Irbesartan Hydrochlorothiazide Zentiva

Medicinal product

(Invented) name

Irbesartan Hydrochlorothiazide Zentiva

Active substance (s)

Irbesartanas/Hidrochlorotiazidas

Strength

150 mg/12,5 mg

Pharmaceutical form

tabletės

Route (s) of administration

vartoti per burną

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

C09DA04, Irbesartan and diuretics

Marketing authorisation holder

Zentiva k.s., Čekija

Date of authorisation

2007-01-19

Date of renewal

Documents

Search in EMA Europe

Stage

Registruotas

Controlled?

No

Controlled substance type

Legal basis

10c

Procedure number

Marketing authorisation procedure

Centrinė registracija

Qualitative and quantitative composition

tablet	1 vnt.
Irbesartanas	150 mg
Hidrochlorotiazidas	12,5 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
26241	28830	1028830	lizdinė plokštelė	N14		Receptinis	EU/1/06/377/001	Netiekiama	-	-	No	-	-
26242	28831	1028831	lizdinė plokštelė	N28		Receptinis	EU/1/06/377/002	Netiekiama	-	-	No	-	-
26243	28832	1028832	lizdinė plokštelė	N56		Receptinis	EU/1/06/377/003	Netiekiama	-	-	No	-	-
26244	28833	1028833	dalomoji lizdinė plokštelė	N56x1		Receptinis	EU/1/06/377/004	Netiekiama	-	-	No	-	-
26245	28834	1028834	lizdinė plokštelė	N98		Receptinis	EU/1/06/377/005	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2007-01-19	Registruotas