Padviram

Medicinal product

(Invented) name

Padviram

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

Sandoz d.d., Slovėnija

Date of authorisation

2017-09-28

Date of renewal

Documents

Stage

Išregistruotas

Controlled?

Controlled substance type

Legal basis

10(1)

Procedure number

NL/H/3893/001/DC

Marketing authorisation procedure

Decentralizuota procedūra

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
98014	84110	1084110	buteliukas	N30		Receptinis	LT/1/17/4137/001	Netiekiama	-	-	No	-	-
98015	84111	1084111	buteliukas	N90 (3x30)		Receptinis	LT/1/17/4137/002	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2020-02-27	Išregistruotas
2017-09-28	Registruotas