Summary of Community decisions on marketing authorisations in respect of medicinal products from 1 March 2009 to 31 March 2009 — (Decisions taken pursuant to Article 34 of Directive 2001/83/EC or Article 38 of Directive 2001/82/EC )
Date: 2009-05-01
Institutions: European Commission
Subjects: EU Member State, market approval, marketing standard, medicinal product, pharmaceutical legislation, withdrawal from the market








C_2009101EN.01001401.xml










1.5.2009   


EN


Official Journal of the European Union


C 101/14





Summary of Community decisions on marketing authorisations in respect of medicinal products from 1 March 2009 to 31 March 2009

(Decisions taken pursuant to Article 34 of Directive 2001/83/EC
 (1)
or Article 38 of Directive 2001/82/EC
 (2)
)

2009/C 101/04
—   Issuing, maintenance or modification of a national marketing authorisation










Date of the decision


Name(s) of the medicinal product


Holder(s) of the marketing authorisation


Member State concerned


Date of notification




4.3.2009


PhotoBarr







Axcan Pharma International BV,




Engelenkampstraat 72,




6131 JJ Sittard,




Nederland






This Decision is addressed to the Member States


5.3.2009




6.3.2009


Tritazide


See Annex I


See Annex I


10.3.2009




6.3.2009


Tritace


See Annex II


See Annex II


10.3.2009




6.3.2009


UMAN BIG


See Annex III


See Annex III


9.3.2009




12.3.2009


Bleomycin Pharmachemie


See Annex IV


See Annex IV


16.3.2009




12.3.2009


Sanohex


See Annex V


See Annex V


16.3.2009




12.3.2009


Sabumalin


See Annex VI


See Annex VI


16.3.2009




27.3.2009


Zoloft


See Annex VII


See Annex VII


31.3.2009






(1)  OJ L 311, 28.11.2001, p. 67.

(2)  OJ L 311, 28.11.2001, p. 1.


ANNEX I
LIST OF THE NAMES, PHARMACEUTICAL FORMS, STRENGTHS OF THE MEDICINAL PRODUCTS, ROUTES OF ADMINISTRATION, MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES










Member State EU/EEA


Marketing authorisation holder


(Invented)
name


Strength


Pharmaceutical form


Route of administration




Austria







SANOFI-AVENTIS GMBH OSTERREICH




SATURN Tower




Leonard-Bernstein-Straße 10




A-1220 Vienna




Austria






Tritazide 25 mg/125 mg Tabletten
Tritazide 5 mg/25 mg Tabletten


2,5 mg/12,5 mg
5 mg/25 mg


Tablet


Oral




Austria







AstraZeneca Österreich GmbH




Schwarzenbergplatz 7




A-1037 Wien




Austria






HYPREN PLUS
HYPREN PLUS FORTE


2,5 mg/12,5 mg
5 mg/25 mg


Tablets


Oral




Belgium







Sanofi-aventis Belgium




Culliganlaan 1C




1831 Diegem




Belgium






TRITAZIDE 5 mg – 25 mg, tabletten


5 mg/25 mg


Tablet


Oral




Bulgaria







AVENTIS PHARMA DEUTSCHLAND GMBH




D-65926 Frankfurt am Main




Germany






TRITACE 2,5 PLUS


2,5 mg/12,5 mg


Tablet


Oral




Bulgaria







SANOFI-AVENTIS BULGARIA EOOD




Alexandar Stamboliyski blvd. 103




office building Sofia Tower, fl. 8,




Sofia 1303




Bulgaria






TRITACE 2,5 PLUS
TRITACE 5 PLUS


2,5 mg/12,5 mg
5 mg/25 mg


Tablet


Oral




Cyprus







SANOFI-AVENTIS CYPRUS LTD




14, Charalambou Mouskou street




2015 – Nicosia




Cyprus






TRIATEC PLUS


5 mg/25 mg


Tablet


Oral




Czech Republic







sanofi-aventis, s.r.o.




Evropská 2590/33c




16000 Praha 6




Czech Republic






TRITAZIDE 2,5/12,5 mg
TRITAZIDE 5/25 mg


2,5 mg/12,5 mg
5 mg/25 mg


Tablet


Oral




Denmark







sanofi-aventis Denmark A/S




Slotsmarken 13




2970 Hørsholm




Denmark






TRIATEC COMP


5 mg/25 mg


Tablet


Oral




Estonia







SANOFI-AVENTIS DEUTSCHLAND GMBH




65926 Frankfurt am Main




Germany






CARDACE COMP


2,5 mg/12,5 mg


Tablet


Oral




Estonia







SANOFI-AVENTIS ESTONIA OÜ




Pärnu mnt. 139 E/211317 Tallinn




Estonia






CARDACE PLUS


5 mg/25 mg


Tablet


Oral




Finland







SANOFI-AVENTIS OY




Huopalahdentie 24




00350 Helsinki




Finland






CARDACE COMP


2,5 mg/12,5 mg


Tablet


Oral




France







SANOFI-AVENTIS France




1-13 boulevard Romain Rolland




75014 Paris




France






COTRIATEC


5 mg/12,5 mg


Tablet


Oral




Germany







SANOFI-AVENTIS DEUTSCHLAND GMBH




Brüningstraße 50




65926 Frankfurt am Main




Germany






Delix 2,5 plus
Delix 5 plus


2,5 mg/12,5 mg
5 mg/25 mg


Tablet


Oral




Germany







WINTHROP ARZNEIMITTEL GMBH




Urmitzer Str. 5




56218 Mülheim-Kärlich




Germany






Ramilich comp 2,5 mg/12,5 mg Tabletten
Ramilich comp 5 mg/25 mg Tabletten


2,5 mg/12,5 mg
5 mg/25 mg


Tablet


Oral




Germany







WINTHROP ARZNEIMITTEL GMBH




Urmitzer Str. 5




56218 Mülheim-Kärlich




Germany






RamiWin comp 2,5 mg/12,5 mg Tabletten
RamiWin comp 5 mg/25 mg Tabletten


2,5 mg/12,5 mg
5 mg/25 mg


Tablet


Oral




Germany







AstraZeneca GmbH




Tinsdaler Weg 183




22880 Wedel




Germany






Vesdil 2,5 Plus
Vesdil 5 Plus


2,5 mg/12,5 mg
5 mg/25 mg


Tablet


Oral




Greece







SANOFI-AVENTIS AEBE




348, Syggrou Avenue




Building A




176-74 Kallithea




Greece






TRIATEC PLUS
TRIATEC PLUS


2,5 mg/12,5 mg
5 mg/25 mg


Tablet


Oral




Hungary







SANOFI-AVENTIS PRIVATE CO LTD




H-1045 Budapest Tó u. 1.-5.




Hungary






TRITACE HCT 2,5/12,5 Tabletta
TRITACE HCT 5/25 Tabletta


2,5 mg/12,5 mg
5 mg/25 mg


Tablet


Oral




Hungary







Zentiva HU Kft




Népfürdő u. 22




1138 Budapest




Hungary






RAMIPRIL HCT – ZENTIVA 2,5 mg/12,5 mg
RAMIPRIL HCT – ZENTIVA 5 mg/25 mg


2,5 mg/12,5 mg
5 mg/25 mg


Tablet


Oral




Iceland


—


 


 


 


 




Ireland







sanofi-aventis Ireland Ltd.




