Brimica Genuair

Medicinal product

(Invented) name

Brimica Genuair

Active substance (s)

Aklidinis/Formoterolio fumaratas dihidratas

Strength

340 µg/12 µg

Pharmaceutical form

dozuoti įkvepiamieji milteliai

Route (s) of administration

įkvėpti

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

R03AL05, Formoterol and aclidinium bromide

Marketing authorisation holder

Covis Pharma Europe B.V. , Nyderlandai

Date of authorisation

2014-11-19

Date of renewal

Documents

Search in EMA Europe

Stage

Registruotas

Controlled?

No

Controlled substance type

Legal basis

10b

Procedure number

Marketing authorisation procedure

Centrinė registracija

Qualitative and quantitative composition

Inhalation powder	1 dozėje
Aklidinis	340 µg
Formoterolio fumaratas dihidratas	12 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
60803	75093	1075093	inhaliatorius	60 dozių N1		Receptinis	EU/1/14/963/001	Tiekiama	-	-	No	-	-
60804	75094	1075094	inhaliatorius	60 dozių N3		Receptinis	EU/1/14/963/002	Netiekiama	-	-	No	-	-
66305	80830	1080830	inhaliatorius	30 dozių N1		Receptinis	EU/1/14/963/003	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2014-11-19	Registruotas