Source: European Medicines Agency (EU) Revision Year: 2021 Publisher: Deciphera Pharmaceuticals (Netherlands) B.V., Atrium Building Floor 4th, Strawinskylaan 3051, 1077ZX, Amsterdam, Netherlands
QINLOCK 50 mg tablets.
| Pharmaceutical Form |
|---|
|
Tablet. White to off-white, approximately 9 × 17 mm, oval shaped tablet, debossed with ‘DC1’ on one side. |
Each tablet contains 50 mg of ripretinib.
Excipient with known effect:
Each tablet contains 179 mg of lactose monohydrate.
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Ripretinib |
Ripretinib is a novel tyrosine kinase inhibitor that inhibits KIT proto-oncogene receptor tyrosine kinase and PDGFRA kinase, including wild type, primary, and secondary mutations. Ripretinib also inhibits other kinases in vitro, such as PDGFRB, TIE2, VEGFR2, and BRAF. |
| List of Excipients |
|---|
|
Crospovidone (E1202) |
White high-density polyethylene (HDPE) bottle with an aluminium foil/polyethylene (PE) tamper evident seal and a white polypropylene (PP) child-resistant closure, together with one PE desiccant canister containing silica gel. Each bottle contains 30 or 90 tablets.
Not all pack sizes may be marketed.
Deciphera Pharmaceuticals (Netherlands) B.V., Atrium Building Floor 4th, Strawinskylaan 3051, 1077ZX, Amsterdam, Netherlands
EU/1/21/1569/001
EU/1/21/1569/002
| Drug | Countries | |
|---|---|---|
| QINLOCK | Austria, Canada, Estonia, France, Hong Kong, Croatia, Ireland, Israel, Italy, Lithuania, Poland, United Kingdom, United States |
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