# C_2007115EN.01001001.xml

| 25.5.2007 | EN | Official Journal of the European Union | C 115/10 |
| --- | --- | --- | --- |

25.5.2007

EN

Official Journal of the European Union

C 115/10

---

Summary of Community decisions on marketing authorizations in respect of medicinal products from 1 April 2007 to 30 April 2007

(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

2

(2007/C 115/04)

—   Issuing, maintenance or modification of a national marketing authorisation

| Date of the decision | Name(s) of the medicinal product | Holder(s) of the marketing authorization | Member State concerned | Date of notification |
| --- | --- | --- | --- | --- |
| 13.4.2007 | Alendronate Hexal | See Annex I | See Annex I | 18.4.2007 |
| 13.4.2007 | Gadovist | See Annex II | See Annex II | 19.4.2007 |
| 13.4.2007 | Gadograf | See Annex III | See Annex III | 19.4.2007 |
| 17.4.2007 | Dolovet | See Annex IV | See Annex IV | 20.4.2007 |
| 17.4.2007 | Suvaxyn Parvo E | See Annex V | See Annex V | 20.4.2007 |
| 19.4.2007 | Suvaxyn Ery | See Annex VI | See Annex VI | 20.4.2007 |

Date of the decision

Name(s) of the medicinal product

Holder(s) of the marketing authorization

Member State concerned

Date of notification

13.4.2007

Alendronate Hexal

See Annex I

See Annex I

18.4.2007

13.4.2007

Gadovist

See Annex II

See Annex II

19.4.2007

13.4.2007

Gadograf

See Annex III

See Annex III

19.4.2007

17.4.2007

Dolovet

See Annex IV

See Annex IV

20.4.2007

17.4.2007

Suvaxyn Parvo E

See Annex V

See Annex V

20.4.2007

19.4.2007

Suvaxyn Ery

See Annex VI

See Annex VI

20.4.2007

—   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 |
| --- | --- | --- | --- | --- |
| 2.4.2007 | Equimectin | See Annex VII | See Annex VII | 3.4.2007 |
| 13.4.2007 | Mefecur | See Annex VIII | See Annex VIII | 19.4.2007 |
| 13.4.2007 | Mefecomb | See Annex IX | See Annex IX | 20.4.2007 |
| 13.4.2007 | Mefelor | See Annex X | See Annex X | 19.4.2007 |
| 13.4.2007 | Mefesan | See Annex XI | See Annex XI | 19.4.2007 |
| 13.4.2007 | Metofelosan | See Annex XII | See Annex XII | 20.4.2007 |
| 13.4.2007 | Metoprolol/Felodipin ‘YES’ | See Annex XIII | See Annex XIII | 18.4.2007 |

Date of the decision

Name(s) of the medicinal product

Holder(s) of the marketing authorization

Member State concerned

Date of notification

2.4.2007

Equimectin

See Annex VII

See Annex VII

3.4.2007

13.4.2007

Mefecur

See Annex VIII

See Annex VIII

19.4.2007

13.4.2007

Mefecomb

See Annex IX

See Annex IX

20.4.2007

13.4.2007

Mefelor

See Annex X

See Annex X

19.4.2007

13.4.2007

Mefesan

See Annex XI

See Annex XI

19.4.2007

13.4.2007

Metofelosan

See Annex XII

See Annex XII

20.4.2007

13.4.2007

Metoprolol/Felodipin ‘YES’

See Annex XIII

See Annex XIII

18.4.2007

---

(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 MEDICINAL PRODUCT, ROUTE OF ADMINISTRATION, APPLICANT, MARKETING AUTHORISATION HOLDER IN THE MEMBER STATES

| Member State | Marketing Authorisation Holder | Applicant | Invented name
  Name | Strength | Pharmaceutical form | Route of administration | Content (concentration) |
| --- | --- | --- | --- | --- | --- | --- | --- |
| Sweden | HEXAL A/S |
| Kanalholmen 8-12 |
| DK-2650 Hvidovre |

Member State

Marketing Authorisation Holder

Applicant

Invented name

Name

Strength

Pharmaceutical form

Route of administration

Content (concentration)

Sweden

HEXAL A/S

Kanalholmen 8-12

DK-2650 Hvidovre

Alendronat HEXAL

10 mg

Tablets

Oral use

10 mg per tablet

Belgium

| HEXAL A/S |
| --- |
| Kanalholmen 8-12 |
| DK-2650 Hvidovre |

HEXAL A/S

Kanalholmen 8-12

DK-2650 Hvidovre

Alendronate Sandoz

10 mg tabletten

10 mg

Tablets

Oral use

10 mg per tablet

Denmark

| HEXAL A/S |
| --- |
| Kanalholmen 8-12 |
| DK-2650 Hvidovre |

HEXAL A/S

Kanalholmen 8-12

DK-2650 Hvidovre

Alendonicht

10 mg

Tablets

Oral use

10 mg per tablet

Greece

| HEXAL A/S |
| --- |
| Kanalholmen 8-12 |
| DK-2650 Hvidovre |

HEXAL A/S

Kanalholmen 8-12

DK-2650 Hvidovre

Forosa

10 mg

Tablets

Oral use

10 mg per tablet

---

ANNEX II

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

| Member State | Marketing Authorisation Holder | Invented name | Strength | Pharmaceutical Form | Route of administration |
| --- | --- | --- | --- | --- | --- |
| Austria | Schering Austria GmbH |
| Wienerbergstraße 41 |
| Euro Plaza-Gebäude F/PF45 |
| A-1121 Wien |

Member State

Marketing Authorisation Holder

Invented name

Strength

Pharmaceutical Form

Route of administration

Austria

Schering Austria GmbH

Wienerbergstraße 41

Euro Plaza-Gebäude F/PF45

A-1121 Wien

Gadovist

1 mmol/ml

Solution for injection

Intravenous use

Austria

| Schering Austria GmbH |
| --- |
| Wienerbergstraße 41 |
| Euro Plaza-Gebäude F/PF45 |
| A-1121 Wien |

Schering Austria GmbH

Wienerbergstraße 41

Euro Plaza-Gebäude F/PF45

A-1121 Wien

Gadovist

1 mmol/ml

Solution for Injection in prefilled syringe

Intravenous use

Belgium

| NV Schering S.A. |
| --- |
| J.E. Mommaertslaan, 14 |
| B-1831 Machelen (Diegem) |

NV Schering S.A.

J.E. Mommaertslaan, 14

B-1831 Machelen (Diegem)

Gadovist

1 mmol/ml

Solution for injection

Intravenous use

Belgium

| NV Schering S.A. |
| --- |
| J.E. Mommaertslaan, 14 |
| B-1831 Machelen (Diegem) |

NV Schering S.A.

J.E. Mommaertslaan, 14

B-1831 Machelen (Diegem)

Gadovist

1 mmol/ml

Solution for Injection in prefilled syringe

Intravenous use

Denmark

| Schering AG |
| --- |
| Müllerstr. 178 |
| D-13342 Berlin-Mitte |

Schering AG

Müllerstr. 178

D-13342 Berlin-Mitte

Gadovist

1 mmol/ml

Solution for injection

Intravenous use

Denmark

| Schering AG |
| --- |
| Müllerstr. 178 |
| D-13342 Berlin-Mitte |

Schering AG

Müllerstr. 178

D-13342 Berlin-Mitte

Gadovist

1 mmol/ml

Solution for Injection in prefilled syringe

Intravenous use

Germany

| Schering Deutschland GmbH |
| --- |
| Max-Dohrn-Strasse 10 |
| D-10589 Berlin |

Schering Deutschland GmbH

Max-Dohrn-Strasse 10

D-10589 Berlin

Gadovist

1 mmol/ml

Solution for injection

Intravenous use

Germany

| Schering Deutschland GmbH |
| --- |
| Max-Dohrn-Strasse 10 |
| D-10589 Berlin |

Schering Deutschland GmbH

Max-Dohrn-Strasse 10

D-10589 Berlin

Gadovist

1 mmol/ml

Solution for Injection in prefilled syringe

Intravenous use

Greece

| Schering Hellas SA |
| --- |
| 466 Irakliou Ave. & 12-14 Kyprou Str. |
| Neo Iraklio |
| GR-14122 Athens |

