Emtricitabine/Tenofovir disoproxil Zentiva

Medicinal product

(Invented) name

Emtricitabine/Tenofovir disoproxil Zentiva

Active substance (s)

Emtricitabinas/Tenofoviro dizoproksilis

Strength

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)

No

ATC code (s)

J05AR03, Tenofovir disoproxil and emtricitabine

Marketing authorisation holder

Zentiva k.s., Čekija

Date of authorisation

2016-11-09

Date of renewal

Documents

Kontrolinis sąrašas, skirtas vaistinį preparatą skiriantiems specialistams.pdf

Paciento kortelė.pdf

Mokomoji medžiaga sveikatos priežiūros specialistams.pdf

Emtricitabine_Tenofovir disoproxil Zentiva mokomoji medžiaga sveikatos priežiūros specialistams.pdf

Mokomoji medžiaga pacientams.pdf

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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.
Emtricitabinas	200 mg
Tenofoviro dizoproksilis	245 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
67176	81720	1081720	buteliukas	N30		Receptinis	EU/1/16/1148/001	Netiekiama	-	-	No	-	-
67177	81721	1081721	buteliukas	N90 (3x30)		Receptinis	EU/1/16/1148/002	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2016-11-09	Registruotas