Dutasteride/Tamsulosin Sandoz [Taduzol]

Medicinal product

(Invented) name

Dutasteride/Tamsulosin Sandoz [Taduzol]

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

Sandoz d.d., Slovėnija

Date of authorisation

2019-10-01

Date of renewal

Documents

4445_1_3 Pakuotės lapelis 200504.docx

4445_1_3 Dutasteride_Tamsulosin Sandoz RPP 200504.docx

Stage

Išregistruotas

Controlled?

No

Controlled substance type

Legal basis

10(1)

Procedure number

DK/H/3001/001/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
102455	88556	1088556	buteliukas	N7		Receptinis	LT/1/19/4445/001	Netiekiama	-	-	No	-	-
102456	88557	1088557	buteliukas	N30		Receptinis	LT/1/19/4445/002	Netiekiama	-	-	No	-	-
102457	88558	1088558	buteliukas	N90		Receptinis	LT/1/19/4445/003	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2020-12-29	Išregistruotas
2019-10-01	Registruotas