Azibiot

Medicinal product

(Invented) name

Azibiot

Active substance (s)

Azitromicinas

Strength

250 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

KRKA, d.d., Novo mesto, Slovėnija

Date of authorisation

2014-08-01

Date of renewal

2019-06-10

Documents

3600 Pakuotės lapelis tab 2022 08 30.docx

3600 Azibiot tab PCS PL 2022 08 30.docx

Stage

Perregistruotas

Controlled?

No

Controlled substance type

Legal basis

10(1)

Procedure number

SK/H/0148/001/DC

Marketing authorisation procedure

Decentralizuota procedūra

Qualitative and quantitative composition

Tabletėje yra	1 vnt.
Azitromicinas	250 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
56144	70226	1070226	lizdinė plokštelė	N4		Receptinis	LT/1/14/3600/001	Netiekiama	-	-	No	-	-
59709	73943	1073943	lizdinė plokštelė	N6		Receptinis	LT/1/14/3600/002	Netiekiama	-	-	No	-	-	Download

Stadijos

Data	Stadija
2019-06-10	Perregistruotas
2014-08-01	Registruotas