Foster

Medicinal product

(Invented) name

Foster

Active substance (s)

Beklometazono dipropionatas/Formoterolio fumaratas dihidratas

Strength

200 µg/6 µg/išpurškime

Pharmaceutical form

įkvepiamieji milteliai

Route (s) of administration

įkvėpti

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

R03AK08, Formoterol and beclometasone

Marketing authorisation holder

Chiesi Pharmaceuticals GmbH, Austrija

Date of authorisation

2016-01-04

Date of renewal

2020-07-15

Documents

3491 Foster 200_6 ikvep milt PL 2021 09 07.docx

3491 Pakuotės lapelis 200_6 ikvep milt 2021 09 07.docx

Stage

Perregistruotas

Controlled?

No

Controlled substance type

Legal basis

10b

Procedure number

DE/H/0873/004/DC

Marketing authorisation procedure

Decentralizuota procedūra

Qualitative and quantitative composition

Viename išpurškime yra	1 išpurškime
Beklometazono dipropionatas	200 µg
Formoterolio fumaratas dihidratas	6 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
59471	73699	1073699	inhaliatorius	120 išpurškimų N1		Receptinis	LT/1/14/3491/004	Netiekiama	-	-	No	-	-
64710	79197	1079197	inhaliatorius	120 išpurškimų N2		Receptinis	LT/1/14/3491/005	Netiekiama	-	-	No	-	-
64711	79198	1079198	inhaliatorius	120 išpurškimų N3		Receptinis	LT/1/14/3491/006	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2020-07-15	Perregistruotas
2016-01-04	Registruotas