Rare disease (orphan) designations

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This page allows you to find information on rare disease (orphan) designations based on applications that have been assessed by the European Medicines Agency's (EMA) Committee for Orphan Medicinal Products (COMP).

An orphan designation allows a pharmaceutical company to benefit from incentives from the European Union to develop a medicine for a rare disease, such as reduced fees and protection from competition once the medicine is placed on the market. Applications for orphan designation are examined by the COMP, which adopts an opinion that is forwarded to the European Commission. The European Commission then decides whether to grant an orphan designation for the medicine in question.

For more information, see Orphan designation.

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EPAR Search results
Active substance Disease / condition Date of decision Decision Medicine name

Ciclosporin

Prevention of corneal graft rejection 2007-10-22 Positive  

Ciclosporin

Treatment of atopic keratoconjunctivitis 2004-04-14 Withdrawn  

Ciclosporin

Treatment of herpes simplex virus stromal keratitis 2007-10-28 Positive  

Ciclosporin

Treatment of moderate and severe closed traumatic brain injury 2010-10-01 Positive  

Ciclosporin

Treatment of vernal keratoconjunctivitis 2006-04-06 Positive  

Ciclosporin (eye drops, solution)

Treatment of atopic keratoconjunctivitis 2009-07-24 Positive  

Ciclosporin (implant)

Prevention of rejection for corneal transplant 2006-11-02 Withdrawn  

Ciclosporin (inhalation use)

Prevention of graft rejection after lung transplantation 2004-07-29 Positive  

Ciclosporin (inhalation use)

Prevention of graft rejection after lung transplantation 2005-03-09 Withdrawn  

Ciclosporin (inhalation use)

Treatment of graft rejection after lung transplantation 2004-07-29 Positive  

Ciclosporin (inhalation use)

Treatment of graft rejection after lung transplantation 2005-03-09 Positive