Abacavir/Lamivudine Mylan

Medicinal product

(Invented) name

Abacavir/Lamivudine Mylan

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

Mylan Pharmaceuticals Limited, Airija

Date of authorisation

2018-04-12

Date of renewal

2022-12-29

Documents

4210 ispej_kortele_.docx

4210 Pakuotės lapelis 2023 12 29.docx

4210 Abacavir_Lamivudine Mylan PCS PL 2023 12 29.docx

Stage

Perregistruotas

Controlled?

No

Controlled substance type

Legal basis

10(1)

Procedure number

EE/H/0265/001

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
99261	85367	1085367	lizdinė plokštelė	N30		Receptinis	LT/1/18/4210/001	Netiekiama	-	-	No	-	-	Download
99262	85368	1085368	lizdinė plokštelė	N60		Receptinis	LT/1/18/4210/002	Netiekiama	-	-	No	-	-
99263	85369	1085369	lizdinė plokštelė	N90		Receptinis	LT/1/18/4210/003	Netiekiama	-	-	No	-	-
99264	85370	1085370	buteliukas	N30		Receptinis	LT/1/18/4210/004	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2022-12-29	Perregistruotas
2018-04-12	Registruotas