Veterinary Medicines

Tendease 50,000 IU/100 g gel for horses

Authorised
  • Levomenthol
  • Hydroxyethyl salicylate
  • Heparin sodium
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Product identification

Medicine name:
Tendease 50,000 IU/100 g gel for horses
Tendease 50.000 IE/100 g gel voor paarden
Active substance:
  • Levomenthol
  • Hydroxyethyl salicylate
  • Heparin sodium
Target species:
  • Horse
Route of administration:
  • Cutaneous use

Product details

Active substance and strength:
  • Levomenthol
    0.50
    gram(s)
    /
    100.00
    gram(s)
  • Hydroxyethyl salicylate
    5.00
    gram(s)
    /
    100.00
    gram(s)
  • Heparin sodium
    50.00
    international unit(s)
    /
    100.00
    gram(s)
Pharmaceutical form:
  • Gel
Withdrawal period by route of administration:
  • Cutaneous use
    • Horse
      • Meat and offal
        0
        day
      • Milk
        no withdrawal period
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QM02AC99
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Netherlands
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:
  • Eurovet Animal Health B.V.
Marketing authorisation date:
Manufacturing sites for batch release:
  • Genera Research Ltd.
Responsible authority:
  • Medicines Evaluation Board
Authorisation number:
  • REG NL 111340
Date of authorisation status change:
Reference member state:
  • Germany
Procedure number:
  • DE/V/0148/001
Concerned member states:
  • Belgium
  • Netherlands

Documents

Combined File of all Documents

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Dutch (PDF)
Published on: 8/02/2022
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Summary of Product Characteristics

English (PDF)
Published on: 14/02/2022
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