EMEA-000309-PIP09-21 - paediatric investigation plan

tocilizumab
PIPHuman

Key facts

Invented name
RoActemra
Active Substance
tocilizumab
Therapeutic area
Immunology-Rheumatology-Transplantation
Decision number
P/0354/2022
PIP number
EMEA-000309-PIP09-21
Pharmaceutical form(s)
Solution for injection
Condition(s) / indication(s)
Treatment of systemic sclerosis
Route(s) of administration
Subcutaneous use
Contact for public enquiries

Roche Registration GmbH

E-mail: global.eu_regulatory_office@roche.com
Tel. +49 7624142892

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

Decision

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