Emtricitabine/Tenofovir disoproxil Krka

Medicinal product

(Invented) name

Emtricitabine/Tenofovir disoproxil Krka

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

2016-12-08

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
67278	81825	1081825	lizdinė plokštelė	N28		Receptinis	EU/1/16/1151/001	Netiekiama	-	-	No	-	-
67280	81827	1081827	buteliukas	N30		Receptinis	EU/1/16/1151/002	Tiekiama	-	-	No	-	-
67279	81826	1081826	lizdinė plokštelė	N84		Receptinis	EU/1/16/1151/003	Netiekiama	-	-	No	-	-
67281	81828	1081828	buteliukas	N90 (3x30)		Receptinis	EU/1/16/1151/004	Netiekiama	-	-	No	-	-
107508	93613	1093613	dalomoji lizdinė plokštelė	N28×1		Receptinis	EU/1/16/1151/005	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2016-12-08	Registruotas