Source: European Medicines Agency (EU) Revision Year: 2019 Publisher: Sun Pharmaceutical Industries Europe B.V., Polarisavenue 87, 2132JH Hoofddorp, Netherlands
Odomzo 200 mg hard capsules.
| Pharmaceutical Form |
|---|
|
Hard capsule (capsule). Opaque pink hard capsule containing white to almost white powder with granules, with “NVR” imprinted in black ink on the cap and “SONIDEGIB 200MG” imprinted in black ink on the body. The size of the capsule is “Size #00” (dimensions 23.3 × 8.53 mm). |
Each hard capsule contains 200 mg sonidegib (as phosphate).
Excipient with known effect: Each hard capsule contains 38.6 mg lactose monohydrate.
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Sonidegib |
Sonidegib is an orally bioavailable inhibitor of the Hh signalling pathway. It binds to Smoothened (Smo), a G protein-coupled receptor-like molecule that positively regulates the Hh pathway. Aberrant Hh signalling has been linked to the pathogenesis of several types of cancer, including basal cell carcinoma (BCC). Sonidegib binding to Smo will inhibit Hh signalling and consequently block signal transduction. |
| List of Excipients |
|---|
|
Capsule content: Crospovidone (Type A) Capsule shell: Gelatin Printing ink: Iron oxide black (E172) |
10 × 1 hard capsule in PCTFE/PVC/Alu perforated unit-dose blisters.
Each pack contains either 10 or 30 hard capsules.
Not all pack sizes may be marketed.
Sun Pharmaceutical Industries Europe B.V., Polarisavenue 87, 2132JH Hoofddorp, Netherlands
EU/1/15/1030/001
EU/1/15/1030/002
14 August 2015
| Drug | Countries | |
|---|---|---|
| ODOMZO | Austria, Australia, Canada, Estonia, Spain, Finland, France, Croatia, Ireland, Israel, Italy, Lithuania, New Zealand, Poland, United States |
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