EMEA-001489-PIP01-13-M01

Key facts

Active substance
4-((2R,3S,4R,5S)-3-(3-Chloro-2-fluorophenyl)-4-(4-chloro-2-fluorophenyl)-4-cyano-5-neopentylpyrrolidine-2-carboxamido)-3-methoxybenzoic acid (RO5503781)
Therapeutic area
Oncology
Decision number
P/0366/2018
PIP number
EMEA-001489-PIP01-13-M01
Pharmaceutical form(s)
  • Film-coated tablet
  • Age-appropriate oral solid dosage form
  • Film-coated dispersible tablet
Condition(s) / indication(s)
  • Treatment of acute lymphoblastic leukaemia
  • Treatment of acute myeloid leukaemia
  • Treatment of all conditions included in the category of malignant neoplasms (except nervous system, haematopoietic and lymphoid tissue)
Route(s) of administration
Oral use
Contact for public enquiries
Roche Registration GmbH

Tel. +41 6168 79411
E-mail: global.paediatrics@roche.com

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

Decision

How useful was this page?

Add your rating