Veterinary Medicines

BIOTILINA 10% premix for medicated feed for pigs and rabbits

Authorised
  • Valnemulin hydrochloride
Download as PDF

Product identification

Medicine name:
BIOTILINA 10% premix for medicated feed for pigs and rabbits
BIOTILINA 100 mg/g gyógypremix sertések és házinyulak részére A.U.V.
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:
  • Hungary
Available in:
  • Hungary
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.
Responsible authority:
  • National Food Chain Safety Office
Authorisation number:
  • 4165/X/20 NÉBIH ÁTI
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

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

English (PDF)
Published on: 22/12/2023
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."