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