Aprovel

Medicinal product

(Invented) name

Aprovel

Active substance (s)

Irbesartanas

Strength

150 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	150 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
5465	10721	1010721	lizdinė plokštelė	N28		Receptinis	EU/1/97/046/004	Netiekiama	-	-	No	-	-
5466	10722	1010722	lizdinė plokštelė	N56		Receptinis	EU/1/97/046/005	Netiekiama	-	-	No	-	-
5467	10723	1010723	lizdinė plokštelė	N98		Receptinis	EU/1/97/046/006	Netiekiama	-	-	No	-	-
2429	8038	1008038	lizdinė plokštelė	N14		Receptinis	EU/1/97/046/011	Netiekiama	-	-	No	-	-
24772	27415	1027415	dalomoji lizdinė plokštelė	N56x1		Receptinis	EU/1/97/046/014	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
1997-08-27	Registruotas