Register of
Medicinal Products

Product class: Authorized package
Medicinal product class: For human use
Package code: 1644432
Name of medicinal product: ADEMPAS
Active substances:
Riociguat
Estonian, English, Latin
ATC code: C02KX05
Dosage form: film-coated tablet
Route of administration: oral use
Strengh: 1,5mg
Amount in package: 42TK
Legal status for supply*: Subject to medicinal prescription
Class of active substance:  
Additional information:  
Indication: Chronic thromboembolic pulmonary hypertension (CTEPH) Adempas is indicated for the treatment of adult patients with WHO Functional Class (FC) II to III with „h inoperable CTEPH, „h persistent or recurrent CTEPH after surgical treatment, to improve exercise capacity (see section 5.1). 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 (see section 5.1).
Safety features: Yes
Summary of product characteristics (SPC):
Package information leaflet (PIL): EST
Labelling:  
Last imported to Estonia: April 28, 2022
Marketing authorization holder: Bayer AG 
Marketing authorization number: EU/1/13/907 
Marketing authorization issued on: March 31, 2014 
Marketing authorization expires on: Unlimited 
Marketing authorization procedure type: Centralised 
Percent Valid from Valid until Valid Diagnosis Doctor's speciality Primary Age Other
100  13.04.2022     Yes  I27.0-I27.0  Pediaater, Kardioloog, Pulmonoloog, Reumatoloog  No  until 4 years  konsiiliumi (vähemalt 3 vastava eriala spetsialisti) otsuse alusel patsientidele, kellele kirurgiline ravi ei ole teostatav või kellel haigus kirurgilise ravi järel püsib või taastekib ning kelle seisund vastab NYHA III-IV funktsionaalsele klassile 
100  13.04.2022     Yes  I27.0-I27.0  Pulmonoloog, Pediaater, Kardioloog, Reumatoloog  No     konsiiliumi (vähemalt 3 vastava eriala spetsialisti) otsuse alusel patsientidele, kellele kirurgiline ravi ei ole teostatav või kellel haigus kirurgilise ravi järel püsib või taastekib ning kelle seisund vastab NYHA III-IV funktsionaalsele klassile 
Reference price:   
Under reference price:   
Reference price of daily dose:   
Description Additional condition
Perearsti õel on õigus välja kirjutada Välja arvatud esmane retsept
Entry/Changing date: January 18, 2019
Legal status for supply – medicinal product on medical prescription or not subject to medical prescription

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