Veterinary Medicines

Ovarelin 50 ug/ml, solution for injection for cattle

Authorised
  • GONADORELIN DIACETATE TETRAHYDRATE
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Product identification

Medicine name:
Ovarelin 50 ug/ml, solution for injection for cattle
OVARELIN 50 µg/ml oldatos injekció szarvasmarhák részére A.U.V.
Active substance:
  • GONADORELIN DIACETATE TETRAHYDRATE
Target species:
  • Cattle
Route of administration:
  • Intramuscular use

Product details

Active substance and strength:
  • GONADORELIN DIACETATE TETRAHYDRATE
    58.13
    microgram(s)
    /
    1.00
    millilitre(s)
Pharmaceutical form:
  • Solution for injection
Withdrawal period by route of administration:
  • Intramuscular use
    • Cattle
      • Meat and offal
        0
        day
      • Milk
        0
        hour
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QH01CA01
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Hungary
Package description:
  • Material of the primary container: Colourless glass vial type I (4 ml). Chlorobutyl stopper. Pack size: Box containing 1 glass vial of 4 ml
  • Material of the primary container: Colourless glass vial type II (10 ml). Chlorobutyl stopper. Pack size: Box containing 1 glass vial of 10 ml
  • Material of the primary container: Colourless glass vial type II (20 ml). Chlorobutyl stopper. Pack size: Box containing 1 glass vial of 20 ml
  • Material of the primary container: Colourless glass vial type II (50 ml). Chlorobutyl stopper. Pack size: Box containing 1 glass vial of 50 ml

Additional information

Entitlement type:
  • Marketing Authorisation
Legal basis of product authorisation:
  • Full application (Article 12(3) of Directive No 2001/82/EC)
Marketing authorisation holder:
  • Ceva-Phylaxia Zrt.
Marketing authorisation date:
Manufacturing sites for batch release:
  • Ceva Sante Animale
Responsible authority:
  • Directorate Of Veterinary Medicinal Products
Authorisation number:
  • 2229/X/07 MgSzH ÁTI
Date of authorisation status change:
Reference member state:
  • Ireland
Procedure number:
  • IE/V/0598/001
Concerned member states:
  • Austria
  • Belgium
  • Croatia
  • Czechia
  • Denmark
  • Estonia
  • Finland
  • Germany
  • Hungary
  • Latvia
  • Lithuania
  • Luxembourg
  • Netherlands
  • Norway
  • Poland
  • Portugal
  • Slovakia
  • Slovenia
  • Sweden
  • United Kingdom (Northern Ireland)

Documents

Summary of Product Characteristics

English (PDF)
Published on: 28/01/2022
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