This brand name is authorized in Australia, Spain, Finland, France, Hong Kong, Croatia, Lithuania, Malta, Netherlands, New Zealand, Poland, Romania, Singapore, Tunisia, United Kingdom, United States, South Africa
The drug BETADINE contains one active pharmaceutical ingredient (API):
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1
Povidone iodine
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. |
Below package inserts are available for further reading:
| Title | Information Source | Document Type | |
|---|---|---|---|
| BETADINE Pressurised aerosol spray | Medicines & Healthcare Products Regulatory Agency (GB) | MPI, EU: SmPC |
This drug has been classified in the anatomical therapeutic chemical (ATC) classification system as follows:
| ATC code | Group title | 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) |
|---|---|---|
| Country: AU | Pharmaceutical Benefits Scheme | Identifier(s): 4411E |
| Country: ES | Centro de información online de medicamentos de la AEMPS | Identifier(s): 36340, 36341, 47120, 54521, 62093, 63804, 66162, 8435701IP, 936339 |
| Country: FI | Lääkealan turvallisuus- ja kehittämiskeskus | Identifier(s): 013031, 456913, 456947, 457028, 457044, 457051, 459230 |
| Country: FR | Base de données publique des médicaments | Identifier(s): 60436479, 60546502, 61037294, 61548837, 61841085, 62390482, 64273983, 64547046, 64930411, 65249362, 67782430, 68964585, 69179872 |
| Country: GB | Medicines & Healthcare Products Regulatory Agency | Identifier(s): 24065 |
| Country: HK | Department of Health Drug Office | Identifier(s): 10847, 10848, 10851, 10852, 10853, 10854, 10856, 12516, 29119, 35331, 62673, 63949 |
| Country: HR | Agencija za lijekove i medicinske proizvode | Identifier(s): HR-H-212010690, HR-H-250346267, HR-H-484176445, HR-H-815384810, HR-H-922339496 |
| Country: LT | Valstybinė vaistų kontrolės tarnyba | Identifier(s): 1007467, 1007468, 1007469, 1017769, 1017770, 1063387, 1063925, 1066397, 1076844, 1078609, 1081604, 1082643, 1082644, 1082701, 1084882, 1085578, 1085692, 1085791, 1087154, 1088177, 1088452, 1088523, 1088633 |
| Country: MT | Medicines Authority | Identifier(s): AA565/84001, MA197/00101, MA197/00102, MA197/00103, MA197/00104, MA197/00105, MA197/00106, MA197/00107 |
| Country: NL | Z-Index G-Standaard | Identifier(s): 12105880, 12105899, 12105902, 12105945, 12106062, 12311448, 12565210, 13997939 |
| Country: NL | Z-Index G-Standaard, PRK | Identifier(s): 1295, 4065, 4073, 73229 |
| Country: NZ | Medicines and Medical Devices Safety Authority | Identifier(s): 20442, 351, 355, 357, 358, 360, 361 |
| Country: PL | Rejestru Produktów Leczniczych | Identifier(s): 100009802, 100009819, 100009854, 100254542, 100285672, 100285732, 100290696, 100293909, 100325130, 100327130, 100335513, 100344073, 100350412, 100378899, 100384492, 100394740, 100397508, 100439388, 100442344, 100448743, 100457229 |
| Country: RO | Agenția Națională a Medicamentului și a Dispozitivelor Medicale | Identifier(s): W03740001, W03740002, W03740003, W12088001, W12089001, W12949001, W12949002 |
| Country: SG | Health Sciences Authority | Identifier(s): 04622P, 15313P, 15344P, 15699P |
| Country: TN | Direction de la Pharmacie et du Médicament | Identifier(s): 6310011, 6310012, 6310013, 6313021, 6313022, 6313023, 6313024, 6313025 |
| Country: US | FDA, National Drug Code | Identifier(s): 0065-0411 |
| Country: ZA | Health Products Regulatory Authority | Identifier(s): 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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