ALKERAN

This brand name is authorized in United States. It is also authorized in Australia, Austria, Brazil, Canada, Estonia, Finland, France, Hong Kong SAR China, Ireland, Israel, Japan, Lithuania, Mexico, Netherlands, New Zealand, Poland, Romania, Singapore, South Africa, Turkey.

Active ingredients

The drug ALKERAN contains one active pharmaceutical ingredient (API):

1
UNII Q41OR9510P - MELPHALAN
 

Melphalan is a bifunctional alkylating agent. Formation of carbonium intermediates from each of the two bis-2-chloroethyl groups enables alkylation through covalent binding with the 7-nitrogen of guanine on DNA, cross-linking the two DNA strands and thereby preventing cell replication.

 
Read more about Melphalan

Medication package inserts

Below package inserts are available for further reading:

Document Type Information Source  
 ALKERAN MPI, EU: SmPC Health Products Regulatory Authority (IE)

Medicine classification

This drug has been classified in the anatomical therapeutic chemical (ATC) classification system as follows:

ATC Group Classification
L01AA03 Melphalan L Antineoplastic and immunomodulating agents → L01 Antineoplastic agents → L01A Alkylating agents → L01AA Nitrogen mustard analogues
Discover more medicines within L01AA03

Authorization and marketing

This drug has been assigned below unique identifiers within the countries it is being marketed:

Country Identification scheme Identifier(s)
AU Pharmaceutical Benefits Scheme 2547C
BR Câmara de Regulação do Mercado de Medicamentos 505617060041517, 505617060041617
CA Health Products and Food Branch 00004715, 02087286
EE Ravimiamet 1004410, 1006434, 1708770
FI Lääkealan turvallisuus- ja kehittämiskeskus 125125
FR Base de données publique des médicaments 68262525, 68708664
HK Department of Health Drug Office 03792, 37994
IE Health Products Regulatory Authority 11193
IL מִשְׂרַד הַבְּרִיאוּת 1069
JP 医薬品医療機器総合機構 4219002F1034, 4219403F1023
LT Valstybinė vaistų kontrolės tarnyba 1000049, 1006932
MX Comisión Federal para la Protección contra Riesgos Sanitarios 62511
NL Z-Index G-Standaard 13669249
NL Z-Index G-Standaard, PRK 35254, 65641
NZ Medicines and Medical Devices Safety Authority 10081, 309
PL Rejestru Produktów Leczniczych 100003930, 100344736
RO Agenția Națională a Medicamentului și a Dispozitivelor Medicale W58865001, W58865002
SG Health Sciences Authority 11822P, 11873P
TR İlaç ve Tıbbi Cihaz Kurumu 8699874080021
US FDA, National Drug Code 52609-0001
ZA Health Products Regulatory Authority 27/26/0506, 27/34/0507, H/26/2744

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