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

Dose: 25 mg MPA, 5 mg estradiol cypionate

Active Pharmaceutical Ingredient (API):
  • 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.

Additional Information

References:

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