This brand name is authorized in Nigeria. It is also authorized in Australia, Brazil, Canada, Croatia, Cyprus, Ecuador, Estonia, France, Hong Kong SAR China, Ireland, Lithuania, Malta, New Zealand, Romania, Singapore, Spain, Turkey, UK, United States.
The drug MAXIDEX contains one active pharmaceutical ingredient (API):
1
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UNII
7S5I7G3JQL - DEXAMETHASONE
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Dexamethasone is a synthetic glucocorticoid; it combines high anti-inflammatory effects with low mineralocorticoid activity. It has an approximately 7 times greater anti-inflammatory potency than prednisolone, another commonly prescribed corticosteroid. At high doses it reduces the immune response. |
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This drug has been approved in Nigeria as follows:
| Identifier | Form | Presentation | Description | Approval |
|---|---|---|---|---|
| 04-1593 | Eye drops | Maxidex Eye drops SOL_DROPS 1 mg/mL 1 X 5ml | 89 RNW-PP-292694 Maxidex Eye drops DEXAMETHASONE dexamethasone 1mg/ml. Preservative: 1 ml of suspension contains 0.1 mg benzalkonium chloride. 04-1593 Drugs Imported Products 15ml POM 1 11/29/2022 NOVARTIS NIGERIA LIMITED, LANDMARK BUILDING 52/54 ISAAC JOHN STREET IKEJA-GRA LAGOS LAGOS 2.34707E+12 arit.onwusah@novartis.com Alcon-Couvreur NV, Alcon-Couvreur NV Rijksweg 14, 2870 Puurs Belgium, Belgium | 31/10/2023 |
Below package inserts are available for further reading:
| Document | Type | Information Source | |
|---|---|---|---|
| MAXIDEX Eye drops, suspension | MPI, EU: SmPC | Medicines & Healthcare Products Regulatory Agency (GB) |
This drug has been classified in the anatomical therapeutic chemical (ATC) classification system as follows:
| ATC Group | Classification | |
|---|---|---|
| S01BA01 | Dexamethasone | 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) |
|---|---|---|
| AU | Pharmaceutical Benefits Scheme | 1288T, 5565X |
| BR | Câmara de Regulação do Mercado de Medicamentos | 500902501161319, 500902502176311 |
| CA | Health Products and Food Branch | 00042560, 00042579 |
| EC | Agencia Nacional de Regulación, Control y Vigilancia Sanitaria | 25.631-04-04 |
| EE | Ravimiamet | 1090932, 1124288 |
| ES | Centro de información online de medicamentos de la AEMPS | 42666 |
| FR | Base de données publique des médicaments | 65238711 |
| GB | Medicines & Healthcare Products Regulatory Agency | 144896, 14919 |
| HK | Department of Health Drug Office | 16913, 46126 |
| HR | Agencija za lijekove i medicinske proizvode | HR-H-085077338, HR-H-444452701 |
| LT | Valstybinė vaistų kontrolės tarnyba | 1001229, 1015648, 1077967, 1078905, 1083467, 1086008, 1086779, 1091414 |
| MT | Medicines Authority | MA1249/01101, PI908/15101A |
| NG | Registered Drug Product Database | 04-1593 |
| NZ | Medicines and Medical Devices Safety Authority | 1064, 1065 |
| RO | Agenția Națională a Medicamentului și a Dispozitivelor Medicale | W63597001 |
| SG | Health Sciences Authority | 04153P, 04840P |
| TR | İlaç ve Tıbbi Cihaz Kurumu | 8699504440515, 8699504710144 |
| US | FDA, National Drug Code | 0998-0615 |
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