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Community register of medicinal products for human use


Product information

Invented name: Opsumit   
Auth. number : EU/1/13/893
Active substance : macitentan
Orphan market exclusivity for "Treatment of pulmonary arterial hypertension" (based on designation EU/3/11/909) started on 27/12/2013
   10 years of market exclusivity
   This orphan market exclusivity will expire on 27/12/2023
ATC: Anatomical main group: C - Cardiovascular system
Therapeutic subgroup: C02 - Antihypertensives
Pharmacological subgroup: C02K - Other antihypertensives
Chemical subgroup: C02KX - Other antihypertensives
Chemical substance: C02KX04 - Macitentan
(See WHO ATC Index)
Indication: Opsumit, as monotherapy or in combination, is indicated for the long-term treatment of pulmonary arterial hypertension (PAH) in adult patients of WHO Functional Class (FC) II to III.
Efficacy has been shown in a PAH population including idiopathic and heritable PAH, PAH associated with connective tissue disorders, and PAH associated with corrected simple congenital heart disease.
Marketing Authorisation Holder: Actelion Registration Ltd
Chiswick Tower, 13th floor, 389 Chiswick High Road, London W4 4AL, United Kingdom
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 Community Register.

European Commission proceduresGoto top of the page

Close date procedure Procedure type EMEA number Decision summary publ decision docs annex
27/12/2013 Centralised - Authorisation EMEA/H/C/2697 (2013)9830 of 20/12/2013
06/01/2014 Centralised - Authorisation - Decision addressed to Member States EMEA/H/C/2697 (2013)9831 of 20/12/2013
28/05/2014 Centralised - Notification EMEA/H/C/2697/N/1
Updated with Decision(2015)223 of 15/01/2015
17/09/2014 Centralised - Variation EMEA/H/C/2697/IA/5
Updated with Decision(2015)223 of 15/01/2015
17/01/2015 PSUSA - Modification EMEA/H/C/2697/PSUV/3 (2015)223 of 15/01/2015
30/07/2015 PSUSA - Modification EMEA/H/C/PSUSA/10115/201410 (2015)5463 of 28/07/2015
06/08/2015 Centralised - Variation EMEA/H/C/2697/II/8
Updated with Decision(2016)4754 of 15/07/2016
07/09/2015 Centralised - Variation EMEA/H/C/2697/IG/612
Updated with Decision(2016)4754 of 15/07/2016
04/03/2016 Centralised - Variation EMEA/H/C/2697/IB/15
Updated with Decision(2016)4754 of 15/07/2016
19/07/2016 Centralised - Yearly update (2016)4754 of 15/07/2016
16/08/2016 Centralised - Variation EMEA/H/C/2697/IG/720
Updated with Decision(2017) 5170 of 17/07/2017
10/01/2017 Centralised - Variation EMEA/H/C/2697/IB/21
Updated with Decision(2017) 5170 of 17/07/2017
19/07/2017 Centralised - Yearly update (2017) 5170 of 17/07/2017
18/01/2018 Centralised - Variation EMEA/H/C/2697/II/25/G