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EMA Product

Zokinvy

Product approved by European Medicines Agency (EU)

Basic Information

Zokinvy

Regulatory Information

EMEA/H/C/005271

Authorised

July 18, 2022

May 19, 2022

3

November 9, 2023

Company Information

Ireland

G24A Arc Labs Research and Innovation Centre SETU West Campus, Carriganore Waterford X91 P20H

Tmc Pharma (Eu Ltd.

Drug Classification

Orphan MedicineAdditional MonitoringExceptional Circumstances

Active Substances Detail

Detailed Information

Therapeutic Indication

### Therapeutic indication Zokinvy is indicated for the treatment of patients 12 months of age and older with a genetically confirmed diagnosis of Hutchinson-Gilford progeria syndrome or a processing-deficient progeroid laminopathy associated with either a heterozygous LMNA mutation with progerin-like protein accumulation or a homozygous or compound heterozygous ZMPSTE24 mutation.

Overview Summary

Zokinvy is a medicine used to treat patients of 12 months and older who are affected by the following rare diseases in which features resembling aging appear in childhood: - Hutchinson-Gilford progeria syndrome; - processing-deficient progeroid laminopathies. The diseases that Zokinvy is used to treat are rare and Zokinvy was designated as ‘orphan medicine’ on [14 December 2018](/en/medicines/human/orphan-designations/eu-3-18-2118) for Hutchinson-Gilford progeria syndrome. Zokinvy contains the active substance lonafarnib.

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