PROTIVITY LYOPHILISATE AND SOLVENT FOR SUSPENSION FOR INJECTION FOR CATTLE
PROTIVITY LYOPHILISATE AND SOLVENT FOR SUSPENSION FOR INJECTION FOR CATTLE
Authorised
- Water for injection
- Mycoplasma bovis, strain N2805-1, Live
Product identification
Medicine name:
PROTIVITY LYOPHILISATE AND SOLVENT FOR SUSPENSION FOR INJECTION FOR CATTLE
Protivity лиофилизат и разтворител за инжекционна суспензия за говеда
Active substance:
- Water for injection
- Mycoplasma bovis, strain N2805-1, Live
Target species:
-
Cattle
Route of administration:
-
Subcutaneous use
Product details
Active substance and strength:
-
Water for injection2.00millilitre(s)1.00Dose
-
Mycoplasma bovis, strain N2805-1, Live2200000.00Colony forming unit1.00Dose
Pharmaceutical form:
-
Lyophilisate and solvent for suspension for injection
Withdrawal period by route of administration:
-
Subcutaneous use
- Cattle
-
All relevant tissues0day
-
Anatomical therapeutic chemical veterinary (ATCvet) codes:
- QI02AE05
Legal status of supply:
-
Veterinary medicinal product subject to veterinary prescription
Authorisation status:
-
Valid
Authorised in:
-
Bulgaria
Package description:
- Type I hydrolytic glass vials containing 10 doses of lyophilisate or 20 ml of solvent.
Additional information
Entitlement type:
-
Marketing Authorisation
Legal basis of product authorisation:
-
Full application - New active substance (Article 12(3) of Directive No 2001/82/EC)
Marketing authorisation holder:
- Zoetis Belgium
Marketing authorisation date:
Manufacturing sites for batch release:
- Zoetis Belgium
Responsible authority:
- Bulgarian Agency For Food Safety
Authorisation number:
- 0022-3177
Date of authorisation status change:
Reference member state:
-
France
Procedure number:
- FR/V/0454/001
Concerned member states:
-
Belgium
-
Bulgaria
-
Cyprus
-
Germany
-
Greece
-
Hungary
-
Ireland
-
Italy
-
Luxembourg
-
Netherlands
-
Poland
-
Portugal
-
Romania
-
Spain
-
United Kingdom (Northern Ireland)
To consult adverse reactions on veterinary medicinal products please go to www.adrreports.eu/vet
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