Veterinary Medicines

BIOTILINA 10% premix for medicated feed for pigs and rabbits

Authorised
  • Valnemulin hydrochloride
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Product identification

Medicine name:
BIOTILINA 10% premix for medicated feed for pigs and rabbits
Biotilina 100 mg/g pré-mistura medicamentosa para alimento medicamentoso para suínos e coelhos
Active substance:
  • Valnemulin hydrochloride
Target species:
  • Pig
  • Rabbit
Route of administration:
  • In-feed use

Product details

Active substance and strength:
  • Valnemulin hydrochloride
    106.50
    milligram(s)
    /
    1.00
    gram(s)
Pharmaceutical form:
  • Premix for medicated feeding stuff
Withdrawal period by route of administration:
  • In-feed use
    • Pig
      • Meat and offal
        1
        day
    • Rabbit
      • Meat and offal
        0
        day
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QJ01XQ02
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Portugal
Package description:
  • bag of 25 kg

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:
  • Vetpharma Animal Health S.L.
Marketing authorisation date:
Manufacturing sites for batch release:
  • Laboratorios Maymo S.A.U.
Responsible authority:
  • Directorate General For Food And Veterinary
Authorisation number:
  • 1342/01/20DFVPT
Date of authorisation status change:
Reference member state:
  • Spain
Procedure number:
  • ES/V/0340/001
Concerned member states:
  • France
  • Greece
  • Hungary
  • Italy
  • Portugal
  • Romania

Documents

Labelling

English (PDF)
Published on: 24/03/2023
Download

Summary of Product Characteristics

English (PDF)
Published on: 22/12/2023
Download

Package Leaflet

English (PDF)
Published on: 22/12/2023
Download

Combined File of all Documents

This document does not exist in this language (English). You can find it in another language below.
Portuguese (PDF)
Published on: 30/01/2024
Download

eu-PUAR-esv0340001-dcp-biotilina-10percent-premix-for-medicated-feed-for-pigs-and-rabbits-en.pdf

English (PDF)
Published on: 22/12/2023
Download
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