Tendease 50,000 IU/100 g gel for horses
Tendease 50,000 IU/100 g gel for horses
Authorised
- Levomenthol
- Hydroxyethyl salicylate
- Heparin sodium
Product identification
Medicine name:
Tendease 50,000 IU/100 g gel for horses
Tendease 50000 IU/100 g Gel
Tendease 50000 IU/100 g Gel
Tendease 50000 IU/100 g Gel
Active substance:
- Levomenthol
- Hydroxyethyl salicylate
- Heparin sodium
Target species:
-
Horse
Route of administration:
-
Cutaneous use
Product details
Active substance and strength:
-
Levomenthol0.50/gram(s)100.00gram(s)
-
Hydroxyethyl salicylate5.00/gram(s)100.00gram(s)
-
Heparin sodium50.00/international unit(s)100.00gram(s)
Pharmaceutical form:
-
Gel
Withdrawal period by route of administration:
-
Cutaneous use
-
Horse
-
Meat and offal0day
-
Milkno withdrawal periodNot authorised for use in horses producing milk for human consumption.
-
-
Anatomical therapeutic chemical veterinary (ATCvet) codes:
- QM02AC99
Legal status of supply:
-
Veterinary medicinal product subject to veterinary prescription
Authorisation status:
-
Valid
Authorised in:
-
Belgium
Package description:
- (ID2): 1 unspecified outer container with 6 Bottle (PolyEthylene) with 300 gram(s) (1800 gram(s))
- (ID1): 1 unspecified outer container with 1 Bottle (PolyEthylene) with 300 gram(s) (300 gram(s))
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:
- Dechra Regulatory B.V.
Marketing authorisation date:
Manufacturing sites for batch release:
- Genera Research Ltd.
Responsible authority:
- Federal Agency For Medicines And Health Products
Authorisation number:
- BE-V434926
Date of authorisation status change:
Reference member state:
-
Germany
Procedure number:
- DE/V/0148/001
Concerned member states:
-
Belgium
-
Netherlands
To consult adverse reactions on veterinary medicinal products please go to www.adrreports.eu/vet
Documents
Package Leaflet
This document does not exist in this language (English). You can find it
in another language below.
Labelling
This document does not exist in this language (English). You can find it
in another language below.