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 or Article 38 of Directive 2001/82/EC)
Date: 2020-04-24
Institutions: Directorate-General for Health and Food Safety, European Commission
Subjects: EU Member State, drug surveillance, market approval, marketing standard, veterinary medicinal product








C_2020135EN.01000801.xml










24.4.2020   


EN


Official Journal of the European Union


C 135/8






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






(1)  OJ L 311, 28.11.2001, p. 67.

(2)  OJ L 311, 28.11.2001, p. 1.




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