Product class:
|
Medicinal product with marketing authorization
|
Medicinal product class:
|
Human medicine
|
Name of medicinal product:
|
NORMOSANG
|
Active substances:
|
|
ATC code:
|
B06AB01
|
Dosage form:
|
concentrate for solution for infusion
|
Strength:
|
25mg 1ml
|
Legal status for supply*:
|
Subject to medicinal prescription
|
Summary of product characteristics (SPC):
|
(last updated January 28, 2020)
|
Package information leaflet (PIL):
|
EST (last updated July 2, 2019)
|
Labelling:
|
(last updated July 2, 2019)
|
Indication:
|
Treatment of acute attacks of hepatic porphyria ( acute intermittent porphyria, porpyria variegata, hereditary coproporphyria).
|
Safety features:
|
Yes
|
Marketing authorization holder:
|
Recordati Rare Diseases
|
Marketing authorization number:
|
524806
|
Marketing authorization issued on:
|
October 20, 2006
|
Marketing authorization expires on:
|
Unlimited
|
Marketing authorization procedure type:
|
Mutual recognition
|
Assessment report:
|
|
Package code
|
Name of medicinal product
|
Dosage form
|
Package
|
Legal status
|
Reimbursements
|
Reference price
|
Last imported
|
PƤritolumaa
|
Additional information
|
1227653
|
NORMOSANG
|
concentrate for solution for infusion
|
25mg 1ml 10ml 4TK
|
Prescription
|
|
|
04.10.2022
|
|
|
Legal status for supply – medicinal product on medical prescription or not subject to medical prescription
You can download Acrobat Reader fromhere