Product class:
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Authorized package
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Medicinal product class:
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For human use
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Package code:
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1839472
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Name of medicinal product:
|
AMBRISENTAN MYLAN
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Active substances:
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|
ATC code:
|
C02KX02
|
Dosage form:
|
film-coated tablet
|
Route of administration:
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oral use
|
Strengh:
|
10mg
|
Amount in package:
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60TK
|
Legal status for supply*:
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Subject to medicinal prescription
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Class of active substance:
|
|
Additional information:
|
üksikannuseline blister
|
Indication:
|
Ambrisentan Mylan is indicated for the treatment of pulmonary arterial hypertension (PAH) in adult patients of WHO Functional Class (FC) II to III, including use in combination treatment (see section 5.1). Efficacy has been shown in idiopathic PAH (IPAH) and in PAH associated with connective tissue disease.
|
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:
|
Mylan Pharmaceuticals Limited
|
Marketing authorization number:
|
EU/1/19/1368
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Marketing authorization issued on:
|
June 20, 2019
|
Marketing authorization expires on:
|
June 24, 2024
|
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:
October 26, 2021
Legal status for supply – medicinal product on medical prescription or not subject to medical prescription
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