Citywest Business Campus




Dublin 24




Ireland






TRITAZIDE Tablets 2,5 mg/12.5 mg


2,5 mg/12,5 mg


Tablet


Oral




Italy







SANOFI-AVENTIS SPA




Viale Bodio, 37/b




20158 Milano




Italy






TRIATEC HCT 2,5
TRIATEC HCT 5


2,5 mg/12,5 mg
5 mg/25 mg


Tablet


Oral




Italy







SANOFI-AVENTIS SPA




Viale Bodio, 37/b




20158 Milano




Italy






RAMIPRIL E IDROCLORITIAZIDE SANOFI-AVENTIS 2,5 mg/12,5 mg
RAMIPRIL E IDROCLORITIAZIDE SANOFI-AVENTIS 5 mg/25 mg


2,5 mg/12,5 mg
5 mg/25 mg


Tablet


Oral




Italy







AstraZeneca S.p.A




Palazzo Volta Via Francesco Sforza




20080 Basiglio (MI)




Italy






UNIPRIL DIUR
2,5 mg + 12,5 mg compresse
UNIPRILDIUR 5 mg + 25 mg compresse


2,5 mg/12,5 mg
5 mg/25 mg


Tablet


Oral




Italy







POLIFARMA SPA




Viale dell′Arte 69




00144 Roma




Italy






IDROQUARK
IDROQUARK


2,5 mg/12,5 mg
5 mg/25 mg


Tablet


Oral




Latvia


—


 


 


 


 




Lithuania


—


 


 


 


 




Luxembourg







Sanofi-aventis Belgium




Culliganlaan 1C




1831 Diegem




Belgium






TRITAZIDE


5 mg/25 mg


Tablet


Oral




Malta


—


 


 


 


 




Netherlands







SANOFI-AVENTIS NETHERLANDS B.V.




Kampenringweg 45 D-E (toren D en E)




NL-2803 PE Gouda




The Netherlands









P.O. Box 2043




NL-2800 BD Gouda




The Netherlands






TRITAZIDE Tabletten 5 mg/25 mg


5 mg/25 mg


Tablet


Oral




Norway


—


 


 


 


 




Poland







SANOFI-AVENTIS DEUTSCHLAND GMBH




D-65926 Frankfurt am Main




Germany






TRITACE 2,5 COMB
TRITACE 5 COMB


2,5 mg/12,5 mg
5 mg/25 mg


Tablet


Oral




Portugal







Sanofi-Aventis Produtos Farmacêuticos, s.a.




Empreendimento Lagoas Park,




Edifício 7 - 3o Piso




2740-244 Porto Salvo




Portugal






RAMICOR D 2,5
RAMICOR D 5


2,5 mg/12.,5 mg
5 mg/25 mg


Tablet


Oral




Portugal







Sanofi-Aventis Produtos Farmacêuticos, s.a.




Empreendimento Lagoas Park,




Edifício 7 - 3o Piso




2740-244 Porto Salvo




Portugal






TRIATEC COMPOSTO
TRIATEC COMPOSTO FORTE


2,5 mg/12,5 mg
5 mg/25 mg


Tablet


Oral




Romania







AVENTIS PHARMA DEUTSCHLAND GMBH




Brüningstraße 50




65926 Frankfurt am Main




Germany






TRITACE 2,5 PLUS
TRITACE 5 PLUS


2,5 mg/12,5 mg
5 mg/25 mg


Tablet


Oral




Slovak Republic







SANOFI-AVENTIS SLOVAKIA s.r.o.,




Žilinská 7-9




81105 Bratislava




Slovak Republic






TRITAZIDE
TRITAZIDE


2,5 mg/12,5 mg
5 mg/25 mg


Tablet


Oral




Slovenia







SANOFI-AVENTIS D.O.O.




Dunajska cesta 119




1000 Ljubljana




Slovenia






TRITAZIDE 2,5 5 mg/12,5 mg tablete
TRITAZIDE 5 mg/25 mg tablete


2,5 mg/12,5 mg
5 mg/25 mg


Tablet


Oral




Spain


—


 


 


 


 




Sweden







sanofi-aventis AB




Box 14142




167 14 Bromma




Sweden






TRIATEC COMP MITE
TRIATEC COMP


2,5 mg/12,5 mg
5 mg/25 mg


Tablet


Oral




United Kingdom


—


 


 


 


 







ANNEX II
LIST OF THE NAMES, PHARMACEUTICAL FORMS, STRENGTHS OF THE MEDICINAL PRODUCTS, ROUTES OF ADMINISTRATION, MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES










Member State EU/EEA


Marketing Authorisation Holder


(Invented)
name


Strength


Pharmaceutical Form


Route of administration




Austria







SANOFI-AVENTIS GMBH OSTERREICH




SATURN Tower




Leonard-Bernstein-Straße 10




A-1220 Vienna




Austria






Tritace 1,25 mg — Tabletten
Tritace 2,5 mg — Tabletten
Tritace 5 mg — Tabletten
Tritace 10 mg — Tabletten


1,25 mg
2,5 mg
5 mg
10 mg


Tablet


Oral




Austria







AstraZeneca Österreich GmbH




Schwarzenbergplatz 7




A-1037 Wien




Austria






HYPREN


1,25 mg
2,5 mg
5 mg


Capsule


Oral




Austria







AstraZeneca Österreich GmbH




Schwarzenbergplatz 7




A-1037 Wien




Austria






HYPREN


10 mg


Tablet


Oral




Belgium







SANOFI-AVENTIS BELGIUM




Culliganlaan 1C




B-1831 Diegem




Belgium






Tritace 1,25 mg, comprimés
Tritace 2,5 mg, comprimés
Tritace 5 mg, comprimés
Tritace 10 mg, comprimés


1,25 mg
2,5 mg
5 mg
10 mg


Tablet


Oral




Belgium







Aventis Pharma S.A.




Boulevard de la Plaine, 9




B-1050 Bruxelles






Tazko 5 mg, comprimés à liberation prolongée


5 mg


Prolonged-release tablet


Oral




Belgium







Aventis Pharma S.A.




Boulevard de la Plaine, 9




B-1050 Bruxelles






Tazko 2,5 mg, comprimés à liberation prolongée


2,5 mg


Prolonged-release tablet


Oral




Belgium







SANOFI-AVENTIS BELGIUM




Culliganlaan 1C




B-1831 Diegem




Belgium






Tritace 10


10 mg


Capsule


Oral




Belgium







NV AstraZeneca SA




Egide Van Ophemstraat 110




B-1180 Brussels




Belgium






Ramace 1,25 mg
Ramace 2,5 mg
Ramace 5 mg


1,25 mg
2,5 mg
5 mg


Tablet


Oral




Bulgaria







SANOFI-AVENTIS BULGARIA EOOD




Alexandar Stamboliyski blvd. 103




office building Sofia Tower, fl. 8, Sofia 1303




Bulgaria






Tritace 2,5
Tritace 5
Tritace 10


2,5 mg
5 mg
10 mg


Tablet


Oral




Cyprus







SANOFI-AVENTIS CYPRUS LTD




14 Charalambou Mouskou street




2015 – Nicosia




Cyprus






Triatec


2,5 mg
5 mg
10 mg


Tablet


Oral




Czech Republic







SANOFI-AVENTIS, S.R.O.




