Source: European Medicines Agency (EU) Revision Year: 2024 Publisher: Roche Registration GmbH, Emil-Barell-Strasse 1, 79639 Grenzach-Wyhlen, Germany
Alecensa 150 mg hard capsules.
| Pharmaceutical Form |
|---|
|
Hard capsule. White hard capsule of 19.2 mm length, with “ALE” printed in black ink on the cap and “150 mg” printed in black ink on the body. |
Each hard capsule contains alectinib hydrochloride equivalent to 150 mg alectinib.
Excipients with known effect: Each hard capsule contains 33.7 mg lactose (as monohydrate) and 6 mg sodium (as sodium laurilsulfate).
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Alectinib |
Alectinib is a highly selective and potent ALK and rearranged during transfection (RET) tyrosine kinase inhibitor. In pre-clinical studies, inhibition of ALK tyrosine kinase activity led to blockage of downstream signalling pathways including signal transducer and activator of transcription 3 (STAT 3) and phosphoinositide 3-kinase (PI3K)/protein kinase B (AKT) and induction of tumour cell death (apoptosis). |
| List of Excipients |
|---|
|
Capsule content: Lactose monohydrate Capsule shell: Hypromellose Printing ink: Red iron oxide (E172) |
Aluminium/aluminium (PA/Alu/PVC/Alu) blisters containing 8 hard capsules.
Pack size: 224 (4 packs of 56) hard capsules.
HDPE bottle with a child-resistant closure and an integrated desiccant.
Pack size: 240 hard capsules.
Not all pack sizes may be marketed.
Roche Registration GmbH, Emil-Barell-Strasse 1, 79639 Grenzach-Wyhlen, Germany
EU/1/16/1169/001
EU/1/16/1169/002
Date of first authorisation: 16 February 2017
Date of latest renewal: 15 July 2022
| Drug | Countries | |
|---|---|---|
| ALECENSA | Austria, Australia, Brazil, Cyprus, Ecuador, Estonia, Spain, Finland, France, Hong Kong, Croatia, Ireland, Israel, Japan, Lithuania, Netherlands, New Zealand, Poland, Romania, Singapore, Tunisia, Turkey, United Kingdom, United States, South Africa |
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