PFIZER LIMITED
LT
NL/H/1732/002
LT/1/96/2037/012
PFIZER LIMITED
LT
NL/H/1732/002
LT/1/96/2037/002
PFIZER LIMITED
LT
NL/H/1732/002
LT/1/96/2037/016
PFIZER LIMITED
LT
NL/H/1732/002
LT/1/96/2037/009
PFIZER LIMITED
LT
NL/H/1732/002
LT/1/96/2037/001
PFIZER LIMITED
LT
NL/H/1732/002
LT/1/96/2037/014
PFIZER LIMITED
LT
NL/H/1732/002
LT/1/96/2037/003
PFIZER LIMITED
LT
NL/H/1732/002
LT/1/96/2037/007
PFIZER LIMITED
LT
NL/H/1732/002
LT/1/96/2037/015
PFIZER LIMITED
LT
NL/H/1732/002
LT/1/96/2037/011
PFIZER LIMITED
LT
NL/H/1732/003
2011010936
PFIZER S.A. (BELGIUM)
LU
NL/H/1732/002
2011010935
PFIZER S.A. (BELGIUM)
LU
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Product Name (in authorisation country) Serlain 20 mg / ml Konzentrat zur Herstellung einer Lösung zum Einnehmen Serlain 100 mg comprimés pelliculés Serlain 50 mg comprimés pelliculés Serlain 20 mg/ml solution à diluer pour solution buvable Serlain 100 mg Filmtabletten Serlain 50 mg Filmtabletten Serlain 20 mg / ml Konzentrat zur Herstellung einer Lösung zum Einnehmen Serlain 100 mg comprimés pelliculés Serlain 50 mg comprimés pelliculés Serlain 20 mg/ml solution à diluer pour solution buvable Zoloft 50 mg apvalkotās tabletes Zoloft 50 mg apvalkotās tabletes Lustral 100 mg film coated tablets Lustral 50 mg film coated tablets Lustral 100 mg film coated tablets
MRP/DCP Authorisation number NL/H/1732/004
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
2011010938
PFIZER S.A. (BELGIUM)
LU
NL/H/1732/003
2011010936
PFIZER S.A. (BELGIUM)
LU
NL/H/1732/002
2011010935
PFIZER S.A. (BELGIUM)
LU
NL/H/1732/004
2011010938
PFIZER S.A. (BELGIUM)
LU
NL/H/1732/003
2011010936
PFIZER S.A. (BELGIUM)
LU
NL/H/1732/002
2011010935
PFIZER S.A. (BELGIUM)
LU
NL/H/1732/004
2011010938
PFIZER S.A. (BELGIUM)
LU
NL/H/1732/003
2011010936
PFIZER S.A. (BELGIUM)
LU
NL/H/1732/002
2011010935
PFIZER S.A. (BELGIUM)
LU
NL/H/1732/004
2011010938
PFIZER S.A. (BELGIUM)
LU
NL/H/1732/002
97-0311
PFIZER LIMITED
LV
NL/H/1732/002
97-0311
PFIZER LIMITED
LV
NL/H/1732/003
MA 505/03202
PFIZER HELLAS, A.E.
MT
NL/H/1732/002
MA 505/03201
PFIZER HELLAS, A.E.
MT
NL/H/1732/003
MA 505/03202
PFIZER HELLAS, A.E.
MT
List of nationally authorised medicinal products EMA/173192/2017
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Product Name (in authorisation country) Lustral 50 mg film coated tablets Zoloft 20 mg/ml, concentraat voor oplossing voor oraal gebruik Zoloft 50, filmomhulde tabletten 50 mg Zoloft 25, filmomhulde tabletten 25 mg Zoloft 100, filmomhulde tabletten 100 mg Zoloft 20 mg/ml, concentraat voor oplossing voor oraal gebruik Zoloft 50, filmomhulde tabletten 50 mg Zoloft 25, filmomhulde tabletten 25 mg Zoloft 100, filmomhulde tabletten 100 mg Sertraline Pfizer 100 mg, filmomhulde tabletten Sertraline Pfizer 50 mg, filmomhulde tabletten Sertraline Pfizer 20 mg/ml, concentraat voor oplossing voor oraal gebruik Sertraline Pfizer 25 mg, filmomhulde tabletten Zoloft 50 mg filmdrasjerte tabletter Zoloft 100 mg filmdrasjerte tabletter
MRP/DCP Authorisation number NL/H/1732/002
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
MA 505/03201
PFIZER HELLAS, A.E.
