This brand name is authorized in Nigeria. It is also authorized in Australia, Croatia, Finland, France, Hong Kong SAR China, Lithuania, Malta, Netherlands, New Zealand, Poland, Romania, Singapore, South Africa, Spain, Tunisia, UK, United States.
The drug BETADINE contains one active pharmaceutical ingredient (API):
1
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UNII
85H0HZU99M - POVIDONE-IODINE
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Povidone iodine is an iodophore that has an established use as a broad-spectrum antiseptic, mainly for the treatment of contaminated wounds and for the preoperative preparation of the skin, mucous membranes and the ocular surface. The organic complex contains approximately 10% of active available iodine. Solutions of povidone iodine gradually release iodine to exert an antimicrobial effect against bacteria, fungi, viruses, and spores. Although povidone iodine is less potent than preparations containing free iodine, it is also less toxic. |
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This drug has been approved in Nigeria as follows:
| Identifier | Form | Presentation | Description | Approval |
|---|---|---|---|---|
| 04-4013 | Gargle | Betadine Germicide Gargle LIQ 2% 1100ML,50ML | Betadine Germicide Gargle 2%-Mint POVIDONE IODINE Povidone Iodine,Citric Acid MonohydrateDibasic Sodium Phosphate, Apr-13 Drugs Imported Products 1100ML,50ML Prescription Only Medicine (POM) 17/10/2022 PHILLIPS PHARMACEUTICALS (NIGERIA) LIMITED, PLOT 122-123 AFRIPRINT ESTATE, ISOLO 8035493198 samson.omattah@phillipsnigeria.com G.S PHARMBUTOR PVT, B-172 INDUSTRIAL AREA BEHROR 301701 RAJASTHAN INDIA, India | 31/08/2023 |
| 04-4018 | Solution | BETADINE SURGICAL SCRUB SOL 7.5% 150 | 67 RNW-PP-277349 BETADINE SURGICAL SCRUB POVIDONE IODINE 7.5% povidone iodine 10% Excipient:Citric Acid Monohydrate, Dibasic Sodium Phosphate, Glycerine, Hyoxyd AAO/Alphox -200, Potassium Iodate, Sodium Hydroxide, Purified Water Apr-18 Drugs Imported Products 150 Prescription Only Medicine (POM) 10/11/2023 PHILLIPS PHARMACEUTICALS (NIGERIA) LIMITED, PLOT 122-123 AFRIPRINT ESTATE, ISOLO 8035493198 samson.omattah@phillipsnigeria.com G.S PHARMABUTOR PVT LTD, G.S PHARMBUTOR PVT LTD B 172 INDUSTRIAL AREA BEHROR 301701 RAJASTHAN , India | 31/01/2024 |
Below package inserts are available for further reading:
| Document | Type | Information Source | |
|---|---|---|---|
| BETADINE Pressurised aerosol spray | 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 | |
|---|---|---|
| A01AB11 | Various | A Alimentary tract and metabolism → A01 Stomatological preparations → A01A Stomatological preparations → A01AB Antiinfectives and antiseptics for local oral treatment |
| D08AG02 | Povidone-iodine | D Dermatologicals → D08 Antiseptics and disinfectants → D08A Antiseptics and disinfectants → D08AG Iodine products |
| D11AC06 | Povidone-iodine | D Dermatologicals → D11 Other dermatological preparations → D11A Other dermatological preparations → D11AC Medicated shampoos |
| G01AX11 | Povidone-iodine | G Genito urinary system and sex hormones → G01 Gynecological antiinfectives and antiseptics → G01A ANTIINFECTIVES AND ANTISEPTICS, EXCL. COMBINATIONS WITH CORTICOSTEROIDS |
This drug has been assigned below unique identifiers within the countries it is being marketed:
| Country | Identification scheme | Identifier(s) |
|---|---|---|
| AU | Pharmaceutical Benefits Scheme | 4411E |
| ES | Centro de información online de medicamentos de la AEMPS | 36340, 36341, 47120, 54521, 62093, 63804, 66162, 8435701IP, 936339 |
| FI | Lääkealan turvallisuus- ja kehittämiskeskus | 013031, 456913, 456947, 457028, 457044, 457051, 459230 |
| FR | Base de données publique des médicaments | 60436479, 60546502, 61037294, 61548837, 61841085, 62390482, 64273983, 64547046, 64930411, 65249362, 67782430, 68964585, 69179872 |
| GB | Medicines & Healthcare Products Regulatory Agency | 24065 |
| HK | Department of Health Drug Office | 10847, 10848, 10851, 10852, 10853, 10854, 10856, 12516, 29119, 35331, 62673, 63949 |
| HR | Agencija za lijekove i medicinske proizvode | HR-H-212010690, HR-H-250346267, HR-H-484176445, HR-H-815384810, HR-H-922339496 |
| LT | Valstybinė vaistų kontrolės tarnyba | 1007467, 1007468, 1007469, 1017769, 1017770, 1063387, 1063925, 1066397, 1076844, 1078609, 1081604, 1082643, 1082644, 1082701, 1084882, 1085578, 1085692, 1085791, 1087154, 1088177, 1088452, 1088523, 1088633 |
| MT | Medicines Authority | AA565/84001, MA197/00101, MA197/00102, MA197/00103, MA197/00104, MA197/00105, MA197/00106, MA197/00107 |
| NG | Registered Drug Product Database | 04-4013, 04-4018 |
| NL | Z-Index G-Standaard | 12105880, 12105899, 12105902, 12105945, 12106062, 12311448, 12565210, 13997939 |
| NL | Z-Index G-Standaard, PRK | 1295, 4065, 4073, 73229 |
| NZ | Medicines and Medical Devices Safety Authority | 20442, 351, 355, 357, 358, 360, 361 |
| PL | Rejestru Produktów Leczniczych | 100009802, 100009819, 100009854, 100254542, 100285672, 100285732, 100290696, 100293909, 100325130, 100327130, 100335513, 100344073, 100350412, 100378899, 100384492, 100394740, 100397508, 100439388, 100442344, 100448743, 100457229 |
| RO | Agenția Națională a Medicamentului și a Dispozitivelor Medicale | W03740001, W03740002, W03740003, W12088001, W12089001, W12949001, W12949002 |
| SG | Health Sciences Authority | 04622P, 15313P, 15344P, 15699P |
| TN | Direction de la Pharmacie et du Médicament | 6310011, 6310012, 6310013, 6313021, 6313022, 6313023, 6313024, 6313025 |
| US | FDA, National Drug Code | 0065-0411 |
| ZA | Health Products Regulatory Authority | 27/13.1/0062, C/16.4/142, C/18.6/143, C/18.6/144, F/18.6/41, P/13.1/65, S/13.1/46 |
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