Trydonis

Medicinal product

(Invented) name

Trydonis

Active substance (s)

Beklometazono dipropionatas/Formoterolio fumaratas dihidratas/Glikopironis

Strength

87 µg/5 µg/9 µg

Pharmaceutical form

suslėgtasis įkvepiamasis tirpalas

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

Pressurised inhalation, solution	1 dozėje
Beklometazono dipropionatas	87 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
99432	85539	1085539	inhaliatorius	60 dozių N1	Receptinis	EU/1/18/1274/001	Netiekiama	-	-	No	-	-
99433	85540	1085540	inhaliatorius	120 dozių N1	Receptinis	EU/1/18/1274/002	Netiekiama	-	-	No	-	-
99434	85541	1085541	inhaliatorius	180 dozių N1	Receptinis	EU/1/18/1274/003	Netiekiama	-	-	No	-	-
99435	85542	1085542	inhaliatorius	120 dozių N2 (240 dozių)	Receptinis	EU/1/18/1274/004	Netiekiama	-	-	No	-	-
99436	85543	1085543	inhaliatorius	120 dozių N3 (360 dozių)	Receptinis	EU/1/18/1274/005	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2018-04-26	Registruotas