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Pharmaceuticals - Community Register
Community register of medicinal products for human use
|Auth. number :||EU/1/13/832|
|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
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.
|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 - Variation||EMEA/H/C/2644/N/9|