Emtricitabine /Tenofovir disoproxil Krka d.d.

Medicinal product

(Invented) name

Emtricitabine /Tenofovir disoproxil Krka d.d.

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

KRKA, d.d., Novo mesto, Slovėnija

Date of authorisation

2017-05-02

Date of renewal

Documents

Search in EMA Europe

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
68328	82904	1082904	lizdinė plokštelė	N28		Receptinis	EU/1/17/1182/001	Netiekiama	-	-	No	-	-
68329	82905	1082905	buteliukas	N30		Receptinis	EU/1/17/1182/002	Netiekiama	-	-	No	-	-
68330	82906	1082906	lizdinė plokštelė	N84		Receptinis	EU/1/17/1182/003	Netiekiama	-	-	No	-	-
68331	82907	1082907	buteliukas	N90 (3x30)		Receptinis	EU/1/17/1182/004	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2017-05-02	Registruotas