Veterinary Medicines

Enrotron Flavour 50 mg Tablets for dogs

Authorised
  • Enrofloxacin
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Product identification

Medicine name:
Enrotron Flavour 50 mg Tablets for dogs
Active substance:
  • Enrofloxacin
Target species:
  • Dog
Route of administration:
  • Oral use

Product details

Active substance and strength:
  • Enrofloxacin
    50.00
    milligram(s)
    /
    1.00
    Tablet
Pharmaceutical form:
  • Tablet
Withdrawal period by route of administration:
  • Oral use
    • Dog
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QJ01MA90
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • United Kingdom (Northern Ireland)
Package description:
  • (ID3) 30 Tablet: unspecified outer container with 1 Blister (Aluminium; Aluminium) with 30 Tablet
  • (ID9) 50 Tablet: unspecified outer container with 1 Blister (Aluminium; PolyVinyl Chloride) with 50 Tablet
  • (ID6) 10 Tablet: unspecified outer container with 1 Blister (Aluminium; PolyVinyl Chloride) with 10 Tablet
  • (ID2) 20 Tablet: unspecified outer container with 1 Blister (Aluminium; Aluminium) with 20 Tablet
  • (ID5) 100 Tablet: unspecified outer container with 1 Blister (Aluminium; Aluminium) with 100 Tablet
  • (ID7) 20 Tablet: unspecified outer container with 1 Blister (Aluminium; PolyVinyl Chloride) with 20 Tablet
  • (ID8) 30 Tablet: unspecified outer container with 1 Blister (Aluminium; PolyVinyl Chloride) with 30 Tablet
  • (ID4) 50 Tablet: unspecified outer container with 1 Blister (Aluminium; Aluminium) with 50 Tablet
  • (ID1) 10 Tablet: unspecified outer container with 1 Blister (Aluminium; Aluminium) with 10 Tablet
  • (ID10) 100 Tablet: unspecified outer container with 1 Blister (Aluminium; PolyVinyl Chloride) with 100 Tablet

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:
  • Animedica GmbH
Marketing authorisation date:
Manufacturing sites for batch release:
  • Animedica GmbH
Responsible authority:
  • The Veterinary Medicines Directorate
Authorisation number:
  • VM 24745/4012
Date of authorisation status change:
Reference member state:
  • Germany
Procedure number:
  • DE/V/0137/001
Concerned member states:
  • Austria
  • Belgium
  • Denmark
  • Finland
  • Greece
  • Hungary
  • Iceland
  • Ireland
  • Luxembourg
  • Netherlands
  • Poland
  • Slovenia
  • United Kingdom (Northern Ireland)

Documents

Summary of Product Characteristics

English (PDF)
Published on: 16/02/2022
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