Veterinary Medicines

Equip Rotavirus Emulsion for Injection for Horses

Authorised
  • Equine rotavirus A, type G3P12, strain H2, Inactivated
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Product identification

Medicine name:
Equip Rotavirus emulsion for injection for horses
Equip Rotavirus Emulsion for Injection for Horses
Active substance:
  • Equine rotavirus A, type G3P12, strain H2, Inactivated
Target species:
  • Horse
Route of administration:
  • Intramuscular use

Product details

Active substance and strength:
  • Equine rotavirus A, type G3P12, strain H2, Inactivated
    74000000.00
    fluorescent assay infectious dose 50%
    /
    1.00
    Dose
Pharmaceutical form:
  • Emulsion for injection
Withdrawal period by route of administration:
  • Intramuscular use
    • Horse
      • Meat and offal
        0
        day
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QI05AA09
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • United Kingdom (Northern Ireland)
Available in:
  • United Kingdom (Northern Ireland)
Package description:
  • Single-dose type I glass syringes (Ph.Eur. 3.2.1) closed with bromobutyl rubber tips (Ph. Eur. 3.2.9).Syringes are supplied in cardboard packs of 3 units.
  • Single-dose type I glass syringes (Ph.Eur. 3.2.1) closed with bromobutyl rubber tips (Ph. Eur. 3.2.9).Syringes are supplied in cardboard packs of 10 units.
  • Single-dose type I glass syringes (Ph.Eur. 3.2.1) closed with bromobutyl rubber tips (Ph. Eur. 3.2.9).Syringes are supplied in cardboard packs of 20 units.
  • Single-dose type I glass syringes (Ph.Eur. 3.2.1) closed with bromobutyl rubber tips (Ph. Eur. 3.2.9).Syringes are supplied in cardboard packs of 40 units.

Additional information

Entitlement type:
  • Marketing Authorisation
Legal basis of product authorisation:
  • Full application (Article 12(3) of Directive No 2001/82/EC)
Marketing authorisation holder:
  • Zoetis Belgium S.A.
Marketing authorisation date:
Manufacturing sites for batch release:
  • Zoetis Belgium SA
Responsible authority:
  • The Veterinary Medicines Directorate
Authorisation number:
  • Vm 60021/3087
Date of authorisation status change:
Reference member state:
  • Ireland
Procedure number:
  • IE/V/0574/001
Concerned member states:
  • France
  • Germany
  • Italy
  • Spain
  • United Kingdom (Northern Ireland)

Documents

Summary of Product Characteristics

English (PDF)
Published on: 1/12/2024
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Combined File of all Documents

English (PDF)
Published on: 1/12/2024
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ie-puar-mr-iev0574001-equip-rotavirus-emulsion-for-injection-for-horses-en.pdf

English (PDF)
Published on: 25/07/2024
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