Veterinary Medicines

INMEVA, SUSPENSION FOR INJECTION

Authorised
  • Chlamydia abortus, strain A22, Inactivated
  • Salmonella enterica, subsp. enterica, serovar Abortusovis, strain Sao, Inactivated
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Product identification

Medicine name:
INMEVA, SUSPENSION FOR INJECTION
Inmeva Suspensie voor injectie
Inmeva Suspension injectable
Inmeva Injektionssuspension
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, Inactivated
    1.00
    relative potency
    /
    1.00
    unit(s)
  • Salmonella enterica, subsp. enterica, serovar Abortusovis, strain Sao, Inactivated
    1.00
    relative potency
    /
    1.00
    unit(s)
Pharmaceutical form:
  • Suspension for injection
Withdrawal period by route of administration:
  • Subcutaneous use
    • Sheep
      • All relevant tissues
        0
        day
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QI04AB
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Belgium
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:
  • Federal Agency For Medicines And Health Products
Authorisation number:
  • BE-V543155
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)

Documents

Summary of Product Characteristics

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Dutch (PDF)
Published on: 31/05/2022
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French (PDF)
Published on: 31/05/2022
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Package Leaflet

This document does not exist in this language (English). You can find it in another language below.
Dutch (PDF)
Published on: 31/05/2022
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French (PDF)
Published on: 31/05/2022
Download
German (PDF)
Published on: 31/05/2022
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