Tullavis 25 mg/ml solution for injection for pigs
Tullavis 25 mg/ml solution for injection for pigs
Authorised
- Tulathromycin
Product identification
Medicine name:
TULLAVIS 25 mg/ml soluție injectabilă pentru porci
Tullavis 25 mg/ml solution for injection for pigs
Active substance:
- Tulathromycin
Target species:
-
Pig
Route of administration:
-
Intramuscular use
Product details
Active substance and strength:
-
Tulathromycin25.00/milligram(s)1.00millilitre(s)
Pharmaceutical form:
-
Solution for injection
Withdrawal period by route of administration:
-
Intramuscular use
-
Pig
-
Meat and offal13day
-
-
Anatomical therapeutic chemical veterinary (ATCvet) codes:
- QJ01FA94
Legal status of supply:
-
Veterinary medicinal product subject to veterinary prescription
Authorisation status:
-
Valid
Authorised in:
-
Romania
Package description:
- Clear glass (Type II Ph. Eur.) vial closed with a bromobutyl rubber stopper and sealed with an aluminium cap.Cardboard box containing 1 vial of 250 m
- Clear glass (Type II Ph. Eur.) vial closed with a bromobutyl rubber stopper and sealed with an aluminium cap.Cardboard box containing 1 vial of 100 ml
- Clear glass (Type II Ph. Eur.) vial closed with a bromobutyl rubber stopper and sealed with an aluminium cap.Cardboard box containing 1 vial of 50 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:
- Industrial Veterinaria S.A.
Marketing authorisation date:
Manufacturing sites for batch release:
- aniMedica Herstellungs GmbH
- Industrial Veterinaria S.A.
- aniMedica Herstellungs GmbH
Responsible authority:
- Institute For Control Of Biological Products And Veterinary Medicines
Authorisation number:
- 250123
Date of authorisation status change:
Reference member state:
-
Ireland
Procedure number:
- IE/V/0892/001
Concerned member states:
-
Austria
-
Belgium
-
Bulgaria
-
Croatia
-
Cyprus
-
Czechia
-
Denmark
-
Estonia
-
Finland
-
France
-
Germany
-
Greece
-
Hungary
-
Italy
-
Latvia
-
Lithuania
-
Netherlands
-
Poland
-
Portugal
-
Romania
-
Slovakia
-
Slovenia
-
Spain
-
United Kingdom (Northern Ireland)
To consult adverse reactions on veterinary medicinal products please go to www.adrreports.eu/vet
Documents
eu-PUAR-esv0359001-dcp-tulavis-25-mg-ml-solution-for-injection-for-pigs-en.pdf
English (PDF)
Download Published on: 22/12/2023