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

UAB Niromed, Lietuva

Date of authorisation

2024-06-28

Date of renewal

Documents

2206_Hydrea_500mg_k_kaps_PL_2024-06-28.docx

2206_Hydrea_500mg_k_kaps_PZ_2024-06-28.docx

Stage

Registruotas

Controlled?

No

Controlled substance type

Legal basis

Procedure number

Marketing authorisation procedure

Lygiagretus importas

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
113970	100086	1100086	buteliukas	N100		Receptinis	LT/L/24/2206/001	Netiekiama	-	-	No	-	-	Download

Stadijos

Data	Stadija
2024-06-28	Registruotas