Veterinary Medicines

INMEVA, SUSPENSION FOR INJECTION

Suspended
  • Chlamydia abortus, strain A22, Inactivated
  • Salmonella enterica, subsp. enterica, serovar Abortusovis, strain Sao, Inactivated
Download as PDF

Product identification

Medicine name:
INMEVA, SUSPENSION FOR INJECTION
Inmeva injektionsvæske, suspension
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:
  • Suspended
Authorised in:
  • Denmark
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:
  • Danish Medicines Agency
Authorisation number:
  • 61285
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

This document does not exist in this language (English). You can find it in another language below.
Danish (PDF)
Published on: 9/07/2023
Download
How useful was this page?:
No votes yet
"Please do not include any personal data, such as your name or contact details. If you do, you consent to the processing of that data in accordance with EMA’s Privacy Statement concerning requests for information or access to documents. If you would like a reply from EMA, please Send a question to EMA instead."