Dutasteride/Tamsulosin Viatris

Medicinal product

(Invented) name

Dutasteride/Tamsulosin Viatris

Active substance (s)

Dutasteridas/Tamsulozino hidrochloridas

Strength

0,5 mg/0,4 mg

Pharmaceutical form

kietosios kapsulės

Route (s) of administration

vartoti per burną

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

G04CA52, Tamsulosin and dutasteride

Marketing authorisation holder

Viatris Limited, Airija

Date of authorisation

2019-10-25

Date of renewal

2024-05-09

Documents

4470 Dutasteride_Tamsulosin Viatris II PL 2025 03 04.docx

4470 Pakuotės lapelis 2025 03 04.docx

Stage

Išregistruotas

Controlled?

No

Controlled substance type

Legal basis

10(1)

Procedure number

FI/H/1152/001

Marketing authorisation procedure

Decentralizuota procedūra

Qualitative and quantitative composition

Kapsulėje yra:	1 vnt.
Dutasteridas	0,5 mg
Tamsulozino hidrochloridas	0,4 mg

Packages

PAKID	NPAKID	NPAKID-7	Pack type	Pack size	Type of packaging	Proposed dispensing/classification	Marketing authorisation no.	Supply status	From	To	Package is in foreign language	From	To	Mock-up
102579	88680	1088680	buteliukas	N7		Receptinis	LT/1/19/4470/001	Netiekiama	-	-	No	-	-
102580	88681	1088681	buteliukas	N30		Receptinis	LT/1/19/4470/002	Netiekiama	-	-	No	-	-
102581	88682	1088682	buteliukas	N90		Receptinis	LT/1/19/4470/003	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2025-10-30	Išregistruotas
2024-05-09	Perregistruotas
2019-10-25	Registruotas