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EMA Product

Tremfya

Product approved by European Medicines Agency (EU)

Basic Information

Tremfya

Regulatory Information

EMEA/H/C/004271

Authorised

November 10, 2017

September 14, 2017

10

September 16, 2024

Company Information

Belgium

Turnhoutseweg 30 B-2340 Beerse

Janssen-Cilag International NV

Active Substances Detail

Detailed Information

Therapeutic Indication

### Therapeutic indication **Plaque psoriasis** Tremfya is indicated for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy. **Psoriatic arthritis** Tremfya, alone or in combination with methotrexate (MTX), is indicated for the treatment of active psoriatic arthritis in adult patients who have had an inadequate response or who have been intolerant to a prior disease-modifying antirheumatic drug (DMARD) therapy (see section 5.1).

Overview Summary

Tremfya is a medicine used to treat moderate to severe plaque psoriasis (a disease causing red, scaly skin patches) when treatments applied to the skin are not suitable. It is also used to treat psoriatic arthritis (scaly skin patches with joint inflammation) alone or with another medicine called methotrexate. For psoriatic arthritis, Tremfya is used when medicines to treat the underlying inflammation (disease-modifying medicines) have not worked well enough or when the patient cannot take these medicines. Tremfya contains the active substance guselkumab.

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