MT
NL/H/1732/004
RVG 24641
PFIZER B.V.
NL
NL/H/1732/002
RVG 16292
PFIZER B.V.
NL
NL/H/1732/001
RVG 105254
PFIZER B.V.
NL
NL/H/1732/003
RVG 105255
PFIZER B.V.
NL
NL/H/1732/004
RVG 24641
PFIZER B.V.
NL
NL/H/1732/002
RVG 16292
PFIZER B.V.
NL
NL/H/1732/001
RVG 105254
PFIZER B.V.
NL
NL/H/1732/003
RVG 105255
PFIZER B.V.
NL
NL/H/1736/002
RVG 105382
PFIZER B.V.
NL
NL/H/1736/001
RVG 105381
PFIZER B.V.
NL
NL/H/1736/003
RVG 105383
PFIZER B.V.
NL
NL/H/1736/004
RVG 106062
PFIZER B.V.
NL
NL/H/1732/002
00-8203
PFIZER AS
NO
NL/H/1732/003
00-8204
PFIZER AS
NO
List of nationally authorised medicinal products EMA/173192/2017
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Product Name (in authorisation country) Zoloft 25 mg filmdrasjerte tabletter Zoloft 20 mg/ml konsentrat til mikstur, oppløsning Zoloft 50 mg filmdrasjerte tabletter Zoloft 100 mg filmdrasjerte tabletter Zoloft 25 mg filmdrasjerte tabletter Zoloft 20 mg/ml konsentrat til mikstur, oppløsning ZOLOFT, 50 mg, tabletki powlekane ZOLOFT, 100 mg, tabletki powlekane ZOLOFT, 50 mg, tabletki powlekane ZOLOFT, 100 mg, tabletki powlekane Zoloft 50 mg comprimidos revestidos por película Zoloft 50 mg comprimidos revestidos por película Zoloft 50 mg comprimidos revestidos por película Zoloft 50 mg comprimidos revestidos por película
MRP/DCP Authorisation number NL/H/1732/001
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
00-7908
PFIZER AS
NO
NL/H/1732/004
99-6843
PFIZER AS
NO
NL/H/1732/002
00-8203
PFIZER AS
NO
NL/H/1732/003
00-8204
PFIZER AS
NO
NL/H/1732/001
00-7908
PFIZER AS
NO
NL/H/1732/004
99-6843
PFIZER AS
NO
NL/H/1732/002
7531
PFIZER EUROPE MA EEIG
PL
NL/H/1732/003
7532
PFIZER EUROPE MA EEIG
PL
NL/H/1732/002
7531
PFIZER EUROPE MA EEIG
PL
NL/H/1732/003
7532
PFIZER EUROPE MA EEIG
PL
NL/H/1732/002
2182780
LABORATÓRIOS PFIZER, LDA.
PT
NL/H/1732/002
5854385
LABORATÓRIOS PFIZER, LDA.
PT
NL/H/1732/002
5830989
LABORATÓRIOS PFIZER, LDA.
PT
NL/H/1732/002
2182681
LABORATÓRIOS PFIZER, LDA.
PT
List of nationally authorised medicinal products EMA/173192/2017
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Product Name (in authorisation country) Zoloft 100 mg comprimidos revestidos por película Zoloft 100 mg comprimidos revestidos por película Zoloft 100 mg comprimidos revestidos por película Zoloft 20 mg/ml concentrado para solução oral Zoloft 50 mg comprimidos revestidos por película Zoloft 50 mg comprimidos revestidos por película Zoloft 50 mg comprimidos revestidos por película Zoloft 50 mg comprimidos revestidos por película Zoloft 100 mg comprimidos revestidos por película Zoloft 100 mg comprimidos revestidos por película Zoloft 100 mg comprimidos revestidos por película Zoloft 20 mg/ml concentrado para solução oral
MRP/DCP Authorisation number NL/H/1732/003
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
5854484
LABORATÓRIOS PFIZER, LDA.