Evropská 2590/33c




16000 Praha 6




Czech Republic






Tritace 1,25
Tritace 2,5
Tritace 5
Tritace 10


1,25 mg
2,5 mg
5 mg
10 mg


Tablet


Oral




Czech Republic







AVENTIS PHARMA DEUTSCHLAND GMBH




Industriepark Höchst




65926 Frankfurt am Main




Germany






RAMIPRIL WINTHROP


1,25 mg
2,5 mg
5 mg


Capsule


Oral




Denmark







SANOFI-AVENTIS DENMARK




A/S Slotsmarken 13




DK-2970 Hoersholm




Denmark






Triatec


1,25 mg
2,5 mg
5 mg


Tablet


Oral




Denmark







SANOFI-AVENTIS DENMARK




A/S Slotsmarken 13




DK-2970 Hoersholm




Denmark






Triatec


10 mg


Capsule, hard


Oral




Estonia







SANOFI-AVENTIS ESTONIA OÜ




Pärnu mnt. 139 E/2 11317 Tallinn




Estonia






Cardace


5 mg
10 mg


Tablet


Oral




Estonia







SANOFI-AVENTIS DEUTSCHLAND GMBH




Industriepark Hoechst




D-65926 Frankfurt am Main




Germany






Cardace


2,5 mg


Tablet


Oral




Finland







SANOFI-AVENTIS OY




Huopalahdentie 24




00350 Helsinki




Finland






Cardace


1,25 mg
2,5 mg
5 mg
10 mg


Tablet


Oral




Finland







SANOFI-AVENTIS OY




Huopalahdentie 24




00350 Helsinki




Finland






Cardace


10 mg


Capsule


Oral




Finland







SANOFI-AVENTIS OY




Huopalahdentie 24




00350 Helsinki




Finland






Ramipril medgenerics 1,25 mg tabletti
Ramipril medgenerics 2,5 mg tabletti
Ramipril medgenerics 5 mg tabletti
Ramipril medgenerics 10 mg tabletti


1,25 mg
2,5 mg
5 mg
10 mg


Tablet


Oral




France







SANOFI- AVENTIS FRANCE




1-13, boulevard Romain Rolland




75014 Paris




France






Triatec 1,25 mg comprime
Triatec 2,5 mg comprime sécable
Triatec 5 mg comprime sécable
Triatec 10 mg comprime sécable
Triateckit, comprime sécable
Ramikit, comprime sécable


1,25 mg
2,5 mg
5 mg
10 mg
2,5 mg/5 mg/10 mg
2,5 mg/5 mg/10 mg


Tablet


Oral




France







SANOFI- AVENTIS FRANCE




1-13, boulevard Romain Rolland




75014 Paris




France






Triatec faible 1,25 mg, gélule
Triatec 2,5 mg, gélule
Triatec 5 mg, gélule


1,25 mg
2,5 mg
5 mg


Capsule


Oral




France







SANOFI- AVENTIS FRANCE




1-13, boulevard Romain Rolland




F-75014 Paris




France






Ramipril winthrop 1,25 mg
Ramipril winthrop 2,5 mg, comprime secable
Ramipril winthrop 5 mg, comprime secable
Ramipril winthrop 10 mg, comprime secable


1,25 mg
2,5 mg
5 mg
10 mg


Tablet


Oral




Germany







SANOFI-AVENTIS DEUTSCHLAND GMBH




Industriepark Hoechst




D-65926 Frankfurt am Main




Germany






Delix 2,5 mg Tabletten
Delix 5 mg Tabletten
Delix protect 10 mg Tabletten
Delix HOPE 10 mg Tabletten
Delix HOPE startset
Delix protect startset


2,5 mg
5 mg
10 mg
10 mg
2,5 mg/5 mg/10 mg
2,5 mg/5 mg/10 mg


Tablet


Oral




Germany







SANOFI-AVENTIS DEUTSCHLAND GMBH




Industriepark Hoechst




D-65926 Frankfurt am Main




Germany






Ramipril protect 2,5 mg Tabletten
Ramipril protect 5 mg Tabletten
Ramipril protect 10 mg Tabletten
Ramipril protect startset


2,5 mg
5 mg
10 mg
2,5 mg/5 mg/10 mg


Tablet


Oral




Germany







WINTHROP ARZNEIMITTEL GmbH




Urmitzer Str. 5




56218 Mülheim-Kärlich




Germany






Ramilich 2,5 mg Tabletten
Ramilich 5 mg Tabletten
Ramilich 10 mg Tabletten
Ramilich startset


2,5 mg
5 mg
10 mg
2,5 mg/5 mg/10 mg


Tablet


Oral




Germany







WINTHROP ARZNEIMITTEL GmbH




Urmitzer Str. 5




56218 Mülheim-Kärlich




Germany






RamiWin 2,5 mg Tabletten
RamiWin 5 mg Tabletten
RamiWin 10 mg Tabletten


2,5 mg
5 mg
10 mg


Tablet


Oral




Germany







AVENTIS PHARMA DEUTSCHLAND GmbH




65926 Frankfurt am Main




Germany






Delix 1,25 mg Tabletten


1,25 mg


Tablet


Oral




Germany







AVENTIS PHARMA DEUTSCHLAND GmbH




65926 Frankfurt am Main




Germany






Delix 1,25 mg Kapseln
Delix P 2,5 mg Kapseln
Delix P 5 mg Kapseln
Delix P 10 mg Kapseln


1,25 mg
2,5 mg
5 mg
10 mg


Capsule, hard


Oral




Germany







AstraZeneca GmbH




Tinsdaler Weg 183




22880 Wedel




Germany






Vesdil 1,25 mg Kapseln
Vesdil 2,5 mg kapseln
Vesdil 5 mg Kapseln


1,25 mg
2,5 mg
5 mg


Capsule, hard


Oral




Germany







AstraZeneca GmbH




Tinsdaler Weg 183




22880 Wedel




Germany






Vesdil 1,25 mg Tabletten
Vesdil 2,5 mg Tabletten
Vesdil N 2,5 mg Tabletten
Vedil 5 mg Tabletten
Vesdil N 5 mg Tabletten
Vesdil protect 10 mg Tabletten


1,25 mg
2,5 mg
2,5 mg
5 mg
5 mg
10 mg


Tablets


Oral




Greece







SANOFI-AVENTIS AEBE




348, Syngrou Av.-Building A




176 74 Kallithea




Greece






Triatec


1,25 mg
2,5 mg
5 mg
10 mg


Tablet


Oral




Hungary







SANOFI-AVENTIS PRIVATE CO LTD




H-1045 Budapest Tó u. 1.-5.




Hungary






Tritace mite 1,25 mg tablet
Tritace 2,5 mg tablet
Tritace 5 mg tablet
Tritace 10 mg tablet


1,25 mg
2,5 mg
5 mg
10 mg


Tablet


Oral




Hungary







SANOFI-AVENTIS PRIVATE CO LTD




H-1045 Budapest Tó u. 1.-5.




Hungary






Ramipril prevent 1,25 mg tablet
Ramipril prevent 2,5 mg tablet
Ramipril prevent 5 mg tablet
Ramipril prevent 10 mg tablet


1,25 mg
2,5 mg
5 mg
10 mg


Tablet


Oral




Hungary







Zentiva HU Kft




Népfürdo u.22




1138 Budapest




Hungary






Ramipril — Zentiva 1,25 mg
Ramipril — Zentiva 2,5 mg
Ramipril — Zentiva 5 mg
Ramipril — Zentiva 10 mg


1,25 mg
2,5 mg
5 mg
10 mg


Tablet


Oral




Iceland


—


 


 


 


 




Ireland







Sanofi-Aventis Ireland Ltd.




Citywest Business Campus,




Dublin 24




Ireland






Tritace 1,25 mg tablets
Tritace 2,5 mg tablets
Tritace 5 mg tablets
Tritace 10 mg tablets


1,25 mg
2,5 mg
5 mg
10 mg


Tablet


Oral




Ireland







Sanofi-Aventis Ireland Ltd.




Citywest Business Campus




Dublin 24




Ireland






Tritace 1,25 mg capsules
Tritace 2,5 mg capsules
Tritace 5 mg capsules
Tritace 10 mg capsules


1,25 mg
2,5 mg
5 mg
10 mg


Capsule


Oral




Ireland







Sanofi-Aventis Ireland Ltd.




Citywest Business Campus




Dublin 24




Ireland






Loavel 1,25 mg
Loavel 2,5 mg
Loavel 5 mg
Loavel 10 mg


1,25 mg
2,5 mg
5 mg
10 mg


Tablet


Oral




Ireland







Sanofi-Aventis Ireland Ltd.




