# C_2009231EN.01003001.xml

| 25.9.2009 | EN | Official Journal of the European Union | C 231/30 |
| --- | --- | --- | --- |

25.9.2009

EN

Official Journal of the European Union

C 231/30

---

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

(Decisions taken pursuant to Article 34 of Directive 2001/83/EC of the European Parliament and of the Council
   (1)
  or Article 38 of Directive 2001/82/EC of the European Parliament and of the Council
   (2)
  )

(Decisions taken pursuant to Article 34 of Directive 2001/83/EC of the European Parliament and of the Council

1

or Article 38 of Directive 2001/82/EC of the European Parliament and of the Council

2

)

2009/C 231/06

—   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 |
| --- | --- | --- | --- | --- |
| 3.8.2009 | Fenflor | See Annex I | See Annex I | 5.8.2009 |
| 3.8.2009 | Shotaflor | See Annex II | See Annex II | 5.8.2009 |

Date of the decision

Name(s) of the medicinal product

Holder(s) of the marketing authorisation

Member State concerned

Date of notification

3.8.2009

Fenflor

See Annex I

See Annex I

5.8.2009

3.8.2009

Shotaflor

See Annex II

See Annex II

5.8.2009

—   Suspension of a national marketing authorisation

Suspension 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 |
| --- | --- | --- | --- | --- |
| 6.8.2009 | Loratadine Sandoz 10 | See Annex III | See Annex III | 7.8.2009 |

Date of the decision

Name(s) of the medicinal product

Holder(s) of the marketing authorisation

Member State concerned

Date of notification

6.8.2009

Loratadine Sandoz 10

See Annex III

See Annex III

7.8.2009

---

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

| Member State | Applicant/Marketing Authorisation Holder | Invented name | Pharmaceutical form | Strength | Animal species | Frequency and route of administration |
| --- | --- | --- | --- | --- | --- | --- |
| Austria | Gosmore Ltd |
| 9 Pitch and Pay Lane |
| Sneyd Park |
| Bristol |
| UNITED KINGDOM |

Member State

Applicant/Marketing Authorisation Holder

Invented name

Pharmaceutical form

Strength

Animal species

Frequency and route of administration

Austria

Gosmore Ltd

9 Pitch and Pay Lane

Sneyd Park

Bristol

UNITED KINGDOM

Fenflor 300 mg/ml solution for injection for cattle

Solution for injection

300 mg/ml

Cattle

Intramuscular injection 20 mg/kg bodyweight (1 ml/15 kg) to be administered twice 48 hours apart

Belgium

| Gosmore Ltd |
| --- |
| 9 Pitch and Pay Lane |
| Sneyd Park |
| Bristol |
| UNITED KINGDOM |

Gosmore Ltd

9 Pitch and Pay Lane

Sneyd Park

Bristol

UNITED KINGDOM

Fenflor 300 mg/ml solution for injection for cattle

Solution for injection

300 mg/ml

Cattle

Intramuscular injection 20 mg/kg bodyweight (1 ml/15 kg) to be administered twice 48 hours apart

Germany

| Gosmore Ltd |
| --- |
| 9 Pitch and Pay Lane |
| Sneyd Park |
| Bristol |
| UNITED KINGDOM |

Gosmore Ltd

9 Pitch and Pay Lane

Sneyd Park

Bristol

UNITED KINGDOM

Fenflor 300 mg/ml solution for injection for cattle

Solution for injection

300 mg/ml

Cattle

Intramuscular injection 20 mg/kg bodyweight (1 ml/15 kg) to be administered twice 48 hours apart

France

| Gosmore Ltd |
| --- |
| 9 Pitch and Pay Lane |
| Sneyd Park |
| Bristol |
| UNITED KINGDOM |

Gosmore Ltd

9 Pitch and Pay Lane

Sneyd Park

Bristol

UNITED KINGDOM

Fenflor 300 mg/ml solution for injection for cattle

Solution for injection

300 mg/ml

Cattle

Intramuscular injection 20 mg/kg bodyweight (1 ml/15 kg) to be administered twice 48 hours apart

Ireland

| Gosmore Ltd |
| --- |
| 9 Pitch and Pay Lane |
| Sneyd Park |
| Bristol |
| UNITED KINGDOM |

Gosmore Ltd

9 Pitch and Pay Lane

Sneyd Park

Bristol

UNITED KINGDOM

Fenflor 300 mg/ml solution for injection for cattle

Solution for injection

300 mg/ml

Cattle

Intramuscular injection 20 mg/kg bodyweight (1 ml/15 kg) to be administered twice 48 hours apart