PT
NL/H/1732/003
2182889
LABORATÓRIOS PFIZER, LDA.
PT
NL/H/1732/003
2182988
LABORATÓRIOS PFIZER, LDA.
PT
NL/H/1732/004
3268083
LABORATÓRIOS PFIZER, LDA.
PT
NL/H/1732/002
2182780
LABORATÓRIOS PFIZER, LDA.
PT
NL/H/1732/002
5854385
LABORATÓRIOS PFIZER, LDA.
PT
NL/H/1732/002
5830989
LABORATÓRIOS PFIZER, LDA.
PT
NL/H/1732/002
2182681
LABORATÓRIOS PFIZER, LDA.
PT
NL/H/1732/003
5854484
LABORATÓRIOS PFIZER, LDA.
PT
NL/H/1732/003
2182889
LABORATÓRIOS PFIZER, LDA.
PT
NL/H/1732/003
2182988
LABORATÓRIOS PFIZER, LDA.
PT
NL/H/1732/004
3268083
LABORATÓRIOS PFIZER, LDA.
PT
List of nationally authorised medicinal products EMA/173192/2017
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Product Name (in authorisation country) Zoloft 50 mg comprimate filmate Zoloft 50 mg comprimate filmate Zoloft 100 mg comprimate filmate Zoloft 100 mg comprimate filmate Zoloft 100 mg comprimate filmate Zoloft 50 mg comprimate filmate Zoloft 100 mg comprimate filmate Zoloft 100 mg comprimate filmate Zoloft 50 mg comprimate filmate Zoloft 100 mg comprimate filmate Zoloft 50 mg comprimate filmate Zoloft 100 mg comprimate filmate Zoloft 50 mg comprimate filmate Zoloft 100 mg comprimate filmate Zoloft 50 mg comprimate filmate Zoloft 100 mg comprimate filmate Zoloft 50 mg comprimate filmate Zoloft 50 mg comprimate filmate
MRP/DCP Authorisation number NL/H/1732/002
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
8227/2015/02
PFIZER EUROPE MA EEIG
RO
NL/H/1732/002
8227/2015/14
PFIZER EUROPE MA EEIG
RO
NL/H/1732/003
8228/2015/02
PFIZER EUROPE MA EEIG
RO
NL/H/1732/003
8228/2015/14
PFIZER EUROPE MA EEIG
RO
NL/H/1732/003
8228/2015/16
PFIZER EUROPE MA EEIG
RO
NL/H/1732/002
8227/2015/16
PFIZER EUROPE MA EEIG
RO
NL/H/1732/003
8228/2015/04
PFIZER EUROPE MA EEIG
RO
NL/H/1732/003
8228/2015/10
PFIZER EUROPE MA EEIG
RO
NL/H/1732/002
8227/2015/10
PFIZER EUROPE MA EEIG
RO
NL/H/1732/003
8228/2015/08
PFIZER EUROPE MA EEIG
RO
NL/H/1732/002
8227/2015/12
PFIZER EUROPE MA EEIG
RO
NL/H/1732/003
8228/2015/06
PFIZER EUROPE MA EEIG
RO
NL/H/1732/002
8227/2015/03
PFIZER EUROPE MA EEIG
RO
NL/H/1732/003
8228/2015/12
PFIZER EUROPE MA EEIG
RO
NL/H/1732/002
8227/2015/15
PFIZER EUROPE MA EEIG
RO
NL/H/1732/003
8228/2015/03
PFIZER EUROPE MA EEIG
RO
NL/H/1732/002
8227/2015/11
PFIZER EUROPE MA EEIG
RO
NL/H/1732/002
8227/2015/01
PFIZER EUROPE MA EEIG
RO
List of nationally authorised medicinal products EMA/173192/2017
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Product Name (in authorisation country) Zoloft 100 mg comprimate filmate Zoloft 50 mg comprimate filmate Zoloft 100 mg comprimate filmate Zoloft 100 mg comprimate filmate Zoloft 100 mg comprimate filmate Zoloft 100 mg comprimate filmate Zoloft 100 mg comprimate filmate Zoloft 20 mg/ml concentrat pentru soluţie orală Zoloft 100 mg comprimate filmate Zoloft 50 mg comprimate filmate Zoloft 50 mg comprimate filmate Zoloft 50 mg comprimate filmate Zoloft 50 mg comprimate filmate Zoloft 50 mg comprimate filmate Zoloft 50 mg comprimate filmate Zoloft 50 mg comprimate filmate Zoloft 50 mg comprimate filmate
