Trimbow

Medicinal product

(Invented) name

Trimbow

Active substance (s)

Beklometazono dipropionatas/Formoterolio fumaratas dihidratas/Glikopironis

Strength

172 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	172 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
105680	91780	1091780	inhaliatorius	60 dozių N1	Receptinis	EU/1/17/1208/006	Netiekiama	-	-	No	-	-
105681	91781	1091781	inhaliatorius	120 dozių N1	Receptinis	EU/1/17/1208/007	Netiekiama	-	-	No	-	-
105683	91783	1091783	inhaliatorius	120 dozių N2	Receptinis	EU/1/17/1208/008	Netiekiama	-	-	No	-	-
105684	91784	1091784	inhaliatorius	120 dozių N3	Receptinis	EU/1/17/1208/009	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2017-07-17	Registruotas