Veterinary Medicines

Simparica Trio 24 mg + 0.48 mg + 100 mg - Chewable tablet

Authorised
  • Sarolaner
  • Moxidectin
  • Pyrantel embonate
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Product identification

Medicine name:
Simparica Trio 24 mg + 0.48 mg + 100 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:24 mg Reference:Hse Index:0
  • Moxidectin
    Presentation_strength:0.48 mg Reference:Ph. Eur. Index:1
  • Pyrantel embonate
    Presentation_strength:100 mg Reference:Ph. Eur. Index:2
Pharmaceutical form:
  • Chewable tablet
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)
Available in:
  • Belgium
  • Bulgaria
  • Croatia
  • Cyprus
  • Czechia
  • Denmark
  • Estonia
  • Greece
  • Hungary
  • Ireland
  • Italy
  • Latvia
  • Lithuania
  • Luxembourg
  • Netherlands
  • Poland
  • Romania
  • Slovakia
  • Spain
  • United Kingdom (Northern Ireland)
Package description:
  • Packaging:Blister (alu/alu), Package_size:3 tablets
  • Packaging:Blister (alu/alu), Package_size:6 tablets
  • Packaging:Blister (alu/alu), Package_size:1 tablet

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 Belgium
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: 5/09/2025
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Bulgarian (PDF)
Published on: 5/09/2025
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Croatian (PDF)
Published on: 5/09/2025
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Czech (PDF)
Published on: 5/09/2025
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Danish (PDF)
Published on: 5/09/2025
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Dutch (PDF)
Published on: 5/09/2025
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Estonian (PDF)
Published on: 5/09/2025
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Finnish (PDF)
Published on: 5/09/2025
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French (PDF)
Published on: 5/09/2025
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German (PDF)
Published on: 5/09/2025
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Greek (PDF)
Published on: 5/09/2025
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Hungarian (PDF)
Published on: 5/09/2025
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Icelandic (PDF)
Published on: 5/09/2025
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Italian (PDF)
Published on: 5/09/2025
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Latvian (PDF)
Published on: 5/09/2025
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Lithuanian (PDF)
Published on: 5/09/2025
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Maltese (PDF)
Published on: 5/09/2025
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Norwegian (PDF)
Published on: 5/09/2025
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Polish (PDF)
Published on: 5/09/2025
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Portuguese (PDF)
Published on: 5/09/2025
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Romanian (PDF)
Published on: 5/09/2025
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Slovak (PDF)
Published on: 5/09/2025
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Slovenian (PDF)
Published on: 5/09/2025
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Spanish (PDF)
Published on: 5/09/2025
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Swedish (PDF)
Published on: 5/09/2025
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ema-puar-v4846-simparicatrio-vra0000240712-en.pdf

English (PDF)
Published on: 21/05/2025
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ema-puar-v4846-simparicatrio-vra0000221746-en.pdf

English (PDF)
Published on: 21/05/2025
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ema-puar-simparica-trio-v-004846-var-ii-0007-g-en.pdf

English (PDF)
Published on: 20/04/2023
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ema-puar-simparica-trio-v-4846-var-vra-0009-g-en.pdf

English (PDF)
Published on: 20/04/2023
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ema-puar-simparica-trio-v-4846-par-en.pdf

English (PDF)
Published on: 16/03/2023
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