# C_2013024EN.01000801.xml

| 25.1.2013 | EN | Official Journal of the European Union | C 24/8 |
| --- | --- | --- | --- |

25.1.2013

EN

Official Journal of the European Union

C 24/8

---

Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 December 2012 to 31 December 2012

(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

)

2013/C 24/02

—   Issuing, maintenance or modification of a national marketing authorization

Issuing, maintenance or modification of a national marketing authorization

| Date of the decision | Name(s) of the medicinal product | Holder(s) of the marketing authorization | Member State concerned | Date of notification |
| --- | --- | --- | --- | --- |
| 17.12.2012 | HIPRALONA ENRO-S and its generics | See Annex I | See Annex I | 19.12.2012 |
| 6.12.2012 | Prefluce+l and associated names | See Annex II | See Annex II | 10.12.2012 |

Date of the decision

Name(s) of the medicinal product

Holder(s) of the marketing authorization

Member State concerned

Date of notification

17.12.2012

HIPRALONA ENRO-S and its generics

See Annex I

See Annex I

19.12.2012

6.12.2012

Prefluce+l and associated names

See Annex II

See Annex II

10.12.2012

—   Suspension of a national marketing authorization

Suspension of a national marketing authorization

| Date of the decision | Name(s) of the medicinal product | Holder(s) of the marketing authorization | Member State concerned | Date of notification |
| --- | --- | --- | --- | --- |
| 20.12.2012 | Loraxin | See Annex III | See Annex III | 21.12.2012 |
| 10.12.2012 | Cilazapril Teva and associated names | See Annex IV | See Annex IV | 12.12.2012 |

Date of the decision

Name(s) of the medicinal product

Holder(s) of the marketing authorization

Member State concerned

Date of notification

20.12.2012

Loraxin

See Annex III

See Annex III

21.12.2012

10.12.2012

Cilazapril Teva and associated names

See Annex IV

See Annex IV

12.12.2012

---

(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 FORM, STRENGTH OF THE VETERINARY MEDICINAL PRODUCTS, ANIMAL SPECIES, ROUTE OF ADMINISTRATION, APPLICANT/MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES

| Member State
  EU/EEA | Applicant/Marketing Authorisation Holder | Name | INN | Strength | Pharmaceutical form | Animal species |
| --- | --- | --- | --- | --- | --- | --- |
| Belgium | GLOBAL VET HEALTH SL |
| C/Capçanes |
| no 12-bajos |
| Polígono Agro-Reus |
| 43206 Reus |
| SPAIN |

Member State

EU/EEA

Applicant/Marketing Authorisation Holder

Name

INN

Strength

Pharmaceutical form

Animal species

Belgium

GLOBAL VET HEALTH SL

C/Capçanes

no 12-bajos

Polígono Agro-Reus

43206 Reus

SPAIN

QUINOFLOX 100 mg/ml

Enrofloxacin

100 mg/ml

Oral solution

Chickens (Broilers, replacement chickens, broiler breeders), Rabbits

Cyprus

| LABORATORIOS KARIZOO, S.A. |
| --- |
| Polígono Industrial La Borda |
| Mas Pujades, 11-12 |
| 08140 Caldes de Montbui |
| Barcelona |
| SPAIN |

LABORATORIOS KARIZOO, S.A.

Polígono Industrial La Borda

Mas Pujades, 11-12

08140 Caldes de Montbui

Barcelona

SPAIN

K-Flox 100 mg/ml Πόσιμο διάλυμα για ορνίθια κρεοπαραγωγής και κουνέλια

Enrofloxacin

100 mg/ml

Oral solution

Chickens (broilers), Rabbits

Spain

| LABORATORIOS HIPRA, |
| --- |
| S.A.Avda. |
| La Selva,135 |
| 17170 Amer |
| SPAIN |

LABORATORIOS HIPRA,

S.A.Avda.

La Selva,135

17170 Amer

SPAIN

HIPRALONA ENRO - S

Enrofloxacin

100 mg/ml

Oral solution

Poultry (Chicken and Turkeys), Rabbits

Spain

| UNIVERSAL FARMA, S.L. |
| --- |
| Gran Via Carlos III 98 - 7a |
| 08028 Barcelona |
| SPAIN |

UNIVERSAL FARMA, S.L.

