Siklos

Medicinal product

(Invented) name

Siklos

Active substance (s)

Hidroksikarbamidas

Strength

100 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)

L01XX05, Hydroxycarbamide

Marketing authorisation holder

THERAVIA, Prancūzija

Date of authorisation

2007-06-29

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.
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
45704	59505	1059505	buteliukas	N60		Receptinis	EU/1/07/397/002	Netiekiama	-	-	No	-	-
45705	59506	1059506	buteliukas	N90		Receptinis	EU/1/07/397/003	Netiekiama	-	-	No	-	-
45706	59507	1059507	buteliukas	N120		Receptinis	EU/1/07/397/004	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2007-06-29	Registruotas