Emtricitabine/Rilpivirine/Tenofovir Alafenamide Viatris

Medicinal product

(Invented) name

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

Viatris Limited, Airija

Date of authorisation

2025-08-19

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
118413	104519	1104519	lizdinė plokštelė	N30	Receptinis	EU/1/25/1966/001	Netiekiama	-	-	No	-	-
118414	104520	1104520	lizdinė plokštelė	N90	Receptinis	EU/1/25/1966/002	Netiekiama	-	-	No	-	-
118415	104521	1104521	dalomoji lizdinė plokštelė	N30×1	Receptinis	EU/1/25/1966/003	Netiekiama	-	-	No	-	-
118416	104522	1104522	dalomoji lizdinė plokštelė	N90×1	Receptinis	EU/1/25/1966/004	Netiekiama	-	-	No	-	-
118417	104523	1104523	buteliukas	N30	Receptinis	EU/1/25/1966/005	Netiekiama	-	-	No	-	-
118418	104524	1104524	buteliukas	N90	Receptinis	EU/1/25/1966/006	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2025-08-19	Registruotas