Symtuza

Medicinal product

(Invented) name

Symtuza

Active substance (s)

Darunaviras/Kobicistatas/Emtricitabinas/Tenofoviras alafenamidas

Strength

800 mg/150 mg/200 mg/10 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)

J05AR22, Emtricitabine, tenofovir alafenamide, darunavir and cobicistat

Marketing authorisation holder

Janssen-Cilag International N.V., Belgija

Date of authorisation

2017-09-21

Date of renewal

Documents

Stage

Registruotas

Controlled?

Controlled substance type

Legal basis

10b

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
98064	84162	1084162	buteliukas	N30		Receptinis	EU/1/17/1225/001	Netiekiama	-	-	No	-	-
98512	84615	1084615	buteliukas	N90 (3x30)		Receptinis	EU/1/17/1225/002	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2017-09-21	Registruotas