NORMOSANG
General data
Product class:
Authorized package
Medicinal product class:
For human use
Package code:
1227653
Name of medicinal product:
NORMOSANG
Active substances:
Hemin
Estonian
,
English
,
Latin
ATC code:
B06AB01
Dosage form:
concentrate for solution for infusion
Route of administration:
intravenous use
Strengh:
25mg 1ml
Amount in package:
10ml 4TK
Legal status for supply*:
Subject to medicinal prescription
Class of active substance:
Additional information:
Indication:
Treatment of acute attacks of hepatic porphyria ( acute intermittent porphyria, porpyria variegata, hereditary coproporphyria).
Safety features:
Yes
Summary of product characteristics (SPC):
(last updated 28 January 2020)
Package information leaflet (PIL):
EST
(last updated 02 July 2019)
Labelling:
(last updated 02 July 2019)
Last imported to Estonia:
04 October 2022
Marketing authorization
Marketing authorization holder:
Recordati Rare Diseases
Marketing authorization number:
524806
Marketing authorization issued on:
20 October 2006
Marketing authorization expires on:
Unlimited
Marketing authorization procedure type:
Mutual recognition
Prices
Reference price:
Under reference price:
Reference price of daily dose:
Entry/Changing date: 23 August 2022
Legal status for supply – medicinal product on medical prescription or not subject to medical prescription