VETERELIN 0.004 mg/ml solution for injection for cattle, horses, pigs, and rabbits
VETERELIN 0.004 mg/ml solution for injection for cattle, horses, pigs, and rabbits
Authorised
- Buserelin
Product identification
Medicine name:
VETERELIN 0.004 mg/ml solution for injection for cattle, horses, pigs, and rabbits
Veterelin 0,004 mg/ml oplossing voor injectie voor runderen, paarden, varkens en konijnen
Active substance:
- Buserelin
Target species:
-
Cattle
-
Horse
-
Pig
-
Other Leporids
Route of administration:
-
Solution for injection
Product details
Active substance and strength:
-
Buserelin0.00milligram(s)1.00millilitre(s)
Pharmaceutical form:
-
Solution for injection
Withdrawal period by route of administration:
-
Solution for injection
- Cattle
-
Milk0hour
-
Meat and offal0day
-
- Horse
-
Meat and offal0day
-
- Pig
-
Meat and offal0day
-
- Other Leporids
-
Meat and offal0day
-
Anatomical therapeutic chemical veterinary (ATCvet) codes:
- QH01CA90
Legal status of supply:
-
Veterinary medicinal product subject to veterinary prescription
Authorisation status:
-
Valid
Authorised in:
-
Netherlands
Package description:
- Colourless glass vials of 10 ml, with bromobutyl rubber closure and aluminium capsules with Flip-off opening ring in PP of blue colour. 5 Bottles of 10 ml.
- Colourless glass vials of 20 ml, with bromobutyl rubber closure and aluminium capsules with Flip-off opening ring in PP of blue colour. 1 Bottle of 20 ml.
- Colourless glass vials of 10 ml, with bromobutyl rubber closure and aluminium capsules with Flip-off opening ring in PP of blue colour. 1 Bottle of 10 ml.
Additional information
Entitlement type:
-
Marketing Authorisation
Legal basis of product authorisation:
-
Generic application (Article 13(1) of Directive No 2001/82/EC)
Marketing authorisation holder:
- Laboratorios Calier S.A.
Marketing authorisation date:
Manufacturing sites for batch release:
- Laboratorios Calier S.A.
Responsible authority:
- Medicines Evaluation Board
Authorisation number:
- REG NL 108021
Date of authorisation status change:
Reference member state:
-
Portugal
Procedure number:
- PT/V/104/001
Concerned member states:
-
Austria
-
Belgium
-
Bulgaria
-
Croatia
-
Denmark
-
France
-
Germany
-
Hungary
-
Ireland
-
Italy
-
Netherlands
-
Poland
-
Romania
-
Spain
-
United Kingdom (Northern Ireland)
To consult adverse reactions on veterinary medicinal products please go to www.adrreports.eu/vet
Documents
Summary of Product Characteristics
English (PDF)
Download Published on: 17/11/2021
Combined File of all Documents
This document does not exist in this language (English). You can find it in another language below.
Dutch (PDF)
Published on: 27/01/2022
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