Source: European Medicines Agency (EU) Revision Year: 2018 Publisher: Novartis Europharm Limited, Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland
Rydapt 25 mg soft capsules.
| Pharmaceutical Form |
|---|
|
Soft capsule (capsule). Pale orange, oblong capsule with red imprint “PKC NVR”. The dimensions of the capsule are approximately 25.4 × 9.2 mm. |
Each soft capsule contains 25 mg midostaurin.
Excipients with known effect: Each soft capsule contains approximately 83 mg ethanol anhydrous and 415 mg macrogolglycerol hydroxystearate.
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Midostaurin |
Midostaurin inhibits multiple receptor tyrosine kinases, including FLT3 and KIT kinase. Midostaurin inhibits FLT3 receptor signalling and induces cell cycle arrest and apoptosis in leukaemic cells expressing FLT3 ITD or TKD mutant receptors or over-expressing FLT3 wild type receptors. |
| List of Excipients |
|---|
|
Capsule content: Macrogolglycerol hydroxystearate Capsule shell: Gelatin Printing ink: Carmine (E120) |
PA/Al/PVC-Al blisters. One blister contains 4 soft capsules.
Packs containing 56 (2 packs of 28) or 112 (4 packs of 28) soft capsules.
Not all pack sizes may be marketed.
Novartis Europharm Limited, Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland
EU/1/17/1218/001-002
18 September 2017
| Drug | Countries | |
|---|---|---|
| RYDAPT | Austria, Australia, Brazil, Cyprus, Estonia, Spain, Finland, France, Hong Kong, Croatia, Ireland, Israel, Italy, Lithuania, Netherlands, New Zealand, Poland, Romania, Singapore, Turkey, United Kingdom, United States |
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