Register of
Medicinal Products

Product class: Authorized package
Medicinal product class: For human use
Package code: 1807657
Name of medicinal product: ADUZIN
Active substances:
Estonian, English, Latin
ATC code: G04CA52
Dosage form: capsule, hard
Route of administration: oral use
Strengh: 0,4mg+0,5mg
Amount in package: 7TK
Legal status for supply*: Subject to medicinal prescription
Class of active substance:  
Additional information:  
Indication: Treatment of moderate to severe symptoms of benign prostatic hyperplasia (BPH). Reduction in the risk of acute urinary retention (AUR) and surgery in patients with moderate to severe symptoms of BPH. For information on effects of treatment and patient populations studied in clinical trials please see section 5.1.
Safety features: Yes
Summary of product characteristics (SPC):  (last updated June 22, 2022)
Package information leaflet (PIL): EST  (last updated June 22, 2022)
Labelling:  (last updated May 19, 2020)
Last imported to Estonia: Never imported to Estonia
Marketing authorization holder: Sandoz Pharmaceuticals d.d. 
Marketing authorization number: 1005820 
Marketing authorization issued on: May 19, 2020 
Marketing authorization expires on: May 19, 2025 
Marketing authorization procedure type: Mutual recognition 
Reference price:   
Under reference price:   
Reference price of daily dose:   
Entry/Changing date: June 22, 2022
Legal status for supply – medicinal product on medical prescription or not subject to medical prescription

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