TOLFENIL 40 mg/ml solution for injection
TOLFENIL 40 mg/ml solution for injection
Authorised
- Tolfenamic acid
Product identification
Medicine name:
TOLFENIL 40 mg/ml solution for injection
TOLFENIL 40 mg/ml, soluție injectabilă
Active substance:
- Tolfenamic acid
Target species:
-
Cattle
-
Pig
-
Dog
-
Cat
Route of administration:
-
Intramuscular use
-
Intravenous use
-
Subcutaneous use
Product details
Active substance and strength:
-
Tolfenamic acid40.00/milligram(s)1.00millilitre(s)
Pharmaceutical form:
-
Solution for injection
Withdrawal period by route of administration:
-
Intramuscular use
-
Cattle
-
Meat and offalno withdrawal periodMeat and offal: 12 days intramuscular use / 4 days intravenous use
-
-
Pig
-
Meat and offal16day
-
-
Cattle
-
Milkno withdrawal periodMilk: Zero days intramuscular use/ 24 hours intravenous use
-
-
-
Intravenous use
-
Cattle
-
Meat and offalno withdrawal periodMeat and offal: 12 days intramuscular use / 4 days intravenous use
-
-
Cattle
-
Milkno withdrawal periodMilk: Zero days intramuscular use/ 24 hours intravenous use
-
-
Anatomical therapeutic chemical veterinary (ATCvet) codes:
- QM01AG02
Legal status of supply:
-
Veterinary medicinal product subject to veterinary prescription
Authorisation status:
-
Valid
Authorised in:
-
Romania
Available in:
-
Romania
Package description:
- Cardboard box with 15 vials of 250 ml
- Cardboard box with 10 vials of 100 ml
- Cardboard box with 5 vials of 20 ml
- Cardboard box with 1 vial of 250 ml
- Cardboard box with 1 vial of 100 ml
- Cardboard box with 1 vial of 20 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:
- Mevet S.A.
Marketing authorisation date:
Manufacturing sites for batch release:
- Mevet S.A.
Responsible authority:
- Institute For Control Of Biological Products And Veterinary Medicines
Authorisation number:
- 210147
Date of authorisation status change:
Reference member state:
-
Spain
Procedure number:
- ES/V/0383/001
Concerned member states:
-
Poland
-
Portugal
-
Romania
To consult adverse reactions on veterinary medicinal products please go to www.adrreports.eu/vet
