EU/3/05/292: Orphan designation for the hearing loss (acute acoustic trauma, sudden deafness and surgery induced acoustic trauma)
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
Overview
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.
Key facts
Active substance |
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
|
Intended use |
Hearing loss (acute acoustic trauma, sudden deafness and surgery induced acoustic trauma)
|
Orphan designation status |
Positive
|
EU designation number |
EU/3/05/292
|
Date of designation |
16/06/2005
|
Sponsor |
Auris Medical Limited
The Black Church Sr. Mary’s Place Dublin D07 P4AX Ireland Tel. +353 7661 54675 Fax +353 1685 3040 E-mail: tm@aurismedical.com |
Patients' organisations
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: