Simparica Trio 48 mg + 0.96 mg + 200 mg - Chewable tablet
Simparica Trio 48 mg + 0.96 mg + 200 mg - Chewable tablet
Authorised
- Sarolaner
- Moxidectin
- Pyrantel embonate
Product identification
Medicine name:
Simparica Trio 48 mg + 0.96 mg + 200 mg - Chewable tablet
Active substance:
- Sarolaner
- Moxidectin
- Pyrantel embonate
Target species:
-
Dog
Route of administration:
-
Oral use
Product details
Active substance and strength:
-
SarolanerPresentation_strength:48 mg Reference:Hse Index:0
-
MoxidectinPresentation_strength:0.96 mg Reference:Ph. Eur. Index:1
-
Pyrantel embonatePresentation_strength:200 mg Reference:Ph. Eur. Index:2
Pharmaceutical form:
-
Chewable tablet
Withdrawal period by route of administration:
-
Oral use
- Dog
Anatomical therapeutic chemical veterinary (ATCvet) codes:
- QP54AB52
Legal status of supply:
-
Veterinary medicinal product subject to veterinary prescription
Authorisation status:
-
Valid
Authorised in:
-
Austria
-
Belgium
-
Bulgaria
-
Croatia
-
Cyprus
-
Czechia
-
Denmark
-
Estonia
-
Finland
-
France
-
Germany
-
Greece
-
Hungary
-
Iceland
-
Ireland
-
Italy
-
Latvia
-
Liechtenstein
-
Lithuania
-
Luxembourg
-
Malta
-
Netherlands
-
Norway
-
Poland
-
Portugal
-
Romania
-
Slovakia
-
Slovenia
-
Spain
-
Sweden
-
United Kingdom (Northern Ireland)
Package description:
- Packaging:Blister (alu/alu), Package_size:6 tablets
- Packaging:Blister (alu/alu), Package_size:1 tablet
- Packaging:Blister (alu/alu), Package_size:3 tablets
Additional information
Entitlement type:
-
Marketing Authorisation
Legal basis of product authorisation:
-
Full application - New active substance (Article 12(3) of Directive No 2001/82/EC)
Marketing authorisation holder:
- Zoetis Belgium
Marketing authorisation date:
Manufacturing sites for batch release:
- Corden Pharma GmbH
- Zoetis Manufacturing & Research Spain S.L.
Responsible authority:
- European Commission
Authorisation number:
This information is not available for this product.
Date of authorisation status change:
To consult adverse reactions on veterinary medicinal products please go to www.adrreports.eu/vet
Documents
Combined File of all Documents
English (PDF)
Download Published on: 20/04/2023
Bulgarian (PDF)
Published on: 20/04/2023
Croatian (PDF)
Published on: 20/04/2023
Czech (PDF)
Published on: 20/04/2023
Danish (PDF)
Published on: 20/04/2023
Dutch (PDF)
Published on: 20/04/2023
Estonian (PDF)
Published on: 20/04/2023
Finnish (PDF)
Published on: 20/04/2023
French (PDF)
Published on: 20/04/2023
German (PDF)
Published on: 20/04/2023
Greek (PDF)
Published on: 20/04/2023
Hungarian (PDF)
Published on: 20/04/2023
Icelandic (PDF)
Published on: 20/04/2023
Italian (PDF)
Published on: 20/04/2023
Latvian (PDF)
Published on: 20/04/2023
Lithuanian (PDF)
Published on: 20/04/2023
Maltese (PDF)
Published on: 20/04/2023
Norwegian (PDF)
Published on: 20/04/2023
Polish (PDF)
Published on: 20/04/2023
Portuguese (PDF)
Published on: 20/04/2023
Romanian (PDF)
Published on: 20/04/2023
Slovak (PDF)
Published on: 20/04/2023
Slovenian (PDF)
Published on: 20/04/2023
Spanish (PDF)
Published on: 20/04/2023
Swedish (PDF)
Published on: 20/04/2023
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