Italy

| Gosmore Ltd |
| --- |
| 9 Pitch and Pay Lane |
| Sneyd Park |
| Bristol |
| UNITED KINGDOM |

Gosmore Ltd

9 Pitch and Pay Lane

Sneyd Park

Bristol

UNITED KINGDOM

Fenflor 300 mg/ml solution for injection for cattle

Solution for injection

300 mg/ml

Cattle

Intramuscular injection 20 mg/kg bodyweight (1 ml/15 kg) to be administered twice 48 hours apart

Poland

| Gosmore Ltd |
| --- |
| 9 Pitch and Pay Lane |
| Sneyd Park |
| Bristol |
| UNITED KINGDOM |

Gosmore Ltd

9 Pitch and Pay Lane

Sneyd Park

Bristol

UNITED KINGDOM

Fenflor 300 mg/ml solution for injection for cattle

Solution for injection

300 mg/ml

Cattle

Intramuscular injection 20 mg/kg bodyweight (1 ml/15 kg) to be administered twice 48 hours apart

Portugal

| Gosmore Ltd |
| --- |
| 9 Pitch and Pay Lane |
| Sneyd Park |
| Bristol |
| UNITED KINGDOM |

Gosmore Ltd

9 Pitch and Pay Lane

Sneyd Park

Bristol

UNITED KINGDOM

Fenflor 300 mg/ml solution for injection for cattle

Solution for injection

300 mg/ml

Cattle

Intramuscular injection 20 mg/kg bodyweight (1 ml/15 kg) to be administered twice 48 hours apart

Spain

| Gosmore Ltd |
| --- |
| 9 Pitch and Pay Lane |
| Sneyd Park |
| Bristol |
| UNITED KINGDOM |

Gosmore Ltd

9 Pitch and Pay Lane

Sneyd Park

Bristol

UNITED KINGDOM

Fenflor 300 mg/ml solution for injection for cattle

Solution for injection

300 mg/ml

Cattle

Intramuscular injection 20 mg/kg bodyweight (1 ml/15 kg) to be administered twice 48 hours apart

The Netherlands

| Gosmore Ltd |
| --- |
| 9 Pitch and Pay Lane |
| Sneyd Park |
| Bristol |
| UNITED KINGDOM |

Gosmore Ltd

9 Pitch and Pay Lane

Sneyd Park

Bristol

UNITED KINGDOM

Fenflor 300 mg/ml solution for injection for cattle

Solution for injection

300 mg/ml

Cattle

Intramuscular injection 20 mg/kg bodyweight (1 ml/15 kg) to be administered twice 48 hours apart

United Kingdom

| Gosmore Ltd |
| --- |
| 9 Pitch and Pay Lane |
| Sneyd Park |
| Bristol |
| UNITED KINGDOM |

Gosmore Ltd

9 Pitch and Pay Lane

Sneyd Park

Bristol

UNITED KINGDOM

Fenflor 300 mg/ml solution for injection for cattle

Solution for injection

300 mg/ml

Cattle

Intramuscular injection 20 mg/kg bodyweight (1 ml/15 kg) to be administered twice 48 hours apart

---

ANNEX II

LIST OF THE NAMES, PHARMACEUTICAL FORM, STRENGTH OF THE VETERINARY MEDICINAL PRODUCT, ANIMAL SPECIES, ROUTE OF ADMINISTRATION, MARKETING AUTHORISATION HOLDER/APPLICANT IN THE MEMBER STATES

| Member State | Applicant/Marketing
  Authorisation Holder | Invented name | Pharmaceutical form | Strength | Animal species | Frequency and route of administration |
| --- | --- | --- | --- | --- | --- | --- |
| Austria | Virbac S.A. |
| 1ère avenue 2065 m L.I.D |
| 06516 Carros Cedex |
| FRANCE |

Member State

Applicant/Marketing

Authorisation Holder

Invented name

Pharmaceutical form

Strength

Animal species

Frequency and route of administration

Austria

Virbac S.A.

1ère avenue 2065 m L.I.D

06516 Carros Cedex

FRANCE

Shotaflor 300 mg/ml solution for injection for cattle

Solution for injection

300 mg/ml

Cattle

Intramuscular injection 20 mg/kg bodyweight (1 ml/15 kg) to be administered twice 48 hours apart

Belgium

| Virbac S.A. |
| --- |
| 1ère avenue 2065 m L.I.D |
| 06516 Carros Cedex |
| FRANCE |

Virbac S.A.

