FML

This brand name is authorized in United States. It is also authorized in Australia, Finland, Hong Kong SAR China, Ireland, Israel, Netherlands, New Zealand, Singapore, South Africa, Turkey, UK.

Active ingredients

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

1	Fluorometholone UNII SV0CSG527L - FLUOROMETHOLONE
	Fluorometholone is a synthetic corticosteroid (glucocorticoid), a derivative of desoxyprednisolone. It is a member of the group of universally known steroids used for the treatment of eye inflammation. Glucocorticosteroids bind to cytoplasmic receptors and control the synthesis of infection mediators thus damping inflammatory reactions (swelling, fibrin deposition, capillary dilatation, phagocyte migration) and also capillary proliferation, collagen deposition and scarring.
	Read more about Fluorometholone

Medication package inserts

Below package inserts are available for further reading:

Document	Type	Information Source
FML Eye drops, suspension	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
S01BA07	Fluorometholone	S Sensory organs → S01 Ophthalmologicals → S01B Antiinflammatory agents → S01BA Corticosteroids, plain
Discover more medicines within S01BA07

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	1204J, 5513E
FI	Lääkealan turvallisuus- ja kehittämiskeskus	584854
GB	Medicines & Healthcare Products Regulatory Agency	142397, 161817, 31498, 31499
HK	Department of Health Drug Office	19538
IE	Health Products Regulatory Authority	64580
IL	מִשְׂרַד הַבְּרִיאוּת	1299
NL	Z-Index G-Standaard	13903802
NL	Z-Index G-Standaard, PRK	2720
NZ	Medicines and Medical Devices Safety Authority	1600
SG	Health Sciences Authority	04347P
TR	İlaç ve Tıbbi Cihaz Kurumu	8699490571033
US	FDA, National Drug Code	0023-0316, 11980-211, 11980-228
ZA	Health Products Regulatory Authority	J/15.2/327