PRODUCT DETAIL

Dutasteride Olpha 0,5 mg mäkké kapsuly

Code

1806F

MA number

87/0376/25-S

Product Form:

cps mol 90x0,5 mg (blis.PVC/PVDC/Al)

MA Status:

R - Valid Marketing Authorisation

Type of procedure:

Decentralised

MAH, country:

AS Olpha, Latvia

Therapeutic Class:

87 - VARIA I

ATC:

G	GENITO URINARY SYSTEM AND SEX HORMONES
G04	UROLOGICALS
G04C	DRUGS USED IN BENIGN PROSTATIC HYPERTROPHY
G04CB	Testosterone-5-alpha reductase inhibitors
G04CB02	Dutasteride

Shelf life:

Container:

blister PVC/PVDC/Al

Route of admin.:

Oral use

Prescription Status:	Medicinal product subject to medical prescription.
Legal basis:	Article 10(1) generic application
MA issued:	11.11.2025
Validity:	11.11.2030
Pediatric contraindication:	Yes
Pediatric warnings:	Yes
SPC:	SPC_Dutasteride Olpha 0,5 mg mäkké kapsuly_cps mol_11/2025_REG.pdf
PIL:	PIL_Dutasteride Olpha 0,5 mg mäkké kapsuly_cps mol_11/2025_REG.pdf
Safety feature	Yes
Data update:	12.11.2025