en

PRODUCT DETAIL

Dutasterid/Tamsulozín FMK

Code 2354D
MA number 77/0269/19-S
Product Form: cps dur 30x0,5 mg/0,4 mg (fľ.HDPE)
MA Status: D - Marketing Authorisation valid for an unlimited period
Type of procedure: Decentralised
MAH, country: Farmak International Sp. z o.o., Poland
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
Pediatric contraindication: Yes
Dokument: VHS_súhrn_Dutasterid_tamsulozin Xantis.pdf  
Dokument: VHS_Dutasterid_tamsulozin Xantis.pdf  
SPC: SPC_Dutasterid_Tamsulozín FMK_cps dur_08_2023.pdf  
PIL: PIL_Dutasterid_Tamsulozín FMK_cps dur_08_2023.pdf  
Safety feature Yes
Data update: 30.04.2024
eu-flag.png sk-flag.png