# C_2020135EN.01000801.xml

| 24.4.2020 | EN | Official Journal of the European Union | C 135/8 |
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24.4.2020

EN

Official Journal of the European Union

C 135/8

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Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 March 2020 to 31 March 2020

(Decisions taken pursuant to Article 34 of Directive 2001/83/EC (1) or Article 38 of Directive 2001/82/EC (2))

(2020/C 135/02)

—   Issuing, maintenance or modification of a national marketing authorization

| Date of the decision | Name(s) of the medicinal product | INN (International Non-Proprietary Name) | Holder(s) of the marketing authorization | Member State concerned | Date of notification |
| --- | --- | --- | --- | --- | --- |
| 4.2.2020 | Ketabel 100 mg/ml | ketamine | See Annex | See Annex | 4.3.2020 |

Date of the decision

Name(s) of the medicinal product

INN (International Non-Proprietary Name)

Holder(s) of the marketing authorization

Member State concerned

Date of notification

4.2.2020

Ketabel 100 mg/ml

ketamine

See Annex

See Annex

4.3.2020

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

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

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ANNEX

List of the names, 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 | Strength | Pharmaceutical form | Animal species | Route of administration |
| --- | --- | --- | --- | --- | --- | --- | --- |
| Austria | Bela-Pharm GmbH & Co. KG
  Lohner Strasse 19
  49377 Vechta
  Germany | Belatamin 100 mg/ml solution for injection | Ketamine | 100 mg/ml | Solution for injection | Cattle, pigs, sheep, goats, horses, dogs, cats, guinea pigs, hamsters, rabbits, rats and mice | Intravenous, intramuscular and intraperitoneal use |
| Bulgaria | Bela-Pharm GmbH & Co. KG
  Lohner Strasse 19
  49377 Vechta
  Germany | Ketabel 100 mg/ml solution for injection | Ketamine | 100 mg/ml | Solution for injection | Cattle, pigs, sheep, goats, horses, dogs, cats, guinea pigs, hamsters, rabbits, rats and mice | Intravenous, intramuscular and intraperitoneal use |
| Czechia | Bela-Pharm GmbH & Co. KG
  Lohner Strasse 19
  49377 Vechta
  Germany | Ketabel 100 mg/ml solution for injection | Ketamine | 100 mg/ml | Solution for injection | Cattle, pigs, sheep, goats, horses, dogs, cats, guinea pigs, hamsters, rabbits, rats and mice | Intravenous, intramuscular and intraperitoneal use |
| Germany | Bela-Pharm GmbH & Co. KG
  Lohner Strasse 19
  49377 Vechta
  Germany | Ketabel 100 mg/ml solution for injection | Ketamine | 100 mg/ml | Solution for injection | Cattle, pigs, sheep, goats, horses, dogs, cats, guinea pigs, hamsters, rabbits, rats and mice | Intravenous, intramuscular and intraperitoneal use |
| Estonia | Bela-Pharm GmbH & Co. KG
  Lohner Strasse 19
  49377 Vechta
  Germany | Ketabel 100 mg/ml solution for injection | Ketamine | 100 mg/ml | Solution for injection | Cattle, pigs, sheep, goats, horses, dogs, cats, guinea pigs, hamsters, rabbits, rats and mice | Intravenous, intramuscular and intraperitoneal use |
| Greece | Bela-Pharm GmbH & Co. KG
  Lohner Strasse 19
  49377 Vechta
  Germany | Ketabel 100 mg/ml solution for injection | Ketamine | 100 mg/ml | Solution for injection | Cattle, pigs, sheep, goats, horses, dogs, cats, guinea pigs, hamsters, rabbits, rats and mice | Intravenous, intramuscular and intraperitoneal use |
| Finland | Bela-Pharm GmbH & Co. KG
  Lohner Strasse 19
  49377 Vechta
  Germany | Ketabel vet. 100 mg/ml solution for injection | Ketamine | 100 mg/ml | Solution for injection | Cattle, pigs, sheep, goats, horses, dogs, cats, guinea pigs, hamsters, rabbits, rats and mice | Intravenous, intramuscular and intraperitoneal use |
| France | Bela-Pharm GmbH & Co. KG
  Lohner Strasse 19
  49377 Vechta
  Germany | Ketabel 100 mg/ml solution for injection | Ketamine | 100 mg/ml | Solution for injection | Cattle, pigs, sheep, goats, horses, dogs, cats, guinea pigs, hamsters, rabbits, rats and mice | Intravenous, intramuscular and intraperitoneal use |
| Hungary | Bela-Pharm GmbH & Co. KG
  Lohner Strasse 19
  49377 Vechta