Citywest Business Campus




Dublin 24




Ireland






Loavel 1,25 mg capsules
Loavel 2,5 mg capsules
Loavel 5 mg capsules
Loavel 10 mg capsules


1,25 mg
2,5 mg
5 mg
10 mg


Capsule


Oral




Ireland







Sanofi-Aventis Ireland Ltd.




Citywest Business Campus




Dublin 24




Ireland






Ramipril 1,25 mg tablets
Ramipril 2,5 mg tablets
Ramipril 5 mg tablets
Ramipril 10 mg tablets


1,25 mg
2,5 mg
5 mg
10 mg


Tablet


Oral




Ireland







Sanofi-Aventis Ireland Ltd.




Citywest Business Campus




Dublin 24




Ireland






Ramipril 1,25 mg capsules
Ramipril 2,5 mg capsules
Ramipril 5 mg capsules
Ramipril 10 mg capsules


1,25 mg
2,5 mg
5 mg
10 mg


Capsule


Oral




Italy







SANOFI-AVENTIS SPA




Viale Bodio, 37/b




20158 Milano




Italy






Triatec 1,25
Triatec
Triatec 5
Triatec
Ramipril sanofi-aventis


1,25 mg
2,5 mg
5 mg
10 mg
1,25 mg
2,5 mg
5 mg
10 mg


Tablet


Oral




Italy







AstraZeneca S.p.A




Palazzo Volta Via Francesco Sforza 20080 Basiglio (MI)




Italy






Unipril 1,25 mg compresse
Unipril 2,5 mg compresse
Unipril 5 mg compresse
Unipril 10 mg compresse


1,25 mg
2,5 mg
5 mg
10 mg


Tablet


Oral




Italy







Polifarma S.p.A.




Viale Dell’ Arte, 69




I – 00144 Roma




Italy






Quark
Quark
Quark
Quark


1,25 mg
2,5 mg
5 mg
10 mg


Tablet


Oral




Latvia







Sanofi-Aventis Latvia SIA




Kr.Valdemara 33-8




LV1010 - Riga




Latvia






Cardace


2,5 mg
5 mg
10 mg


Tablet


Oral




Lithuania







UAB SANOFI-AVENTIS LIETUVA




A. Juozapavičiaus g. 6/2




LT-09310 Vilnius




Lithuania






Cardace


2,5 mg
5 mg
10 mg


Tablet


Oral




Luxembourg







SANOFI-AVENTIS BELGIUM




Culliganlaan 1C




B-1831 Diegem




Belgium






Tritace 1,25 mg, comprimés
Tritace 2,5 mg, comprimés
Tritace 5 mg, comprimés
Tritace 10 mg, comprimés


1,25 mg
2,5 mg
5 mg
10 mg


Tablet


Oral




Luxembourg







SANOFI-AVENTIS BELGIUM




Culliganlaan 1C




B-1831 Diegem




Belgium






Tritace


10 mg


Capsule


Oral




Luxembourg







NV AstraZeneca SA




Egide Van Ophemstraat 110




B-1180 Brussels




Belgium






Ramace 1,25 mg
Ramace 2,5 mg
Ramace 5 mg


1,25 mg
2,5 mg
5 mg


Tablet


Oral




Malta


—


 


 


 


 




Netherlands







SANOFI-AVENTIS NETHERLANDS B.V.




Kampenringweg 45 D-E (toren D en E)




NL-2803 PE Gouda




The Netherlands




P.O. Box 2043




NL-2800 BD Gouda




The Netherlands






Tritace 1,25
Tritace 2,5
Tritace 5
Tritace 10


1,25 mg
2,5 mg
5 mg
10 mg


Tablet


Oral




Netherlands







SANOFI-AVENTIS NETHERLANDS B.V.




Kampenringweg




45 D-E (toren D en E)




NL-2803 PE Gouda




The Netherlands






Tritace 1,25
Tritace 2,5
Tritace 5
Tritace 10


1,25 mg
2,5 mg
5 mg
10 mg


Capsule


Oral




Norway







SANOFI-AVENTIS NORGE AS




Strandveien 15




P.O.Box 133




NO-1325 Lysaker




Norway






Triatec


1,25 mg
2,5 mg
5 mg
10 mg


Tablet


Oral




Norway







SANOFI-AVENTIS NORGE AS




Strandveien 15




P.O.Box 133




NO-1325 Lysaker




Norway






Triatec


10 mg


Capsule


Oral




Norway







WINTHROP MEDICAMENTS




1-13 Boulevard Romain Rolland




F-75159 Paris, Cedex 14




France






Ramipril winthrop


1,25 mg
2,5 mg
5 mg
10 mg


Tablet


Oral




Poland







SANOFI-AVENTIS DEUTSCHLAND GMBH




D-65926 Frankfurt am Main




Germany






Tritace 2,5
Tritace 5
Tritace 10


2,5 mg
5 mg
10 mg


Tablet


Oral




Portugal







Sanofi-Aventis Produtos Farmacêuticos, s.a.




Empreendimento Lagoas Park,




Edifício 7 - 3o Piso




2740-244 Porto Salvo




Portugal






Triatec


2,5 mg
5 mg
10 mg


Tablet


Oral




Portugal







Sanofi-Aventis Produtos Farmacêuticos, s.a.




Empreendimento Lagoas Park,




Edifício 7 - 3o Piso




2740-244 Porto Salvo




Portugal






Triatec


1,25 mg
2,5 mg
5 mg
10 mg


Capsule


Oral




Romania







AVENTIS PHARMA DEUTSCHLAND GMBH




Brüningstraße 50




65926 Frankfurt am Main




Germany






Tritace


2,5 mg
5 mg
10 mg


Tablet


Oral




Romania







SC ZENTIVA S.A.




Bulevardul Theodor Pallady, nr. 50, sector 3




Bucuresti




ROMANIA






Zenra 2,5
Zenra 5
Zenra 10


2,5 mg
5 mg
10 mg


Tablet


Oral




Slovak Republic







SANOFI-AVENTIS SLOVAKIA s.r.o.




Žilinská 7-9




81105 Bratislava




Slovak Republic






Tritace


1,25 mg
2,5 mg
5 mg
10 mg


Tablet


Oral




Slovenia







SANOFI-AVENTIS D.O.O.




Dunajska cesta 119




1000 Ljubljana




Slovenia






Tritace 1,25 mg teblete
Tritace 2,5 mg tablete
Tritace 5 mg tablete
Tritace 10 mg tablete
Tritace Startset


1,25 mg
2,5 mg
5 mg
10 mg
2,5 mg/5 mg/10 mg


Tablet


Oral




Spain







SANOFI-AVENTIS S.A.




Josep Pla 2




08019 Barcelona




Spain






Acovil


1,25 mg
2,5 mg
5 mg
10 mg


Tablet


Oral




Sweden







Sanofi-Aventis AB




Box 14142




167 14 Bromma




Sweden






Triatec
Triatec H.O.P
Triatec Start


1,25 mg
2,5 mg
5 mg
10 mg
2,5 mg/5 mg/10 mg
2,5 mg/5 mg/10 mg


Tablet


Oral




Sweden







WINTHROP MEDICAMENTS




1-13, Boulevard Romain Roland




F-75014 Paris




France






Ramipril winthrop


1,25 mg
2,5 mg
5 mg
10 mg


Tablet


Oral




Sweden







AstraZeneca Sverige




SE-151 85 Södertälje




Sweden






Pramace


1,25 mg
2,5 mg
5 mg
10 mg
Start pack (1,25 + 2,5 + 5 mg)


Tablet


Oral




Sweden







AstraZeneca Sverige




SE-151 85 Södertälje




Sweden






Pramace


10 mg


Capsule


Oral




United Kingdom







AVENTIS PHARMA LTD




50 Kings Hill Avenue




Kings Hill




West Malling




Kent ME19 4AH




Trading as: Sanofi-aventis




One Onslow Street




Guildford




Surrey GU1 4YS




UK






Tritace 1,25 mg tablets
Tritace 2,5 mg tablets
Tritace 5 mg Tablets
Tritace 10 mg tablets


1,25 mg
2,5 mg
5 mg
10 mg


Tablet


Oral




United Kingdom







HOECHST MARION ROUSSEL LTD.




