Veterinary Medicines

Aceprolab 5 mg/ml Solution for injection

Authorised
  • Aceprometazine maleate
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Product identification

Medicine name:
Aceprolab 5 mg/ml Solution for injection
ACEPROLAB 5 mg/ml SOLUCION INYECTABLE
Active substance:
  • Aceprometazine maleate
Target species:
  • Dog
  • Cat
  • Horse (non food-producing)
Route of administration:
  • Intramuscular use
  • Intravenous use

Product details

Active substance and strength:
  • Aceprometazine maleate
    5.00
    milligram(s)
    /
    1.00
    millilitre(s)
Pharmaceutical form:
  • Solution for injection
Withdrawal period by route of administration:
  • Intramuscular use
    • Dog
    • Cat
    • Horse (non food-producing)
  • Intravenous use
    • Dog
    • Cat
    • Horse (non food-producing)
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QN05AA04
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Spain
Available in:
  • Spain
Package description:

Additional information

Entitlement type:
  • Marketing Authorisation
Legal basis of product authorisation:
  • Generic application (Article 13(1) of Directive No 2001/82/EC)
Marketing authorisation holder:
  • Labiana Life Sciences S.A.
Marketing authorisation date:
Manufacturing sites for batch release:
  • Labiana Life Sciences S.A.
Responsible authority:
  • Spanish Agency For Medicines And Health Products
Authorisation number:
  • 3934 ESP
Date of authorisation status change:
Reference member state:
  • Spain
Procedure number:
  • ES/V/0380/001
Concerned member states:
  • Hungary

Documents

Combined File of all Documents

English (PDF)
Published on: 22/11/2022
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Summary of Product Characteristics

This document does not exist in this language (English). You can find it in another language below.
Spanish (PDF)
Published on: 2/02/2024
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Package Leaflet

This document does not exist in this language (English). You can find it in another language below.
Spanish (PDF)
Published on: 2/02/2024
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Labelling

This document does not exist in this language (English). You can find it in another language below.
Spanish (PDF)
Published on: 2/02/2024
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eu-PUAR-esv0380001-dcp-aceprolab-5-mg-ml-solution-for-injection-en.pdf

English (PDF)
Published on: 1/02/2024
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eu-PUAR-esv0380001-dcp-aceprolab-5-mg-ml-solution-for-injection-en.pdf

English (PDF)
Published on: 22/12/2023
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