  Germany | Ketabel 100 mg/ml solution for injection | Ketamine | 100 mg/ml | Solution for injection | Cattle, pigs, sheep, goats, horses, dogs, cats, guinea pigs, hamsters, rabbits, rats and mice | Intravenous, intramuscular and intraperitoneal use |
| Ireland | Bela-Pharm GmbH & Co. KG
  Lohner Strasse 19
  49377 Vechta
  Germany | Ketabel 100 mg/ml solution for injection | Ketamine | 100 mg/ml | Solution for injection | Cattle, pigs, sheep, goats, horses, dogs, cats, guinea pigs, hamsters, rabbits, rats and mice | Intravenous, intramuscular and intraperitoneal use |
| Iceland | Bela-Pharm GmbH & Co. KG
  Lohner Strasse 19
  49377 Vechta
  Germany | Ketabel vet. 100 mg/ml solution for injection | Ketamine | 100 mg/ml | Solution for injection | Cattle, pigs, sheep, goats, horses, dogs, cats, guinea pigs, hamsters, rabbits, rats and mice | Intravenous, intramuscular and intraperitoneal use |
| Lithuania | Bela-Pharm GmbH & Co. KG
  Lohner Strasse 19
  49377 Vechta
  Germany | Ketabel 100 mg/ml solution for injection | Ketamine | 100 mg/ml | Solution for injection | Cattle, pigs, sheep, goats, horses, dogs, cats, guinea pigs, hamsters, rabbits, rats and mice | Intravenous, intramuscular and intraperitoneal use |
| Latvia | Bela-Pharm GmbH & Co. KG
  Lohner Strasse 19
  49377 Vechta
  Germany | Ketabel 100 mg/ml solution for injection | Ketamine | 100 mg/ml | Solution for injection | Cattle, pigs, sheep, goats, horses, dogs, cats, guinea pigs, hamsters, rabbits, rats and mice | Intravenous, intramuscular and intraperitoneal use |
| The Netherlands | Bela-Pharm GmbH & Co. KG
  Lohner Strasse 19
  49377 Vechta
  Germany | Ketabel 100 mg/ml solution for injection | Ketamine | 100 mg/ml | Solution for injection | Cattle, pigs, sheep, goats, horses, dogs, cats, guinea pigs, hamsters, rabbits, rats and mice | Intravenous, intramuscular and intraperitoneal use |
| Norway | Bela-Pharm GmbH & Co. KG
  Lohner Strasse 19
  49377 Vechta
  Germany | Belatamin vet. 100 mg/ml solution for injection | Ketamine | 100 mg/ml | Solution for injection | Cattle, pigs, sheep, goats, horses, dogs, cats, guinea pigs, hamsters, rabbits, rats and mice | Intravenous, intramuscular and intraperitoneal use |
| Portugal | Bela-Pharm GmbH & Co. KG
  Lohner Strasse 19
  49377 Vechta
  Germany | Ketabel 100 mg/ml solution for injection | Ketamine | 100 mg/ml | Solution for injection | Cattle, pigs, sheep, goats, horses, dogs, cats, guinea pigs, hamsters, rabbits, rats and mice | Intravenous, intramuscular and intraperitoneal use |
| Romania | Bela-Pharm GmbH & Co. KG
  Lohner Strasse 19
  49377 Vechta
  Germany | Ketabel 100 mg/ml solution for injection | Ketamine | 100 mg/ml | Solution for injection | Cattle, pigs, sheep, goats, horses, dogs, cats, guinea pigs, hamsters, rabbits, rats and mice | Intravenous, intramuscular and intraperitoneal use |
| Sweden | Bela-Pharm GmbH & Co. KG
  Lohner Strasse 19
  49377 Vechta
  Germany | Ketabel vet. 100 mg/ml solution for injection | Ketamine | 100 mg/ml | Solution for injection | Cattle, pigs, sheep, goats, horses, dogs, cats, guinea pigs, hamsters, rabbits, rats and mice | Intravenous, intramuscular and intraperitoneal use |
| Slovakia | Bela-Pharm GmbH & Co. KG
  Lohner Strasse 19
  49377 Vechta
  Germany | Ketabel 100 mg/ml solution for injection | Ketamine | 100 mg/ml | Solution for injection | Cattle, pigs, sheep, goats, horses, dogs, cats, guinea pigs, hamsters, rabbits, rats and mice | Intravenous, intramuscular and intraperitoneal use |
| Slovenia | Bela-Pharm GmbH & Co. KG
  Lohner Strasse 19
  49377 Vechta
  Germany | Ketabel 100 mg/ml solution for injection | Ketamine | 100 mg/ml | Solution for injection | Cattle, pigs, sheep, goats, horses, dogs, cats, guinea pigs, hamsters, rabbits, rats and mice | Intravenous, intramuscular and intraperitoneal use |
| United Kingdom | Bela-Pharm GmbH & Co. KG
  Lohner Strasse 19
  49377 Vechta
  Germany | Ketabel 100 mg/ml solution for injection | Ketamine | 100 mg/ml | Solution for injection | Cattle, pigs, sheep, goats, horses, dogs, cats, guinea pigs, hamsters, rabbits, rats and mice | Intravenous, intramuscular and intraperitoneal use |

