Darunavir Viatris [Darunavir Mylan]

Medicinal product

(Invented) name

Darunavir Viatris [Darunavir Mylan]

Active substance (s)

Darunaviras

Strength

75 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	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
67575	82129	1082129	lizdinė plokštelė	N480 (PVC/PE/PVDC)		Receptinis	EU/1/16/1140/001	Netiekiama	-	-	No	-	-
67576	82130	1082130	dalomoji lizdinė plokštelė	N480x1 (PVC/PE/PVDC)		Receptinis	EU/1/16/1140/002	Netiekiama	-	-	No	-	-
67577	82131	1082131	lizdinė plokštelė	N480 (Al/PA/PVC/Al)		Receptinis	EU/1/16/1140/003	Netiekiama	-	-	No	-	-
67578	82132	1082132	dalomoji lizdinė plokštelė	N480x1 (Al/PA/PVC/Al)		Receptinis	EU/1/16/1140/004	Netiekiama	-	-	No	-	-
67579	82133	1082133	buteliukas	N480		Receptinis	EU/1/16/1140/005	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2017-01-04	Registruotas