MRP/DCP Authorisation number NL/H/1732/003
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
8228/2015/01
PFIZER EUROPE MA EEIG
RO
NL/H/1732/002
8227/2015/13
PFIZER EUROPE MA EEIG
RO
NL/H/1732/003
8228/2015/07
PFIZER EUROPE MA EEIG
RO
NL/H/1732/003
8228/2015/11
PFIZER EUROPE MA EEIG
RO
NL/H/1732/003
8228/2015/09
PFIZER EUROPE MA EEIG
RO
NL/H/1732/003
8228/2015/15
PFIZER EUROPE MA EEIG
RO
NL/H/1732/003
8228/2015/05
PFIZER EUROPE MA EEIG
RO
NL/H/1732/004
8229/2015/01
PFIZER EUROPE MA EEIG
RO
NL/H/1732/003
8228/2015/13
PFIZER EUROPE MA EEIG
RO
NL/H/1732/002
8227/2015/05
PFIZER EUROPE MA EEIG
RO
NL/H/1732/002
8227/2015/09
PFIZER EUROPE MA EEIG
RO
NL/H/1732/002
8227/2015/07
PFIZER EUROPE MA EEIG
RO
NL/H/1732/002
8227/2015/06
PFIZER EUROPE MA EEIG
RO
NL/H/1732/002
8227/2015/04
PFIZER EUROPE MA EEIG
RO
NL/H/1732/002
8227/2015/08
PFIZER EUROPE MA EEIG
RO
NL/H/1732/002
8227/2015/02
PFIZER EUROPE MA EEIG
RO
NL/H/1732/002
8227/2015/14
PFIZER EUROPE MA EEIG
RO
List of nationally authorised medicinal products EMA/173192/2017
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Product Name (in authorisation country) Zoloft 100 mg comprimate filmate Zoloft 100 mg comprimate filmate Zoloft 100 mg comprimate filmate Zoloft 50 mg comprimate filmate Zoloft 100 mg comprimate filmate Zoloft 100 mg comprimate filmate Zoloft 50 mg comprimate filmate Zoloft 100 mg comprimate filmate Zoloft 50 mg comprimate filmate Zoloft 100 mg comprimate filmate Zoloft 50 mg comprimate filmate Zoloft 100 mg comprimate filmate Zoloft 50 mg comprimate filmate Zoloft 100 mg comprimate filmate Zoloft 50 mg comprimate filmate Zoloft 50 mg comprimate filmate Zoloft 100 mg comprimate filmate Zoloft 50 mg comprimate filmate
MRP/DCP Authorisation number NL/H/1732/003
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
8228/2015/02
PFIZER EUROPE MA EEIG
RO
NL/H/1732/003
8228/2015/14
PFIZER EUROPE MA EEIG
RO
NL/H/1732/003
8228/2015/16
PFIZER EUROPE MA EEIG
RO
NL/H/1732/002
8227/2015/16
PFIZER EUROPE MA EEIG
RO
NL/H/1732/003
8228/2015/04
PFIZER EUROPE MA EEIG
RO
NL/H/1732/003
8228/2015/10
PFIZER EUROPE MA EEIG
RO
NL/H/1732/002
8227/2015/10
PFIZER EUROPE MA EEIG
RO
NL/H/1732/003
8228/2015/08
PFIZER EUROPE MA EEIG
RO
NL/H/1732/002
8227/2015/12
PFIZER EUROPE MA EEIG
RO
NL/H/1732/003
8228/2015/06
PFIZER EUROPE MA EEIG
RO
NL/H/1732/002
8227/2015/03
PFIZER EUROPE MA EEIG
RO
NL/H/1732/003
8228/2015/12
PFIZER EUROPE MA EEIG
RO
NL/H/1732/002
8227/2015/15
PFIZER EUROPE MA EEIG
RO
NL/H/1732/003
8228/2015/03
PFIZER EUROPE MA EEIG
RO
NL/H/1732/002
8227/2015/11
PFIZER EUROPE MA EEIG
RO
