Shortages of hormone replace therapy (HRT) patches: PBS subsidy and substitution of Estradot, Estraderm MX and overseas alternatives
Page last updated: 4 March 2025
The current shortages of HRT patches remain ongoing, with the shortage of some brands extended until December 2025. The shortages are due to manufacturing reasons or an increase in demand for alternate brands. For up-to-date information, please refer to the Therapeutic Goods Administration (TGA) website.
To address the shortages, the TGA has approved the supply of overseas-registered alternatives under section 19A (s19A) of the Therapeutic Goods Act 1989 which allows medicines not currently included in the Australian Register of Therapeutic Goods (ARTG) to be imported into Australia and supplied in place of a registered medicine that is unavailable or in short supply.
The Department of Health and Aged Care has temporarily listed on the PBS a number of HRT patches approved under s19A. The table below summarises the s19A HRT patches that are available on the PBS and whether substitution is allowed.
|
PBS Item in shortage |
S19A medicine |
S19A Responsible Person (or sponsor) |
Date PBS listed |
Notes |
|---|---|---|---|---|
|
ESTALIS CONTINUOUS 50/140 Transdermal patches containing 620 micrograms estradiol (as hemihydrate) with 2.7 mg norethisterone acetate, 8 |
ESTALIS 140/50 (CANADA) Norethindrone acetate and estradiol 140/50 mcg/day transdermal therapeutic system(S19A) |
Medsurge Healthcare Pty Ltd |
1 March 2025 |
|
|
ESTALIS CONTINUOUS 50/250 Transdermal patches containing 510 micrograms estradiol (as hemihydrate) with 4.8 mg norethisterone acetate, 8 |
ESTALIS 250/50 (CANADA) Norethindrone acetate and estradiol 250/50 mcg/day transdermal therapeutic system (S19A) |
Medsurge Healthcare Pty Ltd |
1 March 2025 |
|
|
ESTRADOT 100 Transdermal patches 1.56 mg, 8 |
ESTRAMON (GERMANY, SANDOZ) Transdermal patches 1.56 mg, 24 (S19A) |
Sandoz Pty Ltd |
1 March 2025 |
This product is NOT a-flagged to Estradot 100, Estradiol Transdermal System (Sandoz, USA) and Estraderm MX 100 A new script is required to supply Estramon 100 on the PBS from 1 March 2025. |
|
ESTRADOT 75 Transdermal patches 1.17 mg, 8 |
ESTRAMON (GERMANY, SANDOZ) Transdermal patches 1.17 mg, 24 (S19A) |
Sandoz Pty Ltd |
1 February 2025 |
This product is NOT a-flagged to Estradot 75 A new script is required to supply Estramon 75 on the PBS from 1 February 2025. |
|
ESTRADOT 50 Transdermal patches 780 micrograms, 8 |
ESTRAMON (GERMANY, SANDOZ) Transdermal patches 780 micrograms, 24 (S19A) |
Sandoz Pty Ltd |
1 February 2025 |
This product is NOT a-flagged to Estradot 50 and Estraderm MX 50 A new script is required to supply Estramon 50 on the PBS from 1 February 2025. |
|
ESTRADOT 25 Transdermal patches 390 micrograms, 8 |
ESTRAMON (GERMANY, SANDOZ) Transdermal patches 390 micrograms, 24 (S19A) |
Sandoz Pty Ltd |
1 February 2025 |
This product is NOT a-flagged to Estradot 25 and Estraderm MX 25 A new script is required to supply Estramon 25 on the PBS from 1 February 2025. |
|
ESTRADOT 37.5 estradiol 37.5 microgram transdermal drug delivery system sachet |
ESTRAMON 37.5 (GERMANY) Transdermal patches 585 micrograms, 24 (S19A) |
Medsurge Healthcare Pty Ltd |
1 November 2024 |
This medicine is NOT a-flagged* to Estradot 37.5 and Estradiol Transdermal System (Sandoz, USA) and cannot be substituted at the pharmacy level due to the different pack size.
A new script is required to supply Estramon 37.5 on the PBS from 1 November 2024. |
|
ESTRADOT 50 estradiol 50 microgram transdermal drug delivery system sachet |
ESTRAMON 50 (GERMANY) Transdermal patches 780 micrograms, 24 (S19A) |
Medsurge Healthcare Pty Ltd |
1 November 2024 |
This product is NOT a-flagged* to Estradot 50 and Estraderm MX 50 and cannot be substituted at the pharmacy level due to the different pack size.
A new script is required to supply Estramon 50 on the PBS from 1 November 2024. |
|
ESTRADOT 75 (Estradiol, transdermal patches 1.17 mg, 8)
|
ESTRAMON 75 (GERMANY) (Estradiol, transdermal patches 1.17 mg, 24 (S19A)) |
Medsurge Healthcare Pty Ltd |
1 November 2024 |
This product is NOT a-flagged* to Estradot 75 and cannot be substituted at the pharmacy level due to the different pack size.
A new script is required to supply Estramon 75 on the PBS from 1 November 2024. |
|
ESTRADOT 100 (Estradiol, transdermal patches 1.56 mg, 8)
ESTRADERM MX 100 (Estradiol, transdermal patches 3 mg (as hemihydrate), 8) |
ESTRAMON 100 (GERMANY) (Estradiol, transdermal patches 1.56 mg, 24 (S19A)) |
Medsurge Healthcare Pty Ltd |
1 November 2024 |
This product is NOT a-flagged* to Estradot 100, Estradiol Transdermal System (Sandoz, USA) and Estraderm MX 100 and cannot be substituted at the pharmacy level due to the different pack size.
A new script is required to supply Estramon 100 on the PBS from 1 November 2024. |
|
ESTRADOT 37.5 (Estradiol, transdermal patches 585 micrograms, 8) |
ESTRADIOL TRANSDERMAL SYSTEM (SANDOZ, USA) (Estradiol, transdermal patches 585 micrograms,8) |
Sandoz Pty Ltd |
1 June 2024 |
This product is a-flagged* to Estradot 37.5 and may be substituted at the pharmacy level.
|
|
ESTRADOT 100 (Estradiol, transdermal patches 1.56 mg, 8)
|
ESTRADIOL TRANSDERMAL SYSTEM (SANDOZ, USA) (Estradiol, transdermal patches 1.56 mg, 8) |
Sandoz Pty Ltd |
1 June 2024 |
This product is a-flagged* to Estradot 100 and may be substituted at the pharmacy level. |
*a-flagged - Denotes that brand substitution for these PBS items may be undertaken by pharmacists at the point of dispensing, with the patient’s consent, without differences in clinical effect
PBS subsidy arrangements for medicines subject to a Serious Scarcity Substitution Instrument (SSSI)
The department has enabled pharmacists to substitute Estradot, Estraderm MX and s19A Estradiol Transdermal System (Sandoz, USA) patches under the PBS without needing a new prescription provided conditions are met in accordance with the TGA SSSI. At this time, the s19A Estramon is not included as a PBS substitute in the SSSI, due to the difference in pack size compared to Estradot and Estraderm MX.
For full information on this PBS arrangement, please refer to the PBS website.