Gran Via Carlos III 98 - 7a

08028 Barcelona

SPAIN

LEVOFLOK® 100 mg/ml Oral solution for chickens and rabbits

Enrofloxacin

100 mg/ml

Oral solution

Chickens, Rabbits

Spain

| LABORATORIOS KARIZOO, S.A. |
| --- |
| Polígono Industrial La Borda |
| Mas Pujades, 11-12 |
| 08140 Caldes de Montbui |
| Barcelona |
| SPAIN |

LABORATORIOS KARIZOO, S.A.

Polígono Industrial La Borda

Mas Pujades, 11-12

08140 Caldes de Montbui

Barcelona

SPAIN

K-FLOX 100 mg/ml Oral Solution for chickens and rabbits.

Enrofloxacin

100 mg/ml

Oral solution

Chickens, Rabbits

Spain

| Global Vet Health, SL |
| --- |
| Capcanes, 12 bajos |
| Poligono Agro-Reus |
| 43206 Reus |
| SPAIN |

Global Vet Health, SL

Capcanes, 12 bajos

Poligono Agro-Reus

43206 Reus

SPAIN

QUINOFLOX 100 mg/ml

Enrofloxacin

100 mg/ml

Oral solution

Chickens, Rabbits

Spain

| SP VETERINARIA |
| --- |
| Ctra.Reus-Vinyols, Km, |
| 43330 Ruidoms |
| SPAIN |

SP VETERINARIA

Ctra.Reus-Vinyols, Km,

43330 Ruidoms

SPAIN

COLMYC -C

Enrofloxacin

100 mg/ml

Oral solution

Poultry (Chicken and Turkeys), Rabbits

France

| GLOBAL VET HEALTH SL |
| --- |
| c/Capçanes, no 12-bajos. |
| Polígon Agro-Reus. |
| 43206 Reus |
| SPAIN |

GLOBAL VET HEALTH SL

c/Capçanes, no 12-bajos.

Polígon Agro-Reus.

43206 Reus

SPAIN

Quinoflox 100 mg/ml solution for use in drinking water, chicken and rabbits

Enrofloxacin

100 mg/ml

Oral solution

Chickens (Broilers, replacement chickens, broiler breeders), Rabbits

Italy

| GLOBAL VET HEALTH, S.L. |
| --- |
| Capsanes, 12 - Polígono Agro-Reus |
| E-43206 - REUS (Tarragona) |
| SPAIN |

GLOBAL VET HEALTH, S.L.

Capsanes, 12 - Polígono Agro-Reus

E-43206 - REUS (Tarragona)

SPAIN

QUINOLCEN

Enrofloxacin

100 mg/ml

Oral solution

Chickens, Rabbits

Italy

| LABORATORIOS KARIZOO, S.A. |
| --- |
| Polígono Industrial La Borda |
| Mas Pujades, 11-12 |
| 08140 – CALDES DE MONTBUI (Barcelona) |
| SPAIN |

LABORATORIOS KARIZOO, S.A.

Polígono Industrial La Borda

Mas Pujades, 11-12

08140 – CALDES DE MONTBUI (Barcelona)

SPAIN

K-FLOX 100 mg/ml

Enrofloxacin

100 mg/ml

Oral solution

Chickens, Rabbits

Italy

| VETPHARMA ANIMAL HEALTH, S.L. |
| --- |
| Les Corts, 23 |
| 08028 – BARCELONA |
| SPAIN |

VETPHARMA ANIMAL HEALTH, S.L.

Les Corts, 23

08028 – BARCELONA

SPAIN

NIFLOX 100 mg/ml

Enrofloxacin

100 mg/ml

Oral solution

Chickens, Rabbits

Poland

| Medivet S.A. |
| --- |
| Szkolna 17 |
| 63-100 Śrem |
| POLAND |

Medivet S.A.

Szkolna 17

63-100 Śrem

POLAND

MEDOXIL ORAL 100 mg/ml roztwór doustny dla kur i królików

Enrofloxacinum

100 mg/ml

Oral solution

Chickens, Rabbits

Portugal

| GLOBAL VET HEALTH SL |
| --- |
| C/Capçanes |
| no 12-bajos |
| Polígono Agro-Reus |
| 43206 Reus |
| SPAIN |

GLOBAL VET HEALTH SL

C/Capçanes

no 12-bajos

Polígono Agro-Reus

43206 Reus

SPAIN

Quinoflox 100 mg/ml solução para administração na água de bebida para frangos e coelhos

Enrofloxacin

100 mg

Oral solution

Chickens (Broilers, replacement chickens, broiler breeders) and rabbits

Portugal

| VETPHARMA ANIMAL HEALTH, S.L. |
| --- |
| Les Corts, 23 |
| 08028 Barcelona |
| SPAIN |

VETPHARMA ANIMAL HEALTH, S.L.

