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Domestic Registration
Levonorgestrel Silastic Implant (Ⅱ) was approved for marketing on June 2, 1997. It has a shelf life of 4 years and a contraceptive validity period of 4 years. The product maintains valid marketing authorization in China, with its latest re-registration approved on July 1, 2025. Levonorgestrel Silastic Implant (II) complies with the national drug standard, with the standard number WS₁-(X-281)-2004Z.
International Registration
Levonorgestrel Silastic Implant(Ⅱ) obtained WHO Prequalification (WHO PQ) in June 2017. It has since been advanced for global registration and market promotion, and has been registered in more than 40 countries to date.
| Country | Registration Date | Registration No. | Shelf Life |
|---|---|---|---|
| Colombia | June 2017 | INVIMA 2017M-0017722 | 4 years |
| WHO | June 2017 | RH028 | 3 years |
| Kenya | February 2018 | 4109 | 3 years |
| Congo | September 2018 | 1253/10/05/DGM/0421/2018 | 3 years |
| Ethiopia | May 2017 | ET/04647/MRN/2025 | 3 years |
| Nigeria | August 2018 | 03-6334 | 3 years |
| ……………… | ……………… | ……………… | ……………… |
