EMEA-000309-PIP04-17-M01

Key facts

Invented name
RoActemra
Active substance
tocilizumab
Therapeutic area
Immunology-Rheumatology-Transplantation
Decision number
P/0181/2018
PIP number
EMEA-000309-PIP04-17-M01
Pharmaceutical form(s)
  • Solution for injection (in pre-filled syringe)
  • Concentrate for solution for infusion
Condition(s) / indication(s)
Treatment of systemic sclerosis
Route(s) of administration
Subcutaneous use
Contact for public enquiries
Roche Registration GmbH

Tel.  +41 616879411
E-mail: info.paediatrics@roche.com

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

Decision

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