Register of
Medicinal Products

Product class: Authorized package
Medicinal product class: For human use
Package code: 1460236
Name of medicinal product: ADCIRCA
Active substances:
Tadalafil
Estonian, English, Latin
ATC code: G04BE08
Dosage form: film-coated tablet
Route of administration: oral use
Strengh: 20mg
Amount in package: 56TK
Legal status for supply*: Subject to medicinal prescription
Class of active substance:  
Additional information:  
Indication: 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.
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: Eli Lilly Nederland B.V. 
Marketing authorization number: EU/1/08/476 
Marketing authorization issued on: October 1, 2008 
Marketing authorization expires on: Unlimited 
Marketing authorization procedure type: Centralised 
Reference price:   
Under reference price:   
Reference price of daily dose:   
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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