Apealea

Withdrawn

This medicine's authorisation has been withdrawn

paclitaxel

Overview

On 9 February 2024, the European Commission withdrew the marketing authorisation for Apealea (paclitaxel) in the European Union (EU). The withdrawal was at the request of the marketing authorisation holder, Inceptua AB, which notified the European Commission of its decision to permanently discontinue the marketing of the product for commercial reasons. 

Apealea was granted marketing authorisation in the EU on 20 November 2018 for the treatment of ovarian cancer. The marketing authorisation was initially valid for a 5-year period. It was then granted unlimited validity in 2023. 

Therapeutic alternatives are available throughout the European Union. Patients taking Apealea or participating in a clinical trial are advised to consult their doctor. 

The European Public Assessment Report (EPAR) for Apealea is updated to indicate that the marketing authorisation is no longer valid.

Apealea : EPAR - Medicine overview

Reference Number: EMA/791927/2018

Apealea : EPAR - Risk-management-plan summary

Product information

Apealea : EPAR - Product information

Apealea : EPAR - All authorised presentations

Product details

• Name of medicine:
  Apealea
• Active substance:
  paclitaxel
• International non-proprietary name (INN) or common name:
  paclitaxel
• Therapeutic area (MeSH):
  Ovarian Neoplasms
• Anatomical therapeutic chemical (ATC) code:
  L01CD01

Pharmacotherapeutic group

• Antineoplastic agents
• Taxanes

Therapeutic indication

Apealea in combination with carboplatin is indicated for the treatment of adult patients with first relapse of platinum?sensitive epithelial ovarian cancer, primary peritoneal cancer and fallopian tube cancer.

Authorisation details

• EMA product number:
  EMEA/H/C/004154
• Marketing authorisation holder:
  Inceptua AB

  Gustavslundsv. 143; 16751 Bromma; Sweden

• Opinion adopted:
  20/09/2018
• Marketing authorisation issued:
  20/11/2018
• Withdrawal of marketing authorisation:
  09/02/2024
• Revision:
  7

Assessment history

Changes since initial authorisation of medicine

Apealea : EPAR - Procedural steps taken and scientific information after the authorisation

Apealea-H-C-PSUSA-00002264-201812 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation

Reference Number: EMA/637582/2019

Apealea : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation - Annex I

Initial marketing authorisation documents

Apealea : Orphan designation withdrawal assessment report (initial authorisation)

Reference Number: EMA/COMP/138404/2016

Apealea : EPAR - Public assessment report

Reference Number: EMA/CHMP/785964/2018

CHMP summary of positive opinion for Apealea

Adopted Reference Number: EMA/CHMP/474774/2018