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PRODUCT DETAIL

Dutasteride/Tamsulosin Krka 0,5 mg/0,4 mg tvrdé kapsuly

Code 2577D
MA number 77/0329/19-S
Product Form: cps dur 7x0,5 mg/0,4 mg (fľ.HDPE)
MA Status: R - Valid Marketing Authorisation
Type of procedure: Decentralised
Therapeutic Class: 77 - SYMPATHOLYTICA
ATC:
G GENITO URINARY SYSTEM AND SEX HORMONES
G04 UROLOGICALS
G04C DRUGS USED IN BENIGN PROSTATIC HYPERTROPHY
G04CA Alpha-adrenoreceptor antagonists
G04CA52 Tamsulosin and dutasteride
Shelf life: 24
Container: bottle HDPE
Route of admin.: Oral use
Prescription Status: Medicinal product subject to medical prescription.
Legal basis: Article 10(1) generic application
MA issued: 22.10.2019
Validity: 22.10.2024
MA renewed: Renewal application submitted
Pediatric contraindication: Yes
SPC: SPC_Dutasteride/Tamsulosin Krka 0,5 mg/0,4 mg tvrdé kapsuly_11_2020.docx  
PIL: PIL_Dutasteride/Tamsulosin Krka 0,5 mg/0,4 mg tvrdé kapsuly_11_2020.docx  
Safety feature Yes
Data update: 23.10.2019
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