Vylaer Spiromax

Medicinal product

(Invented) name

Vylaer Spiromax

Active substance (s)

Budezonidas/Formoterolis

Strength

160 µg/4,5 µg

Pharmaceutical form

dozuoti 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

2014-11-19

Date of renewal

Documents

Search in EMA Europe

Stage

Išregistruotas

Controlled?

No

Controlled substance type

Legal basis

Procedure number

Marketing authorisation procedure

Centrinė registracija

Qualitative and quantitative composition

Inhalation powder	1 vnt.
Budezonidas	160 µg
Formoterolis	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
60797	75087	1075087	inhaliatorius	120 dozių N1		Receptinis	EU/1/14/949/001	Netiekiama	-	-	No	-	-
61986	76358	1076358	inhaliatorius	N3x120 dozių		Receptinis	EU/1/14/949/003	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
	Išregistruotas
2014-11-19	Registruotas