Register of
Medicinal Products

Product class: Authorized package
Medicinal product class: For human use
Package code: 1004410
Name of medicinal product: ALKERAN
Active substances:
Melphalan
Estonian, English, Latin
ATC code: L01AA03
Dosage form: film-coated tablet
Route of administration: oral use
Strengh: 2mg
Amount in package: 25TK
Legal status for supply*: Subject to medicinal prescription
Class of active substance:  
Additional information:  
Indication:
Safety features: Yes
Summary of product characteristics (SPC):  (last updated September 21, 2022)
Package information leaflet (PIL): EST  (last updated February 20, 2024)
Labelling:  (last updated January 27, 2017)
Last imported to Estonia: April 9, 2024
Marketing authorization holder: Aspen Pharma Trading Limited 
Marketing authorization number: 100795 
Marketing authorization issued on: April 26, 2000 
Marketing authorization expires on: Unlimited 
Marketing authorization procedure type: National 
Percent Valid from Valid until Valid Diagnosis Doctor's speciality Primary Age Other
100  05.04.2024     Yes  C00-D48  Onkoloog, Hematoloog  No      
50  05.04.2024     Yes      No      
100  05.04.2024     Yes      No  until 4 years   
100  05.04.2024     Yes  C00-D48  Onkoloog, Hematoloog  No  until 4 years   
Reference price:   
Under reference price:   
Reference price of daily dose:   
Entry/Changing date: February 20, 2024
Legal status for supply – medicinal product on medical prescription or not subject to medical prescription

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