SAYANA Suspension for injection Ref.[27683] Active ingredients: Medroxyprogesterone

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2020  Publisher: Pfizer Limited, Sandwich, Kent, CT13 9NJ, United Kingdom

Product name and form

SAYANA PRESS 104 mg/0.65 ml suspension for injection.

Pharmaceutical Form

Suspension for injection.

White to off-white homogeneous suspension.

Qualitative and quantitative composition

SAYANA PRESS single-dose container with 104 mg medroxyprogesterone acetate (MPA) in 0.65 ml suspension for injection.

Excipients with known effect:

Methyl parahydroxybenzoate – 1.04 mg per 0.65 ml.
Propyl parahydroxybenzoate – 0.0975 mg per 0.65 ml.
Sodium – 2.47 mg per 0.65 ml.

For the full list of excipients, see section 6.1.

Active Ingredient Description
Medroxyprogesterone

Medroxyprogesterone acetate exerts anti-oestrogenic, anti-androgenic and antigonadotrophic effects.

List of Excipients

Macrogol 3350
Methyl parahydroxybenzoate (E218)
Propyl parahydroxybenzoate (E216)
Sodium chloride
Polysorbate 80
Monobasic sodium phosphate monohydrate
Disodium phosphate dodecahydrate
Methionine
Povidone
Hydrochloric acid and/or sodium hydroxide for pH adjustment
Water for injection

Pack sizes and marketing

SAYANA PRESS suspension for injection is supplied in a single-dose container in the form of a pre-filled injector containing 0.65 ml. The injector comprises a linear low density polyethylene laminate reservoir with a siliconized AISI Type 304 Stainless Steel 23 gauge thin wall needle attached via a low density polyethylene port and valve.

The pack sizes are:

  • one single-dose container
  • 200 single-dose containers

Not all pack sizes may be marketed.

Marketing authorization holder

Pfizer Limited, Sandwich, Kent, CT13 9NJ, United Kingdom

Marketing authorization dates and numbers

PL 00057/1093

Date of first authorisation: 21/06/2011
Renewal of authorisation: 09/04/2018

Drugs

Drug Countries
SAYANA Austria, Brazil, Ecuador, Israel, Mexico, Netherlands, Romania, United Kingdom

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