Bretaris Genuair

Medicinal product

(Invented) name

Bretaris Genuair

Active substance (s)

Aklidinis

Strength

322 µg

Pharmaceutical form

įkvepiamieji milteliai

Route (s) of administration

įkvėpti

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

R03BB05, Aclidinium bromide

Marketing authorisation holder

Covis Pharma Europe B.V. , Nyderlandai

Date of authorisation

2012-07-20

Date of renewal

Documents

Search in EMA Europe

Stage

Registruotas

Controlled?

No

Controlled substance type

Legal basis

8(3)

Procedure number

Marketing authorisation procedure

Centrinė registracija

Qualitative and quantitative composition

Inhalation powder	1 dozėje
Aklidinis	322 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
53158	67100	1067100	inhaliatorius	30 dozių N1		Receptinis	EU/1/12/781/001	Netiekiama	-	-	No	-	-
53159	67101	1067101	inhaliatorius	60 dozių N1		Receptinis	EU/1/12/781/002	Tiekiama	-	-	No	-	-
53160	67102	1067102	inhaliatorius	60 dozių N3		Receptinis	EU/1/12/781/003	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2012-07-20	Registruotas