Irbesartan Hydrochlorothiazide Zentiva

Medicinal product

(Invented) name

Irbesartan Hydrochlorothiazide Zentiva

Active substance (s)

Irbesartanas/Hidrochlorotiazidas

Strength

300 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	300 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
26246	28835	1028835	lizdinė plokštelė	N14		Receptinis	EU/1/06/377/006	Netiekiama	-	-	No	-	-
26247	28836	1028836	lizdinė plokštelė	N28		Receptinis	EU/1/06/377/007	Netiekiama	-	-	No	-	-
26248	28837	1028837	lizdinė plokštelė	N56		Receptinis	EU/1/06/377/008	Netiekiama	-	-	No	-	-
26249	28838	1028838	dalomoji lizdinė plokštelė	N56x1		Receptinis	EU/1/06/377/009	Netiekiama	-	-	No	-	-
26250	28839	1028839	lizdinė plokštelė	N98		Receptinis	EU/1/06/377/010	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2007-01-19	Registruotas