Apealea

RSS

paclitaxel

Authorised
This medicine is authorised for use in the European Union.

Overview

Apealea is a cancer medicine used to treat women with cancer of the ovary or surrounding structures (the fallopian tube that connects the ovary to the womb, or the peritoneum, the membrane that lines the abdomen).

Apealea is given along with a platinum-based medicine, carboplatin, to patients whose disease responds to platinum-based cancer medicines and has come back after initial treatment.

Apealea contains the active substance paclitaxel.

This EPAR was last updated on 10/05/2019

Authorisation details

Product details
Name
Apealea
Agency product number
EMEA/H/C/004154
Active substance
paclitaxel
International non-proprietary name (INN) or common name
paclitaxel
Therapeutic area (MeSH)
Ovarian Neoplasms
Anatomical therapeutic chemical (ATC) code
L01CD01
Publication details
Marketing-authorisation holder
Oasmia Pharmaceutical AB
Revision
1
Date of issue of marketing authorisation valid throughout the European Union
20/11/2018
Contact address

Vallongatan 1
Uppsala
SE 752 28
Sweden

Product information

14/03/2019 Apealea - EMEA/H/C/004154 - II/0001

Contents

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Pharmacotherapeutic group

paclitaxel

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.

Assessment history

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