Trydonis

Medicinal product

(Invented) name

Trydonis

Active substance (s)

Beklometazono dipropionatas/Formoterolio fumaratas dihidratas/Glikopironis

Strength

88 µg/5 µg/9 µg

Pharmaceutical form

įkvepiamieji milteliai

Route (s) of administration

įkvėpti

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

ATC code (s)

R03AL09, Formoterol, glycopyrronium bromide and beclometasone

Marketing authorisation holder

Chiesi Farmaceutici S.p.A., Italija

Date of authorisation

2018-04-26

Date of renewal

Documents

Stage

Registruotas

Controlled?

Controlled substance type

Legal basis

10c

Procedure number

Marketing authorisation procedure

Centrinė registracija

Qualitative and quantitative composition

Inhalation powder	1 dozėje
Beklometazono dipropionatas	88 µg
Formoterolio fumaratas dihidratas	5 µg
Glikopironis	9 µg

Packages

PAKID	NPAKID	NPAKID-7	Pack type	Pack size	Proposed dispensing/classification	Marketing authorisation no.	Supply status	From	To	Package is in foreign language	From	To
107871	93976	1093976	inhaliatorius	120 dozių N1 (NEXThaler)	Receptinis	EU/1/18/1274/006	Netiekiama	-	-	No	-	-
107872	93977	1093977	inhaliatorius	120 dozių N2 (NEXThaler)	Receptinis	EU/1/18/1274/007	Netiekiama	-	-	No	-	-
107873	93978	1093978	inhaliatorius	120 dozių N3 (NEXThaler)	Receptinis	EU/1/18/1274/008	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2018-04-26	Registruotas