Felimazole 5 mg/ml oral solution for cats
Felimazole 5 mg/ml oral solution for cats
Authorised
- Thiamazole
Product identification
Medicine name:
Felimazole 5 mg/ml oral solution for cats
Felimazole 5 mg/ml solution buvable pour chats
Felimazole 5 mg/ml oplossing voor oraal gebruik voor katten
Felimazole 5 mg/ml Lösung zum Eingeben für Katzen
Active substance:
- Thiamazole
Target species:
-
Cat
Route of administration:
-
Oral use
Product details
Active substance and strength:
-
Thiamazole5.00/milligram(s)1.00millilitre(s)
Pharmaceutical form:
-
Oral solution
Anatomical therapeutic chemical veterinary (ATCvet) codes:
- QH03BB02
Legal status of supply:
-
Veterinary medicinal product subject to veterinary prescription
Authorisation status:
-
Valid
Authorised in:
-
Belgium
Package description:
- Polyethylene terephthalate (PET) amber bottle of 100 ml, closed with a low density polyethylene (LDPE) plug and a high density polyethylene (HDPE) closure. The veterinary medicinal product is supplied with a 1 ml polyethylene (PE) / polypropylene (PP) measuring syringe for administration of the solution to the animal. The syringe is graduated in 0.25 mg increments up to 5 mg. Each closed bottle and accompanying syringe is contained in a cardboard carton.
- Polyethylene terephthalate (PET) amber bottle of 30 ml, closed with a low density polyethylene (LDPE) plug and a high density polyethylene (HDPE) closure. The veterinary medicinal product is supplied with a 1 ml polyethylene (PE) / polypropylene (PP) measuring syringe for administration of the solution to the animal. The syringe is graduated in 0.25 mg increments up to 5 mg. Each closed bottle and accompanying syringe is contained in a cardboard carton.
Additional information
Entitlement type:
-
Marketing Authorisation
Legal basis of product authorisation:
-
Full application - known active substance (Article 8 of Regulation (EU) 2019/6)
Marketing authorisation holder:
- Dechra Regulatory B.V.
Marketing authorisation date:
Manufacturing sites for batch release:
- Genera d.d.
Responsible authority:
- Federal Agency For Medicines And Health Products
Authorisation number:
- BE-V662159
Date of authorisation status change:
Reference member state:
-
Ireland
Procedure number:
- IE/V/0505/004
Concerned member states:
-
Austria
-
Belgium
-
Bulgaria
-
Croatia
-
Czechia
-
Denmark
-
Finland
-
France
-
Germany
-
Greece
-
Hungary
-
Italy
-
Luxembourg
-
Netherlands
-
Norway
-
Poland
-
Portugal
-
Romania
-
Slovakia
-
Slovenia
-
Spain
-
Sweden
-
United Kingdom (Northern Ireland)
To consult adverse reactions on veterinary medicinal products please go to www.adrreports.eu/vet
Documents
Package Leaflet
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Labelling
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