Tolfine 40 mg/ml Oplossing voor injectie
Tolfine 40 mg/ml Oplossing voor injectie
Authorised
- Tolfenamic acid
Product identification
Medicine name:
Tolfine 40 mg/ml Oplossing voor injectie
Tolfine 40 mg/ml Solution injectable
Tolfine 40 mg/ml Injektionslösung
Active substance:
- Tolfenamic acid
Target species:
-
Pig
-
Cattle
Route of administration:
-
Intramuscular use
-
Intravenous use
Product details
Active substance and strength:
-
Tolfenamic acid4.00/gram(s)100.00millilitre(s)
Pharmaceutical form:
-
Solution for injection
Withdrawal period by route of administration:
-
Intramuscular use
-
Pig
-
Meat and offal16day
-
-
Cattle
-
Meat and offal14day
-
Milkno withdrawal period0 days
-
-
-
Intravenous use
-
Cattle
-
Meat and offal7day
-
Milkno withdrawal period0 days
-
-
Anatomical therapeutic chemical veterinary (ATCvet) codes:
- QM01AG02
Legal status of supply:
-
Veterinary medicinal product subject to veterinary prescription
Authorisation status:
-
Valid
Authorised in:
-
Belgium
Package description:
- Tolfine 250 ml Vial Solution for injection
- Tolfine 100 ml Vial Solution for injection
- Tolfine 50 ml Vial Solution for injection
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:
- Vetoquinol
Marketing authorisation date:
Manufacturing sites for batch release:
- Vetoquinol S.A.
- Vetoquinol Biowet Sp. z o.o.
Responsible authority:
- Federal Agency For Medicines And Health Products
Authorisation number:
- BE-V198475
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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Package Leaflet
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Labelling
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