BiResp Spiromax

Medicinal product

(Invented) name

BiResp Spiromax

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)

No

ATC code (s)

R03AK07, Formoterol and budesonide

Marketing authorisation holder

TEVA Pharma B.V., Nyderlandai

Date of authorisation

2014-04-28

Date of renewal

Documents

Search in EMA Europe

Stage

Registruotas

Controlled?

No

Controlled substance type

Legal basis

10(3)

Procedure number

Marketing authorisation procedure

Centrinė registracija

Qualitative and quantitative composition

Inhalation powder	1 dozėje
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
59061	73282	1073282	inhaliatorius	120 dozių N1		Receptinis	EU/1/14/921/001	Netiekiama	-	-	No	-	-
59062	73283	1073283	inhaliatorius	120 dozių N2		Receptinis	EU/1/14/921/002	Netiekiama	-	-	No	-	-
59063	73284	1073284	inhaliatorius	120 dozių N3		Receptinis	EU/1/14/921/003	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2014-04-28	Registruotas