Abacavir/Lamivudine Zentiva

Medicinal product

(Invented) name

Abacavir/Lamivudine Zentiva

Active substance (s)

Abakaviras/Lamivudinas

Strength

600 mg/300 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)

J05AR02, Lamivudine and abacavir

Marketing authorisation holder

Zentiva k.s., Čekija

Date of authorisation

2020-06-29

Date of renewal

2022-02-22

Documents

4586 Pakuotės lapelis 2023 11 30.docx

4586 Abacavir_Lamivudine Zentiva PCS PL 2023 11 30.docx

Stage

Perregistruotas

Controlled?

No

Controlled substance type

Legal basis

10(1)

Procedure number

EE/H/0287/001/E/001

Marketing authorisation procedure

Kartotinė procedūra

Qualitative and quantitative composition

Tabletėje yra	1 vnt.
Abakaviras	600 mg
Lamivudinas	300 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
104583	90685	1090685	lizdinė plokštelė	N30		Receptinis	LT/1/20/4586/001	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2022-02-22	Perregistruotas
2020-06-29	Registruotas