Veterinary Medicine Information website

Porceptal 4µg/ml solution for injection for pigs

Not 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:
  • Surrendered
Authorised in:
  • Cyprus
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 International B.V.
Marketing authorisation date:
Manufacturing sites for batch release:
  • Intervet International GmbH
Responsible authority:
  • Veterinary Services, Ministry Of Agriculture, Natural Resources And Environment
Authorisation number:
  • CY00476V
Date of authorisation status change:
Reference member state:
  • Netherlands
Procedure number:
  • NL/V/0176/001

Documents

Summary of Product Characteristics

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Greek (PDF)
Published on: 9/06/2022
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