Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan

Medicinal product

(Invented) name

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

Mylan Pharmaceuticals Limited, Airija

Date of authorisation

2017-09-05

Date of renewal

Documents

Stage

Registruotas

Controlled?

Controlled substance type

Legal basis

10(1)

Procedure number

Marketing authorisation procedure

Centrinė registracija

Qualitative and quantitative composition

Packages

PAKID	NPAKID	NPAKID-7	Pack type	Pack size	Proposed dispensing/classification	Marketing authorisation no.	Supply status	From	To	Package is in foreign language	From	To
97823	83918	1083918	buteliukas	N30	Receptinis	EU/1/17/1222/001	Netiekiama	-	-	No	-	-
97824	83919	1083919	buteliukas	N90 (3x30)	Receptinis	EU/1/17/1222/002	Netiekiama	-	-	No	-	-
104169	90272	1090272	buteliukas	N90	Receptinis	EU/1/17/1222/003	Netiekiama	-	-	No	-	-
112018	98133	1098133	lizdinė plokštelė	N30	Receptinis	EU/1/17/1222/004	Netiekiama	-	-	No	-	-
112019	98134	1098134	lizdinė plokštelė	N90	Receptinis	EU/1/17/1222/005	Netiekiama	-	-	No	-	-
112020	98135	1098135	dalomoji lizdinė plokštelė	N30×1	Receptinis	EU/1/17/1222/006	Netiekiama	-	-	No	-	-
112021	98136	1098136	dalomoji lizdinė plokštelė	N90×1	Receptinis	EU/1/17/1222/007	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2017-09-05	Registruotas