Cubicin

Medicinal product

(Invented) name

Cubicin

Active substance (s)

Daptomicinas

Strength

500 mg

Pharmaceutical form

milteliai injekciniam ar infuziniam tirpalui

Route (s) of administration

leisti į veną

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

J01XX09, Daptomycin

Marketing authorisation holder

Merck Sharp & Dohme B.V., Nyderlandai

Date of authorisation

2006-01-19

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

Powder for solution for injection or infusion	1 vnt.
Daptomicinas	500 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
25756	28353	1028353	flakonas	N1		Receptinis	EU/1/05/328/002	Netiekiama	-	-	No	-	-
49781	63652	1063652	flakonas	N5		Receptinis	EU/1/05/328/004	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2006-01-19	Registruotas