1ère avenue 2065 m L.I.D

06516 Carros Cedex

FRANCE

Shotaflor 300 mg/ml solution for injection for cattle

Solution for injection

300 mg/ml

Cattle

Intramuscular injection 20 mg/kg bodyweight (1 ml/15 kg) to be administered twice 48 hours apart

Denmark

| Virbac S.A. |
| --- |
| 1ère avenue 2065 m L.I.D |
| 06516 Carros Cedex |
| FRANCE |

Virbac S.A.

1ère avenue 2065 m L.I.D

06516 Carros Cedex

FRANCE

Shotaflor 300 mg/ml solution for injection for cattle

Solution for injection

300 mg/ml

Cattle

Intramuscular injection 20 mg/kg bodyweight (1 ml/15 kg) to be administered twice 48 hours apart

Germany

| Virbac S.A. |
| --- |
| 1ère avenue 2065 m L.I.D |
| 06516 Carros Cedex |
| FRANCE |

Virbac S.A.

1ère avenue 2065 m L.I.D

06516 Carros Cedex

FRANCE

Shotaflor 300 mg/ml solution for injection for cattle

Solution for injection

300 mg/ml

Cattle

Intramuscular injection 20 mg/kg bodyweight (1 ml/15 kg) to be administered twice 48 hours apart

France

| Virbac S.A. |
| --- |
| 1ère avenue 2065 m L.I.D |
| 06516 Carros Cedex |
| FRANCE |

Virbac S.A.

1ère avenue 2065 m L.I.D

06516 Carros Cedex

FRANCE

Shotaflor 300 mg/ml solution for injection for cattle

Solution for injection

300 mg/ml

Cattle

Intramuscular injection 20 mg/kg bodyweight (1 ml/15 kg) to be administered twice 48 hours apart

Greece

| Virbac S.A. |
| --- |
| 1ère avenue 2065 m L.I.D |
| 06516 Carros Cedex |
| FRANCE |

Virbac S.A.

1ère avenue 2065 m L.I.D

06516 Carros Cedex

FRANCE

Shotaflor 300 mg/ml solution for injection for cattle

Solution for injection

300 mg/ml

Cattle

Intramuscular injection 20 mg/kg bodyweight (1 ml/15 kg) to be administered twice 48 hours apart

Ireland

| Virbac S.A. |
| --- |
| 1ère avenue 2065 m L.I.D |
| 06516 Carros Cedex |
| FRANCE |

Virbac S.A.

1ère avenue 2065 m L.I.D

06516 Carros Cedex

FRANCE

Shotaflor 300 mg/ml solution for injection for cattle

Solution for injection

300 mg/ml

Cattle

Intramuscular injection 20 mg/kg bodyweight (1 ml/15 kg) to be administered twice 48 hours apart

Italy

| Virbac S.A. |
| --- |
| 1ère avenue 2065 m L.I.D |
| 06516 Carros Cedex |
| FRANCE |

Virbac S.A.

1ère avenue 2065 m L.I.D

06516 Carros Cedex

FRANCE

Shotaflor 300 mg/ml solution for injection for cattle

Solution for injection

300 mg/ml

Cattle

Intramuscular injection 20 mg/kg bodyweight (1 ml/15 kg) to be administered twice 48 hours apart

Portugal

| Virbac S.A. |
| --- |
| 1ère avenue 2065 m L.I.D |
| 06516 Carros Cedex |
| FRANCE |

Virbac S.A.

1ère avenue 2065 m L.I.D

06516 Carros Cedex

FRANCE

Shotaflor 300 mg/ml solution for injection for cattle

Solution for injection

300 mg/ml

Cattle

Intramuscular injection 20 mg/kg bodyweight (1 ml/15 kg) to be administered twice 48 hours apart

Spain

| Virbac S.A. |
| --- |
| 1ère avenue 2065 m L.I.D |
| 06516 Carros Cedex |
| FRANCE |

Virbac S.A.

1ère avenue 2065 m L.I.D

06516 Carros Cedex

FRANCE

Shotaflor 300 mg/ml solution for injection for cattle

Solution for injection

300 mg/ml

Cattle

Intramuscular injection 20 mg/kg bodyweight (1 ml/15 kg) to be administered twice 48 hours apart

The Netherlands

| Virbac S.A. |
| --- |
| 1ère avenue 2065 m L.I.D |
| 06516 Carros Cedex |
| FRANCE |

Virbac S.A.

