GoResp Digihaler [Budesonide/Formoterol Teva Pharma B.V.]

Medicinal product

(Invented) name

Active substance (s)

Budezonidas/Formoterolio fumaratas dihidratas

Strength

320 µg/9 µg

Pharmaceutical form

įkvepiamieji milteliai

Route (s) of administration

įkvėpti

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

ATC code (s)

R03AK07, Formoterol and budesonide

Marketing authorisation holder

Teva Pharma B.V., Nyderlandai

Date of authorisation

2020-04-03

Date of renewal

Documents

Stage

Registruotas

Controlled?

Controlled substance type

Legal basis

10(3)

Procedure number

Marketing authorisation procedure

Centrinė registracija

Qualitative and quantitative composition

Each delivered dose contains	1 dozėje
Budezonidas	320 µg
Formoterolio fumaratas dihidratas	9 µg

Packages

PAKID	NPAKID	NPAKID-7	Pack type	Pack size	Proposed dispensing/classification	Marketing authorisation no.	Supply status	From	To	Package is in foreign language	From	To
103747	89849	1089849	inhaliatorius	90 dozių N1	Receptinis	EU/1/19/1403/004	Netiekiama	-	-	No	-	-
103748	89850	1089850	inhaliatorius	90 dozių N2	Receptinis	EU/1/19/1403/005	Netiekiama	-	-	No	-	-
103749	89851	1089851	inhaliatorius	90 dozių N3	Receptinis	EU/1/19/1403/006	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2020-04-03	Registruotas