Veterinary Medicines

MUCOSIFFA, LYOPHILISATE AND SOLVENT FOR SUSPENSION FOR INJECTION FOR CATTLE

Authorised
  • Water for injection
  • Bovine viral diarrhea virus, strain Oregon C24, Live
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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 diarrhea virus, strain Oregon C24, Live
Target species:
  • Cattle
Route of administration:
  • Intramuscular use

Product details

Active substance and strength:
  • Water for injection
    2.00
    millilitre(s)
    /
    1.00
    unit(s)
  • Bovine viral diarrhea virus, strain Oregon C24, Live
    3162.00
    cell culture infective dose 50
    /
    1.00
    unit(s)
Pharmaceutical form:
  • Lyophilisate and solvent for suspension for injection
Withdrawal period by route of administration:
  • Intramuscular use
    • Cattle
      • All relevant tissues
        0
        day
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

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: 3/06/2022
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