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 50, 50 mg oplossing voor injectie voor paarden
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:
  • Netherlands
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:
  • Medicines Evaluation Board
Authorisation number:
  • REG NL 113383
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

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: 12/06/2023
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Summary of Product Characteristics

English (PDF)
Published on: 3/05/2024
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