Denham




Uxbridge UB9 5HP




Trading as: Aventis Pharma




50 Kings Hill Avenue




Kings Hill




West Malling




Kent ME19 4AH




Or





Sanofi-aventis




One Onslow Street




Guildford




Surrey GU1 4YS




UK






Tritace 1,25 mg
Tritace 2,5 mg
Tritace 5 mg
Tritace 10 mg


1,25 mg
2,5 mg
5 mg
10 mg


Capsule


Oral




United Kingdom







AVENTIS PHARMA LTD




50 Kings Hill Avenue




Kings Hill




West Malling




Kent ME19 4AH




Trading as: Sanofi-aventis




One Onslow Street




Guildford




Surrey GU1 4YS




UK






Tritace Titration Pack


2,5 mg/5 mg/10 mg


Tablet


Oral




United Kingdom







AVENTIS PHARMA LTD




50 Kings Hill Avenue




Kings Hill




West Malling




Kent ME19 4AH




Trading as: Sanofi-aventis




One Onslow Street




Guildford




Surrey GU1 4YS




UK






Tritace titration pack


2,5 mg
5,0 mg
10 mg


Capsule


Oral




United Kingdom







AVENTIS PHARMA LTD




50 Kings Hill Avenue




Kings Hill




West Malling




Kent ME19 4AH




Trading as: Sanofi-aventis




One Onslow Street




Guildford




Surrey GU1 4YS




UK






Tritace Tablet Titration Pack


2,5 mg
5,0 mg
10 mg


Tablet


Oral







ANNEX III
LIST OF THE NAMES, PHARMACEUTICAL FORM, STRENGTH OF THE MEDICINAL PRODUCTS, ROUTE OF ADMINISTRATION, APPLICANTS AND MARKETING AUTHORISATION HOLDER IN THE MEMBER STATE












Member State EU/EEA


Marketing authorisation holder


Applicant


(Invented)
Name


Strength


Pharmaceutical form


Route of administration


Content
(concentration)




Austria


 







Kedrion S.p.A.




Loc Ai Conti 55051




Castelvecchio Pascoli,




Barga (Lucca) — ITALY






UMAN BIG 180 I.E./ml
Injektionslösung


180 IU/ml


Solution for injection


Intramuscular use


180 IU/ml
540 IU/3 ml




Denmark


 







Kedrion S.p.A.




Loc Ai Conti 55051




Castelvecchio Pascoli,




Barga (Lucca) — ITALY






UMAN BIG


180 IU/ml


Solution for injection


Intramuscular use


180 IU/ml
540 IU/3 ml




Germany


 







Kedrion S.p.A.




Loc Ai Conti 55051




Castelvecchio Pascoli,




Barga (Lucca) — ITALY






UMAN BIG


180 IU/ml


Solution for injection


Intramuscular use


180 IU/ml
540 IU/3 ml




Hungary


 







Kedrion S.p.A.




Loc Ai Conti 55051




Castelvecchio Pascoli,




Barga (Lucca) — ITALY






Umanbig 180 NE/ml


180 IU/ml


Solution for injection


Intramuscular use


180 IU/ml
540 IU/3 ml




Italy







Kedrion S.p.A.




Loc Ai Conti 55051




Castelvecchio Pascoli,




Barga (Lucca) — ITALY






 


UMAN BIG


180 IU/ml


Solution for injection


Intramuscular use


180 IU/ml
540 IU/3 ml




Poland


 







Kedrion S.p.A.




Loc Ai Conti 55051




Castelvecchio Pascoli,




Barga (Lucca) — ITALY






UMAN BIG


180 IU/ml


Solution for injection


Intramuscular use


180 IU/ml
540 IU/3 ml




Portugal


 







Kedrion S.p.A.




Loc Ai Conti 55051




Castelvecchio Pascoli,




Barga (Lucca) — ITALY






UMAN BIG


180 IU/ml


Solution for injection


Intramuscular use


180 IU/ml
540 IU/3 ml




Sweden


 







Kedrion S.p.A.




Loc Ai Conti 55051




Castelvecchio Pascoli,




Barga (Lucca) — ITALY






Umanbig 180 IU/ml solution for injection


180 IU/ml


Solution for injection


Intramuscular use


180 IU/ml
540 IU/3 ml







ANNEX IV
LIST OF THE NAMES, PHARMACEUTICAL FORM, STRENGTH OF THE MEDICINAL PRODUCT, ROUTES OF ADMINISTRATION, APPLICANTS IN THE MEMBER STATES












Member State EU/EEA


Marketing authorisation holder


Applicant


(Invented)
Name


Strength


Pharmaceutical form


Route of administration


Content
(concentration)




Austria


 







Pharmachemie B.V.




Swensweg 5




P.O. Box 552




2003 RN Haarlem, The Netherlands






Bleomycin ‘Pharmachemie’15 000 I.E. - Pulver zur Herstellung einer Injektionslösung


15 U (USP)/vial


powder for solution for injection


Intramuscular injection
Subcutaneous injection
Intravenous administration
Intra-arterial administration
Intra-pleural injection
Local injection


15 U (USP)/vial




Belgium


 







Pharmachemie B.V.




Swensweg 5




P.O. Box 552




2003 RN Haarlem, The Netherlands






BLEOMYCINE TEVA 15U poeder voor oplossing voor injectie


15 U (USP)/vial


powder for solution for injection


Intramuscular injection
Subcutaneous injection
Intravenous administration
Intra-arterial administration
Intra-pleural injection
Intraperitoneal administration
Local/Intratumoral injections


15 U (USP)/vial




Bulgaria


 







Pharmachemie B.V.




Swensweg 5




P.O. Box 552




2003 RN Haarlem, The Netherlands






Bleomycine Teva 15U, прах за инжекционен разтвор


15 U (USP)/vial


powder for solution for injection


Intramuscular injection
Subcutaneous injection
Intravenous administration
Intra-arterial administration
Intra-pleural injection
Intraperitoneal administration
Local/Intratumoral injections


15 U (USP)/vial




Czech Republic


 







Pharmachemie B.V.




Swensweg 5




P.O. Box 552




2003 RN Haarlem, The Netherlands






Bleomycin-Teva 15U, prášek pro přípravu injekčního roztoku


15 U (USP)/vial


powder for solution for injection


Intramuscular injection
Subcutaneous injection
Intravenous administration
Intra-arterial administration
Intra-pleural injection
Intraperitoneal administration
Local/Intratumoral injections


15 U (USP)/vial




Denmark


 







Pharmachemie B.V.




Swensweg 5




P.O. Box 552




2003 RN Haarlem, The Netherlands






Bleomycin ‘Teva’


15 U (USP)/vial


powder for solution for injection


Intramuscular injection
Subcutaneous injection
Intravenous administration
Intra-arterial administration
Intra-pleural injection
Intraperitoneal administration
Local/Intratumoral injections


15 U (USP)/vial




Estonia


 







Pharmachemie B.V.




Swensweg 5




P.O. Box 552




2003 RN Haarlem, The Netherlands






Bleomycin Teva


15 U (USP)/vial


powder for solution for injection


Intramuscular injection
Subcutaneous injection
Intravenous administration
Intra-arterial administration
Intra-pleural injection
Intraperitoneal administration
Local/Intratumoral injections


15 U (USP)/vial




France


 







Pharmachemie B.V.




