Tenofovir disoproxil Viatris [Tenofovir disoproxil Mylan]

Medicinal product

(Invented) name

Active substance (s)

Tenofoviro dizoproksilis

Strength

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)

J05AF07, Tenofovir disoproxil

Marketing authorisation holder

Viatris Limited, Airija

Date of authorisation

2016-12-08

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

Film-coated tablet	1 vnt.
Tenofoviro dizoproksilis	245 mg

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
67276	81823	1081823	buteliukas	N30	Receptinis	EU/1/16/1129/001	Netiekiama	2024-12-01	2025-09-30	No	-	-
101261	87368	1087368	buteliukas	N90 (3x30)	Receptinis	EU/1/16/1129/002	Netiekiama	-	-	No	-	-
101262	87369	1087369	lizdinė plokštelė	N10	Receptinis	EU/1/16/1129/003	Netiekiama	-	-	No	-	-
101263	87370	1087370	lizdinė plokštelė	N30	Receptinis	EU/1/16/1129/004	Netiekiama	-	-	No	-	-
101264	87371	1087371	dalomoji lizdinė plokštelė	N30x1	Receptinis	EU/1/16/1129/005	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2016-12-08	Registruotas