TOLFEDINE CS, 40mg/ml, Injekční roztok
TOLFEDINE CS, 40mg/ml, Injekční roztok
Authorised
- Tolfenamic acid
Product identification
Medicine name:
TOLFEDINE CS, 40mg/ml, Injekční roztok
Active substance:
- Tolfenamic acid
Target species:
-
Cattle
-
Pig
Route of administration:
-
Intravenous use
-
Intramuscular 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:
-
Intravenous use
-
Cattle
-
Meat and offal4day
-
Milk1day
-
-
-
Intramuscular use
-
Pig
-
Meat and offal4day
-
-
Cattle
-
Meat and offal12day
-
Milk12hour
-
-
Anatomical therapeutic chemical veterinary (ATCvet) codes:
- QM01AG02
Legal status of supply:
-
Veterinary medicinal product subject to veterinary prescription
Authorisation status:
-
Valid
Authorised in:
-
Czechia
Available in:
-
Czechia
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 s.r.o.
Marketing authorisation date:
Manufacturing sites for batch release:
- Vetoquinol Biowet Sp. z o.o.
- Vetoquinol S.A.
Responsible authority:
- Institute For State Control Of Veterinary Biologicals And Medicaments
Authorisation number:
- 96/112/04-C
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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in another language below.
Czech (PDF)
Published on: 4/11/2024
Package Leaflet
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in another language below.
Czech (PDF)
Published on: 4/11/2024
Labelling
This document does not exist in this language (English). You can find it
in another language below.
Czech (PDF)
Published on: 4/11/2024