Veterinary Medicines

Enurace 50

Authorised
  • Ephedrine hydrochloride
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Product identification

Medicine name:
Enurace 50
Enurace 50, 50 mg tabletten voor honden
Active substance:
  • Ephedrine hydrochloride
Target species:
  • Dog
Route of administration:
  • Oral use

Product details

Active substance and strength:
  • Ephedrine hydrochloride
    50.00
    milligram(s)
    /
    1.00
    Tablet
Pharmaceutical form:
  • Tablet
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QG04BX90
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Netherlands
Available in:
  • Netherlands
Package description:
  • White polypropylene container containing 100 tablets, with child-resistant closure system, in a cardboard box. The packaging might also contain a polyurethane cover-up.

Additional information

Entitlement type:
  • Marketing Authorisation
Legal basis of product authorisation:
  • Full application - Known active substance (Article 12(3) of Directive No 2001/82/EC)
Marketing authorisation holder:
  • Ecuphar
Marketing authorisation date:
Manufacturing sites for batch release:
  • Ecuphar
  • ACE Pharmaceuticals B.V.
Responsible authority:
  • Medicines Evaluation Board
Authorisation number:
  • REG NL 8125
Date of authorisation status change:
Reference member state:
  • Netherlands
Procedure number:
  • NL/V/0122/001
Concerned member states:
  • Belgium
  • France
  • Germany
  • Italy
  • Spain
  • United Kingdom (Northern Ireland)

Documents

Combined File of all Documents

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Dutch (PDF)
Published on: 24/01/2022
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