Efavirenz/Emtricitabine/Tenofovir disoproxil Krka

Medicinal product

(Invented) name

Active substance (s)

Efavirenzas/Emtricitabinas/Tenofoviro dizoproksilis

Strength

600 mg/200 mg/245 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)

J05AR06, Emtricitabine, tenofovir disoproxil and efavirenz

Marketing authorisation holder

KRKA, d.d., Novo mesto, Slovėnija

Date of authorisation

2018-02-08

Date of renewal

Documents

Stage

Registruotas

Controlled?

Controlled substance type

Legal basis

10(1)

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
98978	85082	1085082	buteliukas	N30		Receptinis	EU/1/17/1263/001	Netiekiama	-	-	No	-	-
98979	85083	1085083	buteliukas	N90 (3x30)		Receptinis	EU/1/17/1263/002	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2018-02-08	Registruotas