EMEA-002438-PIP02-19

Table of contents

Key facts

Active substance
Rilzabrutinib
Therapeutic area
Immunology-Rheumatology-Transplantation
Decision number
P/0306/2020
PIP number
EMEA-002438-PIP02-19
Pharmaceutical form(s)
  • Film-coated tablet
  • Age-appropriate oral solid dosage form
Condition(s) / indication(s)
Treatment of immune thrombocytopenia
Route(s) of administration
  • Oral use
  • Gastric use
Contact for public enquiries
Principia Biopharma, Inc.

Tel.  +1 6504167700
E-mail: info@principiabio.com

Decision type
P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)

Decision

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