Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Stayveer   
Auth. number : EU/1/13/832
INN : bosentan
ATC: Anatomical main group: C - Cardiovascular system
Therapeutic subgroup: C02 - Antihypertensives
Pharmacological subgroup: C02K - Other antihypertensives
Chemical subgroup: C02KX - Other antihypertensives
Chemical substance: C02KX01 - Bosentan
(See WHO ATC Index)
Indication: Treatment of pulmonary arterial hypertension (PAH) to improve exercise capacity and symptoms in patients with WHO functional class III. Efficacy has been shown in:
• Primary (idiopathic and heritable) PAH
• PAH secondary to scleroderma without significant interstitial pulmonary disease
• PAH associated with congenital systemic-to-pulmonary shunts and Eisenmenger's physiology
Some improvements have also been shown in patients with PAH WHO functional class II.
STAYVEER is also indicated to reduce the number of new digital ulcers in patients with systemic sclerosis and ongoing digital ulcer disease.
Marketing Authorisation Holder: Marklas Nederland B.V.
Beneluxlaan 2b, NL-3446 GR Woerden, Nederland

  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
25/06/2013 Centralised - Authorisation EMEA/H/C/2644 (2013)4093 of 24/06/2013
08/01/2014 Centralised - Variation EMEA/H/C/2644/IAin/4
19/02/2014 Centralised - Variation EMEA/H/C/2644/IB/5/G
10/04/2014 Centralised - Variation EMEA/H/C/2644/IB/7/G
13/06/2014 Centralised - Notification EMEA/H/C/2644/N/9