FLAGYL

This brand name is authorized in United States. It is also authorized in Australia, Brazil, Canada, Cyprus, Ecuador, Estonia, Finland, France, Hong Kong SAR China, Ireland, Israel, Italy, Japan, Malta, Mexico, Netherlands, New Zealand, Nigeria, Romania, Singapore, South Africa, Spain, Tunisia, Turkey, UK.

Active ingredients

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

1
UNII 140QMO216E - METRONIDAZOLE
 

Metronidazole is an anti-infectious drug belonging to the pharmacotherapeutic group of nitroimidazole derivatives, which have effect mainly on strict anaerobes. This effect is probably caused by interaction with DNS and different metabolites.

 
Read more about Methronidazole

Medication package inserts

Below package inserts are available for further reading:

Document Type Information Source  
 FLAGYL Suppositories, Oral suspension MPI, EU: SmPC Medicines and Medical Devices Safety Authority (NZ)

Medicine classification

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

ATC Group Classification
G01AF01 Metronidazole G Genito urinary system and sex hormones → G01 Gynecological antiinfectives and antiseptics → G01A ANTIINFECTIVES AND ANTISEPTICS, EXCL. COMBINATIONS WITH CORTICOSTEROIDS → G01AF Imidazole derivatives
Discover more medicines within G01AF01
J01XD01 Metronidazole J Antiinfectives for systemic use → J01 Antibacterials for systemic use → J01X Other antibacterials → J01XD Imidazole derivatives
Discover more medicines within J01XD01
P01AB01 Metronidazole P Antiparasitic products, insecticides and repellents → P01 Antiprotozoals → P01A Agents against amoebiasis and other protozoal diseases → P01AB Nitroimidazole derivatives
Discover more medicines within P01AB01

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 1621H, 1630T, 1636D, 1642K, 3339R, 3341W, 5155H, 5157K
BR Câmara de Regulação do Mercado de Medicamentos 502804501112319, 502804504111313, 502804505150312, 502814070066903, 576720050067217, 576720050067317, 576720050067417, 576720050067517
CA Health Products and Food Branch 01926853, 01926861
EC Agencia Nacional de Regulación, Control y Vigilancia Sanitaria 24.397-1-01-12, 24.405-1-12-11, 24.482-1-02-12, 24.483-1-02-12
EE Ravimiamet 1162594
ES Centro de información online de medicamentos de la AEMPS 34985, 35034, 47656, 55233, 59325
FI Lääkealan turvallisuus- ja kehittämiskeskus 000019, 151217, 398800
FR Base de données publique des médicaments 61659061, 62708127, 65020253, 67965563, 68818192
GB Medicines & Healthcare Products Regulatory Agency 15509, 15702, 39106, 39120
HK Department of Health Drug Office 31148, 31150
IE Health Products Regulatory Authority 25267, 25577, 25666, 41947
IL מִשְׂרַד הַבְּרִיאוּת 806, 807
IT Agenzia del Farmaco 018505038
JP 医薬品医療機器総合機構 2529707H1063, 6419002F1131
MT Medicines Authority AA565/03902, MA1359/02001, MA1359/02003, PI1438/05901A, PI1438/05902A, PI521/05401B, PI521/05402B, PI908/02501A, PI908/02502A
MX Comisión Federal para la Protección contra Riesgos Sanitarios 0417M79, 55754, 62207, 78445
NG Registered Drug Product Database A4-3947
NL Z-Index G-Standaard 13549138
NL Z-Index G-Standaard, PRK 22918, 5207
NZ Medicines and Medical Devices Safety Authority 1473, 1476
RO Agenția Națională a Medicamentului și a Dispozitivelor Medicale W63535001, W63536001
SG Health Sciences Authority 00142P, 01557P, 02201P
TN Direction de la Pharmacie et du Médicament 9103501, 9263331
TR İlaç ve Tıbbi Cihaz Kurumu 8699586690051, 8699586690068, 8699809098572, 8699809706644
US FDA, National Drug Code 0025-1821, 0025-1942
ZA Health Products Regulatory Authority D/20.2.6/228, F/20.2.6/50, J/20.2/151, K/20.2/15, K/20.2/16, Z/20.2.6/295, Z/20.2.6/296

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