Schering Hellas SA

466 Irakliou Ave. & 12-14 Kyprou Str.

Neo Iraklio

GR-14122 Athens

Gadovist

1 mmol/ml

Solution for injection

Intravenous use

Greece

| Schering Hellas SA |
| --- |
| 466 Irakliou Ave. &12-14 Kyprou Str. |
| Neo Iraklio |
| GR-14122 Athens |

Schering Hellas SA

466 Irakliou Ave. &12-14 Kyprou Str.

Neo Iraklio

GR-14122 Athens

Gadovist

1 mmol/ml

Solution for Injection in prefilled syringe

Intravenous use

Spain

| Schering España, S.A. |
| --- |
| c/ Mendez Alvaro, 55 |
| E-28045 Madrid |

Schering España, S.A.

c/ Mendez Alvaro, 55

E-28045 Madrid

Gadovist

1 mmol/ml

Solution for injection

Intravenous use

Spain

| Schering España, S.A. |
| --- |
| c/ Mendez Alvaro, 55 |
| E-28045 Madrid |

Schering España, S.A.

c/ Mendez Alvaro, 55

E-28045 Madrid

Gadovist

1 mmol/ml

Solution for Injection in prefilled syringe

Intravenous use

Finland

| Schering Oy |
| --- |
| Pansiontie 47 |
| Post Box 415 |
| FIN-20101 Turku |

Schering Oy

Pansiontie 47

Post Box 415

FIN-20101 Turku

Gadovist

1 mmol/ml

Solution for injection

Intravenous use

Finland

| Schering Oy |
| --- |
| Pansiontie 47 |
| Post Box 415 |
| FIN-20101 Turku |

Schering Oy

Pansiontie 47

Post Box 415

FIN-20101 Turku

Gadovist

1 mmol/ml

Solution for Injection in prefilled syringe

Intravenous use

France

| Schering SA |
| --- |
| Z.I. Roubaix-Est |
| rue de Toufflers |
| BP 69 |
| F-59452 Lys-Lez-Lannoy Cedex |

Schering SA

Z.I. Roubaix-Est

rue de Toufflers

BP 69

F-59452 Lys-Lez-Lannoy Cedex

Gadovist

1 mmol/ml

Solution for injection

Intravenous use

France

| Schering SA |
| --- |
| Z.I. Roubaix-Est |
| rue de Toufflers |
| BP 69 |
| F-59452 Lys-Lez-Lannoy Cedex |

Schering SA

Z.I. Roubaix-Est

rue de Toufflers

BP 69

F-59452 Lys-Lez-Lannoy Cedex

Gadovist

1 mmol/ml

Solution for Injection in prefilled syringe

Intravenous use

Ireland

| HE Clissmann T/A Schering |
| --- |
| 72 Heather Road |
| Dublin 18 |
| Ireland |

HE Clissmann T/A Schering

72 Heather Road

Dublin 18

Ireland

Gadovist

1 mmol/ml

Solution for injection

Intravenous use

Ireland

| HE Clissmann T/A Schering |
| --- |
| 72 Heather Road |
| Dublin 18 |
| Ireland |

HE Clissmann T/A Schering

72 Heather Road

Dublin 18

Ireland

Gadovist

1 mmol/ml

Solution for Injection in prefilled syringe

Intravenous use

Italy

| Schering S.p.A. |
| --- |
| Via E. Schering, 21 |
| I-20090 Segrate (MI) |

Schering S.p.A.

Via E. Schering, 21

I-20090 Segrate (MI)

Gadovist

1 mmol/ml

Solution for injection

Intravenous use

Italy

| Schering S.p.A. |
| --- |
| Via E. Schering, 21 |
| I-20090 Segrate (MI) |

Schering S.p.A.

Via E. Schering, 21

I-20090 Segrate (MI)

Gadovist

1 mmol/ml

Solution for Injection in prefilled syringe

Intravenous use

Luxembourg

| NV Schering S.A. |
| --- |
| J.E. Mommaertslaan, 14 |
| B-1831 Machelen (Diegem) |

NV Schering S.A.

J.E. Mommaertslaan, 14

B-1831 Machelen (Diegem)

Gadovist

1 mmol/ml

Solution for injection

Intravenous use

Luxembourg

| NV Schering S.A. |
| --- |
| J.E. Mommaertslaan, 14 |
| B-1831 Machelen (Diegem) |

NV Schering S.A.

J.E. Mommaertslaan, 14

B-1831 Machelen (Diegem)

Gadovist

1 mmol/ml

Solution for Injection in prefilled syringe

Intravenous use

Netherlands

| Schering Nederland B.V |
| --- |
| Van Houten Industriepark 1 |
| Postbus 116 |
| 1380 AC Weesp |
| Nederland |

Schering Nederland B.V

Van Houten Industriepark 1

Postbus 116

1380 AC Weesp

Nederland

Gadovist

1 mmol/ml

Solution for injection

Intravenous use

Netherlands

| Schering Nederland B.V |
| --- |
| Van Houten Industriepark 1 |
| Postbus 116 |
| 1380 AC Weesp |
| Nederland |

Schering Nederland B.V

Van Houten Industriepark 1

Postbus 116

1380 AC Weesp

Nederland

Gadovist

1 mmol/ml

Solution for Injection in prefilled syringe

Intravenous use

Norway

| Schering AG |
| --- |
| Müllerstr. 178 |
| D-13342 Berlin-Mitte |

Schering AG

Müllerstr. 178

D-13342 Berlin-Mitte

Gadovist

1 mmol/ml

Solution for injection

Intravenous use

Norway

| Schering AG |
| --- |
| Müllerstr. 178 |
| D-13342 Berlin-Mitte |

Schering AG

Müllerstr. 178

D-13342 Berlin-Mitte

Gadovist

1 mmol/ml

Solution for Injection in prefilled syringe

Intravenous use

Portugal

| Schering Lusitana, Lda |
| --- |
| Estrada Nacional 249, km 15 |
| P.O. Box 16 |
| P-2725-397 Mem Martins |

Schering Lusitana, Lda

Estrada Nacional 249, km 15

P.O. Box 16

P-2725-397 Mem Martins

Gadovist

1 mmol/ml

Solution for injection

Intravenous use

Sweden

| Schering AG |
| --- |
| Müllerstr. 178 |
| D-13342 Berlin-Mitte |

Schering AG

Müllerstr. 178

D-13342 Berlin-Mitte

Gadovist

1 mmol/ml

Solution for injection

Intravenous use

Sweden

| Schering AG |
| --- |
| Müllerstr. 178 |
| D-13342 Berlin-Mitte |
| Allemagne |

Schering AG

Müllerstr. 178

D-13342 Berlin-Mitte

Allemagne

Gadovist

1 mmol/ml

Solution for Injection in prefilled syringe

Intravenous use

United Kingdom

| Schering Health Care Limited |
| --- |
| The Brow |
| Burgess Hill |
| West Sussex RH1F 9NE |
| United Kingdom |

Schering Health Care Limited

The Brow

Burgess Hill

West Sussex RH1F 9NE

United Kingdom

Gadovist

1 mmol/ml

Solution for injection

Intravenous use

United Kingdom

| Schering Health Care Limited |
| --- |
| The Brow |
| Burgess Hill |
| West Sussex RH1F 9NE |
| United Kingdom |

Schering Health Care Limited

The Brow

Burgess Hill

West Sussex RH1F 9NE

United Kingdom

Gadovist

1 mmol/ml

Solution for Injection in prefilled syringe

Intravenous use

---

ANNEX III

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

| Member State | Marketing Authorisation Holder | Invented name | Strength | Pharmaceutical Form | Route of administration |
| --- | --- | --- | --- | --- | --- |
| Germany | Schering Deutschland GmbH |
| Max-Dohrn-Strasse 10 |
| D-10589 Berlin |

Member State

Marketing Authorisation Holder

Invented name

Strength

Pharmaceutical Form

Route of administration

Germany

Schering Deutschland GmbH

Max-Dohrn-Strasse 10

D-10589 Berlin

Gadograf

1 mmol/ml

Solution for injection

Intravenous use

Germany

| Schering Deutschland GmbH |
| --- |
| Max-Dohrn-Strasse 10 |
| D-10589 Berlin |

Schering Deutschland GmbH

Max-Dohrn-Strasse 10

D-10589 Berlin

Gadograf

1 mmol/ml

Solution for Injection in prefilled syringe

Intravenous use

Spain

| Schering España, S.A. |
| --- |
| c/ Mendez Alvaro, 55 |
| E-28045 Madrid |

Schering España, S.A.

