Pharmaceuticals - Community Register

  

Community register of medicinal products for human use
AUTHORISED  

Product information
Invented name: Adempas   
Auth. number : EU/1/13/907
Active substance : riociguat
Orphan market exclusivity for "Treatment of pulmonary arterial hypertension including treatment of chronic thromboembolic pulmonary hypertension" (based on designation EU/3/07/518) started on 31/03/2014
   10 years of market exclusivity
   This orphan market exclusivity will expire on 31/03/2024
ATC: Anatomical main group: C - Cardiovascular system
Therapeutic subgroup: C02 - Antihypertensives
Pharmacological subgroup: C02K - Other antihypertensives
Chemical subgroup: C02KX - Other antihypertensives
Chemical substance: C02KX05 - Riociguat
(See WHO ATC Index)
Indication: Chronic thromboembolic pulmonary hypertension (CTEPH)
Adempas is indicated for the treatment of adult patients with WHO Functional Class (FC) II to III with
• inoperable CTEPH,
• persistent or recurrent CTEPH after surgical treatment, to improve exercise capacity.

Pulmonary arterial hypertension (PAH)
Adempas, as monotherapy or in combination with endothelin receptor antagonists, is indicated for the treatment of adult patients with pulmonary arterial hypertension (PAH) with WHO Functional Class (FC) II to III to improve exercise capacity.
Efficacy has been shown in a PAH population including aetiologies of idiopathic or heritable PAH or
PAH associated with connective tissue disease.
Marketing Authorisation Holder: Bayer AG
D-51368 Leverkusen, Deutschland
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
31/03/2014 Centralised - Authorisation EMEA/H/C/2737 (2014)2152 of 27/03/2014
14/10/2014 Centralised - Variation EMEA/H/C/2737/IB/3/G
Updated with Decision(2015)7213 of 15/10/2015
23/07/2015 Centralised - Variation EMEA/H/C/2737/II/7/G
Updated with Decision(2015)7213 of 15/10/2015
19/10/2015 Centralised - Yearly update (2015)7213 of 15/10/2015
23/11/2015 Centralised - Notification EMEA/H/C/2737/N/9
Updated with Decision(2016)5486 of 22/08/2016
24/08/2016 Centralised - 2-Monthly update EMEA/H/C/2737/IA/13 (2016)5486 of 22/08/2016
26/01/2017 Centralised - Variation EMEA/H/C/2737/II/19
Updated with Decision(2017)3057 of 02/05/2017
14/03/2017 Centralised - Variation EMEA/H/C/2737/IA/21/G
Updated with Decision(2017)3057 of 02/05/2017
04/05/2017 Centralised - Transfer Marketing Authorisation Holder EMEA/H/C/2737/T/22 (2017)3057 of 02/05/2017