1ère avenue 2065 m L.I.D

06516 Carros Cedex

FRANCE

Shotaflor 300 mg/ml solution for injection for cattle

Solution for injection

300 mg/ml

Cattle

Intramuscular injection 20 mg/kg bodyweight (1 ml/15 kg) to be administered twice 48 hours apart

United Kingdom

| Virbac S.A. |
| --- |
| 1ère avenue 2065 m L.I.D |
| 06516 Carros Cedex |
| FRANCE |

Virbac S.A.

1ère avenue 2065 m L.I.D

06516 Carros Cedex

FRANCE

Shotaflor 300 mg/ml solution for injection for cattle

Solution for injection

300 mg/ml

Cattle

Intramuscular injection 20 mg/kg bodyweight (1 ml/15 kg) to be administered twice 48 hours apart

---

ANNEX III

LIST OF THE NAMES, PHARMACEUTICAL FORM, STRENGTHS 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 |
| --- | --- | --- | --- | --- | --- | --- |
| Austria | Sandoz GmbH |
| Biochemiestrasse 10 |
| 6250 Kundl |
| AUSTRIA |

Member State EU/EEA

Marketing Authorisation Holder

Applicant

(Invented) Name

Strength

Pharmaceutical form

Route of administration

Austria

Sandoz GmbH

Biochemiestrasse 10

6250 Kundl

AUSTRIA

Lictyn 10 mg — Tabletten

10 mg

Tablet

Oral use

Bulgaria

| Sandoz B.V. |
| --- |
| Veluwezoom 22 |
| 1327 AH Almere |
| THE NETHERLANDS |

Sandoz B.V.

Veluwezoom 22

1327 AH Almere

THE NETHERLANDS

Loratadin Sandoz

10 mg

Tablet

Oral use

Czech Republic

| Sandoz B.V. |
| --- |
| Veluwezoom 22 |
| 1327 AH Almere |
| THE NETHERLANDS |

Sandoz B.V.

Veluwezoom 22

1327 AH Almere

THE NETHERLANDS

Loratadin Sandoz 10 mg tablety

10 mg

Tablet

Oral use

Denmark

| Sandoz GmbH |
| --- |
| Biochemiestrasse 10 |
| 6250 Kundl |
| AUSTRIA |

Sandoz GmbH

Biochemiestrasse 10

6250 Kundl

AUSTRIA

Loratadin Sandoz

10 mg

Tablet

Oral use

Estonia

| Sandoz B.V. |
| --- |
| Veluwezoom 22 |
| 1327 AH Almere |
| THE NETHERLANDS |

Sandoz B.V.

Veluwezoom 22

1327 AH Almere

THE NETHERLANDS

Lomilan

10 mg

Tablet

Oral use

Finland

| Sandoz GmbH |
| --- |
| Biochemiestrasse 10 |
| 6250 Kundl |
| AUSTRIA |

Sandoz GmbH

Biochemiestrasse 10

6250 Kundl

AUSTRIA

Loratadin Sandoz 10 mg

10 mg

Tablet

Oral use

France

| Sandoz B.V. |
| --- |
| Veluwezoom 22 |
| 1327 AH Almere |
| THE NETHERLANDS |

Sandoz B.V.

Veluwezoom 22

1327 AH Almere

THE NETHERLANDS

Loratadine Sandoz Conseil 10 mg comprimé

10 mg

Tablet

Oral use

Germany

| Sandoz Pharmaceuticals GmbH |
| --- |
| Raiffeisenstr. 11 |
| 83607 Holzkirchen |
| GERMANY |

Sandoz Pharmaceuticals GmbH

Raiffeisenstr. 11

83607 Holzkirchen

GERMANY

Loratadin Sandoz 10 mg Tabletten

10 mg

Tablet

Oral use

Greece

| Sandoz GmbH |
| --- |
| Biochemiestrasse 10 |
| 6250 Kundl |
| AUSTRIA |

Sandoz GmbH

Biochemiestrasse 10

6250 Kundl

AUSTRIA

Tirlor

10 mg

Tablet

Oral use

Hungary

| Sandoz B.V. |
| --- |
| Veluwezoom 22 |
| 1327 AH Almere |
| THE NETHERLANDS |

Sandoz B.V.

Veluwezoom 22

1327 AH Almere

THE NETHERLANDS

Loratadin Sandoz 10 mg tabletta

10 mg

Tablet

Oral use

Italy

| Sandoz B.V. |
| --- |
| Veluwezoom 22 |
| 1327 AH Almere |
| THE NETHERLANDS |

Sandoz B.V.

