GALAZEL
GALAZEL
Authorised
- Mycoplasma agalactiae, strain N-262, Inactivated
Product identification
Medicine name:
GALAZEL
Active substance:
- Mycoplasma agalactiae, strain N-262, Inactivated
Target species:
-
Sheep
-
Goat
Route of administration:
-
Subcutaneous use
Product details
Active substance and strength:
-
Mycoplasma agalactiae, strain N-262, Inactivated70.00/enzyme-linked immunosorbent assay unit2.00millilitre(s)
Pharmaceutical form:
-
Emulsion for injection
Withdrawal period by route of administration:
-
Subcutaneous use
- Sheep
-
Meat and offal0day
-
- Goat
-
Meat and offal0day
-
Anatomical therapeutic chemical veterinary (ATCvet) codes:
- QI04AB
Legal status of supply:
-
Veterinary medicinal product subject to veterinary prescription
Authorisation status:
-
Valid
Authorised in:
-
Spain
Additional information
Entitlement type:
-
Marketing Authorisation
Legal basis of product authorisation:
-
Full application - Known active substance (Article 12(3) of Directive No 2001/82/EC)
Marketing authorisation holder:
- Merck Sharp & Dohme Animal Health S.L.
Marketing authorisation date:
Manufacturing sites for batch release:
- Cz Veterinaria S.A.
Responsible authority:
- The Spanish Agency Of Medicines And Medical Devices
Authorisation number:
- 3172 ESP
Date of authorisation status change:
To consult adverse reactions on veterinary medicinal products please go to www.adrreports.eu/vet
Documents
Summary of Product Characteristics
This document does not exist in this language (English). You can find it in another language below.
Spanish (PDF)
Published on: 1/02/2024
Package Leaflet
This document does not exist in this language (English). You can find it in another language below.
Spanish (PDF)
Published on: 1/02/2024
Labelling
This document does not exist in this language (English). You can find it in another language below.
Spanish (PDF)
Published on: 1/02/2024
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