Xromi

Medicinal product

(Invented) name

Xromi

Active substance (s)

Hidroksikarbamidas

Strength

100 mg/ml

Pharmaceutical form

geriamasis tirpalas

Route (s) of administration

vartoti per burną

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

L01XX05, Hydroxycarbamide

Marketing authorisation holder

Lipomed GmbH, Vokietija

Date of authorisation

2019-07-01

Date of renewal

Documents

Search in EMA Europe

Stage

Registruotas

Controlled?

No

Controlled substance type

Legal basis

10(3)

Procedure number

Marketing authorisation procedure

Centrinė registracija

Qualitative and quantitative composition

Oral solution	1 ml
Hidroksikarbamidas	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
102029	88131	1088131	buteliukas	150 ml, adapteris ir 3 ml ir 12 ml dozavimo švirkštai N1		Receptinis	EU/1/19/1366/001	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2019-07-01	Registruotas