EMEA-002096-PIP01-16-M03

Table of contents

Key facts

Invented name
Rozlytrek
Active substance
Entrectinib
Therapeutic area
Oncology
Decision number
P/0351/2021
PIP number
EMEA-002096-PIP01-16-M03
Pharmaceutical form(s)
  • Capsule, hard
  • Coated granules
Condition(s) / indication(s)
Treatment of all conditions induded in the category of malignant neoplasms ( except haematopoietic and lymphoid tissue neoplasms)
Route(s) of administration
  • Oral use
  • Gastric use
Contact for public enquiries
Roche Registration GmbH

Tel. +41 6169 79411
E-mail: global.paediatrics@roche.com

Decision type
PM: decision on the application for modification of an agreed PIP

Decision

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