RYDAPT Soft capsule Ref.[9132] Active ingredients: Midostaurin

Source: European Medicines Agency (EU)  Revision Year: 2018  Publisher: Novartis Europharm Limited, Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland

Product name and form

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.

Qualitative and quantitative composition

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
Macrogol
Ethanol anhydrous
Maize oil mono-di-triglycerides
All-rac-alpha-tocopherol

Capsule shell:

Gelatin
Glycerol
Titanium dioxide (E171)
Iron oxide yellow (E172)
Iron oxide red (E172)
Purified water

Printing ink:

Carmine (E120)
Hypromellose
Propylene glycol

Pack sizes and marketing

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.

Marketing authorization holder

Novartis Europharm Limited, Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland

Marketing authorization dates and numbers

EU/1/17/1218/001-002

18 September 2017

Drugs

Drug Countries
RYDAPT Austria, Australia, Brazil, Cyprus, Estonia, Spain, Finland, France, Hong Kong, Ireland, Israel, Lithuania, Netherlands, New Zealand, Poland, Romania, Singapore, Turkey, United Kingdom, United States

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