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Pharmaceuticals - Union Register
Union Register of medicinal products for human use
|Auth. number :||EU/1/18/1296|
|Active substance :||inotersen|
|Orphan market exclusivity for "Treatment of ATTR amyloidosis" (based on designation EU/3/14/1250) started on 10/07/2018 10 years of market exclusivity This orphan market exclusivity will expire on 10/07/2028|
|Indication:||Tegsedi is indicated for the treatment of stage 1 or stage 2 polyneuropathy in adult patients with hereditary transthyretin amyloidosis (hATTR).|
|Marketing Authorisation Holder:||Akcea Therapeutics UK Ltd.
Office 32, 19-21 Crawford Street, London, W1H 1PJ, United Kingdom
Information about presentations can be found in the website of the European Medicines Agency under the section "Product Information".|
Likewise, presentations on which there has been a Commission decision are referred in the Summary of Product Characteristics (Annex I to the Commission Decision granting the marketing authorisation) which is available in the Union Register.
|Close date procedure||Procedure type||EMEA number||Decision||summary publ||decision docs||annex|
|10/07/2018||Centralised - Authorisation||EMEA/H/C/4782||(2018)4458 of 6/07/2018|
|14/09/2018||Centralised - Transfer Marketing Authorisation Holder||EMEA/H/C/4782/T/1||(2018)6027 of 12/09/2018|