INMEVA, SUSPENSION FOR INJECTION
INMEVA, SUSPENSION FOR INJECTION
Authorised
- Chlamydia abortus, strain A22, Inactivated
- Salmonella enterica, subsp. enterica, serovar Abortusovis, strain Sao, Inactivated
Product identification
Medicine name:
INMEVA, SUSPENSION FOR INJECTION
Inmeva, suspensão injetável
Active substance:
- Chlamydia abortus, strain A22, Inactivated
- Salmonella enterica, subsp. enterica, serovar Abortusovis, strain Sao, Inactivated
Target species:
-
Sheep
Route of administration:
-
Subcutaneous use
Product details
Active substance and strength:
-
Chlamydia abortus, strain A22, Inactivated1.00relative potency2.00millilitre(s)
-
Salmonella enterica, subsp. enterica, serovar Abortusovis, strain Sao, Inactivated1.00relative potency2.00millilitre(s)
Pharmaceutical form:
-
Suspension for injection
Withdrawal period by route of administration:
-
Subcutaneous use
-
Sheep
-
All relevant tissues0day
-
-
Anatomical therapeutic chemical veterinary (ATCvet) codes:
- QI04AB
Legal status of supply:
-
Veterinary medicinal product subject to veterinary prescription
Authorisation status:
-
Valid
Authorised in:
-
Portugal
Package description:
- Polyethylene (PET) vials of 10ml
- Polyethylene (PET) vials of 250ml
- Polyethylene (PET) vials of 100ml
- Polyethylene (PET) vials of 50ml
Additional information
Entitlement type:
-
Marketing Authorisation
Legal basis of product authorisation:
-
Full application - New active substance (Article 12(3) of Directive No 2001/82/EC)
Marketing authorisation holder:
- Laboratorios Hipra S.A.
Marketing authorisation date:
Manufacturing sites for batch release:
- Laboratorios Hipra, S.A.
Responsible authority:
- Directorate General For Food And Veterinary
Authorisation number:
- 969/01/19DIVPT
Date of authorisation status change:
Reference member state:
-
France
Procedure number:
- FR/V/0350/001
Concerned member states:
-
Austria
-
Belgium
-
Denmark
-
Germany
-
Greece
-
Hungary
-
Ireland
-
Italy
-
Luxembourg
-
Netherlands
-
Poland
-
Portugal
-
Romania
-
Spain
-
Sweden
-
United Kingdom (Northern Ireland)
To consult adverse reactions on veterinary medicinal products please go to www.adrreports.eu/vet
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