Cystadrops - opinion on variation to marketing authorisation

Opinion

EMA has issued an opinion on a change to this medicine's authorisation.

mercaptamine

Opinion

On 25 April 2025, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending a change to the terms of the marketing authorisation for the medicinal product Cystadrops. The marketing authorisation holder for this medicinal product is Recordati Rare Diseases.

The CHMP adopted an extension to the existing indication to include treatment of children from 6 months of age, as follows:¹

Cystadrops is indicated for the treatment of corneal cystine crystal deposits in adults and children from 6 months 2 years of age with cystinosis.

Detailed recommendations for the use of this product will be described in the updated summary of product characteristics (SmPC), which will be published on the EMA website in all official European Union languages after a decision on this change to the marketing authorisation has been granted by the European Commission.

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¹ New text in bold, removed text as strikethrough

CHMP post-authorisation summary of positive opinion for Cystadrops (II-32)

AdoptedReference Number: EMA/CHMP/135105/2025

Key facts

• Name of medicine:
  Cystadrops
• EMA product number:
  EMEA/H/C/003769
• Active substance:
  mercaptamine hydrochloride
• International non-proprietary name (INN) or common name:
  mercaptamine
• Therapeutic area (MeSH):
  Cystinosis
• Anatomical therapeutical chemical (ATC) code:
  S01XA21
• Orphan:

  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.

• Marketing authorisation holder:
  Recordati Rare Diseases
• Date of opinion:
  25/04/2025
• Status:
  Positive