Pharmaceuticals - Union Register

  

Union Register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Xermelo   
Auth. number : EU/1/17/1224
Active substance : telotristat
Orphan market exclusivity for "Treatment of carcinoid syndrome" (based on designation EU/3/09/661) started on 20/09/2017
   10 years of market exclusivity
   This orphan market exclusivity will expire on 20/09/2027
ATC: Anatomical main group: A - Alimentary tract and metabolism
Therapeutic subgroup: A16 - Other alimentary tract and metabolism products
Pharmacological subgroup: A16A - Other alimentary tract and metabolism products
Chemical subgroup: A16AX - Various alimentary tract and metabolism products
Chemical substance: A16AX15 - telotristat
(See WHO ATC Index)
Indication: Xermelo is indicated for the treatment of carcinoid syndrome diarrhoea in combination with somatostatin analogue (SSA) therapy in adults inadequately controlled by SSA therapy.
Marketing Authorisation Holder: Ipsen Pharma
65 quai Georges Gorse, 92100 Boulogne-Billancourt, France
EPAR and active package presentations

Package presentations

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.

European Commission proceduresGoto top of the page

Close date procedure Procedure type EMEA number Decision summary publ decision docs annex
20/09/2017 Centralised - Authorisation EMEA/H/C/3937 (2017)6420 of 18/09/2017
16/01/2018 Centralised - Variation EMEA/H/C/3937/IB/1
Updated with Decision(2018)8684 of 07/12/2018
19/04/2018 Centralised - Notification EMEA/H/C/3937/N/3
Updated with Decision(2018)8684 of 07/12/2018
11/12/2018 Centralised - Yearly update (2018)8684 of 7/12/2018
4/01/2019 Centralised - Variation EMEA/H/C/3937/IB/08
13/03/2019 Centralised - Variation EMEA/H/C/3937/IA/12
14/03/2019 Centralised - Variation EMEA/H/C/003937/II/0010
21/03/2019 Centralised - Variation EMEA/H/C/003937/II/0005