ARIKAYCE liposomal

Medicinal product

(Invented) name

ARIKAYCE liposomal

Active substance (s)

Amikacinas

Strength

590 mg

Pharmaceutical form

purškiamoji įkvepiamoji dispersija

Route (s) of administration

įkvėpti

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

J01GB06, Amikacin

Marketing authorisation holder

Insmed Netherlands B.V., Nyderlandai

Date of authorisation

2020-10-27

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

Nebuliser dispersion	1 vnt.
Amikacinas	590 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
105219	91321	1091321	flakonas	N28 (4 aerozolio galvutės ir purkštuvo rankena Lamira)		Receptinis	EU/1/20/1469/001	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2020-10-27	Registruotas