OVALAXIA ενέσιμο εναιώρημα για πρόβατα
OVALAXIA ενέσιμο εναιώρημα για πρόβατα
Authorised
- Mycoplasma agalactiae, strain AG 8, Inactivated
Product identification
Medicine name:
OVALAXIA ενέσιμο εναιώρημα για πρόβατα
Active substance:
- Mycoplasma agalactiae, strain AG 8, Inactivated
Target species:
-
Sheep
Route of administration:
-
Subcutaneous use
Product details
Active substance and strength:
-
Mycoplasma agalactiae, strain AG 8, Inactivated9.00/log10 colour changing units1.00Dose
Pharmaceutical form:
-
Suspension for injection
Withdrawal period by route of administration:
-
Subcutaneous use
- Sheep
-
Meat and offal0day
-
Anatomical therapeutic chemical veterinary (ATCvet) codes:
- QI04AB
Legal status of supply:
-
Veterinary medicinal product subject to veterinary prescription
Authorisation status:
-
Valid
Authorised in:
-
Greece
Additional information
Entitlement type:
-
Marketing Authorisation
Legal basis of product authorisation:
-
Full application (Article 12(3) of Directive No 2001/82/EC)
Marketing authorisation holder:
- Fatro S.p.A.
Marketing authorisation date:
Manufacturing sites for batch release:
- Fatro S.p.A.
Responsible authority:
- National Organization For Medicines
Authorisation number:
- 68482/30-05-2019/K-0213301
Date of authorisation status change:
To consult adverse reactions on veterinary medicinal products please go to www.adrreports.eu/vet
Documents
Summary of Product Characteristics
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Greek (PDF)
Published on: 22/08/2022
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