Resthizen

Medicinal product

(Invented) name

Resthizen

Active substance (s)

Klaritromicinas

Strength

500 mg

Pharmaceutical form

milteliai infuzinio tirpalo koncentratui

Route (s) of administration

leisti į veną

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

J01FA09, Clarithromycin

Marketing authorisation holder

Zenthique Limited, Malta

Date of authorisation

2023-10-13

Date of renewal

Documents

5246_Resthizen.docx

5246_pakuotes lapelis_2023-10-13.docx

LT_H_188_1_DC_Resthizen_VVP_LT apzvalga.pdf

Stage

Išregistruotas

Controlled?

No

Controlled substance type

Legal basis

10(1)

Procedure number

LT/H/0188/001/DC

Marketing authorisation procedure

Decentralizuota procedūra

Qualitative and quantitative composition

Flakone yra:	1 vnt.
Klaritromicinas	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
111778	97893	1097893	flakonas	N1		Receptinis	LT/1/23/5246/001	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2025-06-30	Išregistruotas
2023-10-13	Registruotas