Aerivio Spiromax

Medicinal product

(Invented) name

Aerivio Spiromax

Active substance (s)

Salmeterolis/Flutikazono propionatas

Strength

50 µg/500 µg

Pharmaceutical form

įkvepiamieji milteliai

Route (s) of administration

įkvėpti

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

R03AK06, Salmeterol and fluticasone

Marketing authorisation holder

Teva B.V., Nyderlandai

Date of authorisation

2016-08-18

Date of renewal

Documents

Search in EMA Europe

Stage

Išregistruotas

Controlled?

No

Controlled substance type

Legal basis

10(3)

Procedure number

Marketing authorisation procedure

Centrinė registracija

Qualitative and quantitative composition

Dozėje yra	1 dozėje
Salmeterolis	50 µg
Flutikazono propionatas	500 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
66340	80865	1080865	inhaliatorius	60 dozių N1		Receptinis	EU/1/16/1122/001	Netiekiama	-	-	No	-	-
66341	80866	1080866	inhaliatorius	60 dozių N3		Receptinis	EU/1/16/1122/002	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2019-10-04	Išregistruotas
2016-08-18	Registruotas