Bronchitol

Medicinal product

(Invented) name

Bronchitol

Active substance (s)

Manitolis

Strength

40 mg

Pharmaceutical form

įkvepiamieji milteliai (kietosios kapsulės)

Route (s) of administration

įkvėpti

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

R05CB16, Mannitol

Marketing authorisation holder

Pharmaxis Europe Limited, Airija

Date of authorisation

2012-04-13

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, hard capsule	1 vnt.
Manitolis	40 mg

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
52144	66062	1066062	lizdinė plokštelė	N10 ir inhaliatorius		Receptinis	EU/1/12/760/001	Netiekiama	-	-	No	-	-
52145	66063	1066063	lizdinė plokštelė	N28x10 ir 2 inhaliatoriai		Receptinis	EU/1/12/760/002	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2012-04-13	Registruotas