FML

This brand name is authorized in Australia, Finland, Hong Kong, Ireland, Israel, Netherlands, New Zealand, Singapore, Turkey, United Kingdom, United States, South Africa

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 about Fluorometholone

Medication package inserts

Below package inserts are available for further reading:

Title Information Source Document Type  
FML Eye drops, suspension 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
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)
Country: AU Pharmaceutical Benefits Scheme Identifier(s): 1204J, 5513E
Country: FI Lääkealan turvallisuus- ja kehittämiskeskus Identifier(s): 584854
Country: GB Medicines & Healthcare Products Regulatory Agency Identifier(s): 142397, 161817, 31498, 31499
Country: HK Department of Health Drug Office Identifier(s): 19538
Country: IE Health Products Regulatory Authority Identifier(s): 64580
Country: IL מִשְׂרַד הַבְּרִיאוּת Identifier(s): 1299
Country: NL Z-Index G-Standaard Identifier(s): 13903802
Country: NL Z-Index G-Standaard, PRK Identifier(s): 2720
Country: NZ Medicines and Medical Devices Safety Authority Identifier(s): 1600
Country: SG Health Sciences Authority Identifier(s): 04347P
Country: TR İlaç ve Tıbbi Cihaz Kurumu Identifier(s): 8699490571033
Country: US FDA, National Drug Code Identifier(s): 0023-0316, 11980-211, 11980-228
Country: ZA Health Products Regulatory Authority Identifier(s): J/15.2/327

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