Simparica

Authorised

This medicine is authorised for use in the European Union

sarolaner

Overview

Up-to-date information on this veterinary medicinal product is available on the Veterinary Medicines Information website

Simparica : EPAR - Summary for the public

Product information

Simparica : EPAR - Product Information

Simparica : EPAR - All Authorised presentations

Product details

• Name of medicine:
  Simparica
• Active substance:
  sarolaner
• International non-proprietary name (INN) or common name:
  sarolaner

Pharmacotherapeutic group

Ectoparasiticides for systemic use

Authorisation details

• EMA product number:
  EMEA/V/C/003991

Assessment history

Changes since initial authorisation of medicine

Simparica : EPAR - Procedural steps taken and scientific information after authorisation

CVMP post-authorisation summary of positive opinion for Simparica (WS)

Adopted Reference Number: EMA/CVMP/780812/2022

Simparica-V-C-3991-II-0006: EPAR - Assessment Report - Variation

Adopted

CVMP post-authorisation summary of positive opinion for Simparica

Reference Number: EMA/CVMP/557544/2017

Initial marketing authorisation documents

Simparica : EPAR - Public assessment report

Adopted

CVMP summary of positive opinion for Simparica

Adopted Reference Number: EMA/CVMP/478463/2015