Zylumit

Medicinal product

(Invented) name

Zylumit

Active substance (s)

Azitromicinas

Strength

500 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)

J01FA10, Azithromycin

Marketing authorisation holder

Rivopharm Ltd., Airija

Date of authorisation

2012-10-30

Date of renewal

2018-06-08

Documents

3110_1_2 Zylumit 500mg tab PCS PL 210205.docx

3110_1_2 Pakuotės lapelis 210205.docx

Stage

Išregistruotas

Controlled?

No

Controlled substance type

Legal basis

10(1)

Procedure number

EE/H/0281/002

Marketing authorisation procedure

Savitarpio pripažinimo procedūra

Qualitative and quantitative composition

Tabletėje yra	1 vnt.
Azitromicinas	500 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
51854	65752	1065752	lizdinė plokštelė	N2		Receptinis	LT/1/12/3110/001	Netiekiama	-	-	No	-	-
54154	68143	1068143	lizdinė plokštelė	N3		Receptinis	LT/1/12/3110/002	Netiekiama	-	-	No	-	-	Download

Stadijos

Data	Stadija
2024-11-28	Išregistruotas
2018-06-08	Perregistruotas
2012-10-30	Registruotas