This brand name is authorized in United States. It is also authorized in Australia, Austria, Brazil, Canada, Estonia, Finland, France, Ireland, Israel, Lithuania, Netherlands, Poland, South Africa, Spain, UK.
The drug KYLEENA 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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Below package inserts are available for further reading:
| Document | Type | Information Source | |
|---|---|---|---|
| KYLEENA Intrauterine delivery system (IUS) | 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 | |
|---|---|---|
| G02BA03 | Plastic IUD with progestogen | G Genito urinary system and sex hormones → G02 Other gynecologicals → G02B Contraceptives for topical use → G02BA Intrauterine contraceptives |
This drug has been assigned below unique identifiers within the countries it is being marketed:
| Country | Identification scheme | Identifier(s) |
|---|---|---|
| AU | Pharmaceutical Benefits Scheme | 11909T |
| BR | Câmara de Regulação do Mercado de Medicamentos | 538920010029707 |
| CA | Health Products and Food Branch | 02459523 |
| EE | Ravimiamet | 1703955, 1703966 |
| ES | Centro de información online de medicamentos de la AEMPS | 81418 |
| FI | Lääkealan turvallisuus- ja kehittämiskeskus | 098089 |
| FR | Base de données publique des médicaments | 63463104 |
| GB | Medicines & Healthcare Products Regulatory Agency | 350589 |
| IE | Health Products Regulatory Authority | 33483 |
| IL | מִשְׂרַד הַבְּרִיאוּת | 8396 |
| LT | Valstybinė vaistų kontrolės tarnyba | 1078678, 1081935 |
| NL | Z-Index G-Standaard, PRK | 141836 |
| PL | Rejestru Produktów Leczniczych | 100358388, 100424748, 100436830, 100447382, 100454476 |
| US | FDA, National Drug Code | 50419-424 |
| ZA | Health Products Regulatory Authority | 47/32.9/0037 |
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