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EMA Product

Zynyz

Product approved by European Medicines Agency (EU)

Basic Information

Zynyz

Regulatory Information

EMEA/H/C/006194

Authorised

April 19, 2024

February 22, 2024

November 29, 2021

Company Information

the netherlands

Paasheuvelweg 25 1105 BP Amsterdam

Incyte Biosciences Distribution B.V.

Drug Classification

Orphan MedicineAdditional Monitoring

Active Substances Detail

Detailed Information

Therapeutic Indication

### Therapeutic indication Zynyz is indicated as monotherapy for the first-line treatment of adult patients with metastatic or recurrent locally advanced Merkel cell carcinoma (MCC) not amenable to curative surgery or radiation therapy.

Overview Summary

Incyte Biosciences Distribution B.V. withdrew its application for a marketing authorisation of Zynyz for the treatment of squamous carcinoma of the anal canal, a cancer of the tissues of the anus. The company withdrew the application on 8 October 2021.

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