Key facts

Invented name
Alecensa
Active Substance
Alectinib
Therapeutic area
Oncology
Decision number
P/0359/2018
PIP number
EMEA-002431-PIP01-18
Pharmaceutical form(s)
Capsule (hard)
Condition(s) / indication(s)
Treatment of non-small cell lung carcinoma (NSCLC)
Route(s) of administration
Oral use
Contact for public enquiries

Roche Registration GmbH

Tel. +41 616879411
E-mail: global.paediatrics@roche.com

Decision type
W: decision granting a waiver in all age groups for all conditions or indications
Decision date

Decision

P/0359/2018: EMA decision of 7 December 2018 on the granting of a product specific waiver for alectinib (Alecensa), (EMEA-002431-PIP01-18)

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