Xenleta

Medicinal product

(Invented) name

Xenleta

Active substance (s)

Lefamulinas

Strength

600 mg

Pharmaceutical form

plėvele dengtos tabletės

Route (s) of administration

vartoti per burną

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

Film-coated tablet	1 vnt.
Lefamulinas	600 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
104797	90898	1090898	lizdinė plokštelė	N10		Receptinis	EU/1/20/1457/002	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2020-07-27	Registruotas