Apealea
paclitaxel
Table of contents
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.
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List item
Apealea : EPAR - Medicine overview (PDF/104.9 KB)
First published: 05/12/2018
EMA/791927/2018 -
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Apealea : EPAR - Risk-management-plan summary (PDF/206.08 KB)
First published: 05/12/2018
Authorisation details
Product details | |
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Name |
Apealea
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Agency product number |
EMEA/H/C/004154
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Active substance |
paclitaxel
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International non-proprietary name (INN) or common name |
paclitaxel
|
Therapeutic area (MeSH) |
Ovarian Neoplasms
|
Anatomical therapeutic chemical (ATC) code |
L01CD01
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Publication details | |
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Marketing-authorisation holder |
Inceptua AB
|
Revision |
7
|
Date of issue of marketing authorisation valid throughout the European Union |
20/11/2018
|
Contact address |
Gustavslundsv. 143 |
Product information
11/09/2023 Apealea - EMEA/H/C/004154 - R/0017
This medicine’s product information is available in all official EU languages.
Select ‘available languages’ to access the language you need.
Product information documents contain:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.
Pharmacotherapeutic group
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Antineoplastic agents
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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.