c/ Mendez Alvaro, 55

E-28045 Madrid

Gadograf

1 mmol/ml

Solution for injection

Intravenous use

Spain

| Schering España, S.A. |
| --- |
| c/ Mendez Alvaro, 55 |
| E-28045 Madrid |

Schering España, S.A.

c/ Mendez Alvaro, 55

E-28045 Madrid

Gadograf

1 mmol/ml

Solution for Injection in prefilled syringe

Intravenous use

---

ANNEX IV

NAME, PHARMACEUTICAL FORM, STRENGTH OF THE MEDICINAL PRODUCT, ANIMAL SPECIES, ROUTES OF ADMINISTRATION, AND MARKETING AUTHORISATION HOLDER

| Member State | Applicant or Marketing Authorisation Holder | Product invented name | Pharmaceutical form | Strength | Animal species | Frequency and route of administration | Recommended dose |
| --- | --- | --- | --- | --- | --- | --- | --- |
| Belgium, Czech Republic, Denmark, Spain, Finland, Italy, Luxembourg, The Netherlands, Norway, Poland and Slovakia | Vetcare Ltd. |
| P. O. Box 99 |
| FIN-24101 Salo |

Member State

Applicant or Marketing Authorisation Holder

Product invented name

Pharmaceutical form

Strength

Animal species

Frequency and route of administration

Recommended dose

Belgium, Czech Republic, Denmark, Spain, Finland, Italy, Luxembourg, The Netherlands, Norway, Poland and Slovakia

Vetcare Ltd.

P. O. Box 99

FIN-24101 Salo

Dolovet vet 2,4 g

Powder

2.4g ketoprofen per sachet of 15g powder

Cattle

(adult animals weighing about 600 kg)

Formula

One bag of 15g once daily for 1 — 3 days. This corresponds to 4mg ketoprofen per kg body weight

Austria and Hungary

As above

Rifen 2,4 g

As above

As above

As above

As above

As above

---

ANNEX V

NAME, PHARMACEUTICAL FORM, STRENGTH OF THE MEDICINAL PRODUCTS, ANIMAL SPECIES, ROUTES OF ADMINISTRATION, AND MARKETING AUTHORISATION HOLDER

| Member State | Marketing Authorisation Holder | Applicant | Product invented name | Pharmaceutical form | Strength | Animal species | Frequency and route of administration | Recommended dose |
| --- | --- | --- | --- | --- | --- | --- | --- | --- |
| Austria | Wyeth Lederle Pharma GmbH, Fort Dodge |
| Waidhausengasse 19/9 |
| A-1140 Vienna |
| Contact: Dr. Attila Romváry |
| Tel: +43 1 912 28 40 |
| Fax: +43 1 911 51 00 |
| Email: romvara@fdah.com |

Member State

Marketing Authorisation Holder

Applicant

Product invented name

Pharmaceutical form

Strength

Animal species

Frequency and route of administration

Recommended dose

Austria

Wyeth Lederle Pharma GmbH, Fort Dodge

Waidhausengasse 19/9

A-1140 Vienna

Contact: Dr. Attila Romváry

Tel: +43 1 912 28 40

Fax: +43 1 911 51 00

Email: romvara@fdah.com

Wyeth Lederle Pharma GmbH, Fort Dodge

Suvaxyn Parvo/E

Emulsion for injection

| — | PPV inducing a HIA titre of at least 160 (in rabbits). |
| --- | --- |

—

PPV inducing a HIA titre of at least 160 (in rabbits).

| — | E. rhusiopathiae: RP ≥ 1 in accordance with the EP |
| --- | --- |

—

E. rhusiopathiae: RP ≥ 1 in accordance with the EP

Porcine

From 5 months: 2 inj. 3-4 wks apart. 2nd dose at least 4 wks before mating.

Annual Revacc-ination: 1 dose during each lacta-tion period 3 to 4 wks before mating.

Intramuscular injection

2 ml

Belgium

| Fort Dodge Animal Health Holland |
| --- |
| C.J. van Houtenlaan 36 |
| 1381 CP Weesp |
| The Netherlands |
| Contact: Dr. Durk Stellingwerf |
| Tel: (31-35) 699 33 72 |
| Fax: (31-35) 699 33 80 |
| Email: stellid@fdah.com |

Fort Dodge Animal Health Holland

C.J. van Houtenlaan 36

1381 CP Weesp

The Netherlands

Contact: Dr. Durk Stellingwerf

Tel: (31-35) 699 33 72

Fax: (31-35) 699 33 80

Email: stellid@fdah.com

Fort Dodge Animal Health Holland

Suvaxyn Parvo/E

Emulsion for injection

| — | PPV inducing a HIA titre of at least 160 (in rabbits). |
| --- | --- |

—

PPV inducing a HIA titre of at least 160 (in rabbits).

| — | E. rhusiopathiae: RP ≥ 1 in accordance with the EP |
| --- | --- |

—

E. rhusiopathiae: RP ≥ 1 in accordance with the EP

Porcine

From 5 months: 2 inj. 3-4 wks apart. 2nd dose at least 4 wks before mating.

Annual Revacc-ination: 1 dose during each lacta-tion period 3 to 4 wks before mating.

Intramuscular injection

2 ml

France

| Fort Dodge Santé Animale S.A. |
| --- |
| 24, Avenue Marcel Dassault |
| BP 440 |
| F-37204 Tours Cedex 3 |
| Contact: Mr. Yves Dehon |
| Tel: +33 2 4774 8979 |
| Fax: +33 2 47748999 |
| Email: dehony@ahp.com |

Fort Dodge Santé Animale S.A.

24, Avenue Marcel Dassault

BP 440

F-37204 Tours Cedex 3

Contact: Mr. Yves Dehon

Tel: +33 2 4774 8979

Fax: +33 2 47748999

Email: dehony@ahp.com

Fort Dodge Santé Animale S.A.

Suvaxyn Parvo/E

Emulsion for injection

| — | PPV inducing a HIA titre of at least 160 (in rabbits). |
| --- | --- |

—

PPV inducing a HIA titre of at least 160 (in rabbits).

| — | E. rhusiopathiae: RP ≥ 1 in accordance with the EP |
| --- | --- |

—

E. rhusiopathiae: RP ≥ 1 in accordance with the EP

Porcine

From 5 months: 2 inj. 3-4 wks apart. 2nd dose at least 4 wks before mating.

Annual Revacc-ination: 1 dose during each lacta-tion period 3 to 4 wks before mating.

Intramuscular injection

2 ml

Germany

| Fort Dodge Veterinär GmbH |
| --- |
| Adenauerstrasse 20 |
| D-52146 Würselen |
| Contact: Dr. Elisabeth Stangl |
| Tel: (49-240) 545 42 16 |
| Fax: (49-240) 545 44 61 |
| Email: stangle@fdah.com |

Fort Dodge Veterinär GmbH

Adenauerstrasse 20

D-52146 Würselen

Contact: Dr. Elisabeth Stangl

Tel: (49-240) 545 42 16

Fax: (49-240) 545 44 61

Email: stangle@fdah.com

Fort Dodge Veterinär GmbH

Suvaxyn Parvo/E

Emulsion for injection

| — | PPV inducing a HIA titre of at least 160 (in rabbits). |
| --- | --- |

—

PPV inducing a HIA titre of at least 160 (in rabbits).

| — | E. rhusiopathiae: RP ≥ 1 in accordance with the EP |
| --- | --- |

—

E. rhusiopathiae: RP ≥ 1 in accordance with the EP

Porcine

From 5 months: 2 inj. 3-4 wks apart. 2nd dose at least 4 wks before mating.

Annual Revacc-ination: 1 dose during each lacta-tion period 3 to 4 wks before mating.

