EMEA-000309-PIP04-17

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Overview

Product details for RoActemra
Invented nameRoActemra
Active substance

Tocilizumab

Decision numberP/0217/2017
PIP numberEMEA-000309-PIP04-17
Pharmaceutical form(s)Solution for injection (in pre-filled syringe)
Condition(s)/indication(s)

Treatment of systemic sclerosis

Route(s) of administrationSubcutaneous use
PIP applicant

Roche Registration Limited
Switzerland
Tel. +41 616879411
E-mail: info.paediatrics@roche.com

Decision typeP: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)

Decision