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ZYKADIA Hard capsule (2018)

Active ingredients: Ceritinib

Product Name and Form

Zykadia 150 mg hard capsules.

Pharmaceutical form

Hard capsule.

Capsule with white opaque body and blue opaque cap, with “LDK 150MG” imprinted on the cap and “NVR” on the body, containing white to almost white powder.

Qualitative and Quantitative Composition

Each hard capsule contains 150 mg ceritinib.

For the full list of excipients, see section 6.1.

Chemical substance
Description
Ceritinib

Ceritinib is an orally highly selective and potent ALK inhibitor. Ceritinib inhibits autophosphorylation of ALK, ALK-mediated phosphorylation of downstream signalling proteins and proliferation of ALK-dependent cancer cells both in vitro and in vivo.

List of excipients

Capsule content:

Microcrystalline cellulose
Low substituted-hydroxypropylcellulose
Sodium starch glycolate (type A)
Magnesium stearate
Silica, colloidal anhydrous

Capsule shell:

Gelatin
Indigotine (E132)
Titanium dioxide (E171)

Printing ink:

Shellac (bleached, de-waxed) glaze 45%
Iron oxide black (E172)
Propylene glycol
Ammonium hydroxide 28%

Pack sizes and Marketing

PVC/polychlorotrifluoroethylene (PCTFE) – Alu blisters containing 10 hard capsules.

Packs containing 40, 90 or 150 (3 packs of 50) hard capsules.

Not all pack sizes may be marketed.

Marketing authorization holder
Authorization dates

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

Date of first authorisation: 06 May 2015

Date of latest renewal: 22 March 2017

Marketing authorization number:

EU/1/15/999/001-003