Flamerio

Medicinal product

(Invented) name

Flamerio

Active substance (s)

Salmeterolis/Flutikazono propionatas

Strength

50 µg/500 µg/dozėje

Pharmaceutical form

dozuoti 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

ELPEN Pharmaceutical Co. Inc., Graikija

Date of authorisation

2012-04-06

Date of renewal

2021-07-23

Documents

2888_Flamerio_perr2021-07-23.docx

2888_pakuotes lapelis_2021-07-23.docx

Stage

Išregistruotas

Controlled?

No

Controlled substance type

Legal basis

10(3)

Procedure number

EE/H/0224/002

Marketing authorisation procedure

Decentralizuota procedūra

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
43814	57591	1057591	dvisluoksnė juostelė	60 dozių N1		Receptinis	LT/1/12/2888/002	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2022-09-30	Išregistruotas
2021-07-23	Perregistruotas
2012-04-06	Registruotas