Swensweg 5




P.O. Box 552




2003 RN Haarlem, The Netherlands






Bleomycine TEVA 15 000 UI, poudre pour solution injectable


15 U (USP)/vial


powder for solution for injection


Intramuscular injection
Subcutaneous injection
Intravenous administration
Intra-arterial administration
Intra-pleural injection
Intraperitoneal administration
Local/Intratumoral injections


15 U (USP)/vial




Germany


 







Pharmachemie B.V.




Swensweg 5




P.O. Box 552




2003 RN Haarlem, The Netherlands






Bleo-TEVA 15 mg Pulver zur Herstellung einer Injektionslösung


15 U (USP)/vial


powder for solution for injection


Intramuscular injection
Intravenous administration
Intra-pleural injection


15 U (USP)/vial




Italy


 







Pharmachemie B.V.




Swensweg 5




P.O. Box 552




2003 RN Haarlem, The Netherlands






Bleomicina TEVA, 15 U polvere per soluzione iniettabile


15 U (USP)/vial


powder for solution for injection


Intramuscular injection
Subcutaneous injection
Intravenous administration
Intra-arterial administration
Intra-pleural injection
Intraperitoneal administration
Local/Intratumoral injections


15 U (USP)/vial




Latvia


 







Pharmachemie B.V.




Swensweg 5




P.O. Box 552




2003 RN Haarlem, The Netherlands






Bleomycin Teva


15 U (USP)/vial


powder for solution for injection


Intramuscular injection
Subcutaneous injection
Intravenous administration
Intra-arterial administration
Intra-pleural injection
Intraperitoneal administration
Local/Intratumoral injections


15 U (USP)/vial




Lithuania


 







Pharmachemie B.V.




Swensweg 5




P.O. Box 552




2003 RN Haarlem, The Netherlands






Bleomycin Teva


15 U (USP)/vial


powder for solution for injection


Intramuscular injection
Subcutaneous injection
Intravenous administration
Intra-arterial administration
Intra-pleural injection
Intraperitoneal administration
Local/Intratumoral injections


15 U (USP)/vial




Luxembourg


 







Pharmachemie B.V.




Swensweg 5




P.O. Box 552




2003 RN Haarlem, The Netherlands






BLEOMYCINE TEVA 15U poudre pour solution injectable


15 U (USP)/vial


powder for solution for injection


Intramuscular injection
Subcutaneous injection
Intravenous administration
Intra-arterial administration
Intra-pleural injection
Local/Intratumoral injections


15 U (USP)/vial




Netherlands


 







Pharmachemie B.V.




Swensweg 5




P.O. Box 552




2003 RN Haarlem, The Netherlands






Bleomycine 15 U (USP), poeder voor oplossing voor injectie


15 U (USP)/vial


powder for solution for injection


Intramuscular injection
Subcutaneous injection
Intravenous administration
Intra-arterial administration
Intra-pleural injection
Intraperitoneal administration
Local/Intratumoral injections


15 U (USP)/vial




Norway


 







Pharmachemie B.V.




Swensweg 5




P.O. Box 552




2003 RN Haarlem, The Netherlands






Bleomycin Teva, Pulver og væske til injeksjonsvæske, oppløsning


15 U (USP)/vial


powder for solution for injection


Intramuscular injection
Subcutaneous injection
Intravenous administration
Intra-arterial administration
Intra-pleural injection
Intraperitoneal administration
Local/Intratumoral injections


15 U (USP)/vial




Poland


 







Pharmachemie B.V.




Swensweg 5




P.O. Box 552




2003 RN Haarlem, The Netherlands






Bleomycin Teva


15 U (USP)/vial


powder for solution for injection


Intramuscular injection
Subcutaneous injection
Intravenous administration
Intra-arterial administration
Intra-pleural injection
Intraperitoneal administration
Local/Intratumoral injections


15 U (USP)/vial




Portugal


 







Pharmachemie B.V.




Swensweg 5




P.O. Box 552




2003 RN Haarlem, The Netherlands






Bleomicina Teva


15 U (USP)/vial


powder for solution for injection


Intramuscular injection
Subcutaneous injection
Intravenous administration
Intra-arterial administration
Intra-pleural injection
Intraperitoneal administration
Local/Intratumoral injections


15 U (USP)/vial




Slovak Republic


 







Pharmachemie B.V.




Swensweg 5




P.O. Box 552




2003 RN Haarlem, The Netherlands






Bleomycin-Teva prášok na injekčný roztok


15 U (USP)/vial


powder for solution for injection


Intramuscular injection
Subcutaneous injection
Intravenous administration
Intra-arterial administration
Intra-pleural injection
Intraperitoneal administration
Local/Intratumoral injections


15 U (USP)/vial




Slovenia


 







Pharmachemie B.V.




Swensweg 5




P.O. Box 552




2003 RN Haarlem, The Netherlands






Bleomicin Teva 15 U (USP), prašek za raztopino za injiciranje


15 U (USP)/vial


powder for solution for injection


Intramuscular injection
Subcutaneous injection
Intravenous administration
Intra-arterial administration
Intra-pleural injection
Intraperitoneal administration
Local/Intratumoral injections


15 U (USP)/vial




Spain


 







Pharmachemie B.V.




Swensweg 5




P.O. Box 552




2003 RN Haarlem, The Netherlands






Bleomicina Teva 15 UI polvo para solución inyectable EFG


15 U (USP)/vial


powder for solution for injection


Intramuscular injection
Subcutaneous injection
Intravenous administration
Intra-arterial administration
Intra-pleural injection
Intraperitoneal administration
Local/Intratumoral injections


15 U (USP)/vial







ANNEX V
LIST OF THE NAMES, PHARMACEUTICAL FORM, STRENGTH OF THE MEDICINAL PRODUCTS, ROUTE OF ADMINISTRATION, APPLICANTS IN THE MEMBER STATES












Member State EU/EEA


Marketing Authorisation Holder


Applicant


(Invented)
Name


Strength


Pharmaceutical Form


Route of administration


Content
(concentration)




Austria


 







Hexal AG




Industriestr. 25




83607 Holzkirchen




Germany






Salbutamol ‘Hexal’ 100 μg/Dosis — Dosieraerosol


100 μg/dose


Pressurised inhalation, suspension


Inhalation use


 




Germany


 







Hexal AG




Industriestr. 25




83607 Holzkirchen




Germany






SalbuHEXAL N Dosieraerosol


100 μg/dose


Pressurised inhalation, suspension


Inhalation use


 




Ireland


 







Hexal AG




Industriestr. 25




83607 Holzkirchen




Germany






Salbul 100 micrograms Pressurised Inhalation Suspension


100 μg/dose


Pressurised inhalation, suspension


Inhalation use


 




Spain


 







Hexal AG




Industriestr. 25




83607 Holzkirchen




Germany






Salbutamol Hexal 100 mcg/dosis suspensión para inhalación en envase a presión EFG


100 μg/dose


Pressurised inhalation, suspension


Inhalation use


 




Sweden


 







Hexal AG




Industriestr. 25




83607 Holzkirchen




Germany






Sanohex


100 μg/dose


Pressurised inhalation, suspension


Inhalation use


 







ANNEX VI
LIST OF THE NAMES, PHARMACEUTICAL FORM, STRENGTH OF THE MEDICINAL PRODUCTS, ROUTE OF ADMINISTRATION, APPLICANTS IN THE MEMBER STATES












Member State EU/EEA


Marketing authorisation holder


Applicant


(Invented)
Name


Strength


Pharmaceutical form


Route of administration


Content
(concentration)




Belgium


 







Hexal AG




Industriestr. 25




83607 Holzkirchen




Germany






Salbutamol Sandoz 100 μg Aërosol, suspensie


100 μg/dose


Pressurised inhalation, suspension


Inhalation use


 




