# C_2013282EN.01000601.xml

| 27.9.2013 | EN | Official Journal of the European Union | C 282/6 |
| --- | --- | --- | --- |

27.9.2013

EN

Official Journal of the European Union

C 282/6

---

Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 August 2013 to 31 August 2013

(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 282/02

—   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 |
| --- | --- | --- | --- | --- |
| 12.8.2013 | Soludox | See Annex I | See Annex I | 13.8.2013 |
| 12.8.2013 | STRENZEN | See Annex II | See Annex II | 14.8.2013 |

Date of the decision

Name(s) of the medicinal product

Holder(s) of the marketing authorization

Member State concerned

Date of notification

12.8.2013

Soludox

See Annex I

See Annex I

13.8.2013

12.8.2013

STRENZEN

See Annex II

See Annex II

14.8.2013

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(1)  OJ L 311, 28.11.2001, p. 67.

1

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

2

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ANNEX I

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

| Member State
  EU/EEA | Marketing authorisation holder | Name | INN | Pharmaceutical form | Strength | Animal species | Route of administration |
| --- | --- | --- | --- | --- | --- | --- | --- |
| Austria | Eurovet Animal Health BV |
| Handelsweg 25 |
| 5531 AE Bladel |
| The Netherlands |

Member State

EU/EEA

Marketing authorisation holder

Name

INN

Pharmaceutical form

Strength

Animal species

Route of administration

Austria

Eurovet Animal Health BV

Handelsweg 25

5531 AE Bladel

The Netherlands

Soludox 500 mg/g Pulver zum Eingeben über das Trinkwasser für Schweine und Hühner

doxycycline hyclate

Powder for use in drinking water

500 mg/g

Pigs and chickens

Oral: In drinking water

Czech Republic

| Eurovet Animal Health BV |
| --- |
| Handelsweg 25 |
| 5531 AE Bladel |
| The Netherlands |

Eurovet Animal Health BV

Handelsweg 25

5531 AE Bladel

The Netherlands

Soludox 500 mg/g prášek pro podání v pitné vodě pro prasata

doxycycline hyclate

Powder for use in drinking water

500 mg/g

Pigs and chickens

Oral: In drinking water

Estonia

| Eurovet Animal Health BV |
| --- |
| Handelsweg 25 |
| 5531 AE Bladel |
| The Netherlands |

Eurovet Animal Health BV

Handelsweg 25

5531 AE Bladel

The Netherlands

Soludox 500 mg/g suukaudse lahuse pulber sigadele ja kanadele

doxycycline hyclate

Powder for use in drinking water

500 mg/g

Pigs and chickens

Oral: In drinking water

Finland

| Eurovet Animal Health BV |
| --- |
| Handelsweg 25 |
| 5531 AE Bladel |
| The Netherlands |

Eurovet Animal Health BV

Handelsweg 25

5531 AE Bladel

The Netherlands

Soludox 500 mg/g jauhe juomaveteen sekoitettavaksi sioille ja kanoille

doxycycline hyclate

Powder for use in drinking water

500 mg/g

Pigs and chickens

Oral: In drinking water

France

| Eurovet Animal Health BV |
| --- |
| Handelsweg 25 |
| 5531 AE Bladel |
| The Netherlands |

Eurovet Animal Health BV

Handelsweg 25

5531 AE Bladel

The Netherlands

Soludox 433 mg/g poudre pour administration dans l'eau de boisson des porcs et des poulets

doxycycline hyclate

Powder for use in drinking water

500 mg/g

Pigs and chickens

Oral: In drinking water

Germany

| Eurovet Animal Health BV |
| --- |
| Handelsweg 25 |
| 5531 AE Bladel |
| The Netherlands |

Eurovet Animal Health BV

Handelsweg 25

5531 AE Bladel

The Netherlands

Soludox 500 mg/g Pulver zum Eingeben über das Trinkwasser für Schweine und Hühner

doxycycline hyclate

Powder for use in drinking water

500 mg/g

Pigs and chickens

Oral: In drinking water

Greece

| Eurovet Animal Health BV |
| --- |
| Handelsweg 25 |
| 5531 AE Bladel |
| The Netherlands |

Eurovet Animal Health BV

Handelsweg 25

5531 AE Bladel

The Netherlands

Soludox 500 mg/g υπό μορφή σκόνης για χρήση σε πόσιμο νερό για χοίρους και κοτόπουλα

doxycycline hyclate

Powder for use in drinking water

500 mg/g

Pigs and chickens

Oral: In drinking water

Italy

| Eurovet Animal Health BV |
| --- |
| Handelsweg 25 |
| 5531 AE Bladel |
| The Netherlands |

