Zokinvy

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lonafarnib

Authorised
This medicine is authorised for use in the European Union.

Overview

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 for Hutchinson-Gilford progeria syndrome.

Zokinvy contains the active substance lonafarnib.

This EPAR was last updated on 01/08/2022

Authorisation details

Product details
Name
Zokinvy
Agency product number
EMEA/H/C/005271
Active substance
Lonafarnib
International non-proprietary name (INN) or common name
lonafarnib
Therapeutic area (MeSH)
  • Progeria
  • Laminopathies
Additional monitoringAdditional monitoring

This medicine is under additional monitoring, meaning that it is monitored even more intensively than other medicines. For more information, see Medicines under additional monitoring.

Exceptional circumstancesExceptional circumstances

This medicine was authorised under exceptional circumstances, because the applicant was unable to provide comprehensive data on the efficacy and safety of the medicine under normal conditions of use. This can happen because the condition to be treated is rare or because collection of full information is not possible or is unethical. For more information, see Pre-authorisation guidance.

OrphanOrphan

This medicine was designated an orphan medicine. This means that it was developed for use against a rare, life-threatening or chronically debilitating condition or, for economic reasons, it would be unlikely to have been developed without incentives. For more information, see Orphan designation.

Publication details
Marketing-authorisation holder
EigerBio Europe Limited
Date of issue of marketing authorisation valid throughout the European Union
18/07/2022
Contact address

1 Castlewood Avenue
Rathmines
Dublin 6 D06 H685
Ireland

Product information

18/07/2022 Zokinvy - EMEA/H/C/005271 -

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Select ‘available languages’ to access the language you need.

 

Product information documents contain:

You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.

Pharmacotherapeutic group

Other alimentary tract and metabolism products

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.

Assessment history

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