Register of
Medicinal Products

Product class: Medicinal product with marketing authorization
Medicinal product class: Human medicine
Name of medicinal product: ADEMPAS
Active substances:
Riociguat
Estonian, English, Latin
ATC code: C02KX05
Dosage form: film-coated tablet
Strength: 2,5mg
Legal status for supply*: Subject to medicinal prescription
Summary of product characteristics (SPC):
Package information leaflet (PIL): EST
Labelling:  
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
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 
Assessment report:   
Description Additional condition
Perearsti õel on õigus välja kirjutada Välja arvatud esmane retsept
Package code Name of medicinal product Dosage form Package Legal status Reimbursements Reference price Last imported Additional information
1644498  ADEMPAS  film-coated tablet  2,5mg 42TK  Prescription  100%    18.03.2022   
1644500  ADEMPAS  film-coated tablet  2,5mg 84TK  Prescription         
1644511  ADEMPAS  film-coated tablet  2,5mg 90TK  Prescription         
1699779  ADEMPAS  film-coated tablet  2,5mg 294TK  Prescription         
Legal status for supply – medicinal product on medical prescription or not subject to medical prescription

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