Skip to main content
Veterinary Medicines

Simparica Trio 3 mg + 0.06 mg + 12.5 mg - Chewable tablet

Authorised
  • Sarolaner
  • Moxidectin
  • Pyrantel embonate

Product identification

Medicine name:
Simparica Trio 3 mg + 0.06 mg + 12.5 mg - Chewable tablet
Active substance:
  • Sarolaner
  • Moxidectin
  • Pyrantel embonate
Target species:
  • Dog
Route of administration:
  • Oral use

Product details

Active substance and strength:
  • Sarolaner
    Presentation_strength:3 mg Reference:Hse Index:0
  • Moxidectin
    Presentation_strength:0.06 mg Reference:Ph. Eur. Index:1
  • Pyrantel embonate
    Presentation_strength:12.5 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
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)
Available in:
  • Belgium
  • Bulgaria
  • Czechia
  • Greece
  • Hungary
  • Ireland
  • Italy
  • Lithuania
  • Luxembourg
  • Netherlands
  • Poland
  • Romania
  • Slovakia
  • Spain
  • United Kingdom (Northern Ireland)
Package description:
  • Packaging:Blister (alu/alu), Package_size:1 tablet
  • Packaging:Blister (alu/alu), Package_size:3 tablets
  • Packaging:Blister (alu/alu), Package_size:6 tablets

Additional information

Entitlement type:
  • Marketing Authorisation
Marketing authorisation holder:
  • Zoetis Belgium
Marketing authorisation date:
Manufacturing sites for batch release:
  • Zoetis Manufacturing & Research Spain S.L.
  • Corden Pharma GmbH
Responsible authority:
  • European Commission
Authorisation number:
This information is not available for this product.
Date of authorisation status change:

Documents

Combined File of all Documents

English (PDF)
Published on: 20/04/2023
Download
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

ema-puar-simparica-trio-v-4846-var-vra-0009-g-en.pdf

English (PDF)
Published on: 20/04/2023
Download

ema-puar-simparica-trio-v-004846-var-ii-0007-g-en.pdf

English (PDF)
Published on: 20/04/2023
Download

ema-puar-simparica-trio-v-4846-par-en.pdf

English (PDF)
Published on: 16/03/2023
Download
How useful was this page?:
No votes yet
"Please do not include any personal data, such as your name or contact details. If you do, you consent to the processing of that data in accordance with EMA’s Privacy Statement concerning requests for information or access to documents. If you would like a reply from EMA, please Send a question to EMA instead."