Aprovel

Medicinal product

(Invented) name

Aprovel

Active substance (s)

Irbesartanas

Strength

75 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

Tablet	1 vnt.
Irbesartanas	75 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
13308	17611	1017611	lizdinė plokštelė	N28		Receptinis	EU/1/97/046/001	Netiekiama	-	-	No	-	-
13309	17612	1017612	lizdinė plokštelė	N56		Receptinis	EU/1/97/046/002	Netiekiama	-	-	No	-	-
13310	17613	1017613	lizdinė plokštelė	N98		Receptinis	EU/1/97/046/003	Netiekiama	-	-	No	-	-
2428	8037	1008037	lizdinė plokštelė	N14		Receptinis	EU/1/97/046/010	Netiekiama	-	-	No	-	-
24771	27414	1027414	dalomoji lizdinė plokštelė	N56x1		Receptinis	EU/1/97/046/013	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
1997-08-27	Registruotas