EMEA-000715-PIP02-11-M06 - paediatric investigation plan

apremilast
PIPHuman

Key facts

Invented name
Otezla
Active Substance
apremilast
Therapeutic area
Immunology-Rheumatology-Transplantation
Decision number
P/0352/2022
PIP number
EMEA-000715-PIP02-11-M06
Pharmaceutical form(s)
  • Tablet
  • Oral liquid
Condition(s) / indication(s)
Treatment of chronic idiopathic arthritis (including rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis and juvenile idiopathic arthritis)
Route(s) of administration
Oral use
Contact for public enquiries

Amgen Europe B.V. 

E-mail: medinfointernational@amgen.com
Tel. +44 (0)1223 420305

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

Decision

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