Combodart

Medicinal product

(Invented) name

Combodart

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

GlaxoSmithKline Trading Services Limited, Airija

Date of authorisation

2010-06-08

Date of renewal

2015-08-06

Documents

2032 Pakuotės lapelis 2024 11 29.docx

2032 Combodart RPP 2024 11 29.docx

Stage

Perregistruotas

Controlled?

No

Controlled substance type

Legal basis

10b

Procedure number

DE/H/2251/001/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
41350	55107	1055107	buteliukas	N30		Receptinis	LT/1/10/2032/002	Tiekiama	-	-	No	-	-	Download

Stadijos

Data	Stadija
2015-08-06	Perregistruotas
2010-06-08	Registruotas