EMEA-000309-PIP01-08-M07

Key facts

Invented name
RoActemra
Active substance
tocilizumab
Therapeutic area
Immunology-Rheumatology-Transplantation
Decision number
P/0266/2015
PIP number
EMEA-000309-PIP01-08-M07
Pharmaceutical form(s)
  • Concentrate for solution for infusion
  • Solution for injection (in prefilled syringe)
Condition(s) / indication(s)
Treatment of chronic idiopathic arthritis (including rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis and juvenile idiopathic arthritis)
Route(s) of administration
  • Intravenous use
  • Subcutaneous use
Contact for public enquiries
Roche Registration Limited
United Kingdom
Tel. +41 6168 79411
Fax +41 6168 79233
E-mail: info.paediatrics@roche.com
Decision type
PM: decision on the application for modification of an agreed PIP
Compliance procedure number
EMEA-C-000309-PIP01-08-M07
Compliance opinion date
23/02/2018
Compliance outcome
positive

Decision

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