Veterinary Medicine Information website

Porceptal 4µg/ml solution for injection for pigs

Authorised
  • Buserelin acetate
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Product identification

Medicine name:
Porceptal 4µg/ml solution for injection for pigs
Active substance:
  • Buserelin acetate
Target species:
  • Pig
Route of administration:
  • Intramuscular use
  • Subcutaneous use

Product details

Active substance and strength:
  • Buserelin acetate
    4.20
    microgram(s)
    /
    1.00
    millilitre(s)
Pharmaceutical form:
  • Solution for injection
Withdrawal period by route of administration:
  • Intramuscular use
    • Pig
      • Meat and offal
        no withdrawal period
  • Subcutaneous use
    • Pig
      • Meat and offal
        no withdrawal period
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QH01CA90
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Germany
Available in:
  • Germany
Package description:
  • Cardboard box containing colourless glass (type II) vials of 50 ml closed with a bromobutyl rubber stopper and an aluminium crimp cap.
  • Cardboard box containing colourless glass (type I) vials of 5 ml closed with an ETFE laminated bromobutyl rubber stopper (type I) and an aluminium crimp cap.
  • Cardboard box containing colourless glass (type I) vials of 10 ml closed with a bromobutyl rubber stopper and an aluminium crimp cap.
  • 5x 10 ml - Cardboard box containing colourless glass (type I) vials of 10 ml closed with a bromobutyl rubber stopper and an aluminium crimp cap.
  • 10x 5 ml - Cardboard box containing colourless glass (type I) vials of 5 ml closed with an ETFE laminated bromobutyl rubber stopper (type I) and an aluminium crimp cap.
  • 10x 2,5 ml - Cardboard box containing colourless glass (type I) vials of 2.5 ml closed with an ETFE laminated bromobutyl rubber stopper (type I) and an aluminium crimp cap.

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:
  • Intervet Deutschland GmbH
Marketing authorisation date:
Manufacturing sites for batch release:
  • Intervet International GmbH
Responsible authority:
  • Federal Office Of Consumer Protection And Food Safety
Authorisation number:
  • 401881.00.00
Date of authorisation status change:
Reference member state:
  • Netherlands
Procedure number:
  • NL/V/0176/001
Concerned member states:
  • Austria
  • Belgium
  • Bulgaria
  • Cyprus
  • Czechia
  • Denmark
  • Estonia
  • France
  • Germany
  • Greece
  • Hungary
  • Italy
  • Latvia
  • Lithuania
  • Luxembourg
  • Poland
  • Portugal
  • Romania
  • Slovakia
  • Slovenia
  • Spain
  • United Kingdom (Northern Ireland)

Documents

Package Leaflet

This document does not exist in this language (English). You can find it in another language below.
German (RTF)
Published on: 20/12/2024
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Summary of Product Characteristics

This document does not exist in this language (English). You can find it in another language below.
German (RTF)
Published on: 20/12/2024
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