Abacavir/Lamivudine Accord

Medicinal product

(Invented) name

Abacavir/Lamivudine Accord

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

Accord Healthcare B.V., Nyderlandai

Date of authorisation

2016-04-06

Date of renewal

2021-10-01

Documents

3900 ispejamoji kortele.docx

3900 Pakuotės lapelis 2023 11 21.docx

3900 Abacavir_Lamivudine Accord PCS PL 2023 11 21.docx

Stage

Perregistruotas

Controlled?

No

Controlled substance type

Legal basis

10(1)

Procedure number

NL/H/3488/001/DC

Marketing authorisation procedure

Decentralizuota 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
61815	76185	1076185	lizdinė plokštelė	N30		Receptinis	LT/1/16/3900/001	Tiekiama	-	-	No	-	-
65455	79959	1079959	lizdinė plokštelė	N90 (3x30)		Receptinis	LT/1/16/3900/002	Netiekiama	-	-	No	-	-
65456	79960	1079960	buteliukas	N30		Receptinis	LT/1/16/3900/003	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2021-10-01	Perregistruotas
2016-04-06	Registruotas