REVERSE
REVERSE
Authorised
- Atipamezole hydrochloride
Product identification
Medicine name:
REVERSE
Reverse 5 mg/ml solução injetável para cães e gatos
Active substance:
- Atipamezole hydrochloride
Target species:
-
Dog
-
Cat
Route of administration:
-
Intramuscular use
Product details
Active substance and strength:
-
Atipamezole hydrochloride5.00/milligram(s)1.00millilitre(s)
Pharmaceutical form:
-
Solution for injection
Withdrawal period by route of administration:
-
Intramuscular use
- Dog
- Cat
Anatomical therapeutic chemical veterinary (ATCvet) codes:
- QV03AB90
Legal status of supply:
-
Veterinary medicinal product subject to veterinary prescription
Authorisation status:
-
Valid
Authorised in:
-
Portugal
Package description:
- box containing 1 vial of 10 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:
- Fatro S.p.A.
Marketing authorisation date:
Manufacturing sites for batch release:
- Labiana Life Sciences S.A.
Responsible authority:
- Directorate General For Food And Veterinary
Authorisation number:
- 987/01/16DFVPT
Date of authorisation status change:
Reference member state:
-
Spain
Procedure number:
- ES/V/0233/001
Concerned member states:
-
Italy
-
Portugal
To consult adverse reactions on veterinary medicinal products please go to www.adrreports.eu/vet
Documents
Summary of Product Characteristics
English (PDF)
Download Published on: 11/04/2023
Package Leaflet
English (PDF)
Download Published on: 11/04/2023
Labelling
English (PDF)
Download Published on: 11/04/2023
Combined File of all Documents
This document does not exist in this language (English). You can find it in another language below.
Portuguese (PDF)
Published on: 11/01/2024
eu-PUAR-reverse-en.pdf
English (PDF)
Download Published on: 11/04/2023
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