Pharmaceuticals - Union Register


Union Register of medicinal products for human use


Product information

Invented name: Stayveer   
Auth. number : EU/1/13/832
Active substance : 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) pulmonary arterial hypertension
• Pulmonary arterial hypertension secondary to scleroderma without significant interstitial pulmonary disease
• Pulmonary arterial hypertension associated with congenital systemic-to-pulmonary shunts and Eisenmenger’s physiology

Some improvements have also been shown in patients with pulmonary arterial hypertension 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, 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 Union 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
8/01/2014 Centralised - Variation EMEA/H/C/2644/IAIN/4
Updated with Decision(2014)10247 of 19/12/2014
19/02/2014 Centralised - Variation EMEA/H/C/2644/IB/5/G
Updated with Decision(2014)10247 of 19/12/2014
10/04/2014 Centralised - Variation EMEA/H/C/2644/IB/7/G
Updated with Decision(2014)10247 of 19/12/2014
13/06/2014 Centralised - Notification EMEA/H/C/2644/N/9
Updated with Decision(2014)10247 of 19/12/2014
5/01/2015 Centralised - Yearly update (2014)10247 of 19/12/2014
30/07/2015 Centralised - 2-Monthly update EMEA/H/C/2644/II/11 (2015)5474 of 28/07/2015
24/08/2015 PSUSA - Modification EMEA/H/C/2644/PSUSA/425/201411 (2015)5967 of 20/08/2015
25/02/2016 Centralised - Variation EMEA/H/C/2644/WS/899/G
Updated with Decision(2016) 6245 of 22/09/2016
15/09/2016 Centralised - Variation EMEA/H/C/2644
Updated with Decision(2017) 6641 of 26/09/2017
26/09/2016 PSUSA - Modification EMEA/H/C/2644/PSUSA/425/201511 (2016) 6245 of 22/09/2016
21/05/2017 Centralised - Variation EMEA/H/C/2644/IB/17
Updated with Decision(2017) 6641 of 26/09/2017
28/09/2017 PSUSA - Modification EMEA/H/C/2644/PSUSA/425/201611 (2017) 6641 of 26/09/2017
10/01/2018 Centralised - Renewal EMEA/H/C/2644/R/21 (2018) 118 of 8/01/2018
12/07/2018 Centralised - Variation EMEA/H/C/2644/II/23