Transcription of Public Assessment Report Mutual Recognition …
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Public Assessment Report Mutual Recognition …
Public Assessment Report Mutual Recognition Procedure SAYANA PRESS 104 ml suspension for injection PL 00057/1093; UK/H/0960/002/DC Medroxyprogesterone acetate Pfizer LimitedPAR SAYANA PRESS 104 ml suspension for injection UK/H/0960/002/DC 2 LAY SUMMARY This is a summary of the Public Assessment Report (PAR) for SAYANA PRESS 104 suspension for injection (PL 00057/1093; UK/H/0960/002/DC). It explains how SAYANA PRESS 104 suspension for injection was assessed and its authorisation recommended, as well as its conditions of use. It is not intended to provide practical advice on how to use this product. For ease of reading, throughout this PAR, the product SAYANA PRESS 104 suspension for injection will be called SAYANA PRESS. For practical information about using SAYANA PRESS, patients should read the Package Leaflet or contact their doctor or pharmacist. What is SAYANA PRESS and what is it used for? SAYANA PRESS is a line-extension of the existing product licence for SAYANA 104 suspension for injection in prefilled syringe (PFS) (PL 00057/0589), using the Uniject delivery system.
Public Assessment Report Mutual Recognition Procedure SAYANA PRESS 104 mg/0.65 ml suspension for injection PL 00057/1093; UK/H/0960/002/DC Medroxyprogesterone acetate
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