EMEA-001523-PIP03-18

Key facts

Invented name
Tremfya
Active substance
guselkumab
Therapeutic area
Immunology-Rheumatology-Transplantation
Decision number
P/0025/2019
PIP number
EMEA-001523-PIP03-18
Pharmaceutical form(s)
Concentrate for solution for injection
Condition(s) / indication(s)
Treatment of chronic idiopathic arthritis (including rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis and juvenile idiopathic arthritis)
Route(s) of administration
Subcutaneous use
Contact for public enquiries
Janssen-Cilag International NV

E-mail: contact@janssen-emea.com
Tel. +32 1460 2111

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

Decision

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