Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Adempas   
Auth. number : EU/1/13/907
INN : riociguat
Orphan status based on designation EU/3/07/518 added on 31/03/2014
10 years of market exclusivity
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 Pharma AG
D-13342 Berlin, 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