Emtricitabine/Tenofovir alafenamide Viatris

Medicinal product

(Invented) name

Emtricitabine/Tenofovir alafenamide Viatris

Active substance (s)

Emtricitabinas/Tenofoviras alafenamidas

Strength

200 mg/25 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)

J05AR17, Emtricitabine and tenofovir alafenamide

Marketing authorisation holder

Viatris Limited, Airija

Date of authorisation

2025-07-18

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

Tabletėje yra:	1 vnt.
Emtricitabinas	200 mg
Tenofoviras alafenamidas	25 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
118160	104268	1104268	lizdinė plokštelė	N30		Receptinis	EU/1/25/1952/003	Netiekiama	-	-	No	-	-
118161	104269	1104269	lizdinė plokštelė	N90		Receptinis	EU/1/25/1952/004	Netiekiama	-	-	No	-	-
118162	104270	1104270	dalomoji lizdinė plokštelė	N30×1		Receptinis	EU/1/25/1952/005	Netiekiama	-	-	No	-	-
118163	104271	1104271	dalomoji lizdinė plokštelė	N90×1		Receptinis	EU/1/25/1952/006	Netiekiama	-	-	No	-	-
118164	104272	1104272	buteliukas	N30		Receptinis	EU/1/25/1952/007	Netiekiama	-	-	No	-	-
118165	104273	1104273	buteliukas	N90		Receptinis	EU/1/25/1952/008	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2025-07-18	Registruotas