Member State EU/EEA

Applicant

Name

INN

Strength

Pharmaceutical form

Animal species

Route of administration

Austria

Bela-Pharm GmbH & Co. KG

Lohner Strasse 19

49377 Vechta

Germany

Belatamin 100 mg/ml solution for injection

Ketamine

100 mg/ml

Solution for injection

Cattle, pigs, sheep, goats, horses, dogs, cats, guinea pigs, hamsters, rabbits, rats and mice

Intravenous, intramuscular and intraperitoneal use

Bulgaria

Bela-Pharm GmbH & Co. KG

Lohner Strasse 19

49377 Vechta

Germany

Ketabel 100 mg/ml solution for injection

Ketamine

100 mg/ml

Solution for injection

Cattle, pigs, sheep, goats, horses, dogs, cats, guinea pigs, hamsters, rabbits, rats and mice

Intravenous, intramuscular and intraperitoneal use

Czechia

Bela-Pharm GmbH & Co. KG

Lohner Strasse 19

49377 Vechta

Germany

Ketabel 100 mg/ml solution for injection

Ketamine

100 mg/ml

Solution for injection

Cattle, pigs, sheep, goats, horses, dogs, cats, guinea pigs, hamsters, rabbits, rats and mice

Intravenous, intramuscular and intraperitoneal use

Germany

Bela-Pharm GmbH & Co. KG

Lohner Strasse 19

49377 Vechta

Germany

Ketabel 100 mg/ml solution for injection

Ketamine

100 mg/ml

Solution for injection

Cattle, pigs, sheep, goats, horses, dogs, cats, guinea pigs, hamsters, rabbits, rats and mice

Intravenous, intramuscular and intraperitoneal use

Estonia

Bela-Pharm GmbH & Co. KG

Lohner Strasse 19

49377 Vechta

Germany

Ketabel 100 mg/ml solution for injection

Ketamine

100 mg/ml

Solution for injection

Cattle, pigs, sheep, goats, horses, dogs, cats, guinea pigs, hamsters, rabbits, rats and mice

Intravenous, intramuscular and intraperitoneal use

Greece

Bela-Pharm GmbH & Co. KG

Lohner Strasse 19

49377 Vechta

Germany

Ketabel 100 mg/ml solution for injection

Ketamine

100 mg/ml

Solution for injection

Cattle, pigs, sheep, goats, horses, dogs, cats, guinea pigs, hamsters, rabbits, rats and mice

Intravenous, intramuscular and intraperitoneal use

Finland

Bela-Pharm GmbH & Co. KG

Lohner Strasse 19

49377 Vechta

Germany

Ketabel vet. 100 mg/ml solution for injection

Ketamine

100 mg/ml

Solution for injection

Cattle, pigs, sheep, goats, horses, dogs, cats, guinea pigs, hamsters, rabbits, rats and mice

Intravenous, intramuscular and intraperitoneal use

France

Bela-Pharm GmbH & Co. KG

Lohner Strasse 19

49377 Vechta

Germany

Ketabel 100 mg/ml solution for injection

Ketamine

100 mg/ml

Solution for injection

Cattle, pigs, sheep, goats, horses, dogs, cats, guinea pigs, hamsters, rabbits, rats and mice

Intravenous, intramuscular and intraperitoneal use

Hungary

Bela-Pharm GmbH & Co. KG

Lohner Strasse 19

49377 Vechta

Germany

Ketabel 100 mg/ml solution for injection

Ketamine

100 mg/ml

Solution for injection

Cattle, pigs, sheep, goats, horses, dogs, cats, guinea pigs, hamsters, rabbits, rats and mice

Intravenous, intramuscular and intraperitoneal use

Ireland

Bela-Pharm GmbH & Co. KG

Lohner Strasse 19

49377 Vechta

Germany

Ketabel 100 mg/ml solution for injection

Ketamine

100 mg/ml

Solution for injection

Cattle, pigs, sheep, goats, horses, dogs, cats, guinea pigs, hamsters, rabbits, rats and mice

