This brand name is authorized in United States. It is also authorized in Australia, Austria, Brazil, Canada, Croatia, Cyprus, Ecuador, Estonia, Finland, France, Hong Kong SAR China, Ireland, Israel, Japan, Lithuania, Malta, Mexico, Netherlands, New Zealand, Poland, Romania, Singapore, South Africa, Spain, Tunisia, Turkey, UK.
The drug MIRENA contains one active pharmaceutical ingredient (API):
1
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UNII
5W7SIA7YZW - LEVONORGESTREL
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The precise mode of action of levonorgestrel as an emergency contraceptive is not known. At the recommended regimen, levonorgestrel is thought to work mainly by preventing ovulation and fertilisation if intercourse has taken place in the preovulatory phase, when the likelihood of fertilisation is the highest. |
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This drug has been classified in the anatomical therapeutic chemical (ATC) classification system as follows:
| ATC Group | Classification | |
|---|---|---|
| G02BA03 | Plastic IUD with progestogen | G Genito urinary system and sex hormones → G02 Other gynecologicals → G02B Contraceptives for topical use → G02BA Intrauterine contraceptives |
| G03AC03 | Levonorgestrel | G Genito urinary system and sex hormones → G03 Sex hormones and modulators of the genital system → G03A Hormonal contraceptives for systemic use → G03AC Progestogens |
This drug has been assigned below unique identifiers within the countries it is being marketed:
| Country | Identification scheme | Identifier(s) |
|---|---|---|
| AU | Pharmaceutical Benefits Scheme | 8633J |
| BR | Câmara de Regulação do Mercado de Medicamentos | 538915090024217 |
| CA | Health Products and Food Branch | 02243005 |
| EC | Agencia Nacional de Regulación, Control y Vigilancia Sanitaria | 30020-10-11 |
| EE | Ravimiamet | 1009493 |
| ES | Centro de información online de medicamentos de la AEMPS | 63158 |
| FI | Lääkealan turvallisuus- ja kehittämiskeskus | 014453 |
| FR | Base de données publique des médicaments | 66349230 |
| GB | Medicines & Healthcare Products Regulatory Agency | 34933, 374031 |
| HK | Department of Health Drug Office | 41251 |
| HR | Agencija za lijekove i medicinske proizvode | HR-H-494254913 |
| IE | Health Products Regulatory Authority | 33526, 33578 |
| IL | מִשְׂרַד הַבְּרִיאוּת | 3519 |
| JP | 医薬品医療機器総合機構 | 2529710X1027 |
| LT | Valstybinė vaistų kontrolės tarnyba | 1012090, 1060572, 1092333, 1092692 |
| MT | Medicines Authority | MA639/02201, PI908/05602A |
| MX | Comisión Federal para la Protección contra Riesgos Sanitarios | 259M99 |
| NL | Z-Index G-Standaard, PRK | 98590 |
| NZ | Medicines and Medical Devices Safety Authority | 7966 |
| PL | Rejestru Produktów Leczniczych | 100157135, 100292360, 100292726, 100324254, 100324691, 100324700, 100326224, 100356610, 100357302, 100359301, 100361309, 100361670, 100384718, 100437515, 100443272, 100455110 |
| RO | Agenția Națională a Medicamentului și a Dispozitivelor Medicale | W64655001 |
| SG | Health Sciences Authority | 07915P |
| TN | Direction de la Pharmacie et du Médicament | 7243091 |
| TR | İlaç ve Tıbbi Cihaz Kurumu | 8699546326716 |
| US | FDA, National Drug Code | 50419-423 |
| ZA | Health Products Regulatory Authority | 32/34/0332 |
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