EMEA-000265-PIP01-08-M04

Key facts

Invented name
Simponi
Active substance
Golimumab
Therapeutic area
Immunology-Rheumatology-Transplantation
Decision number
P/0226/2014
PIP number
EMEA-000265-PIP01-08-M04
Pharmaceutical form(s)
  • Solution for injection
  • Solution for infusion
Condition(s) / indication(s)
Treatment of chronic idiopathic arthritis (including rheumatoid arthritis, spondyloarthritis, psoriatic arthritis, and juvenile idiopathic arthritis)
Route(s) of administration
  • Subcutaneous use
  • Intravenous use
Contact for public enquiries
Janssen Biologics B.V.
The Netherlands
E-mail: info@janssen.immunology.com
Tel +31 202015009
Fax: +31 713065100
Decision type
PM: decision on the application for modification of an agreed PIP
Compliance procedure number
EMEA-C-000265-PIP01-08-M04
Compliance opinion date
10/10/2014
Compliance outcome
positive

Decision

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