Daptomycin Norameda

Medicinal product

(Invented) name

Daptomycin Norameda

Active substance (s)

Daptomicinas

Strength

350 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

UAB Norameda, Lietuva

Date of authorisation

2018-04-26

Date of renewal

2023-11-16

Documents

4214 Daptomycin Norameda 350mg PCS PL 2024 06 21.docx

4214 Pakuotės lapelis 350mg 2024 06 21.docx

Stage

Perregistruotas

Controlled?

No

Controlled substance type

Legal basis

10(1)

Procedure number

EE/H/0409/001

Marketing authorisation procedure

Decentralizuota procedūra

Qualitative and quantitative composition

Flakone yra	1 vnt.
Daptomicinas	350 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
99382	85488	1085488	flakonas	N1		Receptinis	LT/1/18/4214/001	Netiekiama	-	-	No	-	-
99383	85489	1085489	flakonas	N5		Receptinis	LT/1/18/4214/002	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2023-11-16	Perregistruotas
2018-04-26	Registruotas