Equip Rotavirus Emulsion for Injection for Horses
Equip Rotavirus Emulsion for Injection for Horses
Authorised
- Equine rotavirus, strain H2, Inactivated
Product identification
Medicine name:
Equip Rotavirus emulsion for injection for horses
Equip Rotavirus Emulsion for Injection for Horses
Active substance:
- Equine rotavirus, strain H2, Inactivated
Target species:
-
Horse
Route of administration:
-
Intramuscular use
Product details
Active substance and strength:
-
Equine rotavirus, strain H2, Inactivated74000000.00fluorescent assay infectious dose 50%1.00Dose
Pharmaceutical form:
-
Emulsion for injection
Withdrawal period by route of administration:
-
Intramuscular use
- Horse
-
Meat and offal0day
-
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)
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 UK Limited
Marketing authorisation date:
Manufacturing sites for batch release:
- Zoetis Belgium
Responsible authority:
- The Veterinary Medicines Directorate
Authorisation number:
- Vm 42058/4063
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)
To consult adverse reactions on veterinary medicinal products please go to www.adrreports.eu/vet
Documents
Summary of Product Characteristics
English (PDF)
Download Published on: 3/05/2024
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