Talzenna
talazoparib
Table of contents
Overview
Talzenna is a cancer medicine used on its own to treat a type of breast cancer (HER2-negative with BRCA mutations) that has spread beyond the original site, in patients who have been treated with certain medicines which have stopped working or when these medicines are not suitable.
Talzenna contains the active substance talazoparib.
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List item
Talzenna : EPAR - Medicine overview (PDF/74.67 KB)
First published: 08/07/2019
EMA/242902/2019 -
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Talzenna : EPAR - Risk-management-plan summary (PDF/97.28 KB)
First published: 08/07/2019
Last updated: 14/07/2020
Authorisation details
Product details | |
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Name |
Talzenna
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Agency product number |
EMEA/H/C/004674
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Active substance |
talazoparib
|
International non-proprietary name (INN) or common name |
talazoparib
|
Therapeutic area (MeSH) |
Breast Neoplasms
|
Anatomical therapeutic chemical (ATC) code |
L01XK04
|
Additional monitoring |
This medicine is under additional monitoring, meaning that it is monitored even more intensively than other medicines. For more information, see Medicines under additional monitoring. |
Publication details | |
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Marketing-authorisation holder |
Pfizer Europe MA EEIG
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Revision |
6
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Date of issue of marketing authorisation valid throughout the European Union |
20/06/2019
|
Contact address |
Boulevard de la Plaine 17 |
Product information
06/12/2021 Talzenna - EMEA/H/C/004674 - IB/0012
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
Antineoplastic agents
Therapeutic indication
Talzenna is indicated as monotherapy for the treatment of adult patients with germline BRCA1/2 mutations, who have HER2-negative locally advanced or metastatic breast cancer. Patients should have been previously treated with an anthracycline and/or a taxane in the (neo)adjuvant, locally advanced or metastatic setting unless patients were not suitable for these treatments. Patients with hormone receptor (HR)-positive breast cancer should have been treated with a prior endocrine-based therapy, or be considered unsuitable for endocrine-based therapy.