Intramuscular injection

2 ml

Greece

| Wyeth Lederle Pharma GmbH, Fort Dodge |
| --- |
| Waidhausengasse 19/9 |
| A-1140 Vienna |
| Contact: Dr. Eusebio Uruburu |
| Tel: (34-915) 98 13 44 |
| Fax: (34-915) 97 24 34 |
| Email: urubure@fdah.com |

Wyeth Lederle Pharma GmbH, Fort Dodge

Waidhausengasse 19/9

A-1140 Vienna

Contact: Dr. Eusebio Uruburu

Tel: (34-915) 98 13 44

Fax: (34-915) 97 24 34

Email: urubure@fdah.com

Wyeth Lederle Pharma GmbH, Fort Dodge

Suvaxyn Parvo/E

Emulsion for injection

| — | PPV inducing a HIA titre of at least 160 (in rabbits). |
| --- | --- |

—

PPV inducing a HIA titre of at least 160 (in rabbits).

| — | E. rhusiopathiae: RP ≥ 1 in accordance with the EP |
| --- | --- |

—

E. rhusiopathiae: RP ≥ 1 in accordance with the EP

Porcine

From 5 months: 2 inj. 3-4 wks apart. 2nd dose at least 4 wks before mating.

Annual Revacc-ination: 1 dose during each lacta-tion period 3 to 4 wks before mating.

Intramuscular injection

2 ml

Ireland

| Fort Dodge Animal Health Limited |
| --- |
| Flanders Road |
| Hedge End |
| Southampton S030 4QH |
| United Kingdom |
| Contact: Dr. Germán Lastra |
| Tel: (44-14) 89 77 42 21 |
| Fax: (44-14) 89 77 42 51 |
| Email: lastrag@fdah.com |

Fort Dodge Animal Health Limited

Flanders Road

Hedge End

Southampton S030 4QH

United Kingdom

Contact: Dr. Germán Lastra

Tel: (44-14) 89 77 42 21

Fax: (44-14) 89 77 42 51

Email: lastrag@fdah.com

Fort Dodge Animal Health Limited

Suvaxyn Parvo/E

Emulsion for injection

| — | PPV inducing a HIA titre of at least 160 (in rabbits). |
| --- | --- |

—

PPV inducing a HIA titre of at least 160 (in rabbits).

| — | E. rhusiopathiae: RP ≥ 1 in accordance with the EP |
| --- | --- |

—

E. rhusiopathiae: RP ≥ 1 in accordance with the EP

Porcine

From 5 months: 2 inj. 3-4 wks apart. 2nd dose at least 4 wks before mating.

Annual Revacc-ination: 1 dose during each lacta-tion period 3 to 4 wks before mating.

Intramuscular injection

2 ml

Luxembourg

| Fort Dodge Animal Health Holland |
| --- |
| C.J. van Houtenlaan 36 |
| 1381 CP Weesp |
| The Netherlands |
| Contact: Dr. Durk Stellingwerf |
| Tel: (31-35) 699 33 72 |
| Fax: (31-35) 699 33 80 |
| Email: stellid@fdah.com |

Fort Dodge Animal Health Holland

C.J. van Houtenlaan 36

1381 CP Weesp

The Netherlands

Contact: Dr. Durk Stellingwerf

Tel: (31-35) 699 33 72

Fax: (31-35) 699 33 80

Email: stellid@fdah.com

Fort Dodge Animal Health Holland

Suvaxyn Parvo/E

Emulsion for injection

| — | PPV inducing a HIA titre of at least 160 (in rabbits). |
| --- | --- |

—

PPV inducing a HIA titre of at least 160 (in rabbits).

| — | E. rhusiopathiae: RP ≥ 1 in accordance with the EP |
| --- | --- |

—

E. rhusiopathiae: RP ≥ 1 in accordance with the EP

Porcine

From 5 months: 2 inj. 3-4 wks apart. 2nd dose at least 4 wks before mating.

Annual Revacc-ination: 1 dose during each lacta-tion period 3 to 4 wks before mating.

Intramuscular injection

2 ml

Netherlands

| Fort Dodge Animal Health Holland |
| --- |
| C.J. van Houtenlaan 36 |
| 1381 CP Weesp |
| The Netherlands |
| Contact: Dr. Durk Stellingwerf |
| Tel: (31-35) 699 33 72 |
| Fax: (31-35) 699 33 80 |
| Email: stellid@fdah.com |

Fort Dodge Animal Health Holland

C.J. van Houtenlaan 36

1381 CP Weesp

The Netherlands

Contact: Dr. Durk Stellingwerf

Tel: (31-35) 699 33 72

Fax: (31-35) 699 33 80

Email: stellid@fdah.com

Fort Dodge Animal Health Holland

Suvaxyn Parvo/E

Emulsion for injection

| — | PPV inducing a HIA titre of at least 160 (in rabbits). |
| --- | --- |

—

PPV inducing a HIA titre of at least 160 (in rabbits).

| — | E. rhusiopathiae: RP ≥ 1 in accordance with the EP |
| --- | --- |

—

E. rhusiopathiae: RP ≥ 1 in accordance with the EP

Porcine

From 5 months: 2 inj. 3-4 wks apart. 2nd dose at least 4 wks before mating.

Annual Revacc-ination: 1 dose during each lacta-tion period 3 to 4 wks before mating.

Intramuscular injection

2 ml

Norway

| Fort Dodge Veterinaria S.A. |
| --- |
| c/ Camprodón s/n ‘La Riba’ |
| Vall de Bianya (Girona), Spain |
| Contact: Dr. Germán Lastra |
| Tel: +44 1489774221 |
| Fax: +44 1489 774 251 |
| Email: lastrag@fdah.com |

Fort Dodge Veterinaria S.A.

c/ Camprodón s/n ‘La Riba’

Vall de Bianya (Girona), Spain

Contact: Dr. Germán Lastra

Tel: +44 1489774221

Fax: +44 1489 774 251

Email: lastrag@fdah.com

Fort Dodge Veterinaria S.A.

Suvaxyn Parvo/E

Emulsion for injection

| — | PPV inducing a HIA titre of at least 160 (in rabbits). |
| --- | --- |

—

PPV inducing a HIA titre of at least 160 (in rabbits).

| — | E. rhusiopathiae: RP ≥ 1 in accordance with the EP |
| --- | --- |

—

E. rhusiopathiae: RP ≥ 1 in accordance with the EP

Porcine

From 5 months: 2 inj. 3-4 wks apart. 2nd dose at least 4 wks before mating.

Annual Revacc-ination: 1 dose during each lacta-tion period 3 to 4 wks before mating.

Intramuscular injection

2 ml

Sweden

| Fort Dodge Animal Health Holland |
| --- |
| C.J. van Houtenlaan 36 |
| 1381 CP Weesp |
| The Netherlands |
| Contact: Dr. Germán Lastra |
| Tel: +44 1489774221 |
| Fax: +44 1489 774 251 |
| Email: lastrag@fdah.com |

Fort Dodge Animal Health Holland

C.J. van Houtenlaan 36

1381 CP Weesp

The Netherlands

Contact: Dr. Germán Lastra

Tel: +44 1489774221

Fax: +44 1489 774 251

Email: lastrag@fdah.com

Fort Dodge Animal Health Holland

Suvaxyn Parvo/E vet

Emulsion for injection

| — | PPV inducing a HIA titre of at least 160 (in rabbits). |
| --- | --- |

—

PPV inducing a HIA titre of at least 160 (in rabbits).

| — | E. rhusiopathiae: RP ≥ 1 in accordance with the EP |
| --- | --- |

—

E. rhusiopathiae: RP ≥ 1 in accordance with the EP

Porcine

From 5 months: 2 inj. 3-4 wks apart. 2nd dose at least 4 wks before mating.

Annual Revacc-ination: 1 dose during each lacta-tion period 3 to 4 wks before mating.

Intramuscular injection

2 ml

United Kingdom

| Fort Dodge Animal Health Limited |
| --- |
| Flanders Road |
| Hedge End |
| Southampton S030 4QH |
| United Kingdom |
| Tel: (44-14) 89 77 42 21 |
| Fax: (44-14) 89 77 42 51 |
| Email: lastrag@fdah.com |

Fort Dodge Animal Health Limited

Flanders Road

Hedge End

Southampton S030 4QH

United Kingdom

Tel: (44-14) 89 77 42 21

Fax: (44-14) 89 77 42 51

Email: lastrag@fdah.com

Fort Dodge Animal Health Limited

Suvaxyn Parvo/E

Emulsion for injection

| — | PPV inducing a HIA titre of at least 160 (in rabbits). |
| --- | --- |

—

PPV inducing a HIA titre of at least 160 (in rabbits).

| — | E. rhusiopathiae: RP ≥ 1 in accordance with the EP |
| --- | --- |

—

E. rhusiopathiae: RP ≥ 1 in accordance with the EP

Porcine

From 5 months: 2 inj. 3-4 wks apart. 2nd dose at least 4 wks before mating.

