Biktarvy

Medicinal product

(Invented) name

Biktarvy

Active substance (s)

Biktegraviras/Emtricitabinas/Tenofoviras alafenamidas

Strength

30 mg/120 mg/15 mg

Pharmaceutical form

plėvele dengtos tabletės

Route (s) of administration

vartoti per burną

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

ATC code (s)

J05AR20, Emtricitabine, tenofovir alafenamide and bictegravir

Marketing authorisation holder

Gilead Sciences Ireland UC, Airija

Date of authorisation

2018-06-21

Date of renewal

Documents

Stage

Registruotas

Controlled?

Controlled substance type

Legal basis

8(3)

Procedure number

Marketing authorisation procedure

Centrinė registracija

Qualitative and quantitative composition

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
109899	96006	1096006	buteliukas	N30		Receptinis	EU/1/18/1289/005	Netiekiama	-	-	No	-	-
109900	96007	1096007	buteliukas	N90 (3×30)		Receptinis	EU/1/18/1289/006	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2018-06-21	Registruotas