Les Corts, 23

08028 Barcelona

SPAIN

LEVOFLOK® 100 mg/ml Solução oral para frangos de carne e coelhos

Enrofloxacin

100 mg

Oral solution

Chickens (broilers), Rabbits

Portugal

| LABORATORIOS KARIZOO, S.A. |
| --- |
| Polígono Industrial La Borda |
| Mas Pujades, 11-12 |
| 08140 Caldes de Montbui |
| Barcelona |
| SPAIN |

LABORATORIOS KARIZOO, S.A.

Polígono Industrial La Borda

Mas Pujades, 11-12

08140 Caldes de Montbui

Barcelona

SPAIN

K-FLOX 100 mg/ml Solução oral para frangos de carne e coelhos

Enrofloxacin

100 mg

Oral solution

Chickens (broilers), Rabbits

Portugal

| Prodivet-Zn,Nutrição e Comércio de Produtos Químicos |
| --- |
| Farmacêuticos e Cosméticos |
| SA Av. Infante D. Henrique no 333 H 3o Piso Esc. |
| 411800-282 Lisboa |
| PORTUGAL |

Prodivet-Zn,Nutrição e Comércio de Produtos Químicos

Farmacêuticos e Cosméticos

SA Av. Infante D. Henrique no 333 H 3o Piso Esc.

411800-282 Lisboa

PORTUGAL

Prodirox 100 mg/ml solução oral para frangos e coelhos

Enrofloxacin

100 mg

Oral solution

Chickens (broilers), Rabbits

Portugal

| VETLIMA |
| --- |
| Sociedade Distr. Produtos Agro-Pecuários LDA. |
| Centro Empresarial da Rainha |
| Lote 27 |
| 2050-501 Vila Nova Da Rainha |
| PORTUGAL |

VETLIMA

Sociedade Distr. Produtos Agro-Pecuários LDA.

Centro Empresarial da Rainha

Lote 27

2050-501 Vila Nova Da Rainha

PORTUGAL

VETAFLOX 100 mg/ml solução oral para frangos de engorda e coelhos

Enrofloxacin

100 mg

Oral solution

Chickens (broilers), Rabbits

United Kingdom

| Global Vet Health S.L. |
| --- |
| Calle Capcanes |
| n12 Bajos |
| Poligono Agro-Reus |
| 43206 Reus |
| SPAIN |

Global Vet Health S.L.

Calle Capcanes

n12 Bajos

Poligono Agro-Reus

43206 Reus

SPAIN

Quinoflox 100 mg/ml Solution for Use in Drinking Water, Chicken and Rabbits

Enrofloxacin

100 mg/ml

Oral solution

Chickens, Rabbits

---

ANNEX II

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

| Member State
  (in EEA) | Marketing Authorisation Holder | Invented name | Strength | Pharmaceutical form | Route of administration |
| --- | --- | --- | --- | --- | --- |
| Austria | Baxter AG |
| Industriestrasse 67 |
| Vienna 1221 |
| Austria |

Member State

(in EEA)

Marketing Authorisation Holder

Invented name

Strength

Pharmaceutical form

Route of administration

Austria

Baxter AG

Industriestrasse 67

Vienna 1221

Austria

Preflucel Injektionssuspen sion in einer Fertigspritze

15 micrograms haemagglutinin of each of the 3 specified strains as determined by WHO per 0,5 ml dose

suspension for injection in a pre-filled syringe

intramuscular use

Belgium

| Baxter S.A. |
| --- |
| Bd René Branquart 80 |
| 7860 Lessines |
| Belgium |

Baxter S.A.