Annual Revacc-ination: 1 dose during each lacta-tion period 3 to 4 wks before mating.

Intramuscular injection

2 ml

Spain

| Fort Dodge Veterinaria S.A. Ctra. Camprodón s/n ‘La Riba’ |
| --- |
| E-17813 Vall de Bianya (Girona) |
| Tel: (34) 915 98 13 36 |
| Fax: (34) 915 97 24 34 |
| Email: rodrigv2@fdah.com |

Fort Dodge Veterinaria S.A. Ctra. Camprodón s/n ‘La Riba’

E-17813 Vall de Bianya (Girona)

Tel: (34) 915 98 13 36

Fax: (34) 915 97 24 34

Email: rodrigv2@fdah.com

Fort Dodge Veterinaria S.A.

Suvaxyn Parvo/E

Emulsion for injection

| — | PPV inducing a HIA titre of at least 160 (in rabbits). |
| --- | --- |

—

PPV inducing a HIA titre of at least 160 (in rabbits).

| — | E. rhusiopathiae: RP ≥ 1 in accordance with the EP |
| --- | --- |

—

E. rhusiopathiae: RP ≥ 1 in accordance with the EP

Porcine

From 5 months: 2 inj. 3-4 wks apart. 2nd dose at least 4 wks before mating.

Annual Revacc-ination: 1 dose during each lacta-tion period 3 to 4 wks before mating.

Intramuscular injection

2 ml

---

ANNEX VI

NAME, PHARMACEUTICAL FORM, STRENGTH OF THE MEDICINAL PRODUCTS, ANIMAL SPECIES, ROUTES OF ADMINISTRATION, AND MARKETING AUTHORISATION HOLDER

| Member State | Marketing Authorisation Holder | Applicant | Product invented name | Pharmaceutical form | Strength | Animal species | Frequency and route of administration | Recommended dose |
| --- | --- | --- | --- | --- | --- | --- | --- | --- |
| Austria | Wyeth Lederle Pharma GmbH, Fort Dodge |
| Waidhausengasse 19/9 |
| A-1140 Vienna |
| Contact: Dr. Attila Romváry |
| Tel: (43-1) 912 28 40 |
| Fax: (43-1) 911 51 00 |
| Email: romvara@fdah.com |

Member State

Marketing Authorisation Holder

Applicant

Product invented name

Pharmaceutical form

Strength

Animal species

Frequency and route of administration

Recommended dose

Austria

Wyeth Lederle Pharma GmbH, Fort Dodge

Waidhausengasse 19/9

A-1140 Vienna

Contact: Dr. Attila Romváry

Tel: (43-1) 912 28 40

Fax: (43-1) 911 51 00

Email: romvara@fdah.com

Wyeth Lederle Pharma GmbH, Fort Dodge

Suvaxyn Ery

Emulsion for injection

| — | E. rhusiopathiae: RP ≥ 1 in accordance with the EP |
| --- | --- |

—

E. rhusiopathiae: RP ≥ 1 in accordance with the EP

Porcine

From 5 months: 2 inj. 3-4 wks apart. 2nd dose at least 4 wks before mating.

Annual Revacc-ination: 1 dose during each lacta-tion period 3 to 4 wks before mating.

Intramuscular injection

2 ml

Belgium

| Fort Dodge Animal Health Benelux B.V. |
| --- |
| Van Houten Industriepark 25 |
| 1381 MZ Weesp |
| The Netherlands |
| Contact: Dr. Durk Stellingwerf |
| Tel: (31-35) 699 33 72 |
| Fax: (31-35) 699 33 80 |
| Email: stellid@fdah.com |

Fort Dodge Animal Health Benelux B.V.

Van Houten Industriepark 25

1381 MZ Weesp

The Netherlands

Contact: Dr. Durk Stellingwerf

Tel: (31-35) 699 33 72

Fax: (31-35) 699 33 80

Email: stellid@fdah.com

Fort Dodge Animal Health Benelux B.V.

Suvaxyn Ery

Emulsion for injection

| — | E. rhusiopathiae: RP ≥ 1 in accordance with the EP |
| --- | --- |

—

E. rhusiopathiae: RP ≥ 1 in accordance with the EP

Porcine

From 5 months: 2 inj. 3-4 wks apart. 2nd dose at least 4 wks before mating.

Annual Revacc-ination: 1 dose during each lacta-tion period 3 to 4 wks before mating.

Intramuscular injection

2 ml

Czech Republic

| Fort Dodge Animal Health Holland |
| --- |
| C.J van Houtenlaan 36 |
| 1381 CP Weesp |
| The Netherlands |
| Contact: Dr. Durk Stellingwerf |
| Tel: (31-35) 699 33 72 |
| Fax: (31-35) 699 33 80 |
| Email: stellid@fdah.com |

Fort Dodge Animal Health Holland

C.J van Houtenlaan 36

1381 CP Weesp

The Netherlands

Contact: Dr. Durk Stellingwerf

Tel: (31-35) 699 33 72

Fax: (31-35) 699 33 80

Email: stellid@fdah.com

Fort Dodge Animal Health Holland

Suvaxyn Ery

Emulsion for injection

| — | E. rhusiopathiae: RP ≥ 1 in accordance with the EP |
| --- | --- |

—

E. rhusiopathiae: RP ≥ 1 in accordance with the EP

Porcine

From 5 months: 2 inj. 3-4 wks apart. 2nd dose at least 4 wks before mating.

Annual Revacc-ination: 1 dose during each lacta-tion period 3 to 4 wks before mating.

Intramuscular injection

2 ml

Estonia

| Fort Dodge Animal Health Holland |
| --- |
| C.J van Houtenlaan 36 |
| 1381 CP Weesp |
| The Netherlands |
| Contact: Dr. Durk Stellingwerf |
| Tel: (31-35) 699 33 72 |
| Fax: (31-35) 699 33 80 |
| Email: stellid@fdah.com |

Fort Dodge Animal Health Holland

C.J van Houtenlaan 36

1381 CP Weesp

The Netherlands

Contact: Dr. Durk Stellingwerf

Tel: (31-35) 699 33 72

Fax: (31-35) 699 33 80

Email: stellid@fdah.com

Fort Dodge Animal Health Holland

Suvaxyn Ery

Emulsion for injection

| — | E. rhusiopathiae: RP ≥ 1 in accordance with the EP |
| --- | --- |

—

E. rhusiopathiae: RP ≥ 1 in accordance with the EP

Porcine

From 5 months: 2 inj. 3-4 wks apart. 2nd dose at least 4 wks before mating.

Annual Revacc-ination: 1 dose during each lacta-tion period 3 to 4 wks before mating.

Intramuscular injection

2 ml

France

| Fort Dodge Santé Animale S.A. |
| --- |
| 24, Avenue Marcel Dassault |
| BP 440 |
| F-37204 Tours Cedex 3 |
| Contact: Mr. Yves Dehon |
| Tel: +33 2 47 74 89 79 |
| Fax: +33 2 47 74 89 71 |
| Email: dehonyv@fdah.com |

Fort Dodge Santé Animale S.A.

24, Avenue Marcel Dassault

BP 440

F-37204 Tours Cedex 3

Contact: Mr. Yves Dehon

Tel: +33 2 47 74 89 79

Fax: +33 2 47 74 89 71

Email: dehonyv@fdah.com

Fort Dodge Santé Animale S.A.

Suvaxyn Ery

Emulsion for injection

| — | E. rhusiopathiae: RP ≥ 1 in accordance with the EP |
| --- | --- |

—

E. rhusiopathiae: RP ≥ 1 in accordance with the EP

Porcine

From 5 months: 2 inj. 3-4 wks apart. 2nd dose at least 4 wks before mating.

Annual Revacc-ination: 1 dose during each lacta-tion period 3 to 4 wks before mating.

