Miflonide Breezhaler

Medicinal product

(Invented) name

Miflonide Breezhaler

Active substance (s)

Budezonidas

Strength

400 µg

Pharmaceutical form

įkvepiamieji milteliai (kietosios kapsulės)

Route (s) of administration

įkvėpti

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

R03BA02, Budesonide

Marketing authorisation holder

SIA Novartis Baltics , Latvija

Date of authorisation

2002-04-02

Date of renewal

2009-05-13

Documents

1570 Miflonide Breezhaler PCS PL 2022 06 21.docx

1570 Pakuotės lapelis 2022 06 21.docx

Stage

Išregistruotas

Controlled?

No

Controlled substance type

Legal basis

8(3)

Procedure number

Marketing authorisation procedure

Nacionalinė procedūra

Qualitative and quantitative composition

Kapsulėje yra	1 vnt.
Budezonidas	400 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
2813	3730	1003730	lizdinė plokštelė	N60 ir inhaliatorius		Receptinis	LT/1/02/1570/003	Netiekiama	2024-05-31	-	No	-	-	Download

Stadijos

Data	Stadija
2025-07-30	Išregistruotas
2009-05-13	Perregistruotas
2002-04-02	Registruotas