Tenofovir disoproxil Zentiva

Medicinal product

(Invented) name

Tenofovir disoproxil Zentiva

Active substance (s)

Tenofoviro dizoproksilis

Strength

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)

J05AF07, Tenofovir disoproxil

Marketing authorisation holder

Zentiva k.s., Čekija

Date of authorisation

2016-09-15

Date of renewal

Documents

Mokomoji medžiaga sveikatos priežiūros specialistams (suaugusių gydymas).pdf

Mokomoji medžiaga sveikatos priežiūros specialistams (paauglių gydymas).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.
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
66513	81047	1081047	buteliukas	N30		Receptinis	EU/1/16/1127/001	Netiekiama	-	-	No	-	-
66514	81048	1081048	buteliukas	N90 (3x30) (sudėtinė)		Receptinis	EU/1/16/1127/002	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2016-09-15	Registruotas