Register of
Medicinal Products

Product class: Authorized package
Medicinal product class: For human use
Package code: 1227653
Name of medicinal product: NORMOSANG
Active substances:
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 January 28, 2020)
Package information leaflet (PIL): EST  (last updated July 2, 2019)
Labelling:  (last updated July 2, 2019)
Last imported to Estonia: October 4, 2022
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 
Reference price:   
Under reference price:   
Reference price of daily dose:   
Entry/Changing date: August 23, 2022
Legal status for supply – medicinal product on medical prescription or not subject to medical prescription

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