Eurovet Animal Health BV

Handelsweg 25

5531 AE Bladel

The Netherlands

Soludox 500 mg/g polvere da somministrare nell’acqua da bere per suini e polli

doxycycline hyclate

Powder for use in drinking water

500 mg/g

Pigs and chickens

Oral: In drinking water

Italy

| Eurovet Animal Health BV |
| --- |
| Handelsweg 25 |
| 5531 AE Bladel |
| The Netherlands |

Eurovet Animal Health BV

Handelsweg 25

5531 AE Bladel

The Netherlands

Acquadox 500 mg/g polvere da somministrare nell’acqua da bere per suini e polli

doxycycline hyclate

Powder for use in drinking water

500 mg/g

Pigs and chickens

Oral: In drinking water

Latvia

| Eurovet Animal Health BV |
| --- |
| Handelsweg 25 |
| 5531 AE Bladel |
| The Netherlands |

Eurovet Animal Health BV

Handelsweg 25

5531 AE Bladel

The Netherlands

Soludox 500 mg/g pulveris lietošanai ar dzeramo ūdeni cūkām un vistām

doxycycline hyclate

Powder for use in drinking water

500 mg/g

Pigs and chickens

Oral: In drinking water

The Netherlands

| Eurovet Animal Health BV |
| --- |
| Handelsweg 25 |
| 5531 AE Bladel |
| The Netherlands |

Eurovet Animal Health BV

Handelsweg 25

5531 AE Bladel

The Netherlands

Soludox 500 mg/g poeder voor toediening via het drinkwater voor varkens en kippen

doxycycline hyclate

Powder for use in drinking water

500 mg/g

Pigs and chickens

Oral: In drinking water

Slovakia

| Eurovet Animal Health BV |
| --- |
| Handelsweg 25 |
| 5531 AE Bladel |
| The Netherlands |

Eurovet Animal Health BV

Handelsweg 25

5531 AE Bladel

The Netherlands

Soludox 500 mg/g prášok na použitie v pitnej vode pre ošípané

doxycycline hyclate

Powder for use in drinking water

500 mg/g

Pigs and chickens

Oral: In drinking water

Spain

| Eurovet Animal Health BV |
| --- |
| Handelsweg 25 |
| 5531 AE Bladel |
| The Netherlands |

Eurovet Animal Health BV

Handelsweg 25

5531 AE Bladel

The Netherlands

Soludox 500 mg/g polvo para administración en agua de bebida para porcino y pollos

doxycycline hyclate

Powder for use in drinking water

500 mg/g

Pigs and chickens

Oral: In drinking water

United Kingdom

| Eurovet Animal Health BV |
| --- |
| Handelsweg 25 |
| 5531 AE Bladel |
| The Netherlands |

Eurovet Animal Health BV

Handelsweg 25

5531 AE Bladel

The Netherlands

Soludox 500 mg/g powder for use in drinking water for pigs and chickens

doxycycline hyclate

Powder for use in drinking water

500 mg/g

Pigs and chickens

Oral: In drinking water

---

ANNEX II

LIST OF THE NAME, PHARMACEUTICAL FORM, STRENGTH OF THE VETERINARY MEDICINAL PRODUCT, ANIMAL SPECIES, ROUTE OF ADMINISTRATION, APPLICANT IN THE MEMBER STATES

| Member State
  EU/EEA | Applicant | Name | INN | Pharmaceutical form | Strength | Animal species | Route of administration |
| --- | --- | --- | --- | --- | --- | --- | --- |
| Austria | Novartis Animal Health Inc. |
| Schwarzwaldallee 215 |
| CH-4058 Basel |
| Switzerland |

Member State

EU/EEA

Applicant

Name

INN

Pharmaceutical form

Strength

Animal species

Route of administration

Austria

Novartis Animal Health Inc.

Schwarzwaldallee 215

CH-4058 Basel

Switzerland

STRENZEN 500/125 mg/g Pulver zum Eingeben über das Trinkwasser für Schweine

Amoxicillin, clavulanic acid

Powder for use in drinking water

500/125 mg/g

Pigs

Oral: In drinking water

Czech Republic

| Novartis Animal Health Inc. |
| --- |
| Schwarzwaldallee 215 |
| CH-4058 Basel |
| Switzerland |

Novartis Animal Health Inc.

