Veterinary Medicines

Phenoral 100 mg tablet voor honden

Authorised
  • Phenobarbital
Download as PDF

Product identification

Medicine name:
Phenoral 100 mg tablet voor honden
Active substance:
  • Phenobarbital
Target species:
  • Dog
Route of administration:
  • Oral use

Product details

Active substance and strength:
  • Phenobarbital
    100.00
    milligram(s)
    /
    1.00
    Tablet
Pharmaceutical form:
  • Tablet
Withdrawal period by route of administration:
  • Oral use
    • Dog
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QN03AA02
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Netherlands
Package description:

Additional information

Entitlement type:
  • Marketing Authorisation
Legal basis of product authorisation:
  • Well-established use application (Article 13a of Directive No 2001/82/EC)
Marketing authorisation holder:
  • Dechra Regulatory B.V.
Marketing authorisation date:
Manufacturing sites for batch release:
  • Genera d.d.
  • Lelypharma B.V.
Responsible authority:
  • Medicines Evaluation Board
Authorisation number:
  • REG NL 109800
Date of authorisation status change:

Documents

Combined File of all Documents

This document does not exist in this language (English). You can find it in another language below.
Dutch (PDF)
Published on: 21/03/2023
Download
How useful was this page?:
No votes yet
"Please do not include any personal data, such as your name or contact details. If you do, you consent to the processing of that data in accordance with EMA’s Privacy Statement concerning requests for information or access to documents. If you would like a reply from EMA, please Send a question to EMA instead."