Intramuscular injection

2 ml

Germany

| Fort Dodge Veterinär GmbH |
| --- |
| Adenauerstrasse 20 |
| D-52146 Würselen |
| Contact: Dr. Elisabeth Stangl |
| Tel: (49-240) 545 42 16 |
| Fax: (49 24) 545 44 61 |
| Email: stangle@fdah.com |

Fort Dodge Veterinär GmbH

Adenauerstrasse 20

D-52146 Würselen

Contact: Dr. Elisabeth Stangl

Tel: (49-240) 545 42 16

Fax: (49 24) 545 44 61

Email: stangle@fdah.com

Fort Dodge Veterinär GmbH

Suvaxyn Ery

Emulsion for injection

| — | E. rhusiopathiae: RP ≥ 1 in accordance with the EP |
| --- | --- |

—

E. rhusiopathiae: RP ≥ 1 in accordance with the EP

Porcine

From 5 months: 2 inj. 3-4 wks apart. 2nd dose at least 4 wks before mating.

Annual Revacc-ination: 1 dose during each lacta-tion period 3 to 4 wks before mating.

Intramuscular injection

2 ml

Greece

| Fort Dodge Animal Health Holland |
| --- |
| C.J van Houtenlaan 36 |
| 1381 CP Weesp |
| The Netherlands |
| Contact: Dr. Germán Lastra |
| Tel: (44-14) 89 77 42 21 |
| Fax: (44-14) 89 77 42 51 |
| Email: lastrag@fdah.com |

Fort Dodge Animal Health Holland

C.J van Houtenlaan 36

1381 CP Weesp

The Netherlands

Contact: Dr. Germán Lastra

Tel: (44-14) 89 77 42 21

Fax: (44-14) 89 77 42 51

Email: lastrag@fdah.com

Fort Dodge Animal Health Holland

Suvaxyn Ery

Emulsion for injection

| — | E. rhusiopathiae: RP ≥ 1 in accordance with the EP |
| --- | --- |

—

E. rhusiopathiae: RP ≥ 1 in accordance with the EP

Porcine

From 5 months: 2 inj. 3-4 wks apart. 2nd dose at least 4 wks before mating.

Annual Revacc-ination: 1 dose during each lacta-tion period 3 to 4 wks before mating.

Intramuscular injection

2 ml

Ireland

| Fort Dodge Animal Health Limited |
| --- |
| Flanders Road |
| Hedge End |
| Southampton S030 4QH |
| United Kingdom |
| Contact: Dr. Germán Lastra |
| Tel: (44-14) 89 77 42 21 |
| Fax: (44-14) 89 77 42 51 |
| Email: lastrag@fdah.com |

Fort Dodge Animal Health Limited

Flanders Road

Hedge End

Southampton S030 4QH

United Kingdom

Contact: Dr. Germán Lastra

Tel: (44-14) 89 77 42 21

Fax: (44-14) 89 77 42 51

Email: lastrag@fdah.com

Fort Dodge Animal Health Limited

Suvaxyn Ery

Emulsion for injection

| — | E. rhusiopathiae: RP ≥ 1 in accordance with the EP |
| --- | --- |

—

E. rhusiopathiae: RP ≥ 1 in accordance with the EP

Porcine

From 5 months: 2 inj. 3-4 wks apart. 2nd dose at least 4 wks before mating.

Annual Revacc-ination: 1 dose during each lacta-tion period 3 to 4 wks before mating.

Intramuscular injection

2 ml

Italy

| Fort Dodge Animal Health SpA |
| --- |
| Via Nettunense 90 |
| I-04011 Aprilia |
| Tel: (39-06) 927 151 |
| Fax: (39-06) 23 32 55 55 |
| Email: bollaa@fdah.com |

Fort Dodge Animal Health SpA

Via Nettunense 90

I-04011 Aprilia

Tel: (39-06) 927 151

Fax: (39-06) 23 32 55 55

Email: bollaa@fdah.com

Fort Dodge Animal Health SpA

Suvaxyn Ery

Emulsion for injection

| — | E. rhusiopathiae: RP ≥ 1 in accordance with the EP |
| --- | --- |

—

E. rhusiopathiae: RP ≥ 1 in accordance with the EP

Porcine

From 5 months: 2 inj. 3-4 wks apart. 2nd dose at least 4 wks before mating.

Annual Revacc-ination: 1 dose during each lacta-tion period 3 to 4 wks before mating.

Intramuscular injection

2 ml

Lithuania

| Fort Dodge Animal Health Holland |
| --- |
| C.J van Houtenlaan 36 |
| 1381 CP Weesp |
| The Netherlands |
| Contact: Dr. Durk Stellingwerf |
| Tel: (31-35) 699 33 72 |
| Fax: (31-35) 699 33 80 |
| Email: stellid@fdah.com |

Fort Dodge Animal Health Holland

C.J van Houtenlaan 36

1381 CP Weesp

The Netherlands

Contact: Dr. Durk Stellingwerf

Tel: (31-35) 699 33 72

Fax: (31-35) 699 33 80

Email: stellid@fdah.com

Fort Dodge Animal Health Holland

Suvaxyn Ery

Emulsion for injection

| — | E. rhusiopathiae: RP ≥ 1 in accordance with the EP |
| --- | --- |

—

E. rhusiopathiae: RP ≥ 1 in accordance with the EP

Porcine

From 5 months: 2 inj. 3-4 wks apart. 2nd dose at least 4 wks before mating.

Annual Revacc-ination: 1 dose during each lacta-tion period 3 to 4 wks before mating.

Intramuscular injection

2 ml

Luxembourg

| Fort Dodge Animal Health Benelux B.V. |
| --- |
| Van Houten Industriepark 25 |
| 1381 MZ Weesp |
| The Netherlands |
| Contact: Dr. Durk Stellingwerf |
| Tel: (31-35) 699 33 72 |
| Fax: (31-35) 699 33 80 |
| Email: stellid@fdah.com |

Fort Dodge Animal Health Benelux B.V.

Van Houten Industriepark 25

1381 MZ Weesp

The Netherlands

Contact: Dr. Durk Stellingwerf

Tel: (31-35) 699 33 72

Fax: (31-35) 699 33 80

Email: stellid@fdah.com

Fort Dodge Animal Health Benelux B.V.

Suvaxyn Ery

Emulsion for injection

| — | E. rhusiopathiae: RP ≥ 1 in accordance with the EP |
| --- | --- |

—

E. rhusiopathiae: RP ≥ 1 in accordance with the EP

Porcine

From 5 months: 2 inj. 3-4 wks apart. 2nd dose at least 4 wks before mating.

Annual Revacc-ination: 1 dose during each lacta-tion period 3 to 4 wks before mating.

Intramuscular injection

2 ml

Malta

| Fort Dodge Animal Health Holland |
| --- |
| C.J van Houtenlaan 36 |
| 1381 CP Weesp |
| The Netherlands |
| Contact: Dr. Durk Stellingwerf |
| Tel: (31-35) 699 33 72 |
| Fax: (31-35) 699 33 80 |
| Email: stellid@fdah.com |

Fort Dodge Animal Health Holland

C.J van Houtenlaan 36

1381 CP Weesp

The Netherlands

Contact: Dr. Durk Stellingwerf

Tel: (31-35) 699 33 72

Fax: (31-35) 699 33 80

Email: stellid@fdah.com

Fort Dodge Animal Health Holland

Suvaxyn Ery

Emulsion for injection

| — | E. rhusiopathiae: RP ≥ 1 in accordance with the EP |
| --- | --- |

—

E. rhusiopathiae: RP ≥ 1 in accordance with the EP

Porcine

From 5 months: 2 inj. 3-4 wks apart. 2nd dose at least 4 wks before mating.

Annual Revacc-ination: 1 dose during each lacta-tion period 3 to 4 wks before mating.

Intramuscular injection

2 ml

Netherlands

| Fort Dodge Animal Health Benelux B.V. |
| --- |
| Van Houten Industriepark 25 |
| 1381 MZ Weesp |
| The Netherlands |
| Contact: Dr. Durk Stellingwerf |
| Tel: (31-35) 699 33 72 |
| Fax: (31-35) 699 33 80 |
| Email: stellid@fdah.com |

Fort Dodge Animal Health Benelux B.V.

Van Houten Industriepark 25

1381 MZ Weesp

The Netherlands

Contact: Dr. Durk Stellingwerf

Tel: (31-35) 699 33 72

Fax: (31-35) 699 33 80

Email: stellid@fdah.com

Fort Dodge Animal Health Benelux B.V.

Suvaxyn Ery

Emulsion for injection

| — | E. rhusiopathiae: RP ≥ 1 in accordance with the EP |
| --- | --- |

—

E. rhusiopathiae: RP ≥ 1 in accordance with the EP

Porcine

From 5 months: 2 inj. 3-4 wks apart. 2nd dose at least 4 wks before mating.

