EMEA-002096-PIP01-16-M03 - paediatric investigation plan

Entrectinib
PIPHuman

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

Decision type
PM: decision on the application for modification of an agreed PIP
Decision date
Compliance procedure number
EMEA-C-002096-PIP01-16-M03
Compliance opinion date
Compliance outcome
Positive

Decision

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