Aprovel

Medicinal product

(Invented) name

Aprovel

Active substance (s)

Irbesartanas

Strength

300 mg

Pharmaceutical form

tabletės

Route (s) of administration

vartoti per burną

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

C09CA04, Irbesartan

Marketing authorisation holder

Sanofi Winthrop Industrie, Prancūzija

Date of authorisation

1997-08-27

Date of renewal

Documents

Search in EMA Europe

Stage

Registruotas

Controlled?

No

Controlled substance type

Legal basis

8(3)

Procedure number

Marketing authorisation procedure

Centrinė registracija

Qualitative and quantitative composition

Tablets	1 vnt.
Irbesartanas	300 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
5468	4073	1004073	lizdinė plokštelė	N28		Receptinis	EU/1/97/046/007	Netiekiama	-	-	No	-	-
5469	10724	1010724	lizdinė plokštelė	N56		Receptinis	EU/1/97/046/008	Netiekiama	-	-	No	-	-
5470	10725	1010725	lizdinė plokštelė	N98		Receptinis	EU/1/97/046/009	Netiekiama	-	-	No	-	-
2430	8039	1008039	lizdinė plokštelė	N14		Receptinis	EU/1/97/046/012	Netiekiama	-	-	No	-	-
24773	27416	1027416	dalomoji lizdinė plokštelė	N56x1		Receptinis	EU/1/97/046/015	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
1997-08-27	Registruotas