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Pharmaceuticals - Union Register
Union Register of medicinal products for human use
|Auth. number :||EU/1/18/1297|
|Active substance :||tisagenlecleucel|
|Orphan market exclusivity for "Treatment of B-lymphoblastic leukaemia/lymphoma" (based on designation EU/3/14/1266) started on 27/08/2018 10 years of market exclusivity This orphan market exclusivity will expire on 27/08/2028 Orphan market exclusivity for "Treatment of diffuse large B-cell lymphoma" (based on designation EU/3/16/1745) started on 27/08/2018 10 years of market exclusivity This orphan market exclusivity will expire on 27/08/2028|
|Indication:||Kymriah is indicated for the treatment of:|
- Paediatric and young adult patients up to 25 years of age with B cell acute lymphoblastic leukaemia (ALL) that is refractory, in relapse post transplant or in second or later relapse.
- Adult patients with relapsed or refractory diffuse large B cell lymphoma (DLBCL) after two or more lines of systemic therapy.
|Marketing Authorisation Holder:||Novartis Europharm Limited
Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland
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|
|27/08/2018||Centralised - Authorisation||EMEA/H/C/4090||(2018)5717 of 23/08/2018|