NL/H/1732/002
8227/2015/01
PFIZER EUROPE MA EEIG
RO
NL/H/1732/003
8228/2015/01
PFIZER EUROPE MA EEIG
RO
NL/H/1732/002
8227/2015/13
PFIZER EUROPE MA EEIG
RO
List of nationally authorised medicinal products EMA/173192/2017
Page 17/24
Product Name (in authorisation country) Zoloft 100 mg comprimate filmate Zoloft 100 mg comprimate filmate Zoloft 100 mg comprimate filmate Zoloft 100 mg comprimate filmate Zoloft 100 mg comprimate filmate Zoloft 20 mg/ml concentrat pentru soluţie orală Zoloft 100 mg comprimate filmate Zoloft 50 mg comprimate filmate Zoloft 50 mg comprimate filmate Zoloft 50 mg comprimate filmate Zoloft 50 mg comprimate filmate Zoloft 50 mg comprimate filmate Zoloft 50 mg comprimate filmate Zoloft 100 mg filmdragerad tablett Zoloft 50 mg filmdragerad tablett Zoloft 25 mg filmdragerad tablett Zoloft 20 mg/ml koncentrat till oral lösning
MRP/DCP Authorisation number NL/H/1732/003
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
8228/2015/07
PFIZER EUROPE MA EEIG
RO
NL/H/1732/003
8228/2015/11
PFIZER EUROPE MA EEIG
RO
NL/H/1732/003
8228/2015/09
PFIZER EUROPE MA EEIG
RO
NL/H/1732/003
8228/2015/15
PFIZER EUROPE MA EEIG
RO
NL/H/1732/003
8228/2015/05
PFIZER EUROPE MA EEIG
RO
NL/H/1732/004
8229/2015/01
PFIZER EUROPE MA EEIG
RO
NL/H/1732/003
8228/2015/13
PFIZER EUROPE MA EEIG
RO
NL/H/1732/002
8227/2015/05
PFIZER EUROPE MA EEIG
RO
NL/H/1732/002
8227/2015/09
PFIZER EUROPE MA EEIG
RO
NL/H/1732/002
8227/2015/07
PFIZER EUROPE MA EEIG
RO
NL/H/1732/002
8227/2015/06
PFIZER EUROPE MA EEIG
RO
NL/H/1732/002
8227/2015/04
PFIZER EUROPE MA EEIG
RO
NL/H/1732/002
8227/2015/08
PFIZER EUROPE MA EEIG
RO
NL/H/1732/003
12567
PFIZER AB
SE
NL/H/1732/002
12566
PFIZER AB
SE
NL/H/1732/001
16689
PFIZER AB
SE
NL/H/1732/004
15504
PFIZER AB
SE
List of nationally authorised medicinal products EMA/173192/2017
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Product Name (in authorisation country) Zoloft 100 mg filmdragerad tablett Zoloft 50 mg filmdragerad tablett Zoloft 25 mg filmdragerad tablett Zoloft 20 mg/ml koncentrat till oral lösning Zoloft 100 mg filmsko obložene tablete Zoloft 100 mg filmsko obložene tablete Zoloft 100 mg filmsko obložene tablete Zoloft 100 mg filmsko obložene tablete Zoloft 100 mg filmsko obložene tablete Zoloft 100 mg filmsko obložene tablete Zoloft 100 mg filmsko obložene tablete Zoloft 100 mg filmsko obložene tablete Zoloft 100 mg filmsko obložene tablete Zoloft 50 mg filmsko obložene tablete Zoloft 100 mg filmsko obložene tablete Zoloft 100 mg filmsko obložene tablete Zoloft 100 mg filmsko obložene tablete
MRP/DCP Authorisation number NL/H/1732/003
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
12567
PFIZER AB
SE
NL/H/1732/002
12566
PFIZER AB
SE
NL/H/1732/001
16689
PFIZER AB
SE
NL/H/1732/004
15504
PFIZER AB
SE
NL/H/1732/003
H/94/01718/017
PFIZER LUXEMBOURG SARL
