Giona Easyhaler

Medicinal product

(Invented) name

Giona Easyhaler

Active substance (s)

Budezonidas

Strength

100 µg/dozėje

Pharmaceutical form

įkvepiamieji milteliai

Route (s) of administration

įkvėpti

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

R03BA02, Budesonide

Marketing authorisation holder

Orion Corporation, Suomija

Date of authorisation

2006-01-18

Date of renewal

2008-01-25

Documents

0399 Giona Easyhaler PZ PL 2023 01 10.docx

0399 pakuotes lapelis 2023 01 10.docx

Stage

Perregistruotas

Controlled?

No

Controlled substance type

Legal basis

10(1)

Procedure number

DE/H/0402/001/MR

Marketing authorisation procedure

Savitarpio pripažinimo procedūra

Qualitative and quantitative composition

Dozėje yra	1 dozėje
Budezonidas	100 µg

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
14507	18751	1018751	inhaliatorius	daugiadozis inhaliatorius (200 dozių), N1		Receptinis	LT/1/05/0399/001	Netiekiama	-	-	No	-	-
14508	18752	1018752	inhaliatorius	daugiadozis inhaliatorius (200 dozių), N2		Receptinis	LT/1/05/0399/002	Netiekiama	-	-	No	-	-
14509	18753	1018753	inhaliatorius	daugiadozis inhaliatorius su apsauginiu dangteliu (200 dozių), N1		Receptinis	LT/1/05/0399/003	Netiekiama	-	-	No	-	-
50685	64573	1064573	inhaliatorius	daugiadozis inhaliatorius (200 dozių), N3		Receptinis	LT/1/05/0399/010	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2008-01-25	Perregistruotas
2006-01-18	Registruotas