Dutasteride/Tamsulosin Krka

Medicinal product

(Invented) name

Dutasteride/Tamsulosin Krka

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

KRKA, d.d., Novo mesto, Slovėnija

Date of authorisation

2019-10-25

Date of renewal

2024-07-05

Documents

4469 Pakuotės lapelis 2025 01 01.docx

Finasteridas_dutasteridas laiškas gydytojams _DHCP.pdf

4469 Dutasteride_Tamsulosin Krka II PL 2025 01 01.docx

Stage

Perregistruotas

Controlled?

No

Controlled substance type

Legal basis

10(1)

Procedure number

SK/H/0300/001

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
102576	88677	1088677	buteliukas	N7		Receptinis	LT/1/19/4469/001	Netiekiama	-	-	No	-	-
102577	88678	1088678	buteliukas	N30		Receptinis	LT/1/19/4469/002	Netiekiama	-	-	No	-	-
102578	88679	1088679	buteliukas	N90		Receptinis	LT/1/19/4469/003	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2024-07-05	Perregistruotas
2019-10-25	Registruotas