BroPair Spiromax

Medicinal product

(Invented) name

BroPair Spiromax

Active substance (s)

Salmeterolis/Flutikazono propionatas

Strength

12,75 µg/100 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

2021-03-26

Date of renewal

Documents

Search in EMA Europe

Stage

Išregistruotas

Controlled?

No

Controlled substance type

Legal basis

8(3)

Procedure number

Marketing authorisation procedure

Centrinė registracija

Qualitative and quantitative composition

Inhalation powder	1 dozėje
Salmeterolis	12,75 µg
Flutikazono propionatas	100 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
106238	92339	1092339	inhaliatorius	60 dozių N1		Receptinis	EU/1/21/1534/001	Netiekiama	-	-	No	-	-
106239	92340	1092340	inhaliatorius	60 dozių N3 (3x1)		Receptinis	EU/1/21/1534/002	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2025-05-23	Išregistruotas
2021-03-26	Registruotas