Tamsulosin hydrochloride/Dutasteride Teva

Medicinal product

(Invented) name

Tamsulosin hydrochloride/Dutasteride Teva

Active substance (s)

Tamsulozino hidrochloridas/Dutasteridas

Strength

0,4 mg/0,5 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

Teva B.V., Nyderlandai

Date of authorisation

2021-04-23

Date of renewal

2022-12-29

Documents

4727_pakuotes lapelis_2022-12-29.docx

4727_Tamsul_HCl_Dutast_Teva_perr2022-12-29.docx

Stage

Išregistruotas

Controlled?

No

Controlled substance type

Legal basis

10(1)

Procedure number

NL/H/4492/001/E001

Marketing authorisation procedure

Kartotinė procedūra

Qualitative and quantitative composition

Kapsulėje yra:	1 vnt.
Tamsulozino hidrochloridas	0,4 mg
Dutasteridas	0,5 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
106359	92460	1092460	buteliukas	N7		Receptinis	LT/1/21/4727/001	Netiekiama	-	-	No	-	-
106360	92461	1092461	buteliukas	N30		Receptinis	LT/1/21/4727/002	Netiekiama	-	-	No	-	-	Download
106361	92462	1092462	buteliukas	N90		Receptinis	LT/1/21/4727/003	Netiekiama	-	-	No	-	-
106362	92463	1092463	buteliukas	N180 (2x90)		Receptinis	LT/1/21/4727/004	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2024-08-30	Išregistruotas
2022-12-29	Perregistruotas
2021-04-23	Registruotas