SI
NL/H/1732/003
H/94/01718/032
PFIZER LUXEMBOURG SARL
SI
NL/H/1732/003
H/94/01718/022
PFIZER LUXEMBOURG SARL
SI
NL/H/1732/003
H/94/01718/018
PFIZER LUXEMBOURG SARL
SI
NL/H/1732/003
H/94/01718/020
PFIZER LUXEMBOURG SARL
SI
NL/H/1732/003
H/94/01718/025
PFIZER LUXEMBOURG SARL
SI
NL/H/1732/003
H/94/01718/021
PFIZER LUXEMBOURG SARL
SI
NL/H/1732/003
H/94/01718/028
PFIZER LUXEMBOURG SARL
SI
NL/H/1732/003
H/94/01718/019
PFIZER LUXEMBOURG SARL
SI
NL/H/1732/002
H/94/01718/002
PFIZER LUXEMBOURG SARL
SI
NL/H/1732/003
H/94/01718/026
PFIZER LUXEMBOURG SARL
SI
NL/H/1732/003
H/94/01718/024
PFIZER LUXEMBOURG SARL
SI
NL/H/1732/003
H/94/01718/029
PFIZER LUXEMBOURG SARL
SI
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Product Name (in authorisation country) Zoloft 100 mg filmsko obložene tablete Zoloft 100 mg filmsko obložene tablete Zoloft 100 mg filmsko obložene tablete Zoloft 100 mg filmsko obložene tablete Zoloft 50 mg filmsko obložene tablete Zoloft 50 mg filmsko obložene tablete Zoloft 50 mg filmsko obložene tablete Zoloft 50 mg filmsko obložene tablete Zoloft 50 mg filmsko obložene tablete Zoloft 50 mg filmsko obložene tablete Zoloft 50 mg filmsko obložene tablete Zoloft 50 mg filmsko obložene tablete Zoloft 50 mg filmsko obložene tablete Zoloft 50 mg filmsko obložene tablete Zoloft 50 mg filmsko obložene tablete Zoloft 50 mg filmsko obložene tablete Zoloft 50 mg filmsko obložene tablete Zoloft 50 mg filmsko obložene tablete
MRP/DCP Authorisation number NL/H/1732/003
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
H/94/01718/027
PFIZER LUXEMBOURG SARL
SI
NL/H/1732/003
H/94/01718/023
PFIZER LUXEMBOURG SARL
SI
NL/H/1732/003
H/94/01718/031
PFIZER LUXEMBOURG SARL
SI
NL/H/1732/003
H/94/01718/030
PFIZER LUXEMBOURG SARL
SI
NL/H/1732/002
H/94/01718/001
PFIZER LUXEMBOURG SARL
SI
NL/H/1732/002
H/94/01718/012
PFIZER LUXEMBOURG SARL
SI
NL/H/1732/002
H/94/01718/006
PFIZER LUXEMBOURG SARL
SI
NL/H/1732/002
H/94/01718/009
PFIZER LUXEMBOURG SARL
SI
NL/H/1732/002
H/94/01718/011
PFIZER LUXEMBOURG SARL
SI
NL/H/1732/002
H/94/01718/004
PFIZER LUXEMBOURG SARL
SI
NL/H/1732/002
H/94/01718/016
PFIZER LUXEMBOURG SARL
SI
NL/H/1732/002
H/94/01718/007
PFIZER LUXEMBOURG SARL
SI
NL/H/1732/002
H/94/01718/015
PFIZER LUXEMBOURG SARL
SI
NL/H/1732/002
H/94/01718/013
PFIZER LUXEMBOURG SARL
SI
NL/H/1732/002
H/94/01718/008
PFIZER LUXEMBOURG SARL
SI
NL/H/1732/002
H/94/01718/010
PFIZER LUXEMBOURG SARL
SI
NL/H/1732/002
H/94/01718/014
PFIZER LUXEMBOURG SARL
SI
NL/H/1732/002
H/94/01718/005
PFIZER LUXEMBOURG SARL
SI
List of nationally authorised medicinal products EMA/173192/2017