Annual Revacc-ination: 1 dose during each lacta-tion period 3 to 4 wks before mating.

Intramuscular injection

2 ml

Norway

| Fort Dodge Veterinär GmbH |
| --- |
| Adenauerstrasse 20 |
| D-52146 Würselen |
| Contact: Dr. Germán Lastra |
| Tel: (44-14) 89 77 42 21 |
| Fax: (44-14) 89 77 42 51 |
| Email: lastrag@fdah.com |

Fort Dodge Veterinär GmbH

Adenauerstrasse 20

D-52146 Würselen

Contact: Dr. Germán Lastra

Tel: (44-14) 89 77 42 21

Fax: (44-14) 89 77 42 51

Email: lastrag@fdah.com

Fort Dodge Veterinär GmbH

Suvaxyn Ery

Emulsion for injection

| — | E. rhusiopathiae: RP ≥ 1 in accordance with the EP |
| --- | --- |

—

E. rhusiopathiae: RP ≥ 1 in accordance with the EP

Porcine

From 5 months: 2 inj. 3-4 wks apart. 2nd dose at least 4 wks before mating.

Annual Revacc-ination: 1 dose during each lacta-tion period 3 to 4 wks before mating.

Intramuscular injection

2 ml

Portugal

| Fort Dodge Veterinària Lda. |
| --- |
| Rua Dr. António Loureiro Borges, n.o 2, |
| Arquiparque-Miraflores |
| P-1495-131 Algés |
| Contact: Dr. Virginia Rodríguez |
| Tel: (34-91) 598 13 43 |
| Fax: (34-91) 597 24 34 |
| Email: rodrigv2@fdah.com |

Fort Dodge Veterinària Lda.

Rua Dr. António Loureiro Borges, n.o 2,

Arquiparque-Miraflores

P-1495-131 Algés

Contact: Dr. Virginia Rodríguez

Tel: (34-91) 598 13 43

Fax: (34-91) 597 24 34

Email: rodrigv2@fdah.com

Fort Dodge Veterinària Lda.

Suvaxyn Ery

Emulsion for injection

| — | E. rhusiopathiae: RP ≥ 1 in accordance with the EP |
| --- | --- |

—

E. rhusiopathiae: RP ≥ 1 in accordance with the EP

Porcine

From 5 months: 2 inj. 3-4 wks apart. 2nd dose at least 4 wks before mating.

Annual Revacc-ination: 1 dose during each lacta-tion period 3 to 4 wks before mating.

Intramuscular injection

2 ml

Slovak Republic

| Fort Dodge Animal Health Holland |
| --- |
| C.J van Houtenlaan 36 |
| 1381 CP Weesp |
| The Netherlands |
| Contact: Dr. Durk Stellingwerf |
| Tel: (31-35) 699 33 72 |
| Fax: (31-35) 699 33 80 |
| Email: stellid@fdah.com |

Fort Dodge Animal Health Holland

C.J van Houtenlaan 36

1381 CP Weesp

The Netherlands

Contact: Dr. Durk Stellingwerf

Tel: (31-35) 699 33 72

Fax: (31-35) 699 33 80

Email: stellid@fdah.com

Fort Dodge Animal Health Holland

Suvaxyn Ery

Emulsion for injection

| — | E. rhusiopathiae: RP ≥ 1 in accordance with the EP |
| --- | --- |

—

E. rhusiopathiae: RP ≥ 1 in accordance with the EP

Porcine

From 5 months: 2 inj. 3-4 wks apart. 2nd dose at least 4 wks before mating.

Annual Revacc-ination: 1 dose during each lacta-tion period 3 to 4 wks before mating.

Intramuscular injection

2 ml

United Kingdom

| Fort Dodge Animal Health Limited |
| --- |
| Flanders Road |
| Hedge End |
| Southampton S030 4QH |
| United Kingdom |
| Contact: Dr. Germán Lastra |
| Tel: (44-14) 89 77 42 21 |
| Fax: (44-14) 89 77 42 51 |
| Email: lastrag@fdah.com |

Fort Dodge Animal Health Limited

Flanders Road

Hedge End

Southampton S030 4QH

United Kingdom

Contact: Dr. Germán Lastra

Tel: (44-14) 89 77 42 21

Fax: (44-14) 89 77 42 51

Email: lastrag@fdah.com

Fort Dodge Animal Health Limited

Suvaxyn Ery

Emulsion for injection

| — | E. rhusiopathiae: RP ≥ 1 in accordance with the EP |
| --- | --- |

—

E. rhusiopathiae: RP ≥ 1 in accordance with the EP

Porcine

From 5 months: 2 inj. 3-4 wks apart. 2nd dose at least 4 wks before mating.

Annual Revacc-ination: 1 dose during each lacta-tion period 3 to 4 wks before mating.

Intramuscular injection

2 ml

Hungary

| Fort Dodge Animal Health Holland |
| --- |
| C.J van Houtenlaan 36 |
| 1381 CP Weesp |
| The Netherlands |
| Contact: Dr. Durk Stellingwerf |
| Tel: (31-35) 699 33 72 |
| Fax: (31-35) 699 33 80 |
| Email: stellid@fdah.com |

Fort Dodge Animal Health Holland

C.J van Houtenlaan 36

1381 CP Weesp

The Netherlands

Contact: Dr. Durk Stellingwerf

Tel: (31-35) 699 33 72

Fax: (31-35) 699 33 80

Email: stellid@fdah.com

Fort Dodge Animal Health Holland

Suvaxyn Ery

Emulsion for injection

| — | E. rhusiopathiae: RP ≥ 1 in accordance with the EP |
| --- | --- |

—

E. rhusiopathiae: RP ≥ 1 in accordance with the EP

Porcine

From 5 months: 2 inj. 3-4 wks apart. 2nd dose at least 4 wks before mating.

Annual Revacc-ination: 1 dose during each lacta-tion period 3 to 4 wks before mating.

Intramuscular injection

2 ml

Spain

| Fort Dodge Veterinaria, S.A. |
| --- |
| Ctra. Camprodón s/n ‘La Riba’ |
| E-17813 Vall de Bianya (Girona) |
| Contact: Dra Virginia Rodríguez |
| Tel: (34-91) 598 13 36 |
| Fax: (34-91) 597 24 34 |
| Email: rodrigv2@fdah.com |

Fort Dodge Veterinaria, S.A.

Ctra. Camprodón s/n ‘La Riba’

E-17813 Vall de Bianya (Girona)

Contact: Dra Virginia Rodríguez

Tel: (34-91) 598 13 36

Fax: (34-91) 597 24 34

Email: rodrigv2@fdah.com

Fort Dodge Veterinaria, S.A.

Suvaxyn Ery

Emulsion for injection

| — | E. rhusiopathiae: RP ≥ 1 in accordance with the EP |
| --- | --- |

—

E. rhusiopathiae: RP ≥ 1 in accordance with the EP

Porcine

From 5 months: 2 inj. 3-4 wks apart. 2nd dose at least 4 wks before mating.

Annual Revacc-ination: 1 dose during each lacta-tion period 3 to 4 wks before mating.

Intramuscular injection

2 ml

---

ANNEX VII

NAME, PHARMACEUTICAL FORM, STRENGTH OF THE MEDICINAL PRODUCT, ANIMAL SPECIES, ROUTES OF ADMINISTRATION, AND MARKETING AUTHORISATION HOLDER

| Member State | Applicant or Marketing Authorisation Holder | Product invented name | Pharmaceutical form | Strength | Animal species | Frequency and route of administration | Recommended dose |
| --- | --- | --- | --- | --- | --- | --- | --- |
| Netherlands, Austria, Belgium, Denmark, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Luxembourg, Norway, Poland, Portugal and Spain | Le Vet B.V.
  The Netherlands | Equimectine | Oral gel | 12 mg/g | Horses | Oral use. A single administration of 0.2 mg ivermectin per kg of bodyweight. Retreatment should be done according to the epidemiological situation, but not at less than 30 days interval | A single administration of 0.2 mg ivermectin per kg of bodyweight |

Member State

Applicant or Marketing Authorisation Holder

Product invented name

Pharmaceutical form

Strength

Animal species

Frequency and route of administration

Recommended dose

Netherlands, Austria, Belgium, Denmark, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Luxembourg, Norway, Poland, Portugal and Spain

Le Vet B.V.

