On 8 April 2014, orphan designation (EU/3/14/1259) was granted by the European Commission to Insmed Limited, United Kingdom, for amikacin sulfate for the treatment of nontuberculous mycobacterial lung disease.
The sponsor’s address was updated in February 2019.
The sponsorship was transferred to Insmed Netherlands B.V., Netherlands, in February 2019.
The sponsor’s address was updated in October 2020.
Amikacin sulfate has been authorised in the EU as Arikayce liposomal since 27 October 2020.
Treatment of nontuberculous mycobacterial lung disease
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Review of designation
Documents related to this orphan designation evaluation
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: