Veterinary Medicines

Hypophysin LA 35 µg/ml solution for injection for cattle and pigs

Authorised
  • Carbetocin
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Product identification

Medicine name:
Hypophysin LA 35 µg/ml solution for injection for cattle and pigs
HYPOPHYSIN LA 35 MCG/ML soluție injectabila pentru bovine și porcine
Active substance:
  • Carbetocin
Target species:
  • Cattle
  • Pig
Route of administration:
  • Intravenous use
  • Intramuscular use

Product details

Active substance and strength:
  • Carbetocin
    35.00
    microgram(s)
    /
    1.00
    millilitre(s)
Pharmaceutical form:
  • Solution for injection
Withdrawal period by route of administration:
  • Intravenous use
    • Cattle
      • Milk
        0
        hour
      • Meat and offal
        0
        day
    • Pig
      • Meat and offal
        0
        day
  • Intramuscular use
    • Cattle
      • Milk
        0
        hour
      • Meat and offal
        0
        day
    • Pig
      • Meat and offal
        0
        day
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QH01BB03
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Romania
Available in:
  • Romania
Package description:
  • (ID5) 100 millilitre(s): unspecified outer container with 1 Vial (glass) with 100 millilitre(s)
  • (ID3) 50 millilitre(s): unspecified outer container with 1 Vial (glass) with 50 millilitre(s)
  • (ID2) 20 millilitre(s): unspecified outer container with 1 Vial (glass) with 20 millilitre(s)
  • (ID1) 10 millilitre(s): unspecified outer container with 1 Vial (glass) with 10 millilitre(s)

Additional information

Entitlement type:
  • Marketing Authorisation
Legal basis of product authorisation:
  • Hybrid application (Article 13(3) of Directive No 2001/82/EC)
Marketing authorisation holder:
  • Veyx Pharma GmbH
Marketing authorisation date:
Manufacturing sites for batch release:
  • Veyx Pharma GmbH
  • Veyx-Pharma B.V.
Responsible authority:
  • Institute For Control Of Biological Products And Veterinary Medicines
Authorisation number:
  • 190312
Date of authorisation status change:
Reference member state:
  • Germany
Procedure number:
  • DE/V/0156/001
Concerned member states:
  • Austria
  • Belgium
  • Bulgaria
  • Czechia
  • Estonia
  • France
  • Hungary
  • Ireland
  • Italy
  • Latvia
  • Lithuania
  • Luxembourg
  • Netherlands
  • Poland
  • Portugal
  • Romania
  • Slovakia
  • Slovenia
  • Spain
  • United Kingdom (Northern Ireland)

Documents

Combined File of all Documents

English (PDF)
Published on: 4/12/2025
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Romanian (PDF)
Published on: 5/11/2025
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2401958-paren-20140521.pdf

English (PDF)
Published on: 4/12/2025
Download