Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2020 Publisher: Pfizer Limited, Sandwich, Kent, CT13 9NJ, United Kingdom
SAYANA PRESS 104 mg/0.65 ml suspension for injection.
| Pharmaceutical Form |
|---|
|
Suspension for injection. White to off-white homogeneous suspension. |
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 |
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:
Not all pack sizes may be marketed.
Pfizer Limited, Sandwich, Kent, CT13 9NJ, United Kingdom
PL 00057/1093
Date of first authorisation: 21/06/2011
Renewal of authorisation: 09/04/2018
| Drug | Countries | |
|---|---|---|
| SAYANA | Austria, Brazil, Ecuador, Israel, Mexico, Netherlands, Romania, United Kingdom |
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