Rogiola 10 mg chewable tablets for dogs
Rogiola 10 mg chewable tablets for dogs
Authorised
- Robenacoxib
Product identification
Medicine name:
Rogiola 10 mg μασώμενα δισκία για σκύλους
Rogiola 10 mg chewable tablets for dogs
Active substance:
- Robenacoxib
Target species:
-
Dog
Route of administration:
-
Oral use
Product details
Active substance and strength:
-
Robenacoxib10.00/milligram(s)1.00Tablet
Pharmaceutical form:
-
Chewable tablet
Anatomical therapeutic chemical veterinary (ATCvet) codes:
- QM01AH91
Legal status of supply:
-
Veterinary medicinal product subject to veterinary prescription
Authorisation status:
-
Valid
Authorised in:
-
Cyprus
Package description:
- OPA/Al/PVC/Aluminium perforated blister containing 10 tablets: 10 x 1 chewable tablet in perforated unit dose blisters, in a cardboard box.
- OPA/Al/PVC/Aluminium perforated blister containing 10 tablets: 30 x 1 chewable tablet in perforated unit dose blisters, in a cardboard box.
- OPA/Al/PVC/Aluminium perforated blister containing 10 tablets: 60 x 1 chewable tablet in perforated unit dose blisters, in a cardboard box.
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:
- TAD Pharma GmbH
- Krka-Farma d.o.o.
- KRKA tovarna zdravil d.d. Novo mesto
Responsible authority:
- Veterinary Services, Ministry Of Agriculture, Natural Resources And Environment
Authorisation number:
- CY00957V
Date of authorisation status change:
Reference member state:
-
Ireland
Procedure number:
- IE/V/0785/002
Concerned member states:
-
Austria
-
Belgium
-
Cyprus
-
Denmark
-
Finland
-
France
-
Germany
-
Greece
-
Italy
-
Netherlands
-
Norway
-
Portugal
-
Spain
-
Sweden
To consult adverse reactions on veterinary medicinal products please go to www.adrreports.eu/vet
