Gumbohatch (--) - Lyophilisate and solvent for suspension for injection
Gumbohatch (--) - Lyophilisate and solvent for suspension for injection
Authorised
- Infectious bursal disease virus, strain 1052, Live
Product identification
Medicine name:
Gumbohatch (--) - Lyophilisate and solvent for suspension for injection
Active substance:
- Infectious bursal disease virus, strain 1052, Live
Target species:
-
Chicken
-
Chicken (embryonated eggs)
Route of administration:
-
In ovo
-
Subcutaneous use
Product details
Active substance and strength:
-
Infectious bursal disease virus, strain 1052, LivePresentation_strength:10¹·⁴⁸ - 10²·⁶³ PU Reference:Hse Index:0
Pharmaceutical form:
-
Lyophilisate and solvent for suspension for injection
Withdrawal period by route of administration:
-
In ovo
- Chicken
-
Not applicable0dayZero days
-
- Chicken (embryonated eggs)
-
Not applicable0dayZero days
-
-
Subcutaneous use
- Chicken
-
Not applicable0dayZero days
-
- Chicken (embryonated eggs)
-
Not applicable0dayZero days
-
Anatomical therapeutic chemical veterinary (ATCvet) codes:
- QI01AD09
Legal status of supply:
-
Veterinary medicinal product subject to veterinary prescription
Authorisation status:
-
Valid
Authorised in:
-
Austria
-
Belgium
-
Bulgaria
-
Croatia
-
Cyprus
-
Czechia
-
Denmark
-
Estonia
-
Finland
-
France
-
Germany
-
Greece
-
Hungary
-
Iceland
-
Ireland
-
Italy
-
Latvia
-
Liechtenstein
-
Lithuania
-
Luxembourg
-
Malta
-
Netherlands
-
Norway
-
Poland
-
Portugal
-
Romania
-
Slovakia
-
Slovenia
-
Spain
-
Sweden
-
United Kingdom (Northern Ireland)
Package description:
- Packaging:Vial (glass), Package_size:10 vials, Content:2500 doses
- Packaging:Vial (glass), Package_size:10 vials, Content:2000 doses
- Packaging:Vial (glass), Package_size:10 vials, Content:4000 doses
- Packaging:Vial (glass), Package_size:10 vials, Content:5000 doses
- Packaging:Vial (glass), Package_size:10 vials, Content:1000 doses
- Packaging:Vial (glass), Package_size:10 vials, Content:10000 doses
- Packaging:Vial (glass), Package_size:10 vials, Content:8000 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:
- Laboratorios Hipra, S.A.
Marketing authorisation date:
Manufacturing sites for batch release:
- Laboratorios Hipra S.A.
Responsible authority:
- European Commission
Authorisation number:
This information is not available for this product.
Date of authorisation status change:
To consult adverse reactions on veterinary medicinal products please go to www.adrreports.eu/vet
Documents
Combined File of all Documents
English (PDF)
Download Published on: 10/07/2023
Bulgarian (PDF)
Published on: 10/07/2023
Croatian (PDF)
Published on: 10/07/2023
Czech (PDF)
Published on: 10/07/2023
Danish (PDF)
Published on: 10/07/2023
Dutch (PDF)
Published on: 10/07/2023
Estonian (PDF)
Published on: 10/07/2023
Finnish (PDF)
Published on: 10/07/2023
French (PDF)
Published on: 10/07/2023
German (PDF)
Published on: 10/07/2023
Greek (PDF)
Published on: 10/07/2023
Hungarian (PDF)
Published on: 10/07/2023
Icelandic (PDF)
Published on: 10/07/2023
Italian (PDF)
Published on: 10/07/2023
Latvian (PDF)
Published on: 10/07/2023
Lithuanian (PDF)
Published on: 10/07/2023
Maltese (PDF)
Published on: 10/07/2023
Norwegian (PDF)
Published on: 10/07/2023
Polish (PDF)
Published on: 10/07/2023
Portuguese (PDF)
Published on: 10/07/2023
Romanian (PDF)
Published on: 10/07/2023
Slovak (PDF)
Published on: 10/07/2023
Slovenian (PDF)
Published on: 10/07/2023
Spanish (PDF)
Published on: 10/07/2023
Swedish (PDF)
Published on: 10/07/2023
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