FLUDARA

This brand name is authorized in Australia, Canada, Cyprus, Estonia, Finland, France, Hong Kong, Ireland, Japan, Lithuania, Malta, Netherlands, New Zealand, Poland, Romania, Singapore, Turkey, United Kingdom, South Africa

Active ingredients

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

1 Fludarabine UNII 1X9VK9O1SC - FLUDARABINE PHOSPHATE

Fludarabine is a water-soluble fluorinated nucleotide analogue of the antiviral agent vidarabine 9-β-D-arabinofuranosyladenine (ara-A) that is relatively resistant to deamination by adenosine deaminase. Fludarabine phosphate is rapidly dephosphorylated to 2F-ara-A which is taken up by cells and then phosphorylated intracellularly by deoxycytidine kinase to the active triphosphate, 2F-ara-ATP. This metabolite has been shown to inhibit ribonucleotide reductase, DNA polymerase α/δ and ε, DNA primase and DNA ligase thereby inhibiting DNA synthesis. Read about Fludarabine

Medication package inserts

Below package inserts are available for further reading:

Title	Information Source	Document Type
FLUDARA Powder for solution for injection or infusion	Medicines & Healthcare Products Regulatory Agency (GB)	MPI, EU: SmPC
FLUDARA Film-coated tablets	Medicines & Healthcare Products Regulatory Agency (GB)	MPI, EU: SmPC

Medicine classification

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

ATC code	Group title	Classification
L01BB05	Fludarabine	L Antineoplastic and immunomodulating agents → L01 Antineoplastic agents → L01B Antimetabolites → L01BB Purine analogues
Discover more medicines within L01BB05

Authorization and marketing

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

Country	Identification scheme	Identifier(s)
Country: AU	Pharmaceutical Benefits Scheme	Identifier(s): 9184J
Country: CA	Health Products and Food Branch	Identifier(s): 02246226
Country: EE	Ravimiamet	Identifier(s): 1596551, 1722361
Country: FI	Lääkealan turvallisuus- ja kehittämiskeskus	Identifier(s): 395342, 524399
Country: FR	Base de données publique des médicaments	Identifier(s): 61324127, 62751438
Country: GB	Medicines & Healthcare Products Regulatory Agency	Identifier(s): 43555, 43557, 48463
Country: HK	Department of Health Drug Office	Identifier(s): 50447
Country: IE	Health Products Regulatory Authority	Identifier(s): 88247, 88249
Country: JP	医薬品医療機器総合機構	Identifier(s): 4229002F1022, 4229400D1033
Country: LT	Valstybinė vaistų kontrolės tarnyba	Identifier(s): 1004848, 1004849
Country: MT	Medicines Authority	Identifier(s): MA596/00301, MA596/00302
Country: NL	Z-Index G-Standaard, PRK	Identifier(s): 61379
Country: NZ	Medicines and Medical Devices Safety Authority	Identifier(s): 10472
Country: PL	Rejestru Produktów Leczniczych	Identifier(s): 100145391
Country: RO	Agenția Națională a Medicamentului și a Dispozitivelor Medicale	Identifier(s): W56210001, W56210002
Country: SG	Health Sciences Authority	Identifier(s): 11143P
Country: TR	İlaç ve Tıbbi Cihaz Kurumu	Identifier(s): 8699809098312, 8699809779167
Country: ZA	Health Products Regulatory Authority	Identifier(s): 28/26/0605, 36/26/0422