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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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1460236
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Name of medicinal product:
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ADCIRCA
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Active substances:
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ATC code:
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G04BE08
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Dosage form:
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film-coated tablet
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Route of administration:
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oral use
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Strengh:
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20mg
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Amount in package:
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56TK
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Legal status for supply*:
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Subject to medicinal prescription
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Class of active substance:
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Additional information:
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Indication:
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Adults
Treatment of pulmonary arterial hypertension (PAH) classified as WHO functional class II and III, to
improve exercise capacity (see section 5.1).
Efficacy has been shown in idiopathic PAH (IPAH) and in PAH related to collagen vascular disease.
Paediatric population
Treatment of paediatric patients aged 2 years and above with pulmonary arterial hypertension (PAH)
classified as WHO functional class II and III.
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Safety features:
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Yes
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Summary of product characteristics (SPC):
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Package information leaflet (PIL):
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EST
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Labelling:
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Last imported to Estonia:
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Never imported to Estonia
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Marketing authorization holder:
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Eli Lilly Nederland B.V.
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Marketing authorization number:
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EU/1/08/476
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Marketing authorization issued on:
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October 1, 2008
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Marketing authorization expires on:
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Unlimited
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Marketing authorization procedure type:
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Centralised
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Reference price:
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Under reference price:
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Reference price of daily dose:
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Entry/Changing date:
March 27, 2023
Legal status for supply – medicinal product on medical prescription or not subject to medical prescription
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