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Product Name (in authorisation country) Zoloft 50 mg filmsko obložene tablete Zoloft 20 mg/ml koncentrat za peroralno raztopino Zoloft 100 mg filmsko obložene tablete Zoloft 100 mg filmsko obložene tablete Zoloft 100 mg filmsko obložene tablete Zoloft 100 mg filmsko obložene tablete Zoloft 100 mg filmsko obložene tablete Zoloft 100 mg filmsko obložene tablete Zoloft 100 mg filmsko obložene tablete Zoloft 100 mg filmsko obložene tablete Zoloft 100 mg filmsko obložene tablete Zoloft 50 mg filmsko obložene tablete Zoloft 100 mg filmsko obložene tablete Zoloft 100 mg filmsko obložene tablete Zoloft 100 mg filmsko obložene tablete Zoloft 100 mg filmsko obložene tablete Zoloft 100 mg filmsko obložene tablete
MRP/DCP Authorisation number NL/H/1732/002
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
H/94/01718/003
PFIZER LUXEMBOURG SARL
SI
NL/H/1732/004
H/94/01718/033
PFIZER LUXEMBOURG SARL
SI
NL/H/1732/003
H/94/01718/017
PFIZER LUXEMBOURG SARL
SI
NL/H/1732/003
H/94/01718/032
PFIZER LUXEMBOURG SARL
SI
NL/H/1732/003
H/94/01718/022
PFIZER LUXEMBOURG SARL
SI
NL/H/1732/003
H/94/01718/018
PFIZER LUXEMBOURG SARL
SI
NL/H/1732/003
H/94/01718/020
PFIZER LUXEMBOURG SARL
SI
NL/H/1732/003
H/94/01718/025
PFIZER LUXEMBOURG SARL
SI
NL/H/1732/003
H/94/01718/021
PFIZER LUXEMBOURG SARL
SI
NL/H/1732/003
H/94/01718/028
PFIZER LUXEMBOURG SARL
SI
NL/H/1732/003
H/94/01718/019
PFIZER LUXEMBOURG SARL
SI
NL/H/1732/002
H/94/01718/002
PFIZER LUXEMBOURG SARL
SI
NL/H/1732/003
H/94/01718/026
PFIZER LUXEMBOURG SARL
SI
NL/H/1732/003
H/94/01718/024
PFIZER LUXEMBOURG SARL
SI
NL/H/1732/003
H/94/01718/029
PFIZER LUXEMBOURG SARL
SI
NL/H/1732/003
H/94/01718/027
PFIZER LUXEMBOURG SARL
SI
NL/H/1732/003
H/94/01718/023
PFIZER LUXEMBOURG SARL
SI
List of nationally authorised medicinal products EMA/173192/2017
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Product Name (in authorisation country) Zoloft 100 mg filmsko obložene tablete Zoloft 100 mg filmsko obložene tablete Zoloft 50 mg filmsko obložene tablete Zoloft 50 mg filmsko obložene tablete Zoloft 50 mg filmsko obložene tablete Zoloft 50 mg filmsko obložene tablete Zoloft 50 mg filmsko obložene tablete Zoloft 50 mg filmsko obložene tablete Zoloft 50 mg filmsko obložene tablete Zoloft 50 mg filmsko obložene tablete Zoloft 50 mg filmsko obložene tablete Zoloft 50 mg filmsko obložene tablete Zoloft 50 mg filmsko obložene tablete Zoloft 50 mg filmsko obložene tablete Zoloft 50 mg filmsko obložene tablete Zoloft 50 mg filmsko obložene tablete Zoloft 50 mg filmsko obložene tablete
MRP/DCP Authorisation number NL/H/1732/003
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
H/94/01718/031
PFIZER LUXEMBOURG SARL
SI
NL/H/1732/003
H/94/01718/030
PFIZER LUXEMBOURG SARL
SI
NL/H/1732/002
H/94/01718/001
PFIZER LUXEMBOURG SARL
SI
NL/H/1732/002
H/94/01718/012
PFIZER LUXEMBOURG SARL
SI
NL/H/1732/002
H/94/01718/006
PFIZER LUXEMBOURG SARL
SI
NL/H/1732/002
H/94/01718/009
PFIZER LUXEMBOURG SARL
SI
NL/H/1732/002
H/94/01718/011
PFIZER LUXEMBOURG SARL