Denmark


 







Hexal AG




Industriestr. 25




83607 Holzkirchen




Germany






Salbutamol Sandoz


100 μg/dose


Pressurised inhalation, suspension


Inhalation use


 




Estonia


 







Hexal AG




Industriestr. 25




83607 Holzkirchen




Germany






Salbutamol Sandoz 100 mikrogrammi/annuses


100 μg/dose


Pressurised inhalation, suspension


Inhalation use


 




Finland


 







Hexal AG




Industriestr. 25




83607 Holzkirchen




Germany






Salbutamol Sandoz


100 μg/dose


Pressurised inhalation, suspension


Inhalation use


 




Germany


 







Hexal AG




Industriestr. 25




83607 Holzkirchen




Germany






Salbutamol Sandoz 100 mikrogramm Dosieraerosol Druckgas-inhalation, Suspension


100 μg/dose


Pressurised inhalation, suspension


Inhalation use


 




Greece


 







Hexal AG




Industriestr. 25




83607 Holzkirchen




Germany






Salbutamol/Sandoz


100 μg/dose


Pressurised inhalation, suspension


Inhalation use


 




Hungary


 







Hexal AG




Industriestr. 25




83607 Holzkirchen




Germany






Salbutamol Sandoz 100 μg túlnyomásos inhalációs szuszpenzió


100 μg/dose


Pressurised inhalation, suspension


Inhalation use


 




Italy


 







Hexal AG




Industriestr. 25




83607 Holzkirchen




Germany






Salbutamolo Sandoz


100 μg/dose


Pressurised inhalation, suspension


Inhalation use


 




Latvia


 







Hexal AG




Industriestr. 25




83607 Holzkirchen




Germany






Salbutamol Sandoz


100 μg/dose


Pressurised inhalation, suspension


Inhalation use


 




Lithuania


 







Hexal AG




Industriestr. 25




83607 Holzkirchen




Germany






Salbutamol Sandoz


100 μg/dose


Pressurised inhalation, suspension


Inhalation use


 




Netherlands


 







Hexal AG




Industriestr. 25




83607 Holzkirchen




Germany






Salbutamol Sandoz aërosol 100 μg/dosis, aërosol, suspensie 100 microgram per dosis


100 μg/dose


Pressurised inhalation, suspension


Inhalation use


 




Norway


 







Hexal AG




Industriestr. 25




83607 Holzkirchen




Germany






Salbutamol Sandoz


100 μg/dose


Pressurised inhalation, suspension


Inhalation use


 




Poland


 







Hexal AG




Industriestr. 25




83607 Holzkirchen




Germany






SalbuLEK


100 μg/dose


Pressurised inhalation, suspension


Inhalation use


 




Portugal


 







Sandoz Farmacêutica, Lda.




Alameda da Beloura - Edifício 1, Piso 2 - Escritório 15




2710-693 Sintra




Portugal






Salbutamol Sandoz


100 μg/dose


Pressurised inhalation, suspension


Inhalation use


 




Slovenia


 







Hexal AG




Industriestr. 25




83607 Holzkirchen




Germany






Salbutamol Lek 100 mikrogramov inhalacijska suspenzija pod tlakom


100 μg/dose


Pressurised inhalation, suspension


Inhalation use


 




Spain


 







Hexal AG




Industriestr. 25




83607 Holzkirchen




Germany






Salbutamol Sandoz 100 mcg/dosis suspensión para inhalación en envase a presción EFG


100 μg/dose


Pressurised inhalation, suspension


Inhalation use


 




Sweden


 







Hexal AG




Industriestr. 25




83607 Holzkirchen




Germany






Sabumalin


100 μg/dose


Pressurised inhalation, suspension


Inhalation use


 




United Kingdom


 







Hexal AG




Industriestr. 25




83607 Holzkirchen




Germany






Salbutamol 100 microgram per actuation pressurised inhalation, suspension


100 μg/dose


Pressurised inhalation, suspension


Inhalation use


 







ANNEX VII

LIST OF THE NAMES, PHARMACEUTICAL FORMS, STRENGTHS OF THE MEDICINAL PRODUCTS, ROUTE OF ADMINISTRATION, MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES












Member State EU/EEA


Marketing Authorisation Holder


(Invented) Name


Strength


Pharmaceutical Form


Route of administration


Content
(Concentration)




Austria







Pfizer Corporation Austria GmbH




Floridsdorfer Hauptstr 1,




1210 Wien






Tresleen 50 mg - Filmtabletten


50 mg


Film-coated tablets


Oral use


 




Belgium







PFIZER S.A.




Boulevard de la Plaine, 17




1050 Brussels






Serlain


50 mg
100 mg


Film-coated tablets


Oral use


 




Belgium







PFIZER S.A.




Boulevard de la Plaine, 17




1050 Brussels






Serlain


20 mg/ml


Concentrate for oral solution


Oral use


20 mg/ml




Bulgaria







PFIZER EUROPE MA EEIG




Ramsgate Road




Sandwich




Kent CT13 9NJ






Zoloft


50 mg


Film-coated tablets


Oral use


50 mg




Cyprus







Pfizer Hellas A.E.,




243 Messoghion Ave.,




154 51 Ν. Psychiko, Athens




Greece






Zoloft


50 mg
100 mg


Film-coated tablet


Oral use


 




Czech Republic







Pfizer s.r.o.,




Stroupežnického 17




150 00 Praha 5




Czech Republic






Zoloft 50 mg
Zoloft 100 mg


50 mg
100 mg


Film-coated tablets


Oral use


 




Denmark







Pfizer ApS




Lautrupvang 8




DK-2750 Ballerup






Zoloft


25 mg
50 mg
100 mg


Film-coated tablets


Oral use


 




Denmark







Pfizer ApS




Lautrupvang 8




DK-2750 Ballerup






Zoloft


20 mg/ml


Concentrate for oral solution


Oral use


20 mg/ml




Estonia







Pfizer Europe MA EEIG




Ramsgate Road




Sandwich




Kent CT13 9NJ




United Kingdom






Zoloft


50 mg


Film-coated tablet


Oral use


 




Finland







Pfizer Oy




Tietokuja 4




00330 Helsinki






Zoloft


50 mg
100 mg


Film-coated tablet


Oral use


 




Finland







Pfizer Oy




Tietokuja 4




00330 Helsinki






Zoloft


20 mg/ml


Concentrate for oral solution


Oral use


20 mg/ml




France







Pfizer Holding France




23-25 avenue du Dr Lannelongue




75014 Paris






Zoloft


25 mg
50 mg
100 mg


Capsules, hard


Oral use


 




France







Pfizer Holding France




23-25 avenue du Dr Lannelongue




75014 Paris






Zoloft


20 mg/ml


Concentrate for oral solution


Oral use


20 mg/ml




France







Pfizer Holding France




23-25 avenue du Dr Lannelongue




75014 Paris






Sertraline Pfizer


25 mg
50 mg


Capsules, hard


Oral use


 




France







Pfizer Holding France




23-25 avenue du Dr Lannelongue




75014 Paris






Sertraline Beral


100 mg


Capsules, hard


Oral use


 




France







Pfizer Holding France




23-25 avenue du Dr Lannelongue




75014 Paris






Sertraline Beral


20 mg/ml


Concentrate for oral solution


Oral use


20 mg/ml




Germany







Pfizer Pharma GmbH




Linkstr. 10




10785 Berlin






Zoloft 50 mg
Zoloft 100 mg


50 mg
100 mg


Film-coated tablet


Oral use


 




Germany







Pfizer Pharma GmbH




Linkstr. 10




10785 Berlin






Zoloft Lösungskonzentrat


20 mg/ml


Concentrate for oral solution


Oral use


20 mg/ml




Greece







Pfizer Hellas A.E.,




243 Messoghion Ave.,




154 51 Ν. Psychiko Athens




Greece






Zoloft


50 mg
100 mg


Film-coated tablets


Oral use


 




Hungary







Pfizer Kft.




