EU/3/05/292: Orphan designation for the hearing loss (acute acoustic trauma, sudden deafness and surgery induced acoustic trauma)
On 16 June 2005, orphan designation (EU/3/05/292) was granted by the European Commission to Laboratoires Auris SAS, France, for H-D-Asp-D-Gln-D-Ser-D-Arg-D-Pro-D-Val-D-Gln-D-Pro-D-Phe-D-Leu-D-Asn-D-Leu-D-Thr-D-Thr-D-Pro-D-Arg-D-Lys-D-Pro-D-Arg-D-Pro-D-Pro-D-Arg-D-Arg-D-Arg-D-Gln-D-Arg-D-Arg-D-Lys-D-Lys-D-Arg-D-Gly-NH2 (AM-111) for the treatment of acute sensorineural hearing loss (acute acoustic trauma, sudden deafness and surgery induced acoustic trauma).
The sponsorship was transferred to Auris Medical Limited, Ireland, in January 2009.
Hearing loss (acute acoustic trauma, sudden deafness and surgery induced acoustic trauma)
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Documents related to this orphan designation evaluation
EU/3/05/292: Public summary of positive opinion for orphan designation of H-D-Asp-D-Gln-D-Ser-D-Arg-D-Pro-D-Val-D-Gln-D-Pro-D-Phe-D-Leu-D-Asn-D-Leu-D-Thr-D-Thr-D-Pro-D-Arg-D-Lys-D-Pro-D-Arg-D-Pro-D-Pro-D-Arg-D-Arg-D-Arg... (PDF/136.67 KB)
First published: 21/09/2009
Last updated: 17/10/2013
For contact details of patients’ organisations whose activities are targeted at rare diseases, see:
Orphanet, a database containing information on rare diseases, which includes a directory of patients’ organisations registered in Europe.
European Organisation for Rare Diseases (EURORDIS), a non-governmental alliance of patient organisations and individuals active in the field of rare diseases.
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: