Veterinary Medicines

Innovax-ND-IBD (--) - Suspension and solvent for suspension for injection

Authorised

Turkey herpesvirus, strain HVP360 (cell-associated), expressing fusion protein gene of Newcastle disease virus and VP2 protein gene of Infectious bursal disease virus, Live

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Product identification

Medicine name:

Innovax-ND-IBD (--) - Suspension and solvent for suspension for injection

Active substance:

Turkey herpesvirus, strain HVP360 (cell-associated), expressing fusion protein gene of Newcastle disease virus and VP2 protein gene of Infectious bursal disease virus, Live

Target species:

Chicken
Chicken (embryonated eggs)

Route of administration:

In ovo
Subcutaneous use

Product details

Active substance and strength:

Turkey herpesvirus, strain HVP360 (cell-associated), expressing fusion protein gene of Newcastle disease virus and VP2 protein gene of Infectious bursal disease virus, Live

Presentation_strength:10³·³-10⁴·⁶ PFU Reference:Hse Index:0

Pharmaceutical form:

Concentrate and solvent for suspension for injection

Withdrawal period by route of administration:

In ovo
- Chicken
  - Not applicable
    
    0
    
    day
    
    Zero days
- Chicken (embryonated eggs)
  - Not applicable
    
    0
    
    day
    
    Zero days
Subcutaneous use
- Chicken
  - Not applicable
    
    0
    
    day
    
    Zero days
- Chicken (embryonated eggs)
  - Not applicable
    
    0
    
    day
    
    Zero days

Anatomical therapeutic chemical veterinary (ATCvet) codes:

QI01AD16

Legal status of supply:

Veterinary medicinal product subject to veterinary prescription

Authorisation status:

Valid

Authorised in:

Available in:

Austria
Belgium
Bulgaria
Cyprus
Czechia
Denmark
France
Germany
Greece
Hungary
Ireland
Italy
Netherlands
Poland
Portugal
Romania
Spain
United Kingdom (Northern Ireland)

Package description:

Packaging:Concentrate: ampoule (glass), Package_size:Concentrate: 1 ampoule, Content:Concentrate: 2 ml (4000 doses)
Packaging:Concentrate: ampoule (glass), Package_size:Concentrate: 1 ampoule, Content:Concentrate: 2 ml (2000 doses)

Additional information

Entitlement type:

Marketing Authorisation

Legal basis of product authorisation:

Full application - New active substance (Article 12(3) of Directive No 2001/82/EC)

Marketing authorisation holder:

Intervet International B.V.

Marketing authorisation date:

22/08/2017

Manufacturing sites for batch release:

Intervet International B.V.

Responsible authority:

European Commission

Authorisation number:

This information is not available for this product.

Date of authorisation status change:

22/08/2017

To consult adverse reactions on veterinary medicinal products please go to www.adrreports.eu/vet

Documents

Combined File of all Documents

English (PDF)

Published on: 12/07/2023

Other languages (24)

Bulgarian (PDF)

Published on: 12/07/2023

Croatian (PDF)

Published on: 12/07/2023

Czech (PDF)

Published on: 12/07/2023

Danish (PDF)

Published on: 12/07/2023

Dutch (PDF)

Published on: 12/07/2023

Estonian (PDF)

Published on: 12/07/2023

Finnish (PDF)

Published on: 12/07/2023

French (PDF)

Published on: 12/07/2023

German (PDF)

Published on: 12/07/2023

Greek (PDF)

Published on: 12/07/2023

Hungarian (PDF)

Published on: 12/07/2023

Icelandic (PDF)

Published on: 12/07/2023

Italian (PDF)

Published on: 12/07/2023

Latvian (PDF)

Published on: 12/07/2023

Lithuanian (PDF)

Published on: 12/07/2023

Maltese (PDF)

Published on: 12/07/2023

Norwegian (PDF)

Published on: 12/07/2023

Polish (PDF)

Published on: 12/07/2023

Portuguese (PDF)

Published on: 12/07/2023

Romanian (PDF)

Published on: 12/07/2023

Slovak (PDF)

Published on: 12/07/2023

Slovenian (PDF)

Published on: 12/07/2023

Spanish (PDF)

Published on: 12/07/2023

Swedish (PDF)

Published on: 12/07/2023

ema-puar-v4422-innovax-nd-ibd-ii-0004-en.pdf

English (PDF)

Published on: 24/04/2024

ema-puar-innovax-nd-ibd-v-4422-par-en.pdf

English (PDF)

Published on: 14/03/2023