EMEA-002247-PIP02-17

Table of contents

Key facts

Active substance
Ivosidenib
Therapeutic area
Oncology
Decision number
P/0406/2019
PIP number
EMEA-002247-PIP02-17
Pharmaceutical form(s)
  • Film-coated tablet
  • Age-appropriate oral solid dosage form
Condition(s) / indication(s)
  • Treatment of all conditions included in the category of malignant neoplasms (except central nervous system tumours, haematopoietic and lymphoid tissue neoplasms)
  • Treatment of malignant neoplasms of the central nervous system
Route(s) of administration
  • Oral use
  • Naso-gastric use
Contact for public enquiries
Les Laboratoires Servier

Tel. + 33 1 55 72 60 00
E-mail: mail.pip.enquiries@servier.com
Decision type
RP: decision refers to a refusal on a proposed Paediatric Investigation Plan

Decision

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