Newflend ND H9 (--) - Concentrate and solvent for suspension for injection
Newflend ND H9 (--) - Concentrate and solvent for suspension for injection
Authorised
- Turkey herpesvirus, strain rHVT/ND (cell-associated), expressing fusion protein gene of Newcastle disease virus (strain D-26), Live
Product identification
Medicine name:
Newflend ND H9 (--) - Concentrate and solvent for suspension for injection
Active substance:
- Turkey herpesvirus, strain rHVT/ND (cell-associated), expressing fusion protein gene of Newcastle disease virus (strain D-26), Live
Target species:
-
Chicken
-
Chicken (embryonated eggs)
Route of administration:
-
In ovo
-
Subcutaneous use
Product details
Active substance and strength:
-
Turkey herpesvirus, strain rHVT/ND (cell-associated), expressing fusion protein gene of Newcastle disease virus (strain D-26), LivePresentation_strength:from 3,000 to 12,000 PFU/dose Reference:HSE Index:0
Pharmaceutical form:
-
Concentrate 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:
- QI01AD
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:Concentrate: ampoule (glass); solvent: bag (PVC), Package_size:Concentrate: 1 ampoule, Content:4000 doses
- Packaging:Concentrate: ampoule (glass); solvent: bag (PVC), Package_size:Concentrate: 1 ampoule, Content:2000 doses
- Packaging:Concentrate: ampoule (glass); solvent: bag (PVC), Package_size:Concentrate: 1 ampoule, Content:1000 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:
- Ceva-Phylaxia Co. Ltd
Marketing authorisation date:
Manufacturing sites for batch release:
- Ceva-Phylaxia Veterinary Biologicals Co. Ltd.
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: 28/08/2023
Bulgarian (PDF)
Published on: 28/08/2023
Croatian (PDF)
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Czech (PDF)
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Danish (PDF)
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Dutch (PDF)
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Estonian (PDF)
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Finnish (PDF)
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French (PDF)
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German (PDF)
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Greek (PDF)
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Hungarian (PDF)
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Icelandic (PDF)
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Italian (PDF)
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Latvian (PDF)
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Lithuanian (PDF)
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Maltese (PDF)
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Norwegian (PDF)
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Polish (PDF)
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Portuguese (PDF)
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Romanian (PDF)
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Slovak (PDF)
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Slovenian (PDF)
Published on: 28/08/2023
Spanish (PDF)
Published on: 28/08/2023
Swedish (PDF)
Published on: 28/08/2023
ema-puar-v5860-newflend-nd-h9-en.pdf
English (PDF)
Download Published on: 28/08/2023
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