FLUDARA

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

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 more about Fludarabine

Medication package inserts

Below package inserts are available for further reading:

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

Medicine classification

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

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