Veterinary Medicines

SynVet-50; 50 mg solution for injection for horses

Authorised
  • SODIUM HYALURONATE
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Product identification

Medicine name:
SynVet-50; 50 mg solution for injection for horses
Synvet 20 mg/ml injektionsvæske, opløsning
Active substance:
  • SODIUM HYALURONATE
Target species:
  • Horse
Route of administration:
  • Intraarticular use

Product details

Active substance and strength:
  • SODIUM HYALURONATE
    50.00
    milligram(s)
    /
    1.00
    Syringe
Pharmaceutical form:
  • Solution for injection
Withdrawal period by route of administration:
  • Intraarticular use
    • Horse
      • Meat and offal
        0
        day
      • Milk
        0
        hour
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QM09AX01
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Denmark
Package description:
  • Single-dose glass syringe barrel with luer tip and rigid tip capType 1 glass syringe, lubricated with dimethicone. Styrene-butadiene rubber cap.Bromobutyl rubber plunger.Available in single carton overwrapped with plastic film.
  • Single-dose glass syringe barrel with luer tip and rigid tip capType 1 glass syringe, lubricated with dimethicone. Styrene-butadiene rubber cap.Bromobutyl rubber plunger.Available in packs of 6 single cartons overwrapped with plastic film.

Additional information

Entitlement type:
  • Marketing Authorisation
Legal basis of product authorisation:
  • Well-established use application (Article 13a of Directive No 2001/82/EC)
Marketing authorisation holder:
  • Equi Pharma Limited
Marketing authorisation date:
Manufacturing sites for batch release:
  • CROMA-PHARMA GmbH
Responsible authority:
  • Danish Medicines Agency
Authorisation number:
  • 52938
Date of authorisation status change:
Reference member state:
  • Ireland
Procedure number:
  • IE/V/0580/001
Concerned member states:
  • Austria
  • Belgium
  • Denmark
  • France
  • Germany
  • Netherlands
  • Norway
  • Sweden
  • United Kingdom (Northern Ireland)

Documents

Summary of Product Characteristics

English (PDF)
Published on: 9/03/2025
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Danish (PDF)
Published on: 28/04/2025
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