Cyclofem
Description: Combined monthly injectable.
Product Details
User: Female
Hormonal: Yes
Delivery Method: Injectable
Duration Type: Short-acting
Duration: Monthly
Regimen: - single injection administered monthly
- single injection administered monthly
Dose: 25 mg MPA, 5 mg estradiol cypionate
Active Pharmaceutical Ingredient (API): - medroxyprogesterone acetate
- estradiol cypionate
- medroxyprogesterone acetate
- estradiol cypionate
Multipurpose Preventive Technology (MPT): No
Status Details
Developer: Concept Foundation, Sun Pharmaceuticals, India, WHO HRP, PT. Tunggal Idaman Abdi
Project Phase: Limited Market Availability
Development Stage: SRA/WHO PQ Approved
Active Development: Yes
Status Details: - CycloFem is registered and in use in Mexico, Indonesia, Thailand, Hong Kong, and a few countries in Latin America. Concept Foundation has the commercial rights. CONRAD conducted PK studies on CycloFem to support the US FDA approval process.
- The same formulation was previously approved by the US FDA as Lunelle (in 2000), marketed by Pfizer, but was removed from the market because of production problems.
- Cyclofem was added to the WHO Model List of Essential Medicines in 2007.
- CycloFem is registered and in use in Mexico, Indonesia, Thailand, Hong Kong, and a few countries in Latin America. Concept Foundation has the commercial rights. CONRAD conducted PK studies on CycloFem to support the US FDA approval process.
- The same formulation was previously approved by the US FDA as Lunelle (in 2000), marketed by Pfizer, but was removed from the market because of production problems.
- Cyclofem was added to the WHO Model List of Essential Medicines in 2007.
Additional Information
References: Concept foundation website: https://www.conceptfoundation.org/
Concept foundation website: https://www.conceptfoundation.org/