Veluwezoom 22

1327 AH Almere

THE NETHERLANDS

Loratadina Hexal AG 10 mg compresse

10 mg

Tablet

Oral use

Latvia

| Sandoz B.V. |
| --- |
| Verovskova 57 |
| SI-1000 Ljubljana |
| SLOVENIA |

Sandoz B.V.

Verovskova 57

SI-1000 Ljubljana

SLOVENIA

Lomilan 10 mg tabletes

10 mg

Tablet

Oral use

Lithuania

| Sandoz B.V. |
| --- |
| Veluwezoom 22 |
| 1327 AH Almere |
| THE NETHERLANDS |

Sandoz B.V.

Veluwezoom 22

1327 AH Almere

THE NETHERLANDS

Lomilan

10 mg

Tablet

Oral use

Netherlands

| Sandoz B.V. |
| --- |
| Veluwezoom 22 |
| 1327 AH Almere |
| THE NETHERLANDS |

Sandoz B.V.

Veluwezoom 22

1327 AH Almere

THE NETHERLANDS

Loratadine Sandoz 10, tabletten 10 mg

10 mg

Tablet

Oral use

Norway

| Sandoz GmbH |
| --- |
| Biochemiestrasse 10 |
| 6250 Kundl |
| AUSTRIA |

Sandoz GmbH

Biochemiestrasse 10

6250 Kundl

AUSTRIA

Loratadin Sandoz 10 mg

10 mg

Tablet

Oral use

Poland

| Sandoz B.V. |
| --- |
| Veluwezoom 22 |
| 1327 AH Almere |
| THE NETHERLANDS |

Sandoz B.V.

Veluwezoom 22

1327 AH Almere

THE NETHERLANDS

Flonidan tab

10 mg

Tablet

Oral use

Portugal

| Sandoz Farmacêutica, Lda. |
| --- |
| PRT Alameda da Beloura |
| Edifício 1, 2.o — Escritório 15 |
| 2710-693 Sintra |
| PORTUGAL |

Sandoz Farmacêutica, Lda.

PRT Alameda da Beloura

Edifício 1, 2.o — Escritório 15

2710-693 Sintra

PORTUGAL

Loratadina Sandoz 10 mg Comprimidos

10 mg

Tablet

Oral use

Romania

| Sandoz B.V. |
| --- |
| Veluwezoom 22 |
| 1327 AH Almere |
| THE NETHERLANDS |

Sandoz B.V.

Veluwezoom 22

1327 AH Almere

THE NETHERLANDS

Loratadina Sandoz 10 mg comprimate

10 mg

Tablet

Oral use

Slovak Republic

| Sandoz B.V. |
| --- |
| Veluwezoom 22 |
| 1327 AH Almere |
| THE NETHERLANDS |

Sandoz B.V.

Veluwezoom 22

1327 AH Almere

THE NETHERLANDS

Flonidan 10 mg tablety

10 mg

Tablet

Oral use

Slovenia

| Sandoz B.V. |
| --- |
| Veluwezoom 22 |
| 1327 AH Almere |
| THE NETHERLANDS |

Sandoz B.V.

Veluwezoom 22

1327 AH Almere

THE NETHERLANDS

Florin 10 mg tablete

10 mg

Tablet

Oral use

Spain

| Sandoz Farmacéutica, S.A. |
| --- |
| Gran Via de los Corts Catalanes, 764 |
| 08013 Barcelona |
| SPAIN |

Sandoz Farmacéutica, S.A.

Gran Via de los Corts Catalanes, 764

08013 Barcelona

SPAIN

Loratadina Genpril 10 mg Comprimidos EFG

10 mg

Tablet

Oral use

Sweden

| Sandoz GmbH |
| --- |
| Biochemiestrasse 10 |
| 6250 Kundl |
| AUSTRIA |

Sandoz GmbH

Biochemiestrasse 10

6250 Kundl

AUSTRIA

Loratadin Sandoz 10 mg

10 mg

Tablet

Oral use

United Kingdom

| Sandoz Limited |
| --- |
| Woolmer way |
| Bordon, Hants |
| GU35 9QE |
| UNITED KINGDOM |

Sandoz Limited

Woolmer way

Bordon, Hants

GU35 9QE

UNITED KINGDOM

Loratadine 10 mg Tablets

10 mg

Tablet

Oral use

---