Xenleta

Medicinal product

(Invented) name

Xenleta

Active substance (s)

Lefamulinas

Strength

150 mg

Pharmaceutical form

koncentratas ir tirpiklis infuziniam tirpalui

Route (s) of administration

leisti į veną

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

J01XX12, lefamulin

Marketing authorisation holder

Venipharm, Prancūzija

Date of authorisation

2020-07-27

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

Concentrate and solvent for solution for infusion	1 ml
Lefamulinas	150 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
104796	90897	1090897	flakonas	15 ml ir maišelis tirpiklio (250 ml) N2		Receptinis	EU/1/20/1457/001	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2020-07-27	Registruotas