Veterinary Medicines

Gamrozyne 150 mg/ml Solution for Injection for Cattle, Sheep and Pigs

Authorised
  • Gamithromycin
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Product identification

Medicine name:
Gamrozyne 150 mg/ml Solution for Injection for Cattle, Sheep and Pigs
GAMROZYNE 150 mg/ml SOLUCION INYECTABLE PARA BOVINO, OVINO Y PORCINO
Active substance:
  • Gamithromycin
Target species:
  • Pig
  • Cattle
  • Sheep
Route of administration:
  • Intramuscular use
  • Subcutaneous use

Product details

Active substance and strength:
  • Gamithromycin
    150.00
    milligram(s)
    /
    1.00
    millilitre(s)
Pharmaceutical form:
  • Solution for injection
Withdrawal period by route of administration:
  • Intramuscular use
    • Pig
      • Meat and offal
        16
        day
  • Subcutaneous use
    • Cattle
      • Meat and offal
        64
        day
    • Sheep
      • Meat and offal
        29
        day
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QJ01FA95
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Spain
Package description:
  • Type 1 glass vials of 100 ml with a chlorobutyl rubber stopper and an aluminium seal.Cardboard box containing 1 vial of 100 ml.
  • Type 1 glass vials of 250 ml with a chlorobutyl rubber stopper and an aluminium seal.Cardboard box containing 1 vial of 250 ml.
  • Type 1 glass vials of 500 ml with a chlorobutyl rubber stopper and an aluminium seal.Cardboard box containing 1 vial of 500 ml.

Additional information

Entitlement type:
  • Marketing Authorisation
Legal basis of product authorisation:
  • Generic application (Article 18 of Regulation (EU) 2019/6)
Marketing authorisation holder:
  • Bimeda Animal Health Limited
Marketing authorisation date:
Manufacturing sites for batch release:
  • Bimeda Animal Health Limited
Responsible authority:
  • Spanish Agency Of Medicines And Medical Devices
Authorisation number:
  • 4352 ESP
Date of authorisation status change:
Reference member state:
  • Ireland
Procedure number:
  • IE/V/0883/001
Concerned member states:
  • Denmark
  • France
  • Spain
  • Sweden
  • United Kingdom (Northern Ireland)
Generic of:

Documents

Summary of Product Characteristics

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Spanish (PDF)
Published on: 21/10/2024
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Package Leaflet

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Spanish (PDF)
Published on: 21/10/2024
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Labelling

This document does not exist in this language (English). You can find it in another language below.
Spanish (PDF)
Published on: 21/10/2024
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