Dutasteride/Tamsulosin Exeltis

Medicinal product

(Invented) name

Dutasteride/Tamsulosin Exeltis

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

UAB Exeltis Baltics , Lietuva

Date of authorisation

2019-10-25

Date of renewal

Documents

4468 Dutasteride_Tamsulosin Exelis PL 2021 11 06.docx

4468 Pakuotės lapelis 2021 11 06.docx

Stage

Išregistruotas

Controlled?

No

Controlled substance type

Legal basis

10(1)

Procedure number

DK/H/2910/001/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
102573	88674	1088674	buteliukas	N7		Receptinis	LT/1/19/4468/001	Netiekiama	-	-	No	-	-
102574	88675	1088675	buteliukas	N30		Receptinis	LT/1/19/4468/002	Netiekiama	-	-	No	-	-	Download
102575	88676	1088676	buteliukas	N90		Receptinis	LT/1/19/4468/003	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2024-09-27	Išregistruotas
2019-10-25	Registruotas