Veterinary Medicines

Vitofyllin 50 mg film-coated tablets for dogs

Authorised
  • Propentofylline
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Product identification

Medicine name:
Vitofyllin 50 mg film-coated tablets for dogs
Vitofyllin 50 mg filmomhulde tabletten voor honden
Active substance:
  • Propentofylline
Target species:
  • Dog
Route of administration:
  • Oral use

Product details

Active substance and strength:
  • Propentofylline
    50.00
    milligram(s)
    /
    1.00
    Tablet
Pharmaceutical form:
  • Film-coated tablet
Withdrawal period by route of administration:
  • Oral use
    • Dog
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QC04AD90
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Netherlands
Available in:
  • Netherlands
Package description:
  • (ID2) 140 Film-coated tablet: unspecified outer container with 10 Blister (PolyVinyl Chloride; PolyVinylidene Chloride; Aluminium) each with 14 Film-coated tablet
  • (ID1) 56 Film-coated tablet: unspecified outer container with 4 Blister (PolyVinyl Chloride; PolyVinylidene Chloride; Aluminium) each with 14 Film-coated 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:
  • Wirtschaftsgenossenschaft deutscher Tieraerzte eG
Marketing authorisation date:
Manufacturing sites for batch release:
  • Artesan Pharma GmbH & Co. KG
Responsible authority:
  • Medicines Evaluation Board
Authorisation number:
  • REG NL 109549
Date of authorisation status change:
Reference member state:
  • Germany
Procedure number:
  • DE/V/0198/001
Concerned member states:
  • Austria
  • Belgium
  • Bulgaria
  • Croatia
  • Cyprus
  • Czechia
  • Denmark
  • Estonia
  • Finland
  • France
  • Greece
  • Hungary
  • Ireland
  • Italy
  • Latvia
  • Lithuania
  • Luxembourg
  • Netherlands
  • Norway
  • Poland
  • Portugal
  • Romania
  • Slovakia
  • Slovenia
  • Spain
  • Sweden
  • United Kingdom (Northern Ireland)

Documents

Combined File of all Documents

English (PDF)
Published on: 27/09/2022
Download
Dutch (PDF)
Published on: 22/08/2023
Updated on: 23/08/2023
Download

Summary of Product Characteristics

English (PDF)
Published on: 15/02/2022
Download
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