Hydrea

Medicinal product

(Invented) name

Hydrea

Active substance (s)

Hidroksikarbamidas

Strength

500 mg

Pharmaceutical form

kietosios kapsulės

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

Cheplapharm Arzneimittel GmbH, Vokietija

Date of authorisation

1998-10-22

Date of renewal

2012-06-15

Documents

0429 Pakuotės lapelis 2025 02 07.docx

0429 Hydrea PCS PL 2025 02 07.docx

Stage

Perregistruotas

Controlled?

No

Controlled substance type

Legal basis

8(3)

Procedure number

Marketing authorisation procedure

Nacionalinė procedūra

Qualitative and quantitative composition

Kapsulėje yra	1 vnt.
Hidroksikarbamidas	500 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
15412	2639	1002639	buteliukas	N100		Receptinis	LT/1/98/0429/001	Tiekiama	2025-07-28	-	No	-	-	Download

Stadijos

Data	Stadija
2012-06-15	Perregistruotas
1998-10-22	Registruotas