This brand name is authorized in Nigeria. It is also authorized in Austria, Brazil, Estonia, France, Ireland, Italy, Lithuania, Malta, Netherlands, South Africa, Tunisia, UK.
The drug MONURIL contains one active pharmaceutical ingredient (API):
1
|
UNII
7FXW6U30GY - FOSFOMYCIN TROMETHAMINE
|
|
Fosfomycin exerts a bactericidal effect on proliferating pathogens by preventing the enzymatic synthesis of the bacterial cell wall. Fosfomycin inhibits the first stage of intracellular bacterial cell wall synthesis by blocking peptidoglycan synthesis. |
|
This drug has been approved in Nigeria as follows:
| Identifier | Form | Presentation | Description | Approval |
|---|---|---|---|---|
| B4-4173 | Granules for solution | Monuril Granules GRAN_F_SOL 3 g 3 g x 1's (in sachet) | Granules for oral solution. Sachets are a four layer laminate: paper, polyethylene, aluminium, polyethylene. Sachets are supplied in cardboard outer containing 1 sachet | 25/09/2024 |
Below package inserts are available for further reading:
| Document | Type | Information Source | |
|---|---|---|---|
| MONURIL Granules for oral solution | 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 | |
|---|---|---|
| J01XX01 | Fosfomycin | J Antiinfectives for systemic use → J01 Antibacterials for systemic use → J01X Other antibacterials → J01XX Other antibacterials |
This drug has been assigned below unique identifiers within the countries it is being marketed:
| Country | Identification scheme | Identifier(s) |
|---|---|---|
| BR | Câmara de Regulação do Mercado de Medicamentos | 533801001135411, 533815020007803 |
| EE | Ravimiamet | 1607880, 1642126, 1770005, 1773873 |
| FR | Base de données publique des médicaments | 67951706, 67972426 |
| GB | Medicines & Healthcare Products Regulatory Agency | 329828, 387731, 398343 |
| IE | Health Products Regulatory Authority | 19325 |
| IT | Agenzia del Farmaco | 025680024 |
| LT | Valstybinė vaistų kontrolės tarnyba | 1092925, 1092926 |
| MT | Medicines Authority | AA1116/00101, AA908/20701 |
| NG | Registered Drug Product Database | B4-4173 |
| NL | Z-Index G-Standaard | 13722409 |
| NL | Z-Index G-Standaard, PRK | 30724 |
| TN | Direction de la Pharmacie et du Médicament | 2983011 |
| ZA | Health Products Regulatory Authority | 55/20.1.1/0357 |
© All content on this website, including data entry, data processing, decision support tools, "RxReasoner" logo and graphics, is the intellectual property of RxReasoner and is protected by copyright laws. Unauthorized reproduction or distribution of any part of this content without explicit written permission from RxReasoner is strictly prohibited. Any third-party content used on this site is acknowledged and utilized under fair use principles.