Darunavir Viatris [Darunavir Mylan]

Medicinal product

(Invented) name

Darunavir Viatris [Darunavir Mylan]

Active substance (s)

Darunaviras

Strength

150 mg

Pharmaceutical form

plėvele dengtos tabletės

Route (s) of administration

vartoti per burną

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

J05AE10, Darunavir

Marketing authorisation holder

Viatris Limited, Airija

Date of authorisation

2017-01-04

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

Film-coated tablet	1 vnt.
Darunaviras	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
67580	82134	1082134	lizdinė plokštelė	N240 (PVC/PE/PVDC)		Receptinis	EU/1/16/1140/006	Netiekiama	-	-	No	-	-
67581	82135	1082135	dalomoji lizdinė plokštelė	N240x1 (PVC/PE/PVDC)		Receptinis	EU/1/16/1140/007	Netiekiama	-	-	No	-	-
67582	82136	1082136	lizdinė plokštelė	N240 (Al/PA/PVC/Al)		Receptinis	EU/1/16/1140/008	Netiekiama	-	-	No	-	-
67583	82137	1082137	dalomoji lizdinė plokštelė	N240x1 (Al/PA/PVC/Al)		Receptinis	EU/1/16/1140/009	Netiekiama	-	-	No	-	-
67584	82138	1082138	buteliukas	N60		Receptinis	EU/1/16/1140/010	Netiekiama	-	-	No	-	-
67585	82139	1082139	buteliukas	N240		Receptinis	EU/1/16/1140/011	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2017-01-04	Registruotas