Bd René Branquart 80

7860 Lessines

Belgium

Preflucel

15 μg-0,5 ml

suspension for injection

intramuscular use

Czech Republic

| Baxter AG |
| --- |
| Industriestrasse 67 |
| Vienna 1221 |
| Austria |

Baxter AG

Industriestrasse 67

Vienna 1221

Austria

PREFLUCEL

0,5 ml per dose

suspension for injection

intramuscular use

Denmark

| Baxter A/S |
| --- |
| Gydevang 43 |
| DK-3450 Allerød |
| Denmark |

Baxter A/S

Gydevang 43

DK-3450 Allerød

Denmark

Preflucel

15 microgram

suspension for injection in a prefilled syringe

intramuscular use

Finland

| Baxter Oy |
| --- |
| Tammasaarenkatu 1 |
| PL 119 |
| 00181 Helsinki |
| Finland |

Baxter Oy

Tammasaarenkatu 1

PL 119

00181 Helsinki

Finland

Preflucel

15 mikrog HA/0,5 ml

15 mikrog HA/0,5 ml

15 mikrog HA/0,5 ml

suspension for injection in pre-filled syringe

intramuscular use

Germany

| Baxter Deutschland GmbH |
| --- |
| Edisonstraße 4 |
| 85716 Unterschleißheim |
| Germany |

Baxter Deutschland GmbH

Edisonstraße 4

85716 Unterschleißheim

Germany

PREFLUCEL

15 μgHA

15 μgHA

15 μgHA

suspension for injection in prefilled syringe

intramuscular use

Ireland

| Baxter Healthcare Limited |
| --- |
| Caxton Way |
| Thetford |
| Norfolk IP24 3SE |
| United Kingdom |

Baxter Healthcare Limited

Caxton Way

Thetford

Norfolk IP24 3SE

United Kingdom

Preflucel suspension for injection in a pre- filled syringe

15 microgram

suspension for injection

intramuscular use

Italy

| Baxter S.p.A. |
| --- |
| Piazzale dell'Industria 20 |
| Rome 00144 |
| Italy |

Baxter S.p.A.

Piazzale dell'Industria 20

Rome 00144

Italy

PREFLUCELL

15 micrograms

suspension for injection in a pre-filled syringe

intramuscular use

Norway

| Baxter AS |
| --- |
| Gjerdrums vei 11 |
| N-0484 Oslo |
| Norway |

Baxter AS

Gjerdrums vei 11

N-0484 Oslo

Norway

Preflucel

15 μg hemagglutinin of each of the 3 influenza virus strains

suspension for injection in a pre-filled syringe

intramuscular use

Poland

| Baxter Polska Sp. z o.o. |
| --- |
| Kruczkowskiego 8 |
| 00-380 Warszawa |
| Poland |

Baxter Polska Sp. z o.o.

Kruczkowskiego 8

00-380 Warszawa

Poland

Preflucel

A/California/07/2009 (H1N1)-

15 micrograms HA A/Perth/16/2009 (H3N2) like strain used (A/Victoria/210/2009)-

15 micrograms HA B/Brisbane/60/2008 (B)-

15 micrograms HA/HA**

per 0,5 ml dose

suspension for injection in a pre-filled syringe

intramuscular use

Portugal

| Baxter Médico-Farmacêutica, |
| --- |
| Lda. |
| Zona Industrial da Abrunheira |
| Edifício 10 |
| Sintra Business Park |
| 2710-089 Sintra |
| Portugal |

Baxter Médico-Farmacêutica,

Lda.

Zona Industrial da Abrunheira

Edifício 10

Sintra Business Park

2710-089 Sintra

Portugal

Preflucel

A/California/7/2009 (H1N1) - like virus →

0,015 mg A/Perth/16/2009 (H3N2) - like virus →

0,015 mg

B/Brisbane/60/2008 →

0,015 mg

suspension for injection in a pre-filled syringe

intramuscular Use

Spain

| Baxter, S.L. |
| --- |
| Polígono Industrial Sector 14 |
| Pouet de Camilo, 2 |
| Ribarroja del Turia |
| Valencia 46394 |
| Spain |

Baxter, S.L.

Polígono Industrial Sector 14

Pouet de Camilo, 2

Ribarroja del Turia

Valencia 46394

Spain

PREFLUCEL SUSPENSION INYECTABLE EN JERINGA PRECARGADA

A/California/07/2009 (H1N1)-

15 micrograms HA; A/Perth/16/2009 (H3N2) like strain used: (A/Victoria/210/2009)-

15 micrograms HA; B/Brisbane/60/2008 (B)-

15 micrograms HA, per 0,5 ml dose

suspension for injection in prefilled syringe

intramuscular use

Sweden

| Baxter Medical AB |
| --- |
| Torshamnsgatan 35 |
| Box 63 |
| 164 94 Kista |
| Sweden |

Baxter Medical AB

Torshamnsgatan 35

Box 63

164 94 Kista

Sweden

Preflucel

(NA)

solution for injection, pre filled syringe

intramuscular use

The Netherlands

| Baxter B.V. |
| --- |
| Kobaltweg 49 |
| 3542 CE Utrecht |
| The Netherlands |

Baxter B.V.

