Qinlock
ripretinib
Table of contents
Overview
Qinlock is a cancer medicine used to treat gastrointestinal stromal tumour (GIST), a cancer of the stomach and bowel, in adults with advanced disease who have already been treated with three or more medicines of the ‘kinase inhibitor’ class, including a medicine called imatinib.
GIST is rare, and Qinlock was designated an ‘orphan medicine’ (a medicine used in rare diseases) on 12 October 2017.
Qinlock contains the active substance ripretinib.
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Qinlock : EPAR - Medicine overview (PDF/108.28 KB)
First published: 23/11/2021
EMA/604575/2021 -
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Qinlock : EPAR - Risk-management-plan summary (PDF/248.59 KB)
First published: 23/11/2021
Last updated: 30/08/2023
Authorisation details
Product details | |
---|---|
Name |
Qinlock
|
Agency product number |
EMEA/H/C/005614
|
Active substance |
ripretinib
|
International non-proprietary name (INN) or common name |
ripretinib
|
Therapeutic area (MeSH) |
Gastrointestinal Stromal Tumors
|
Anatomical therapeutic chemical (ATC) code |
L01
|
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. |
Orphan |
This medicine was designated an orphan medicine. This means that it was developed for use against a rare, life-threatening or chronically debilitating condition or, for economic reasons, it would be unlikely to have been developed without incentives. For more information, see Orphan designation. |
Publication details | |
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Marketing-authorisation holder |
Deciphera Pharmaceuticals (Netherlands) B.V.
|
Revision |
5
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Date of issue of marketing authorisation valid throughout the European Union |
18/11/2021
|
Contact address |
Atrium Building Floor 4th |
Product information
21/06/2023 Qinlock - EMEA/H/C/005614 - 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
Qinlock is indicated for the treatment of adult patients with advanced gastrointestinal stromal tumour (GIST) who have received prior treatment with three or more kinase inhibitors, including imatinib.