Detailed SMPC and OD register data for: Adempas
Data as extracted from Orphan Designation Register
Product (OD)
Adempas
PL number (OD)
PLGB 00010/0670
OD Designation ID (OD)
OD1
Active substance (OD)
riociguat, Methyl 4,6-diamino-2-[1-(2-fluorobenzyl)-1H-pyrazolo[3,4-b]pyridine-3-yl]-5-pyrimidinyl(methyl)carbamate
Data as extracted from SMPC. (PS: More information at bottom of the page)
Product (SMPC)
PL Number (SMPC)
Composition/ Active Substance (SMPC)
Dose form (SMPC)
Marketing Authorisation holder details (SMPC)
AI match to EMA Substance Dictionary
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SMPC composition / active substance
Matched EMA substance
EMA SMS ID
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Further information for:
Select a section below to read the detailed content extracted from the SMPC / Orphan Designation register.
OD Indication (OD)
Adempas is indicated for the treatment of adult patients with WHO Functional Class (FC) II to III with - inoperable CTEPH - persistent or recurrent CTEPH after surgical treatment, to improve exercise capacity. 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.
Full Designation Number(OD)
PLGB 00010/0670 - 0674/OD1
Orphan Condition(OD)
Chronic thromboembolic pulmonary hypertension (CTEPH)
All Indications (SMPC)
All Contraindications (SMPC)
Warnings/Precautions (SMPC)
Interactions (SMPC)
Pregnancy/Lactation (SMPC)
Driving/Machines (SMPC)
Undesirable effects (SMPC)
Overdose (SMPC)
Shelf life (SMPC)
Storage (SMPC)
Container description (SMPC)
Handling/Disposal (SMPC)
SMPC_URL