Giona Easyhaler

Medicinal product

(Invented) name

Giona Easyhaler

Active substance (s)

Budezonidas

Strength

200 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 pakuotes lapelis 2023 01 10.docx

0399 Giona Easyhaler PZ PL 2023 01 10.docx

Stage

Perregistruotas

Controlled?

No

Controlled substance type

Legal basis

10(1)

Procedure number

DE/H/0402/002/MR

Marketing authorisation procedure

Savitarpio pripažinimo procedūra

Qualitative and quantitative composition

Dozėje yra	1 dozėje
Budezonidas	200 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
14510	4444	1004444	inhaliatorius	daugiadozis inhaliatorius (200 dozių), N1		Receptinis	LT/1/05/0399/004	Netiekiama	-	-	No	-	-
14512	18755	1018755	inhaliatorius	daugiadozis inhaliatorius (200 dozių), N2		Receptinis	LT/1/05/0399/005	Netiekiama	-	-	No	-	-
14511	18754	1018754	inhaliatorius	daugiadozis inhaliatorius su apsauginiu dangteliu (200 dozių), N1		Receptinis	LT/1/05/0399/006	Tiekiama	-	-	No	-	-	Download
50693	64581	1064581	inhaliatorius	daugiadozis inhaliatorius (120 dozių), N1		Receptinis	LT/1/05/0399/011	Netiekiama	-	-	No	-	-
50694	64582	1064582	inhaliatorius	daugiadozis inhaliatorius (200 dozių), N3		Receptinis	LT/1/05/0399/012	Netiekiama	-	-	No	-	-

Stadijos

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