Symbicort Turbuhaler

Medicinal product

(Invented) name

Symbicort Turbuhaler

Active substance (s)

Budezonidas/Formoterolio fumaratas dihidratas

Strength

80 µg/4,5 µg/dozėje

Pharmaceutical form

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

UAB Niromed, Lietuva

Date of authorisation

2026-10-02

Date of renewal

Documents

3618_Symbicort Turbuhaler_80_4.5_PZ.docx

3618_Symbicort Turbuhaler_80_4.5_PL.docx

Stage

Registruotas

Controlled?

No

Controlled substance type

Legal basis

Procedure number

Marketing authorisation procedure

Lygiagretus importas

Qualitative and quantitative composition

Kiekvienoje įkvepiamoje (praeinančioje per kandiklį) dozėje:	1 dozėje
Budezonidas	80 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
122503	108613	1108613	inhaliatorius	60 dozių N1		Receptinis	LT/L/26/3618/001	Netiekiama	-	-	No	-	-	Download

Stadijos

Data	Stadija
2026-10-02	Registruotas