Intravenous, intramuscular and intraperitoneal use

Iceland

Bela-Pharm GmbH & Co. KG

Lohner Strasse 19

49377 Vechta

Germany

Ketabel vet. 100 mg/ml solution for injection

Ketamine

100 mg/ml

Solution for injection

Cattle, pigs, sheep, goats, horses, dogs, cats, guinea pigs, hamsters, rabbits, rats and mice

Intravenous, intramuscular and intraperitoneal use

Lithuania

Bela-Pharm GmbH & Co. KG

Lohner Strasse 19

49377 Vechta

Germany

Ketabel 100 mg/ml solution for injection

Ketamine

100 mg/ml

Solution for injection

Cattle, pigs, sheep, goats, horses, dogs, cats, guinea pigs, hamsters, rabbits, rats and mice

Intravenous, intramuscular and intraperitoneal use

Latvia

Bela-Pharm GmbH & Co. KG

Lohner Strasse 19

49377 Vechta

Germany

Ketabel 100 mg/ml solution for injection

Ketamine

100 mg/ml

Solution for injection

Cattle, pigs, sheep, goats, horses, dogs, cats, guinea pigs, hamsters, rabbits, rats and mice

Intravenous, intramuscular and intraperitoneal use

The Netherlands

Bela-Pharm GmbH & Co. KG

Lohner Strasse 19

49377 Vechta

Germany

Ketabel 100 mg/ml solution for injection

Ketamine

100 mg/ml

Solution for injection

Cattle, pigs, sheep, goats, horses, dogs, cats, guinea pigs, hamsters, rabbits, rats and mice

Intravenous, intramuscular and intraperitoneal use

Norway

Bela-Pharm GmbH & Co. KG

Lohner Strasse 19

49377 Vechta

Germany

Belatamin vet. 100 mg/ml solution for injection

Ketamine

100 mg/ml

Solution for injection

Cattle, pigs, sheep, goats, horses, dogs, cats, guinea pigs, hamsters, rabbits, rats and mice

Intravenous, intramuscular and intraperitoneal use

Portugal

Bela-Pharm GmbH & Co. KG

Lohner Strasse 19

49377 Vechta

Germany

Ketabel 100 mg/ml solution for injection

Ketamine

100 mg/ml

Solution for injection

Cattle, pigs, sheep, goats, horses, dogs, cats, guinea pigs, hamsters, rabbits, rats and mice

Intravenous, intramuscular and intraperitoneal use

Romania

Bela-Pharm GmbH & Co. KG

Lohner Strasse 19

49377 Vechta

Germany

Ketabel 100 mg/ml solution for injection

Ketamine

100 mg/ml

Solution for injection

Cattle, pigs, sheep, goats, horses, dogs, cats, guinea pigs, hamsters, rabbits, rats and mice

Intravenous, intramuscular and intraperitoneal use

Sweden

Bela-Pharm GmbH & Co. KG

Lohner Strasse 19

49377 Vechta

Germany

Ketabel vet. 100 mg/ml solution for injection

Ketamine

100 mg/ml

Solution for injection

Cattle, pigs, sheep, goats, horses, dogs, cats, guinea pigs, hamsters, rabbits, rats and mice

Intravenous, intramuscular and intraperitoneal use

Slovakia

Bela-Pharm GmbH & Co. KG

Lohner Strasse 19

49377 Vechta

Germany

Ketabel 100 mg/ml solution for injection

Ketamine

100 mg/ml

Solution for injection

Cattle, pigs, sheep, goats, horses, dogs, cats, guinea pigs, hamsters, rabbits, rats and mice

Intravenous, intramuscular and intraperitoneal use

Slovenia

Bela-Pharm GmbH & Co. KG

Lohner Strasse 19

49377 Vechta

Germany

Ketabel 100 mg/ml solution for injection

Ketamine

100 mg/ml

Solution for injection

Cattle, pigs, sheep, goats, horses, dogs, cats, guinea pigs, hamsters, rabbits, rats and mice

Intravenous, intramuscular and intraperitoneal use

United Kingdom

Bela-Pharm GmbH & Co. KG

Lohner Strasse 19

49377 Vechta

Germany

Ketabel 100 mg/ml solution for injection

Ketamine

100 mg/ml

Solution for injection

Cattle, pigs, sheep, goats, horses, dogs, cats, guinea pigs, hamsters, rabbits, rats and mice

Intravenous, intramuscular and intraperitoneal use

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