Normosang

Medicinal product

(Invented) name

Normosang

Active substance (s)

Žmogaus heminas

Strength

25 mg/ml

Pharmaceutical form

koncentratas infuziniam tirpalui

Route (s) of administration

leisti į veną

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

B06AB, Heme products

Marketing authorisation holder

Recordati Rare Diseases, Prancūzija

Date of authorisation

2008-02-22

Date of renewal

2022-10-24

Documents

Normosang mokomoji medziaga sveikatos prieziuros specialistams.pdf

1024 Pakuotės lapelis 2025 01 22.docx

1024 Normosang RPP 2025 01 22.docx

Stage

Perregistruotas

Controlled?

No

Controlled substance type

Legal basis

8(3)

Procedure number

FR/H/0140/001/E/001

Marketing authorisation procedure

Kartotinė procedūra

Qualitative and quantitative composition

1 ml koncentrato yra:	1 ml
Žmogaus heminas	25 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
18747	22291	1022291	ampulė	10 ml N4		Receptinis	LT/1/08/1024/001	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2022-10-24	Perregistruotas
2008-02-22	Registruotas