Emtricitabine/Tenofovir disoproxil Accordpharma

Medicinal product

(Invented) name

Emtricitabine/Tenofovir disoproxil Accordpharma

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

Accord Healthcare B.V., Nyderlandai

Date of authorisation

2020-01-24

Date of renewal

2024-01-19

Documents

Paciento kortele PrEP indikacijai.pdf

Kontrolinis sąrašas vaistinį preparatą skiriantiems asmenims PrEP indikacijai.pdf

4502 Emtricit_Tenofovir disopr Accordpharma RPP 2024 08 29.docx

Mokomoji medziaga pacientams PrEP indikacijai.pdf

4502 Pakuotės lapelis 2024 08 29.docx

Stage

Perregistruotas

Controlled?

No

Controlled substance type

Legal basis

10(1)

Procedure number

NL/H/4213/001/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
103127	89228	1089228	dalomoji lizdinė plokštelė	N30x1		Receptinis	LT/1/20/4502/001	Tiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2024-01-19	Perregistruotas
2020-01-24	Registruotas