Dutamsin

Medicinal product

(Invented) name

Dutamsin

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

G.L. Pharma GmbH, Austrija

Date of authorisation

2019-10-01

Date of renewal

Documents

4442_1_3 Pakuotės lapelis 200416.docx

4442_1_3 Dutamsin kaps PCS PL 200416.docx

Stage

Išregistruotas

Controlled?

No

Controlled substance type

Legal basis

10(1)

Procedure number

DK/H/2909/001/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
102418	88518	1088518	buteliukas	N7		Receptinis	LT/1/19/4442/001	Netiekiama	-	-	No	-	-
102419	88519	1088519	buteliukas	N30		Receptinis	LT/1/19/4442/002	Netiekiama	-	-	No	-	-	Download
102420	88520	1088520	buteliukas	N90		Receptinis	LT/1/19/4442/003	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2022-12-01	Išregistruotas
2019-10-01	Registruotas