1123 Budapest




Alkotás u. 53.




MOM Park F Épület






Zoloft 50 mg film tabletta


50 mg


Film-coated tablets


Oral use


 




Hungary







Pfizer Kft.




1123 Budapest




Alkotás u. 53.




MOM Park F Épület






Zoloft 20 mg/ml oldat


20 mg/ml


Concentrate for oral Solution


Oral use


20 mg/ml




Iceland







Pfizer ApS




Lautrupvang 8




DK-2750 Ballerup






Zoloft


25 mg
50 mg
100 mg


Film-coated tablets


Oral use


 




Iceland







Pfizer ApS




Lautrupvang 8




DK-2750 Ballerup






Zoloft


20 mg/ml


Concentrate for oral solution


Oral use


20 mg/ml




Ireland







Pfizer Healthcare Ireland




9 Riverwalk




National Digital Park




Citywest Business Campus




Dublin 24




Ireland






Lustral


50 mg
100 mg


Film-coated tablet


Oral use


 




Italy







Pfizer Italia S.r.l.




S.S. 156, Km 50




04010 Borgo San Michele (LT)






Zoloft


25 mg
50 mg
100 mg


Film-coated tablets


Oral use


 




Italy







Pfizer Italia S.r.l.




S.S. 156, Km 50




04010 Borgo San Michele (LT)






Zoloft


50 mg


Capsules, hard


Oral use


 




Italy







Pfizer Italia S.r.l.




S.S. 156, Km 50




04010 Borgo San Michele (LT)






Zoloft


20 mg/ml


Concentrate for oral solution


Oral use


20 mg/ml




Italy







Bioindustria Farmaceutici S.r.l.




S.S. 156, Km 50




04010 Borgo San Michele (LT)






Tatig


50 mg
100 mg


Film-coated tablets


Oral use


 




Italy







Bioindustria Farmaceutici S.r.l.




S.S. 156, Km 50




04010 Borgo San Michele (LT)






Tatig


50 mg


Capsules, hard


Oral use


 




Italy







Bioindustria Farmaceutici S.r.l.




S.S. 156, Km 50




04010 Borgo San Michele (LT)






Tatig


20 mg/ml


Concentrate for oral solution


Oral use


20 mg/ml




Latvia







Pfizer Limited




Ramsgate Road




Sandwich




Kent CT13 9NJ




United Kingdom






Zoloft


50 mg


Film-coated tablets


Oral use


 




Lithuania







Pfizer Limited, UK,




Ramsgate Road,




Sandwich




Kent CT13 9NJ




United Kingdom






Zoloft


50 mg


Film-coated tablets


Oral use


 




Luxembourg







PFIZER S.A




Boulevard de la Plaine, 17 1050 Brussels






Serlain


50 mg
100 mg


Film-coated tablets


Oral use


 




Luxembourg







PFIZER S.A.




Boulevard de la Plaine, 17




1050 Brussels






Serlain


20 mg/ml


Concentrate for oral solution


Oral use


20 mg/ml




Malta







Pfizer Hellas A.E.,




243 Messoghion Ave.,




154 51 Ν. Psychiko




Athens




Greece






Lustral


50 mg
100 mg


Film-coated tablets


Oral use


 




Netherlands







Pfizer bv




Rivium Westlaan 142




2909 LD Capelle a/d IJssel






Zoloft 50


50 mg


Film-coated tablet


Oral use


 




Netherlands







Pfizer bv




Rivium Westlaan 142




2909 LD Capelle a/d IJssel






Zoloft 20 mg/ml


20 mg/ml


Concentrate for oral solution


Oral use


20 mg/ml




Norway







Pfizer AS




POBox 3




1324 Lysaker




Norway






Zoloft


25 mg
50 mg
100 mg


Film-coated tablets


Oral use


 




Norway







Pfizer AS




POBox 3




1324 Lysaker




Norway






Zoloft


20 mg/ml


Concentrate for oral solution


Oral use


20 mg/ml




Poland







Pfizer Europe MA EEIG




Ramsgate Road




Sandwich




Kent CT13 9NJ




United Kingdom






Zoloft


50 mg
100 mg


Film-coated tablets


Oral use


 




Poland







Pfizer Europe MA EEIG




Ramsgate Road




Sandwich




Kent CT13 9 NJ




United Kingdom






Zoloft


20 mg/ml


Concentrate for Oral solution


Oral use


20 mg/ml




Portugal







Laboratórios Pfizer Lda.




Lagoas Park




Edifício 10




2740-271 Porto Salvo




Portugal






Zoloft


50 mg
100 mg


Film-coated tablet


Oral use


 




Portugal







Laboratórios Pfizer Lda.




Lagoas Park




Edifício 10




2740-271 Porto Salvo




Portugal






Zoloft


20 mg/ml


Concentrate for oral solution


Oral use


20 mg/ml




Romania







Pfizer Europe MA EEIG




Ramsgate Road




Sandwich




Kent CT13 9 NJ




United Kingdom






Zoloft 50 mg
Zoloft 100 mg


50 mg
100 mg


Film-coated tablets


Oral use


 




Romania







Pfizer Europe MA EEIG




Ramsgate Road




Sandwich




Kent CT13 9 NJ




United Kingdom






Zoloft


20 mg/ml


Concentrate for Oral solution


Oral use


20 mg/ml




Slovak Republic







Pfizer Europe MA EEIG




Ramsgate Road




Sandwich




Kent CT13 9NJ




United Kingdom






Zoloft


50 mg
100 mg


Film-coated tablets


Oral use


 




Slovak Republic







Pfizer Europe MA EEIG




Ramsgate Road




Sandwich




Kent CT13 9NJ




United Kingdom






Zoloft OC


20 mg/ml


Concentrate for oral solution


Oral use


20 mg/ml




Slovenia







Pfizer Luxembourg SARL




Rond-Point du Kirchberg 51




Avenue J.F. Kennedy




L-1855 Luxembourg






Zoloft


50 mg
100 mg


Film-coated tablets


Oral use


 




Slovenia







Pfizer Luxembourg SARL




Rond-Point du Kirchberg 51




Avenue J.F. Kennedy




L-1855 Luxembourg






Zoloft


20 mg/ml


Concentrate for oral solution


Oral use


20 mg/ml




Spain







Pfizer S.A.




Avda. de Europa, 20 B




Parque Empresarial La Moraleja




28108 Alcobendas (Madrid) Spain






Besitran


50 mg
100 mg


Film-coated tablet


Oral use


 




Spain







Pfizer S.A.




Avda. de Europa, 20 B




Parque Empresarial La Moraleja




28108 Alcobendas (Madrid) Spain






Besitran


20 mg/ml


Concentrate for oral solution


Oral use


20 mg/ml




Spain







Pfizer S.A.




Avda. de Europa, 20 B




Parque Empresarial La Moraleja




28108 Alcobendas (Madrid) Spain






Sertralina Pfizer


50 mg
100 mg


Film-coated tablet


Oral use


 




Sweden







Pfizer AB




Vetenskapsvägen 10




191 90 Sollentuna




Sweden






Zoloft


25 mg
50 mg
100 mg
25 + 50 mg (initiation pack)


Film-coated tablets


Oral use


 




Sweden







Pfizer AB




Vetenskapsvägen 10




191 90 Sollentuna




Sweden






Zoloft


20 mg/ml


Concentrate for oral solution


Oral use


20 mg/ml




United Kingdom







Pfizer Ltd




Ramsgate Road




Sandwich




Kent CT13 9NJ




United Kingdom






Lustral


50 mg
100 mg


Film-coated tablets


Oral use