Dutrozen

Medicinal product

(Invented) name

Dutrozen

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

Zentiva k.s., Čekija

Date of authorisation

2019-09-12

Date of renewal

2024-02-07

Documents

4434 Pakuotės lapelis 2024 08 19.docx

4434 Dutrozen II PL 2024 08 19.docx

Finasteridas_dutasteridas laiškas gydytojams _DHCP.pdf

Stage

Perregistruotas

Controlled?

No

Controlled substance type

Legal basis

10(1)

Procedure number

CZ/H/0815/001/DC

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
102358	88458	1088458	buteliukas	N7		Receptinis	LT/1/19/4434/001	Netiekiama	-	-	No	-	-
102359	88459	1088459	buteliukas	N30		Receptinis	LT/1/19/4434/002	Netiekiama	-	-	No	-	-	Download
102360	88460	1088460	buteliukas	N90		Receptinis	LT/1/19/4434/003	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2024-02-07	Perregistruotas
2019-09-12	Registruotas