GUDAIR
GUDAIR
Authorised
- Mycobacterium avium, subsp. paratuberculosis, strain 316F, Inactivated
Product identification
Medicine name:
GUDAIR
GUDAIR EMULSION INYECTABLE PARA OVINO Y CAPRINO
Active substance:
- Mycobacterium avium, subsp. paratuberculosis, strain 316F, Inactivated
Target species:
-
Sheep
-
Goat
Route of administration:
-
Subcutaneous use
Product details
Active substance and strength:
-
Mycobacterium avium, subsp. paratuberculosis, strain 316F, Inactivated2.00/tuberculin unit(s)1.00millilitre(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:
- QI03AB01
Legal status of supply:
-
Veterinary medicinal product subject to veterinary prescription
Authorisation status:
-
Valid
Authorised in:
-
Spain
Available in:
-
Spain
Package description:
- box containing 1 vial of 30 ml (30 doses)
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:
- CZ Vaccines S.A.U.
Marketing authorisation date:
Manufacturing sites for batch release:
- Cz Veterinaria S.A.
Responsible authority:
- Spanish Agency For Medicines And Health Products
Authorisation number:
- 2792 ESP
Date of authorisation status change:
Reference member state:
-
Spain
Procedure number:
- ES/V/0210/001
Concerned member states:
-
France
-
Iceland
-
Norway
-
Portugal
To consult adverse reactions on veterinary medicinal products please go to www.adrreports.eu/vet
Documents
Summary of Product Characteristics
English (PDF)
Download Published on: 6/04/2023
Spanish (PDF)
Published on: 24/04/2024
Combined File of all Documents
English (PDF)
Download Published on: 21/11/2022
es-puar-gudair-es.pdf
Spanish (PDF)
Download Published on: 17/03/2023
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