MUCOSIFFA, LYOPHILISATE AND SOLVENT FOR SUSPENSION FOR INJECTION FOR CATTLE
MUCOSIFFA, LYOPHILISATE AND SOLVENT FOR SUSPENSION FOR INJECTION FOR CATTLE
Authorised
- Water for injection
- Bovine viral diarrhoea virus, strain Oregon C24, Live
Product identification
Medicine name:
MUCOSIFFA, LYOPHILISATE AND SOLVENT FOR SUSPENSION FOR INJECTION FOR CATTLE
Mucosiffa, süstesuspensiooni lüofilisaat ja lahusti veistele
Active substance:
- Water for injection
- Bovine viral diarrhoea virus, strain Oregon C24, Live
Target species:
-
Cattle
Route of administration:
-
Intramuscular use
Product details
Active substance and strength:
-
Water for injection2.00millilitre(s)1.00unit(s)
-
Bovine viral diarrhoea virus, strain Oregon C24, Live3162.00cell culture infective dose 501.00unit(s)
Pharmaceutical form:
-
Lyophilisate and solvent for suspension for injection
Withdrawal period by route of administration:
-
Intramuscular use
- Cattle
-
All relevant tissues0day
-
Anatomical therapeutic chemical veterinary (ATCvet) codes:
- QI02AD02
Legal status of supply:
-
Veterinary medicinal product subject to veterinary prescription
Authorisation status:
-
Valid
Authorised in:
-
Estonia
Package description:
- Box with 50 dose of lyophilisate in vial and 100 ml of solvent in vial
- Box with 20 dose of lyophilisate in vial and 40 ml of solvent in vial
- Box with 5 dose of lyophilisate in vial and 10 ml of solvent in vial
- Box with 2 dose of lyophilisate in vial and 4 ml of solvent in vial
- Box with 10 dose of lyophilisate in vial and 20 ml of solvent in vial
- Box with 1 dose of lyophilisate in vial and 2 ml of solvent in vial
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:
- Ceva-Phylaxia Zrt.
Marketing authorisation date:
Manufacturing sites for batch release:
- Ceva-Phylaxia Veterinary Biologicals Co. Ltd.
Responsible authority:
- State Agency Of Medicines
Authorisation number:
- 2215
Date of authorisation status change:
Reference member state:
-
France
Procedure number:
- FR/V/0395/001
Concerned member states:
-
Bulgaria
-
Croatia
-
Cyprus
-
Estonia
-
Greece
-
Hungary
-
Latvia
-
Lithuania
-
Luxembourg
-
Malta
-
Portugal
-
Romania
-
Slovenia
To consult adverse reactions on veterinary medicinal products please go to www.adrreports.eu/vet
Documents
Summary of Product Characteristics
This document does not exist in this language (English). You can find it
in another language below.
Estonian (PDF)
Published on: 9/07/2024
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