EMEA-002096-PIP01-16-M01

Key facts

Active substance
Entrectinib
Therapeutic area
Oncology
Decision number
P/0010/2019
PIP number
EMEA-002096-PIP01-16-M01
Pharmaceutical form(s)
  • Capsule, hard
  • Age-appropriate solid dosage form
Condition(s) / indication(s)
Treatment of all conditions included in the category of malignant neoplasms (except central nervous system, haematopoietic and lymphoid tissue neoplasms)
Route(s) of administration
Oral use
Contact for public enquiries
Roche Registration GmbH

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

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

Decision

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