|
Product class:
|
Authorized package
|
|
Medicinal product class:
|
For human use
|
|
Package code:
|
1644487
|
|
Name of medicinal product:
|
ADEMPAS
|
|
Active substances:
|
|
|
ATC code:
|
C02KX05
|
|
Dosage form:
|
film-coated tablet
|
|
Route of administration:
|
oral use
|
|
Strengh:
|
2mg
|
|
Amount in package:
|
90TK
|
|
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:
|
Never imported to Estonia
|
|
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
|
|
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:
September 25, 2023
Legal status for supply – medicinal product on medical prescription or not subject to medical prescription
You can download Acrobat Reader fromhere