Odefsey

Medicinal product

(Invented) name

Odefsey

Active substance (s)

Emtricitabinas/Rilpivirinas/Tenofoviras alafenamidas

Strength

200 mg/25 mg/25 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)

J05AR19, Emtricitabine, tenofovir alafenamide and rilpivirine

Marketing authorisation holder

Gilead Sciences Ireland UC, Airija

Date of authorisation

2016-06-21

Date of renewal

Documents

Stage

Registruotas

Controlled?

Controlled substance type

Legal basis

8(3)

Procedure number

Marketing authorisation procedure

Centrinė registracija

Qualitative and quantitative composition

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
66036	80552	1080552	buteliukas	N30		Receptinis	EU/1/16/1112/001	Netiekiama	-	-	No	-	-
66037	80553	1080553	buteliukas	N90 (3x30)		Receptinis	EU/1/16/1112/002	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2016-06-21	Registruotas