The Therapeutic Goods Administration (TGA) is advising health professionals and consumers of a current shortage for all strengths of PROGYNOVA estradiol valerate tablets. Due to manufacturing issues the shortage is expected to continue until May 2022.
PROGYNOVA tablets are used for short-term relief of symptoms associated with menopause.
The TGA has made a Serious Scarcity Substitution Instrument (SSSI) to assist patients in accessing their medicine from their pharmacist without delay, ensure treatments are not interrupted and relieve workload pressure on prescribers and pharmacists.
The Therapeutic Goods (Serious Scarcity and Substitutable Medicine) (Estradiol Valerate) Instrument 2021 has been made to:
- Declare PROGYNOVA estradiol valerate 1 mg tablet (AUST R: 10708) and PROGYNOVA estradiol valerate 2 mg tablet (AUST R: 323720) as scarce medicines; and
- Specify ESTROFEM estradiol (as hemihydrate) 1 mg tablet (AUST R: 188520), ESTROFEM estradiol (as hemihydrate) 2 mg tablet (AUST R: 188521) and ZUMENON estradiol (as hemihydrate) 2 mg tablet (AUST R: 75888) as substitutable medicines that pharmacists are permitted to dispense in substitution for the scarce medicines and specify the circumstances in which that substitution is permitted
The SSSI is in force from 13 August 2021 until 1 May 2022. The TGA may, however, revoke the SSSI before its end date if the serious scarcity is resolved, or safety concerns are identified.
