Emtricitabine/Tenofovir disoproxil Sandoz

Medicinal product

(Invented) name

Emtricitabine/Tenofovir disoproxil Sandoz

Active substance (s)

Emtricitabinas/Tenofoviro dizoproksilis

Strength

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)

No

ATC code (s)

J05AR03, Tenofovir disoproxil and emtricitabine

Marketing authorisation holder

Sandoz d.d., Slovėnija

Date of authorisation

2017-04-27

Date of renewal

2022-06-23

Documents

4072 Emtricitabine_Tenofovir disoproxil Sandoz RPP 2024 05 28.docx

4072 Pakuotės lapelis 2024 05 28.docx

Stage

Perregistruotas

Controlled?

No

Controlled substance type

Legal basis

10(1)

Procedure number

FI/H/0910/001/DC

Marketing authorisation procedure

Decentralizuota procedūra

Qualitative and quantitative composition

Tabletėje yra:	1 vnt.
Emtricitabinas	200 mg
Tenofoviro dizoproksilis	245 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
65015	79511	1079511	lizdinė plokštelė	N30		Receptinis	LT/1/17/4072/001	Netiekiama	-	-	No	-	-	Download
68139	82705	1082705	lizdinė plokštelė	N60		Receptinis	LT/1/17/4072/002	Netiekiama	-	-	No	-	-
68140	82706	1082706	lizdinė plokštelė	N90		Receptinis	LT/1/17/4072/003	Netiekiama	-	-	No	-	-
68141	82707	1082707	buteliukas	N30		Receptinis	LT/1/17/4072/004	Netiekiama	-	-	No	-	-
68142	82708	1082708	buteliukas	N60 (2x30)		Receptinis	LT/1/17/4072/005	Netiekiama	-	-	No	-	-
68143	82709	1082709	buteliukas	N90 (3x30)		Receptinis	LT/1/17/4072/006	Netiekiama	-	-	No	-	-
97601	83695	1083695	lizdinė plokštelė	N10		Receptinis	LT/1/17/4072/007	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2022-06-23	Perregistruotas
2017-04-27	Registruotas