The Netherlands

Equimectine

Oral gel

12 mg/g

Horses

Oral use. A single administration of 0.2 mg ivermectin per kg of bodyweight. Retreatment should be done according to the epidemiological situation, but not at less than 30 days interval

A single administration of 0.2 mg ivermectin per kg of bodyweight

---

ANNEX VIII

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

| Member State | Marketing Authorisation Holder | Applicant | Invented name | Strength | Pharmaceutical Form | Route of administration |
| --- | --- | --- | --- | --- | --- | --- |
| Denmark | Sandoz Pharmaceuticals GmbH |
| Carl-Zeiss-Ring 3 |
| D-85737 Ismaning |

Member State

Marketing Authorisation Holder

Applicant

Invented name

Strength

Pharmaceutical Form

Route of administration

Denmark

Sandoz Pharmaceuticals GmbH

Carl-Zeiss-Ring 3

D-85737 Ismaning

Mefecur

50/5 mg

Prolonged-release tablet

oral

Germany

| Sandoz Pharmaceuticals GmbH |
| --- |
| Carl-Zeiss-Ring 3 |
| D-85737 Ismaning |

Sandoz Pharmaceuticals GmbH

Carl-Zeiss-Ring 3

D-85737 Ismaning

Felodipin Metoprolol Sandoz 5 mg/47,5 mg Retardtabletten

50/5 mg

Prolonged-release tablet

oral

---

ANNEX IX

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

| Member State | Marketing Authorisation Holder | Applicant | Invented name | Strength | Pharmaceutical Form | Route of administration |
| --- | --- | --- | --- | --- | --- | --- |
| Denmark | ratiopharm GmbH |
| Graf-Arco-Str. 3 |
| D-89079 Ulm |

Member State

Marketing Authorisation Holder

Applicant

Invented name

Strength

Pharmaceutical Form

Route of administration

Denmark

ratiopharm GmbH

Graf-Arco-Str. 3

D-89079 Ulm

Mefecomb 50 mg/5 mg

50/5 mg

Prolonged-release tablet

oral

Germany

| ratiopharm GmbH |
| --- |
| Graf-Arco-Str. 3 |
| D-89079 Ulm |

ratiopharm GmbH

Graf-Arco-Str. 3

D-89079 Ulm

Metoprololtartrat/Felodipin-ratiopharm 50 mg/5 mg Retardtabletten

50/5 mg

Prolonged-release tablet

oral

Finland

| ratiopharm GmbH |
| --- |
| Graf-Arco-Str. 3 |
| D-89079 Ulm |

ratiopharm GmbH

Graf-Arco-Str. 3

D-89079 Ulm

Mefecomb 50 mg/5 mg depot-tabletti

50/5 mg

Prolonged-release tablet

oral

Luxembourg

| ratiopharm GmbH |
| --- |
| Graf-Arco-Str. 3 |
| D-89079 Ulm |

ratiopharm GmbH

Graf-Arco-Str. 3

D-89079 Ulm

Metoprololtartrat/Felodipin-ratiopharm 50 mg/5 mg Retardtabletten

50/5 mg

Prolonged-release tablet

oral

---

ANNEX X

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

| Member State | Marketing Authorisation Holder | Applicant | Invented name | Strength | Pharmaceutical Form | Route of administration |
| --- | --- | --- | --- | --- | --- | --- |
| Denmark | ratiopharm GmbH |
| Graf-Arco-Str. 3 |
| D-89079 Ulm |

Member State

Marketing Authorisation Holder

Applicant

Invented name

Strength

Pharmaceutical Form

Route of administration

Denmark

ratiopharm GmbH

Graf-Arco-Str. 3

D-89079 Ulm

Mefelor

50/5 mg

Prolonged-release tablet

oral

Germany

| AbZ-Pharma GmbH |
| --- |
| Dr.-Georg-Spohn-Str. 7 |
| D-89143 Blaubeuren |

AbZ-Pharma GmbH

Dr.-Georg-Spohn-Str. 7

D-89143 Blaubeuren

Metoprololtartrat/Felodipin AbZ 50 mg/5 mg Retardtabletten

50/5 mg

Prolonged-release tablet

oral

---

ANNEX XI

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

| Member State | Marketing Authorisation Holder | Applicant | Invented name | Strength | Pharmaceutical Form | Route of administration |
| --- | --- | --- | --- | --- | --- | --- |
| Denmark | CT Arzneimittel GmbH |
| Lengeder Str. 42a |
| D-13407 Berlin |

Member State

Marketing Authorisation Holder

Applicant

Invented name

Strength

Pharmaceutical Form

Route of administration

Denmark

CT Arzneimittel GmbH

Lengeder Str. 42a

D-13407 Berlin

Mefesan

50/5 mg

Prolonged-release tablet

oral

Germany

| CT Arzneimittel GmbH |
| --- |
| Lengeder Str. 42a |
| D-13407 Berlin |

CT Arzneimittel GmbH

Lengeder Str. 42a

D-13407 Berlin

Metoprololtartrat/Felodipin-CT 50 mg/5 mg Retardtabletten

50/5 mg

Prolonged-release tablet

oral

---

ANNEX XII

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

| Member State | Marketing Authorisation Holder | Applicant | Invented name | Strength | Pharmaceutical Form | Route of administration |
| --- | --- | --- | --- | --- | --- | --- |
| Denmark | YES Pharmaceutical Development Services GmbH |
| Bahnstraße 42-46 |
| D-61381 Friedrichsdorf |

Member State

Marketing Authorisation Holder

Applicant

Invented name

Strength

Pharmaceutical Form

Route of administration

Denmark

YES Pharmaceutical Development Services GmbH

Bahnstraße 42-46

D-61381 Friedrichsdorf

Metofelosan

50/5 mg

Prolonged-release tablet

oral

Germany

| ALIUD PHARMA GmbH & Co. KG |
| --- |
| Gottlieb-Daimler-Str. 19 |
| D-89150 Laichingen |

ALIUD PHARMA GmbH & Co. KG

Gottlieb-Daimler-Str. 19

D-89150 Laichingen

Metocomb AL 50 mg/5 mg Retardtabletten

50/5 mg

Prolonged-release tablet

oral

---

ANNEX XIII

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

| Member State | Marketing Authorisation Holder | Applicant | Invented name | Strength | Pharmaceutical Form | Route of administration |
| --- | --- | --- | --- | --- | --- | --- |
| Denmark | YES Pharmaceutical Development Services GmbH |
| Bahnstraße 42-46 |
| D-61381 Friedrichsdorf |

Member State

Marketing Authorisation Holder

Applicant

Invented name

Strength

Pharmaceutical Form

Route of administration

Denmark

YES Pharmaceutical Development Services GmbH

Bahnstraße 42-46

D-61381 Friedrichsdorf

Metoprolol/Felodipin ‘YES’

50/5 mg

Prolonged-release tablet

oral

Belgium

| Eurogenerics N.V. |
| --- |
| Heizel Esplanade Heysel b22 |
| B-1020 Brussels |

Eurogenerics N.V.

Heizel Esplanade Heysel b22

B-1020 Brussels

Co-Metoprolol EG 50/5 mg tablets (prolonged release)

50/5 mg

Prolonged-release tablet

oral

Germany

| STADApharm GmbH |
| --- |
| Stadastr. 2-18 |
| D-61118 Bad Vilbel |

STADApharm GmbH

Stadastr. 2-18

D-61118 Bad Vilbel

Metoplus STADA 50 mg/5 mg Retardtabletten

50/5 mg

Prolonged-release tablet

oral

Finland

| STADA Arzneimittel AG |
| --- |
| Stadastr. 2-18 |
| D-61118 Bad Vilbel |

STADA Arzneimittel AG

Stadastr. 2-18

D-61118 Bad Vilbel

Metoprololitartraatti/Felodipiini STADA 50 mg/5 mg depottabletti

50/5 mg

Prolonged-release tablet

oral

Luxembourg

| Eurogenerics N.V. |
| --- |
| Heizel Esplanade Heysel b22 |
| B-1020 Brussels |

Eurogenerics N.V.

Heizel Esplanade Heysel b22

B-1020 Brussels

Co-Metoprolol EG 50/5 mg tablets (prolonged release)

50/5 mg

Prolonged-release tablet

oral

---