Leaflet SAYANA 104mg suspension for injection in pre-filled syringe


Indicated for: contraception; gynecologic hormonal disorders

Route of administration: injectable

Substance: medroxyprogesterone (progestogen)

ATC: G03AC06 (Genito urinary system and sex hormones | Hormonal contraceptives for systemic use | Progestogens)

Medroxyprogesterone is a synthetic progestin primarily used for the treatment of menstrual disorders, endometriosis, and as part of hormone replacement therapy. It is also used as an injectable contraceptive.

This medication works by regulating hormone levels and preventing excessive growth of the uterine lining. When used as a contraceptive, medroxyprogesterone inhibits ovulation and thickens cervical mucus, thereby preventing fertilization.

Medroxyprogesterone is administered in the form of tablets or injections, depending on the medical indication. It is important to follow the dosing schedule recommended by the doctor to ensure the effectiveness of the treatment.

Adverse effects may include weight gain, mood changes, or irregular bleeding. Patients with a history of thrombosis or severe liver disease should use this medication with caution.

General data about SAYANA 104mg

  • Substance: medroxyprogesterone
  • Date of last drug list: 01-06-2023
  • Commercial code: W61424001
  • Concentration: 104mg
  • Pharmaceutical form: suspension for injection in pre-filled syringe
  • Quantity: 1
  • Product type: original
  • Prescription restrictions: P-RF - Medicines prescription that is retained in the pharmacy (not renewable).

Marketing authorisation

  • Manufacturer: PFIZER MANUFACTURING BELGIUM NV - BELGIA
  • Holder: PFIZER EUROPE MA EEIG - BELGIA
  • Number: 13356/2020/01
  • Shelf life: 5 years-seringa preumpluta unopeneda;Dupa deschiderea seringii preumplute - a se utiliza imediat

Pharmaceutical forms available for medroxyprogesterone

Concentrations available for medroxyprogesterone

  • 104mg
  • 10mg
  • 150mg
  • 500mg