Kobaltweg 49

3542 CE Utrecht

The Netherlands

Preflucel

2011/2012, suspensie voor injectie 0,5 ml

0,5 ml per dose

suspension for injection

intramuscular use

United Kingdom

| Baxter Healthcare Limited |
| --- |
| Caxton Way |
| Thetford |
| Norfolk IP24 3SE |
| United Kingdom |

Baxter Healthcare Limited

Caxton Way

Thetford

Norfolk IP24 3SE

United Kingdom

Preflucel

15 mcg hemagglutinin of each of the 3 influenza virus strains

suspension for injection in a pre-filled syringe

intramuscular use

---

ANNEX III

LIST OF THE NAMES, PHARMACEUTICAL FORM, STRENGTH OF THE MEDICINAL PRODUCTS, ROUTE OF ADMINISTRATION, APPLICANTS/MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES

| Member State
  EU/EEA | Marketing authorisation holder | Applicant | (Invented) Name | Strength | Pharmaceutical form | Route of administration |
| --- | --- | --- | --- | --- | --- | --- |
| Czech Republic | | Vitabalans Oy |
| Varastokatu 8 |
| 13500 Hämeenlinna |
| Finland |

Member State

EU/EEA

Marketing authorisation holder

Applicant

(Invented) Name

Strength

Pharmaceutical form

Route of administration

Czech Republic

Vitabalans Oy

Varastokatu 8

13500 Hämeenlinna

Finland

Loratadine Vitabalans 10 mg tablety

10 mg

tablet

oral use

Denmark

| Vitabalans Oy |
| --- |
| Varastokatu 8 |
| 13500 Hämeenlinna |
| Finland |

Vitabalans Oy

Varastokatu 8

13500 Hämeenlinna

Finland

Loraxin

10 mg

tablet

oral use

Estonia

| Vitabalans Oy |
| --- |
| Varastokatu 8 |
| 13500 Hämeenlinna |
| Finland |

Vitabalans Oy

Varastokatu 8

13500 Hämeenlinna

Finland

Loratadine Vitabalans

10 mg

tablet

oral use

Finland

| Vitabalans Oy |
| --- |
| Varastokatu 8 |
| 13500 Hämeenlinna |
| Finland |

Vitabalans Oy

Varastokatu 8

13500 Hämeenlinna

Finland

| Vitabalans Oy |
| --- |
| Varastokatu 8 |
| 13500 Hämeenlinna |
| Finland |

Vitabalans Oy

Varastokatu 8

13500 Hämeenlinna

Finland

Loraxin

10 mg

tablet

oral use

Hungary

| Vitabalans Oy |
| --- |
| Varastokatu 8 |
| 13500 Hämeenlinna |
| Finland |

Vitabalans Oy

Varastokatu 8

13500 Hämeenlinna

Finland

Loraxin

10 mg

tablet

oral use

Latvia

| Vitabalans Oy |
| --- |
| Varastokatu 8 |
| 13500 Hämeenlinna |
| Finland |

Vitabalans Oy

Varastokatu 8

13500 Hämeenlinna

Finland

Loratadine Vitabalans 10 mg tabletes

10 mg

tablet

oral use

Lithuania

| Vitabalans Oy |
| --- |
| Varastokatu 8 |
| 13500 Hämeenlinna |
| Finland |

Vitabalans Oy

Varastokatu 8

13500 Hämeenlinna

Finland

Loraxin

10 mg

tablet

oral use

Norway

| Vitabalans Oy |
| --- |
| Varastokatu 8 |
| 13500 Hämeenlinna |
| Finland |

Vitabalans Oy

Varastokatu 8

13500 Hämeenlinna

Finland

Loratadine Vitabalans

10 mg

tablet

oral use

Poland

| Vitabalans Oy |
| --- |
| Varastokatu 8 |
| 13500 Hämeenlinna |
| Finland |

Vitabalans Oy

Varastokatu 8

13500 Hämeenlinna

Finland

Loratadine Vitabalans

10 mg

tablet

oral use

Slovak Republic

| Vitabalans Oy |
| --- |
| Varastokatu 8 |
| 13500 Hämeenlinna |
| Finland |

