Darunavir Viatris [Darunavir Mylan]

Medicinal product

(Invented) name

Darunavir Viatris [Darunavir Mylan]

Active substance (s)

Darunaviras

Strength

800 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	800 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
67613	82167	1082167	lizdinė plokštelė	N30 (PVC/PE/PVDC)		Receptinis	EU/1/16/1140/039	Netiekiama	-	-	No	-	-
67614	82168	1082168	dalomoji lizdinė plokštelė	N30x1 (PVC/PE/PVDC)		Receptinis	EU/1/16/1140/040	Netiekiama	-	-	No	-	-
67615	82169	1082169	lizdinė plokštelė	N30 (Al/PA/PVC/Al)		Receptinis	EU/1/16/1140/041	Netiekiama	-	-	No	-	-
67616	82170	1082170	dalomoji lizdinė plokštelė	N30x1 (Al/PA/PVC/Al)		Receptinis	EU/1/16/1140/042	Netiekiama	-	-	No	-	-
67617	82171	1082171	buteliukas	N30		Receptinis	EU/1/16/1140/043	Netiekiama	-	-	No	-	-
67618	82172	1082172	buteliukas	N60		Receptinis	EU/1/16/1140/044	Netiekiama	-	-	No	-	-
67619	82173	1082173	buteliukas	N90		Receptinis	EU/1/16/1140/045	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2017-01-04	Registruotas