This brand name is authorized in Nigeria. It is also authorized in Austria, Croatia, Cyprus, Ecuador, France, Hong Kong SAR China, Ireland, Israel, Malta, Netherlands, New Zealand, Poland, Romania, Singapore, South Africa, Spain, Tunisia, Turkey, UK.
The drug GAVISCON contains a combination of these active pharmaceutical ingredients (APIs):
1
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UNII
C269C4G2ZQ - SODIUM ALGINATE
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Alginic acid is a polysaccharide distributed widely in the cell walls of brown algae which is hydrophilic and forms a viscous gum when hydrated. Its salts with metals such as sodium and calcium are known as alginates. It is a significant component of the biofilms produced by the bacterium Pseudomonas aeruginosa, a major pathogen found in the lungs of some people who have cystic fibrosis. The biofilm and P. aeruginosa have a high resistance to antibiotics and are susceptible to inhibition by macrophages. |
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2
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UNII
8MDF5V39QO - SODIUM BICARBONATE
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Sodium bicarbonate has antacid properties. Sodium bicarbonate causes neutralisation of gastric acid with the production of carbon dioxide. |
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3
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UNII
H0G9379FGK - CALCIUM CARBONATE
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Calcium carbonate releases, in a pH-dependent manner, calcium ions in the stomach. Calcium carbonate is widely used as antacid and extensively used as a dietary supplement. |
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This drug has been approved in Nigeria as follows:
| Identifier | Form | Presentation | Description | Approval |
|---|---|---|---|---|
| A4-7058 | Suspension | Gaviscon Peppermint Liquid Suspension SUSP 80 mg; 133.5 mg; 250 mg 200ML | 52 RNW-PP-227120 Gaviscon Peppermint Liquid Suspension Sodium Alginate BP 500mg,Sodium Bicarbonate PH.EUR.267mg, Calcium Carbonate PH.EUR 160mg Sodium Alginate-250.0mg,Sodium Bicarbonate-113.5mg,Calcium Carbonate-80.0mg,Carbomer-32.5mg,Methyl Parahydroxy benzoate-20.0mg,Propyi Parahydroxy Benzoate-3'0mg,Saccharrin Sodium-5.0mg,Peppermint Oil-0.50mg,Sodium Hydroxide-13.335mg Water Purified-5.0ml A4-7058 Drugs Imported Products 200ml Over The Counter (OTC) 9/9/2021 RECKITT BENCKISER NIGERIA LIMITED, HERITAGE PLACE, 21 LUGARD AVENUE , IKOYI LAGOS LAGOS 8174600370 Uzo.Amatokwu@reckitt.com Reckitt Benckiser Healthcare Limited (UK), Dansom Lane, Hull, HU8 7DS, United Kingdom, United Kingdom | 31/01/2024 |
| A4-9366 | Suspension | Gaviscon Double Action Liquid SUSP 250 mg/5 mL; 133.5 mg/5 mL; 80 mg/5 mL 150 mL (in amber glass Winchester bottle) | Oral Suspension. An opaque, off-white to cream suspension with the odour and flavour of peppermint | 31/07/2024 |
This drug has been classified in the anatomical therapeutic chemical (ATC) classification system as follows:
| ATC Group | Classification | |
|---|---|---|
| A02BX | Other drugs for peptic ulcer and gastro-oesophageal reflux disease (GORD) | A Alimentary tract and metabolism → A02 Drugs for acid related disorders → A02B DRUGS FOR PEPTIC ULCER AND GASTRO-OESOPHAGEAL REFLUX DISEASE (GORD) |
| A02BX13 | Alginic acid | A Alimentary tract and metabolism → A02 Drugs for acid related disorders → A02B DRUGS FOR PEPTIC ULCER AND GASTRO-OESOPHAGEAL REFLUX DISEASE (GORD) → A02BX Other drugs for peptic ulcer and gastro-oesophageal reflux disease (GORD) |
This drug has been assigned below unique identifiers within the countries it is being marketed:
| Country | Identification scheme | Identifier(s) |
|---|---|---|
| EC | Agencia Nacional de Regulación, Control y Vigilancia Sanitaria | 5908-MEE-0121, 6067-MEE-0321, H3210113, H3300213, H3330213 |
| ES | Centro de información online de medicamentos de la AEMPS | 74718, 74728, 79018, 79019, 79613 |
| FR | Base de données publique des médicaments | 65777274, 67557241 |
| GB | Medicines & Healthcare Products Regulatory Agency | 106550, 106551, 135081, 147450, 159793, 236593, 30310, 30312, 30318, 30319, 308056, 344837, 344840, 344841, 344842, 344847, 344848, 344849, 380398, 380399, 380441, 43752, 43755 |
| HK | Department of Health Drug Office | 56200, 58058, 58080, 58432, 58656, 62985 |
| HR | Agencija za lijekove i medicinske proizvode | HR-H-782276059, HR-H-824012801 |
| IE | Health Products Regulatory Authority | 26514 |
| IL | מִשְׂרַד הַבְּרִיאוּת | 5271, 5272, 5482 |
| MT | Medicines Authority | AA565/10002, MA096/00301, MA096/00307, PI1438/04201A, PI770/16201A, PI908/22901A |
| NG | Registered Drug Product Database | A4-7058, A4-9366 |
| NL | Z-Index G-Standaard, PRK | 16411, 81671 |
| NZ | Medicines and Medical Devices Safety Authority | 11466, 11468, 12180, 1286, 1289, 13357, 13358, 13586, 15655, 21076, 21172 |
| PL | Rejestru Produktów Leczniczych | 100232581, 100232760, 100233037, 100293980, 100434913 |
| RO | Agenția Națională a Medicamentului și a Dispozitivelor Medicale | W65991001, W65991002, W65991003, W65991004, W65991005, W65991006, W65991007, W65991008, W65991009, W65991010, W65991011, W65991012, W65991013, W65991014, W65991015, W65991016, W65991017, W65991018, W65991019, W65991020, W66096001, W66096002, W66096003, W66096004, W66096005, W66096006, W66096007, W66096008, W66096009, W66096010, W66096011, W66096012, W66097001, W66097002, W66097003, W66097004, W66097005, W66097006, W66097007, W66097008, W66097009, W66097010, W66097011, W66097012, W66097013, W66097014, W66097015, W66097016, W66097017, W66097018, W66097019, W66097020, W66097021, W66097022, W66098001, W66098002, W66098003, W66098004, W66098005, W66098006, W66098007, W66098008, W66098009, W66098010, W66098011, W66098012, W66098013, W66098014, W66098015, W66098016, W66098017, W66098018 |
| SG | Health Sciences Authority | 09494P, 13738P, 13947P, 14016P, 14194P |
| TN | Direction de la Pharmacie et du Médicament | 10673011 |
| TR | İlaç ve Tıbbi Cihaz Kurumu | 8690570080001, 8690570081060, 8690570700039, 8690570701067 |
| ZA | Health Products Regulatory Authority | 42/11.10/0263, 43/13.1/1104, 43/13.1/1105, A38/11.10/0444, A38/11.10/0446, A38/11.10/0447, A38/11.10/445 |
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