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

Medicinal product

(Invented) name

Active substance (s)

Budezonidas/Formoterolio fumaratas dihidratas

Strength

160 µg/4,5 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	160 µg
Formoterolio fumaratas dihidratas	4,5 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
103744	89846	1089846	inhaliatorius	180 dozių N1	Receptinis	EU/1/19/1403/001	Netiekiama	-	-	No	-	-
103745	89847	1089847	inhaliatorius	180 dozių N2	Receptinis	EU/1/19/1403/002	Netiekiama	-	-	No	-	-
103746	89848	1089848	inhaliatorius	180 dozių N3	Receptinis	EU/1/19/1403/003	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2020-04-03	Registruotas