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

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

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

Decision

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