Saflutin

Medicinal product

(Invented) name

Saflutin

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

UAB Inteli Generics Nord, Lietuva

Date of authorisation

2015-10-16

Date of renewal

2020-11-20

Documents

Saflutin_AR.pdf

3820 Saflutin_doz_ikv_milt_perr2020-11-20.doc

3820 pakuotes lapelis_2020-11-20.doc

Stage

Perregistruotas

Controlled?

No

Controlled substance type

Legal basis

10(3)

Procedure number

Marketing authorisation procedure

Nacionalinė procedūra

Qualitative and quantitative composition

Kiekvienoje 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
61056	75367	1075367	daugiadozė talpyklė	60 dozių N1		Receptinis	LT/1/15/3820/003	Tiekiama	-	-	No	-	-	Download

Stadijos

Data	Stadija
2020-11-20	Perregistruotas
2015-10-16	Registruotas