Aceprolab 5 mg/ml Solution for injection
  • Aceprometazine maleate
  • Valid
Authorised in these countries:
  • Spain
Export to PDF

Product identification

Medicine name:
Aceprolab 5 mg/ml Solution for injection
ACEPROLAB 5 mg/ml SOLUCION INYECTABLE
Active substance and strength:
  • Aceprometazine maleate
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QN05AA04
Authorisation number:
  • 3934 ESP
Product identification number:
  • be458e8b-24de-4588-8a0d-58e5a1123629
Permanent identification number:
  • 600000038143

Product details

Legal status of supply:
This information is not available for this product.
Pharmaceutical form:
  • Solution for injection
Withdrawal period by route of administration:
  • Intramuscular use
    • Dog
    • Cat
  • Intravenous use
    • Dog
    • Cat

Availability

Package description:
  • box containing 1 vial of 100 ml
  • box containing 1 vial of 25 ml
Manufacturing sites for batch release:
  • Labiana
Source wholesaler:
This information is not available for this product.
Destination wholesaler:
This information is not available for this product.

Authorisation details

Authorisation status:
  • Valid
Authorisation procedure type:
  • Marketing Authorisation
Procedure number:
  • ES/V/0380/001
Date of authorisation status change:
Legal basis of product authorisation:
  • Generic application (Article 13(1) of Directive No 2001/82/EC)
Authorisation country:
  • Spain
Responsible authority:
  • The Spanish Agency Of Medicines And Medical Devices
Marketing authorisation holder:
  • Labiana
Marketing authorisation issued:
Reference member state:
  • Spain
Concerned member states:
  • Hungary
Reference product identifier:
This information is not available for this product.
Source product identifier:
This information is not available for this product.

Additional information

To consult adverse reactions on veterinary medicinal products please go to www.adrreports.eu/vet

Documents

eu-PUAR-aceprolab-5-mg-ml-solution-for-injection-en.pdf (PDF)
First published:
Last updated:
Combined File of all Documents (PDF)
First published:
Last updated:
Summary of Product Characteristics (PDF)
First published:
Last updated:
Package Leaflet (PDF)
First published:
Last updated:
Labelling (PDF)
First published:
Last updated:
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."