Vitabalans Oy

Varastokatu 8

13500 Hämeenlinna

Finland

Loratadine Vitabalans 10 mg

10 mg

tablet

oral use

Slovenia

| Vitabalans Oy |
| --- |
| Varastokatu 8 |
| 13500 Hämeenlinna |
| Finland |

Vitabalans Oy

Varastokatu 8

13500 Hämeenlinna

Finland

Loratadine Vitabalans 10 mg tablete

10 mg

tablet

oral use

Sweden

| Vitabalans Oy |
| --- |
| Varastokatu 8 |
| 13500 Hämeenlinna |
| Finland |

Vitabalans Oy

Varastokatu 8

13500 Hämeenlinna

Finland

Loratadine Vitabalans

10 mg

tablet

oral use

---

ANNEX IV

LIST OF THE NAMES, PHARMACEUTICAL FORM, 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 |
| --- | --- | --- | --- | --- | --- |
| Austria | Teva Pharma B.V. |
| Computerweg 10 |
| 3542 DR Utrecht |
| The Netherlands |

Member State

EU/EEA

Marketing Authorisation Holder

(Invented) Name

Strength

Pharmaceutical Form

Route of administration

Austria

Teva Pharma B.V.

Computerweg 10

3542 DR Utrecht

The Netherlands

Cilazapril TEVA 0,5 mg Filmtabletten

0,5 mg

Film-coated tablet

Oral use

Austria

| Teva Pharma B.V. |
| --- |
| Computerweg 10 |
| 3542 DR Utrecht |
| The Netherlands |

Teva Pharma B.V.

Computerweg 10

3542 DR Utrecht

The Netherlands

Cilazapril TEVA 2,5 mg Filmtabletten

2,5 mg

Film-coated tablet

Oral use

Austria

| Teva Pharma B.V. |
| --- |
| Computerweg 10 |
| 3542 DR Utrecht |
| The Netherlands |

Teva Pharma B.V.

Computerweg 10

3542 DR Utrecht

The Netherlands

Cilazapril TEVA 5 mg Filmtabletten

5,0 mg

Film-coated tablet

Oral use

Czech Republic

| Teva Pharmaceuticals CR, s.r.o. |
| --- |
| Radlická 3185/1c |
| 150 00 Praha 5, |
| Czech Republic |

Teva Pharmaceuticals CR, s.r.o.

Radlická 3185/1c

150 00 Praha 5,

Czech Republic

CILAZAPRIL TEVA 5 MG

5 mg

Film-coated tablet

Oral use

Czech Republic

| Teva Pharmaceuticals CR, s.r.o. |
| --- |
| Radlická 3185/1c |
| 150 00 Praha 5, |
| Czech Republic |

Teva Pharmaceuticals CR, s.r.o.

Radlická 3185/1c

150 00 Praha 5,

Czech Republic

CILAZAPRIL TEVA 2,5 MG

2,5 mg

Film-coated tablet

Oral use

France

| TEVA SANTE |
| --- |
| 110 ESPLANADE DU GENERAL DE GAULLE |
| 92931 PARIS LA DEFENSE CEDEX |
| FRANCE |

TEVA SANTE

110 ESPLANADE DU GENERAL DE GAULLE

92931 PARIS LA DEFENSE CEDEX

FRANCE

CILAZAPRIL TEVA

1 mg, comprimé pelliculé sécable

1 mg

Film-coated tablet

Oral use

France

| TEVA SANTE |
| --- |
| 110 ESPLANADE DU GENERAL DE GAULLE |
| 92931 PARIS LA DEFENSE CEDEX |
| FRANCE |

TEVA SANTE

110 ESPLANADE DU GENERAL DE GAULLE

92931 PARIS LA DEFENSE CEDEX

FRANCE

CILAZAPRIL TEVA 0,5 mg, comprimé pelliculé sécable

0,5 mg

Film-coated tablet

Oral use

France

| TEVA SANTE |
| --- |
| 110 ESPLANADE DU GENERAL DE GAULLE |
| 92931 PARIS LA DEFENSE CEDEX |
| FRANCE |

TEVA SANTE

110 ESPLANADE DU GENERAL DE GAULLE

92931 PARIS LA DEFENSE CEDEX

FRANCE

CILAZAPRIL TEVA 2,5 mg, comprimé pelliculé sécable

2,5 mg

Film-coated tablet

Oral use

Poland

| 123ratio Sp. z o.o. |
| --- |
| ul. Emilii Plater 53 |
| 00-113 Warsaw |
| Poland |

