Galapan 75 micrograms/ml solution for injection for cattle, horses and pigs
Galapan 75 micrograms/ml solution for injection for cattle, horses and pigs
Authorised
- R-Cloprostenol sodium
Product identification
Medicine name:
Galapan 75 micrograms/ml solution for injection for cattle, horses and pigs
Galapan 75 micrograms/ml solution for injection for cattle, horses and pigs
Active substance:
- R-Cloprostenol sodium
Target species:
-
Cattle
-
Horse
-
Pig
Route of administration:
-
Intramuscular use
Product details
Active substance and strength:
-
R-Cloprostenol sodium78.88/microgram(s)1.00millilitre(s)
Pharmaceutical form:
-
Solution for injection
Withdrawal period by route of administration:
-
Intramuscular use
-
Cattle
-
Meat and offal1dayMeat and offal
-
Milk0hour
-
-
Horse
-
Meat and offal1day
-
Milk0hour
-
-
Pig
-
Meat and offal1day
-
-
Anatomical therapeutic chemical veterinary (ATCvet) codes:
- QG02AD90
Legal status of supply:
-
Veterinary medicinal product subject to veterinary prescription
Authorisation status:
-
Valid
Authorised in:
-
Ireland
Package description:
- Colourless vials of type I glass containing 20 ml of solution for injection, with chlorobutyl rubber stoppers and aluminium caps. Presentation: Cardboard box of 1 vial of 20 ml
- Colourless vials of type I glass containing 50 ml of solution for injection, with chlorobutyl rubber stoppers and aluminium caps. Presentation: Cardboard box of 1 vial of 50 ml
- Colourless vials of type I glass containing 20 ml of solution for injection, with chlorobutyl rubber stoppers and aluminium caps. Presentation: Cardboard box of 5 vials of 20 ml
Additional information
Entitlement type:
-
Marketing Authorisation
Legal basis of product authorisation:
-
Informed Consent application (Article 21 of Regulation (EU) 2019/6)
Marketing authorisation holder:
- Industrial Veterinaria S.A.
Marketing authorisation date:
Manufacturing sites for batch release:
- Industrial Veterinaria S.A.
- Industrial Veterinaria S.A.
- aniMedica GmbH
Responsible authority:
- Health Products Regulatory Authority
Authorisation number:
- VPA10509/010/001
Date of authorisation status change:
Reference member state:
-
Ireland
Procedure number:
- IE/V/0630/001
Concerned member states:
-
Spain
Informed consent reference:
To consult adverse reactions on veterinary medicinal products please go to www.adrreports.eu/vet
