Airbufo Forspiro

Medicinal product

(Invented) name

Airbufo Forspiro

Active substance (s)

Budezonidas/Formoterolio fumaratas dihidratas

Strength

320 µg/9 µg

Pharmaceutical form

dozuoti įkvepiamieji milteliai

Route (s) of administration

įkvėpti

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

R03AK07, Formoterol and budesonide

Marketing authorisation holder

Sandoz d.d., Slovėnija

Date of authorisation

2021-04-23

Date of renewal

Documents

4728 Airbufo Forspiro PL 2021 12 20.docx

4728 Pakuotės lapelis 2021 12 20.docx

Stage

Išregistruotas

Controlled?

No

Controlled substance type

Legal basis

10(3)

Procedure number

SE/H/1688/002/DC

Marketing authorisation procedure

Decentralizuota procedūra

Qualitative and quantitative composition

Dozėje yra	1 dozėje
Budezonidas	320 µg
Formoterolio fumaratas dihidratas	9 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
106364	92465	1092465	inhaliatorius	60 dozių N1		Receptinis	LT/1/21/4728/001	Netiekiama	-	-	No	-	-
106365	92466	1092466	inhaliatorius	60 dozių N2		Receptinis	LT/1/21/4728/002	Netiekiama	-	-	No	-	-
106366	92467	1092467	inhaliatorius	60 dozių N3		Receptinis	LT/1/21/4728/003	Netiekiama	-	-	No	-	-
106367	92468	1092468	inhaliatorius	60 dozių N6		Receptinis	LT/1/21/4728/004	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2022-10-28	Išregistruotas
2021-04-23	Registruotas