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 μg/ml oplossing voor injectie voor runderen en varkens
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:
This information is not available for this product.
Authorisation status:
  • Valid
Authorised in:
  • Netherlands
Available in:
  • Netherlands
Package description:
  • (ID5) 100 millilitre(s): unspecified outer container with 1 Vial (Glass) with 100 millilitre(s)
  • (ID4) 600 millilitre(s): unspecified outer container with 12 Vial (Glass) each with 50 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)
  • (ID6) 1200 millilitre(s): unspecified outer container with 12 Vial (Glass) each with 100 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
Responsible authority:
  • Medicines Evaluation Board
Authorisation number:
  • REG NL 113682
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

This document does not exist in this language (English). You can find it in another language below.
Dutch (PDF)
Published on: 8/02/2022
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Summary of Product Characteristics

English (PDF)
Published on: 14/02/2022
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