Aceprolab 5 mg/ml Solution for injection
Aceprolab 5 mg/ml Solution for injection
Authorised
- Aceprometazine maleate
Product identification
Medicine name:
Aceprolab 5 mg/ml Solution for injection
Aceprolab 5 mg/ml oldatos injekció A.U.V.
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 maleate5.00/milligram(s)1.00millilitre(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:
-
Hungary
Package description:
- box containing 1 vial of 100 ml
- box containing 1 vial of 25 ml
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:
- Directorate Of Veterinary Medicinal Products
Authorisation number:
- 4200/X/20 NÉBIH ÁTI
Date of authorisation status change:
Reference member state:
-
Spain
Procedure number:
- ES/V/0380/001
Concerned member states:
-
Hungary
To consult adverse reactions on veterinary medicinal products please go to www.adrreports.eu/vet
Documents
eu-PUAR-esv0380001-dcp-aceprolab-5-mg-ml-solution-for-injection-en.pdf
English (PDF)
Download Published on: 22/12/2023
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