Xerava

Medicinal product

(Invented) name

Xerava

Active substance (s)

Eravaciklinas

Strength

100 mg

Pharmaceutical form

milteliai infuzinio tirpalo koncentratui

Route (s) of administration

leisti į veną

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

J01AA13, Eravacycline

Marketing authorisation holder

PAION Pharma GmbH, Vokietija

Date of authorisation

2018-09-20

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 concentrate for solution for infusion	1 vnt.
Eravaciklinas	100 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
106041	92142	1092142	flakonas	N1		Receptinis	EU/1/18/1312/003	Netiekiama	-	-	No	-	-
106042	92143	1092143	flakonas	N12 (12x1)		Receptinis	EU/1/18/1312/004	Netiekiama	-	-	No	-	-
106872	92975	1092975	flakonas	N10		Receptinis	EU/1/18/1312/005	Tiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2018-09-20	Registruotas