123ratio Sp. z o.o.

ul. Emilii Plater 53

00-113 Warsaw

Poland

Cilazaprilum 123ratio

1 mg

Film-coated tablet

Oral use

Poland

| 123ratio Sp. z o.o. |
| --- |
| ul. Emilii Plater 53 |
| 00-113 Warsaw |
| Poland |

123ratio Sp. z o.o.

ul. Emilii Plater 53

00-113 Warsaw

Poland

Cilazaprilum 123ratio

2,5 mg

Film-coated tablet

Oral use

Poland

| 123ratio Sp. z o.o. |
| --- |
| ul. Emilii Plater 53 |
| 00-113 Warsaw |
| Poland |

123ratio Sp. z o.o.

ul. Emilii Plater 53

00-113 Warsaw

Poland

Cilazaprilum 123ratio

5 mg

Film-coated tablet

Oral use

Spain

| TEVA PHARMA, S.L.U. |
| --- |
| C/Anabel Segura, 11 |
| Edificio Albatros B, 1a planta |
| 28108 Alcobendas (Madrid) |
| Spain |

TEVA PHARMA, S.L.U.

C/Anabel Segura, 11

Edificio Albatros B, 1a planta

28108 Alcobendas (Madrid)

Spain

CILAZAPRIL TEVA 1 mg comprimidos recubiertos con película EFG

1 mg

Film-coated tablet

Oral use

Spain

| TEVA PHARMA, S.L.U. |
| --- |
| C/Anabel Segura, 11 |
| Edificio Albatros B, 1a planta |
| 28108 Alcobendas (Madrid) |
| Spain |

TEVA PHARMA, S.L.U.

C/Anabel Segura, 11

Edificio Albatros B, 1a planta

28108 Alcobendas (Madrid)

Spain

CILAZAPRIL TEVA 5 mg comprimidos recubiertos con película EFG

5 mg

Film-coated tablet

Oral use

Spain

| TEVA PHARMA, S.L.U. |
| --- |
| C/Anabel Segura, 11 |
| Edificio Albatros B, 1a planta |
| 28108 Alcobendas (Madrid) |
| Spain |

TEVA PHARMA, S.L.U.

C/Anabel Segura, 11

Edificio Albatros B, 1a planta

28108 Alcobendas (Madrid)

Spain

CILAZAPRIL TEVA 2,5 mg comprimidos recubiertos con película EFG

2,5 mg

Film-coated tablet

Oral use

United Kingdom

| Teva UK Ltd, |
| --- |
| Brampton Road, |
| Hampden Park, |
| Eastbourne, |
| BN22 9AG, |
| United Kingdom |

Teva UK Ltd,

Brampton Road,

Hampden Park,

Eastbourne,

BN22 9AG,

United Kingdom

Cilazapril 0,5 mg tablets

0,5 mg

Tablet

Oral use

United Kingdom

| Teva UK Ltd, |
| --- |
| Brampton Road, |
| Hampden Park, |
| Eastbourne, |
| BN22 9AG, |
| United Kingdom |

Teva UK Ltd,

Brampton Road,

Hampden Park,

Eastbourne,

BN22 9AG,

United Kingdom

Cilazapril 1 mg tablets

1 mg

Tablet

Oral use

United Kingdom

| Teva UK Ltd, |
| --- |
| Brampton Road, |
| Hampden Park, |
| Eastbourne, |
| BN22 9AG, |
| United Kingdom |

Teva UK Ltd,

Brampton Road,

Hampden Park,

Eastbourne,

BN22 9AG,

United Kingdom

Cilazapril 2,5 mg tablets

2,5 mg

Tablet

Oral use

United Kingdom

| Teva UK Ltd, |
| --- |
| Brampton Road, |
| Hampden Park, |
| Eastbourne, |
| BN22 9AG, |
| United Kingdom |

Teva UK Ltd,

Brampton Road,

Hampden Park,

Eastbourne,

BN22 9AG,

United Kingdom

Cilazapril 5 mg tablets

5 mg

Tablet

Oral use

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