Revised SPCs: Progynova (estradiol valerate) 1 and 2 mg tablets

SPCs have been updated as a result of the PRAC signal on hormone replacement therapy and new information on the known risk of breast cancer.

SPS commentary:

In May 2020, the European Medicines Agency’s safety committee (PRAC) recommended updating the current safety information for hormone replacement therapy used to treat symptoms of the menopause based on evidence from a large study published in The Lancet n August 2019, which confirmed the known higher risk of breast cancer in women using HRT. Furthermore, the results showed that the risk may continue to be increased for ten years or more after stopping HRT, if it has been used for more than five years.


electronic Medicines compendium

Resource links:

PRAC recommendations