Trimbow

Medicinal product

(Invented) name

Trimbow

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

2017-07-17

Date of renewal

Documents

Stage

Registruotas

Controlled?

Controlled substance type

Legal basis

10b

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
68828	83425	1083425	inhaliatorius	60 dozių N1	Receptinis	EU/1/17/1208/001	Netiekiama	-	-	No	-	-
68829	83426	1083426	inhaliatorius	120 dozių N1	Receptinis	EU/1/17/1208/002	Netiekiama	-	-	No	-	-
68832	83429	1083429	inhaliatorius	180 dozių N1	Receptinis	EU/1/17/1208/003	Tiekiama	-	-	No	-	-
68830	83427	1083427	inhaliatorius	120 dozių N2 (240 dozių, sudėtinė)	Receptinis	EU/1/17/1208/004	Netiekiama	-	-	No	-	-
68831	83428	1083428	inhaliatorius	120 dozių N3 (360 dozių, sudėtinė)	Receptinis	EU/1/17/1208/005	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2017-07-17	Registruotas