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ALECENSA Hard capsule (2018)

Active ingredients: Alectinib

Product Name and Form

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.

Qualitative and Quantitative Composition

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.

Chemical substance
Description
Alectinib

Alectinib is a highly selective and potent ALK and RET tyrosine kinase inhibitor. In preclinical studies, inhibition of ALK tyrosine kinase activity led to blockage of downstream signalling pathways including STAT 3 and PI3K/AKT and induction of tumour cell death (apoptosis).

List of excipients

__Capsule content

Lactose monohydrate
Hydroxypropylcellulose
Sodium laurilsulfate
Magnesium stearate
Carmellose calcium

Capsule shell:

Hypromellose
Carrageenan
Potassium chloride
Titanium dioxide (E171)
Maize starch
Carnauba wax

Printing ink:

Red iron oxide (E172)
Yellow iron oxide (E172)
Indigo carmine aluminum lake (E132)
Carnauba wax
White shellac
Glyceryl monooleate

Pack sizes and Marketing

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.

Marketing authorization holder
Authorization dates

Roche Registration GmbH, Emil-Barell-Strasse 1, 79639, Grenzach-Wyhlen, Germany

Date of first authorisation: 16 February 2017

Date of latest renewal: 1 December 2017

Marketing authorization number:

EU/1/16/1169/001

EU/1/16/1169/002