EU/3/06/360: Orphan designation for the treatment of vernal keratoconjunctivitis



On 6 April 2006, orphan designation (EU/3/06/360) was granted by the European Commission to Novagali Pharma, France, for ciclosporin for the treatment of vernal keratoconjunctivitis.

In March 2015, Novagali Pharma SA changed name to SANTEN SAS.

The sponsorship was transferred to Santen Oy, Finland, in January 2016.

Ciclosporin has been authorised in the EU as Verkazia since 6 July 2018.

For a list of the administrative updates to this public summary of opinion please refer to the PDF document below.

Key facts

Active substance
Medicine name
Intended use
Treatment of vernal keratoconjunctivitis
Orphan designation status
EU designation number
Date of designation
Santen Oy
Niittyhaankatu 20
FI-33720 Tampere
Tel. +358 3 284 8111
Fax +358 3 318 19 00

Review of designation

On 31 May 2018 the Committee for Orphan Medicinal Products (COMP) completed its review of the designation EU/3/06/360 for Verkazia (ciclosporin) as an orphan medicinal product in the treatment of vernal keratoconjunctivitis. The COMP assessed whether, at the time of marketing authorisation, the medicinal product still met the criteria for orphan designation. The Committee looked at the seriousness and prevalence of the condition, and the existence of other methods of treatment. As other methods of treatment are authorised in the European Union (EU), the COMP also considered whether the medicine is of significant benefit to patients with vernal keratoconjunctivitis. The COMP recommended that the orphan designation of the medicine be maintained1.

1The maintenance of the orphan designation at time of marketing authorisation would, except in specific situations, give an orphan medicinal product 10 years of market exclusivity in the EU. This means that in the 10 years after its authorisation similar products with the same therapeutic indication cannot be placed on the market.

Documents related to this orphan designation evaluation

  • List item

    Recommendation for maintenance of orphan designation at the time of marketing authorisation: Verkazia (ciclosporin) for the treatment of vernal keratoconjunctivitis (PDF/70.16 KB)

    First published: 12/07/2018

  • Patients' organisations

    For contact details of patients’ organisations whose activities are targeted at rare diseases, see:

    • European Organisation for Rare Diseases (EURORDIS), a non-governmental alliance of patient organisations and individuals active in the field of rare diseases.

    • Orphanet, a database containing information on rare diseases, which includes a directory of patients’ organisations registered in Europe.

    EU register of orphan medicines

    The list of medicines that have received an orphan designation in the EU is available on the European Commission's website:

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