# C_2009101EN.01001401.xml

| 1.5.2009 | EN | Official Journal of the European Union | C 101/14 |
| --- | --- | --- | --- |

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)
  )

(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

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 |

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.

1

(2)  OJ L 311, 28.11.2001, p. 1.

2

---

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

AstraZeneca Österreich GmbH

Schwarzenbergplatz 7

A-1037 Wien

Austria

HYPREN

10 mg

Tablet

Oral

Belgium

| SANOFI-AVENTIS BELGIUM |
| --- |
| Culliganlaan 1C |
| B-1831 Diegem |
| 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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

SANOFI-AVENTIS OY

Huopalahdentie 24

00350 Helsinki

Finland

Cardace

10 mg

Capsule

Oral

Finland

| SANOFI-AVENTIS OY |
| --- |
| Huopalahdentie 24 |
| 00350 Helsinki |
| 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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

Pfizer Oy

Tietokuja 4

00330 Helsinki

Zoloft

50 mg

100 mg

Film-coated tablet

Oral use

Finland

| Pfizer Oy |
| --- |
| Tietokuja 4 |
| 00330 Helsinki |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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) |

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) |

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) |

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) |

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) |

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) |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

Pfizer Ltd

Ramsgate Road

Sandwich

Kent CT13 9NJ

United Kingdom

Lustral

50 mg

100 mg

Film-coated tablets

Oral use

---