Product class:
|
Medicinal product with marketing authorization
|
Medicinal product class:
|
Human medicine
|
Name of medicinal product:
|
ADEMPAS
|
Active substances:
|
|
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
|
PƤritolumaa
|
Additional information
|
1644498
|
ADEMPAS
|
film-coated tablet
|
2,5mg 42TK
|
Prescription
|
100%
|
|
10.01.2024
|
|
|
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
|
|
|
|
|
|
3042942
|
ADEMPAS
|
film-coated tablet
|
2,5mg 42TK
|
Prescription
|
100%
|
|
13.03.2024
|
|
PT: Abacus Medicine A/S
|
Legal status for supply – medicinal product on medical prescription or not subject to medical prescription
You can download Acrobat Reader fromhere