Dutasteride/Tamsulosin Olpha [Dutasteride/Tamsulosin Olainfarm]

Medicinal product

(Invented) name

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)

ATC code (s)

G04CA52, Tamsulosin and dutasteride

Marketing authorisation holder

Olpha AS, Latvija

Date of authorisation

2019-11-11

Date of renewal

2025-02-14

Documents

Stage

Perregistruotas

Controlled?

Controlled substance type

Legal basis

10(1)

Procedure number

LV/H/0323/001/

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	Proposed dispensing/classification	Marketing authorisation no.	Supply status	From	To	Package is in foreign language	From	To
102805	88906	1088906	buteliukas	N7	Receptinis	LT/1/19/4487/001	Netiekiama	-	-	No	-	-
102806	88907	1088907	buteliukas	N30	Receptinis	LT/1/19/4487/002	Tiekiama	2025-11-02	-	No	-	-
102807	88908	1088908	buteliukas	N90	Receptinis	LT/1/19/4487/003	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2025-02-14	Perregistruotas
2019-11-11	Registruotas