DIVENCE PENTA (--) - Lyophilisate and solvent for emulsion for injection
DIVENCE PENTA (--) - Lyophilisate and solvent for emulsion for injection
Authorised
- Bovine respiratory syncytial virus, strain Lym-56, Live
- Infectious bovine rhinotracheitis virus, strain CEDDEL, gE- tk- double-gene deleted, Live
- Bovine parainfluenza virus 3, strain SF-4, Inactivated
- Bovine viral diarrhoea virus 1, E2 protein, recombinant
- Bovine viral diarrhoea virus 2, E2 protein, recombinant
Product identification
Medicine name:
DIVENCE PENTA (--) - Lyophilisate and solvent for emulsion for injection
Active substance:
- Bovine respiratory syncytial virus, strain Lym-56, Live
- Infectious bovine rhinotracheitis virus, strain CEDDEL, gE- tk- double-gene deleted, Live
- Bovine parainfluenza virus 3, strain SF-4, Inactivated
- Bovine viral diarrhoea virus 1, E2 protein, recombinant
- Bovine viral diarrhoea virus 2, E2 protein, recombinant
Target species:
-
Cattle
Route of administration:
-
Intramuscular use
Product details
Active substance and strength:
-
Bovine respiratory syncytial virus, strain Lym-56, LivePresentation_strength:10⁵·² - 10⁶·⁵ CCID50 Comments:lyophilisate (per dose of 2ml) Index:0
-
Infectious bovine rhinotracheitis virus, strain CEDDEL, gE- tk- double-gene deleted, LivePresentation_strength:10⁶·³ - 10⁷·⁶ CCID50* Comments:lyophilisate (per dose of 2ml) Index:1
-
Bovine parainfluenza virus 3, strain SF-4, InactivatedPresentation_strength:≥ 20⁶·² EU** Comments:lyophilisate (per dose of 2ml) Index:2
-
Bovine viral diarrhoea virus 1, E2 protein, recombinantPresentation_strength:≥ 31.6 EU** Comments:lyophilisate (per dose of 2ml) Index:3
-
Bovine viral diarrhoea virus 2, E2 protein, recombinantPresentation_strength:≥ 21.0 EU** Comments:lyophilisate (per dose of 2ml) Index:4
Pharmaceutical form:
-
Lyophilisate and solvent for emulsion for injection
Withdrawal period by route of administration:
-
Intramuscular use
- Cattle
-
All relevant tissues0dayZero days
-
Anatomical therapeutic chemical veterinary (ATCvet) codes:
- QI02AH
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:Lyophilisate: vial (glass); Solvent; vial (PET), Package_size:Lyophlisate: 1 vial + Solvent: 1 vial, Content:Lyophilisate: 10 doses; solvent: 20 ml
- Packaging:Lyophilisate: vial (glass); Solvent; vial (PET), Package_size:Lyophlisate: 1 vial + Solvent: 1 vial, Content:Lyophilisate: 20 doses; solvent: 40 ml
- Packaging:Lyophilisate: vial (glass); Solvent; vial (PET), Package_size:Lyophlisate: 1 vial + Solvent: 1 vial, Content:Lyophilisate: 5 doses; solvent: 10 ml
Additional information
Entitlement type:
-
Marketing Authorisation
Legal basis of product authorisation:
-
Full application - new active substance (Article 8 of Regulation (EU) 2019/6)
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: 31/05/2024
Bulgarian (PDF)
Published on: 31/05/2024
Croatian (PDF)
Published on: 31/05/2024
Czech (PDF)
Published on: 31/05/2024
Danish (PDF)
Published on: 31/05/2024
Dutch (PDF)
Published on: 31/05/2024
Estonian (PDF)
Published on: 31/05/2024
Finnish (PDF)
Published on: 31/05/2024
French (PDF)
Published on: 31/05/2024
German (PDF)
Published on: 31/05/2024
Greek (PDF)
Published on: 31/05/2024
Hungarian (PDF)
Published on: 31/05/2024
Icelandic (PDF)
Published on: 31/05/2024
Italian (PDF)
Published on: 31/05/2024
Latvian (PDF)
Published on: 31/05/2024
Lithuanian (PDF)
Published on: 31/05/2024
Maltese (PDF)
Published on: 31/05/2024
Norwegian (PDF)
Published on: 6/06/2024
Polish (PDF)
Published on: 21/06/2024
Portuguese (PDF)
Published on: 31/05/2024
Romanian (PDF)
Published on: 31/05/2024
Slovak (PDF)
Published on: 31/05/2024
Slovenian (PDF)
Published on: 31/05/2024
Spanish (PDF)
Published on: 31/05/2024
Swedish (PDF)
Published on: 31/05/2024
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