Atazanavir Viatris [Atazanavir Mylan]

Medicinal product

(Invented) name

Atazanavir Viatris [Atazanavir Mylan]

Active substance (s)

Atazanaviras

Strength

300 mg

Pharmaceutical form

kietosios kapsulės

Route (s) of administration

vartoti per burną

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

J05AE08, Atazanavir

Marketing authorisation holder

Viatris Limited, Airija

Date of authorisation

2016-08-22

Date of renewal

Documents

Search in EMA Europe

Stage

Registruotas

Controlled?

No

Controlled substance type

Legal basis

10(1)

Procedure number

Marketing authorisation procedure

Centrinė registracija

Qualitative and quantitative composition

Capsule, hard	1 vnt.
Atazanaviras	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
66301	80826	1080826	lizdinė plokštelė	N30 (OPA/Al/PVC-Al)		Receptinis	EU/1/16/1091/007	Netiekiama	-	-	No	-	-
66302	80827	1080827	dalomoji lizdinė plokštelė	N30x1 (OPA/Al/PVC-Al)		Receptinis	EU/1/16/1091/008	Netiekiama	-	-	No	-	-
66303	80828	1080828	buteliukas	N30		Receptinis	EU/1/16/1091/009	Netiekiama	-	-	No	-	-
66304	80829	1080829	buteliukas	N90		Receptinis	EU/1/16/1091/010	Netiekiama	-	-	No	-	-
100855	86966	1086966	lizdinė plokštelė	N30 (PVC/PVDC/Al)		Receptinis	EU/1/16/1091/016	Netiekiama	-	-	No	-	-
100856	86967	1086967	dalomoji lizdinė plokštelė	N30x1 (PVC/PVDC/Al)		Receptinis	EU/1/16/1091/017	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2016-08-22	Registruotas