Schwarzwaldallee 215

CH-4058 Basel

Switzerland

STRENZEN 500/125 mg/g prášek pro podání v pitné vodě pro prasata

Amoxicillin, clavulanic acid

Powder for use in drinking water

500/125 mg/g

Pigs

Oral: In drinking water

Denmark

| Novartis Animal Health Inc. |
| --- |
| Schwarzwaldallee 215 |
| CH-4058 Basel |
| Switzerland |

Novartis Animal Health Inc.

Schwarzwaldallee 215

CH-4058 Basel

Switzerland

STRENZEN 500/125 mg pulver til anvendelse i drikkevand til svin

Amoxicillin, clavulanic acid

Powder for use in drinking water

500/125 mg/g

Pigs

Oral: In drinking water

France

| Novartis Animal Health Inc. |
| --- |
| Schwarzwaldallee 215 |
| CH-4058 Basel |
| Switzerland |

Novartis Animal Health Inc.

Schwarzwaldallee 215

CH-4058 Basel

Switzerland

STRENZEN 500/125 mg/g poudre pour eau de boisson porcs

Amoxicillin, clavulanic acid

Powder for use in drinking water

500/125 mg/g

Pigs

Oral: In drinking water

Germany

| Novartis Animal Health Inc. |
| --- |
| Schwarzwaldallee 215 |
| CH-4058 Basel |
| Switzerland |

Novartis Animal Health Inc.

Schwarzwaldallee 215

CH-4058 Basel

Switzerland

STRENZEN 500/125 mg/g Pulver zum Eingeben über das Trinkwasser für Schweine

Amoxicillin, clavulanic acid

Powder for use in drinking water

500/125 mg/g

Pigs

Oral: In drinking water

Ireland

| Novartis Animal Health Inc. |
| --- |
| Schwarzwaldallee 215 |
| CH-4058 Basel |
| Switzerland |

Novartis Animal Health Inc.

Schwarzwaldallee 215

CH-4058 Basel

Switzerland

STRENZEN 500/125 mg/g powder for use in drinking water for pigs

Amoxicillin, clavulanic acid

Powder for use in drinking water

500/125 mg/g

Pigs

Oral: In drinking water

Italy

| Novartis Animal Health Inc. |
| --- |
| Schwarzwaldallee 215 |
| CH-4058 Basel |
| Switzerland |

Novartis Animal Health Inc.

Schwarzwaldallee 215

CH-4058 Basel

Switzerland

STRENZEN 500/125 mg/g polvere per somministrazione in acqua da bere per suini

Amoxicillin, clavulanic acid

Powder for use in drinking water

500/125 mg/g

Pigs

Oral: In drinking water

The Netherlands

| Novartis Animal Health Inc. |
| --- |
| Schwarzwaldallee 215 |
| CH-4058 Basel |
| Switzerland |

Novartis Animal Health Inc.

Schwarzwaldallee 215

CH-4058 Basel

Switzerland

STRENZEN 500/125 mg/g poeder voor gebruik in drinkwater voor varkens.

Amoxicillin, clavulanic acid

Powder for use in drinking water

500/125 mg/g

Pigs

Oral: In drinking water

Portugal

| Novartis Animal Health Inc. |
| --- |
| Schwarzwaldallee 215 |
| CH-4058 Basel |
| Switzerland |

Novartis Animal Health Inc.

Schwarzwaldallee 215

CH-4058 Basel

Switzerland

STRENZEN 500/125 mg/g pó para utilização na água de bebida em suínos

Amoxicillin, clavulanic acid

Powder for use in drinking water

500/125 mg/g

Pigs

Oral: In drinking water

Spain

| Novartis Animal Health Inc. |
| --- |
| Schwarzwaldallee 215 |
| CH-4058 Basel |
| Switzerland |

Novartis Animal Health Inc.

Schwarzwaldallee 215

CH-4058 Basel

Switzerland

STRENZEN 500/125 mg/g polvo para uso en agua de bebida para porcino

Amoxicillin, clavulanic acid

Powder for use in drinking water

500/125 mg/g

Pigs

Oral: In drinking water

United Kingdom

| Novartis Animal Health Inc. |
| --- |
| Schwarzwaldallee 215 |
| CH-4058 Basel |
| Switzerland |

Novartis Animal Health Inc.

Schwarzwaldallee 215

CH-4058 Basel

Switzerland

STRENZEN 500/125 mg/g powder for use in drinking water for pigs

Amoxicillin, clavulanic acid

Powder for use in drinking water

500/125 mg/g

Pigs

Oral: In drinking water

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