EMEA-000366-PIP01-08-M06

Key facts

Invented name
Humira
Active substance
adalimumab
Therapeutic area
Gastroentology-Hepatology
Decision number
P/0324/2013
PIP number
EMEA-000366-PIP01-08-M06
Pharmaceutical form(s)
Solution for injection
Condition(s) / indication(s)
  • Treatment of psoriasis
  • Treatment of Crohn's disease
  • Treatment of chronic idiopathic arthritis (including rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis and juvenile idiopathic arthritis)
Route(s) of administration
Subcutaneous use
Contact for public enquiries
AbbVie Ltd
Unied Kingdom
E-mail: paediatricteam@abbvie.com
Tel. +44 (0)791 988 1614
Fax +44 (0)1628 672 566
Decision type
PM: decision on the application for modification of an agreed PIP
Compliance procedure number
EMEA-C-000366-PIP01-08-M06
Compliance opinion date
20/06/2014
Compliance outcome
positive

Decision

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