Key facts

Invented name
Rinvoq
Active Substance
upadacitinib
Therapeutic area
  • Dermatology
  • Immunology-Rheumatology-Transplantation
Decision number
P/0166/2021
PIP number
EMEA-001741-PIP04-17-M02
Pharmaceutical form(s)
  • Age-appropriate oral liquid dosage form
  • Age-appropriate oral solid dosage form
  • Prolonged-release capsule
  • Prolonged-release tablet
Condition(s) / indication(s)
Treatment of atopic dermatitis
Route(s) of administration
Oral use
Contact for public enquiries

AbbVie Ltd

E-mail: paediatricteam@abbvie.com
Tel. +44 (0)1628 408248

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

Decision

P/0166/2021: EMA decision of 14 April 2021 on the acceptance of a modification of an agreed paediatric investigation plan for upadacitinib (Rinvoq), (EMEA-001741-PIP04-17-M02)

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