Arocenia, 10mg/ml, Solution for injection
Arocenia, 10mg/ml, Solution for injection
Authorised
- Maropitant
Product identification
Medicine name:
Arocenia, 10mg/ml, Solution for injection
Arocenia 10 mg/ml raztopina za injiciranje za pse in mačke
Active substance:
- Maropitant
Target species:
-
Dog
-
Cat
Route of administration:
-
Intravenous use
-
Subcutaneous use
Product details
Active substance and strength:
-
Maropitant10.00milligram(s)1.00millilitre(s)
Pharmaceutical form:
-
Solution for injection
Withdrawal period by route of administration:
-
Intravenous use
- Dog
- Cat
-
Subcutaneous use
- Dog
- Cat
Anatomical therapeutic chemical veterinary (ATCvet) codes:
- QA04AD90
Legal status of supply:
-
Veterinary medicinal product subject to veterinary prescription
Authorisation status:
-
Valid
Authorised in:
-
Slovenia
Package description:
- Glass Vial 1 x 20.0 millilitre(s)
Additional information
Entitlement type:
-
Marketing Authorisation
Legal basis of product authorisation:
-
Generic application (Article 18 of Regulation (EU) 2019/6)
Marketing authorisation holder:
- KRKA tovarna zdravil d.d. Novo mesto
Marketing authorisation date:
Manufacturing sites for batch release:
- Krka d.d. Novo Mesto
- Tad Pharma GmbH
Responsible authority:
- Agency For Medicinal Products And Medical Devices Of The Republic Of Slovenia
Authorisation number:
- DC/V/0790/001
Date of authorisation status change:
Reference member state:
-
Czechia
Procedure number:
- CZ/V/0179/001
Concerned member states:
-
Belgium
-
Croatia
-
Estonia
-
Germany
-
Hungary
-
Latvia
-
Lithuania
-
Netherlands
-
Poland
-
Portugal
-
Romania
-
Slovakia
-
Slovenia
-
United Kingdom (Northern Ireland)
To consult adverse reactions on veterinary medicinal products please go to www.adrreports.eu/vet
Documents
Summary of Product Characteristics
This document does not exist in this language (English). You can find it in another language below.
Slovenian (PDF)
Published on: 20/11/2023
Package Leaflet
This document does not exist in this language (English). You can find it in another language below.
Slovenian (PDF)
Published on: 20/11/2023
Labelling
This document does not exist in this language (English). You can find it in another language below.
Slovenian (PDF)
Published on: 20/11/2023
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