SI
NL/H/1732/002
H/94/01718/004
PFIZER LUXEMBOURG SARL
SI
NL/H/1732/002
H/94/01718/016
PFIZER LUXEMBOURG SARL
SI
NL/H/1732/002
H/94/01718/007
PFIZER LUXEMBOURG SARL
SI
NL/H/1732/002
H/94/01718/015
PFIZER LUXEMBOURG SARL
SI
NL/H/1732/002
H/94/01718/013
PFIZER LUXEMBOURG SARL
SI
NL/H/1732/002
H/94/01718/008
PFIZER LUXEMBOURG SARL
SI
NL/H/1732/002
H/94/01718/010
PFIZER LUXEMBOURG SARL
SI
NL/H/1732/002
H/94/01718/014
PFIZER LUXEMBOURG SARL
SI
NL/H/1732/002
H/94/01718/005
PFIZER LUXEMBOURG SARL
SI
NL/H/1732/002
H/94/01718/003
PFIZER LUXEMBOURG SARL
SI
List of nationally authorised medicinal products EMA/173192/2017
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Product Name (in authorisation country)
MRP/DCP Authorisation number NL/H/1732/004
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
H/94/01718/033
PFIZER LUXEMBOURG SARL
SI
NL/H/1732/004
30/0207/01–S
PFIZER EUROPE MA EEIG
SK
NL/H/1732/003
30/0430/10–S
PFIZER EUROPE MA EEIG
SK
NL/H/1732/002
30/0090/96–S
PFIZER EUROPE MA EEIG
SK
NL/H/1732/004
30/0207/01–S
PFIZER EUROPE MA EEIG
SK
NL/H/1732/003
30/0430/10–S
PFIZER EUROPE MA EEIG
SK
NL/H/1732/002
30/0090/96–S
PFIZER EUROPE MA EEIG
SK
NL/H/1732/002
PL 00057/0308
PFIZER LIMITED
UK
NL/H/1732/003
PL 0057/0309
PFIZER LIMITED
UK
not available
PL 44041/0031
NOUMED LIFE SCIENCES
UK
not available
PL 44041/0032
NOUMED LIFE SCIENCES
UK
NL/H/1732/002
PL 00057/0308
PFIZER LIMITED
UK
NL/H/1732/003
PL 0057/0309
PFIZER LIMITED
UK
not available
PL 21880/0097
MEDREICH PLC
UK
Sertraline 100mg Tablets
not available
PL 21880/0098
MEDREICH PLC
UK
Sertraline 50 mg filmcoated tablet Sertraline 100 mg filmcoated tablet
not available
PL 11311/0491
UK
not available
PL 11311/0492
TILLOMED LABORATORIES LTD TILLOMED LABORATORIES LTD
Zoloft 20 mg/ml koncentrat za peroralno raztopino ZOLOFT OC 20 mg/ml koncentrát na perorálny roztok ZOLOFT 100 mg filmom obalené tablety ZOLOFT 50 mg filmom obalené tablety ZOLOFT OC 20 mg/ml koncentrát na perorálny roztok ZOLOFT 100 mg filmom obalené tablety ZOLOFT 50 mg filmom obalené tablety LUSTRAL® 50 mg film coated tablets LUSTRAL® 100 mg film coated tablets Sertraline 50 mg Filmcoated Tablets Sertraline 100mg Filmcoated Tablets LUSTRAL® 50 mg film coated tablets LUSTRAL® 100 mg film coated tablets Sertraline 50 mg Tablets
List of nationally authorised medicinal products EMA/173192/2017
UK
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Product Name (in authorisation country) Sertraline 100 mg film coated tablets Sertraline 50 mg film coated tablets
MRP/DCP Authorisation number NL/H/1736/002
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
PL 00057/1205
PFIZER LIMITED
UK
NL/H/1736/001
PL 00057/1204
PFIZER LIMITED
UK
List of nationally authorised medicinal products EMA/173192/2017
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