Symbicort

Medicinal product

(Invented) name

Symbicort

Active substance (s)

Budezonidas/Formoterolio fumaratas dihidratas

Strength

160 µg/4,5 µg/išpurškime

Pharmaceutical form

suslėgtoji įkvepiamoji suspensija

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

AstraZeneca AB, Švedija

Date of authorisation

2016-07-22

Date of renewal

2021-09-22

Documents

2496 Symbicort 160 PZ PL 2024 12 02.docx

2496 Pakuotės lapelis 2024 12 02.docx

Stage

Perregistruotas

Controlled?

No

Controlled substance type

Legal basis

10b

Procedure number

SE/H/0229/003/DC

Marketing authorisation procedure

Decentralizuota procedūra

Qualitative and quantitative composition

Kiekvienoje išpurškiamoje (iš prietaiso atpalaiduojamoje) dozėje yra	1 išpurškime
Budezonidas	160 µg
Formoterolio fumaratas dihidratas	4,5 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
60223	74497	1074497	inhaliatorius	120 išpurškimų N1		Receptinis	LT/1/11/2496/026	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2021-09-22	Perregistruotas
2016-07-22	Registruotas