Shortages of hormone replace therapy (HRT) patches: PBS subsidy and substitution of Estradot, Estraderm MX and overseas alternatives
Page last updated: 20 December 2024
The current shortages of HRT patches remain ongoing, with the shortage of some brands extended until June and 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.
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Temporary PBS listing of s19A HRT patches |
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PBS Item in shortage |
S19A medicine |
S19A Responsible Person (or sponsor) |
Date PBS listed |
Notes |
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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. |
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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. |
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ESTRADOT 75 (Estradiol, transdermal patches 1.17 mg, 8)
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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 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 75 on the PBS from 1 November 2024. |
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ESTRADOT 100 (Estradiol, transdermal patches 1.17 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. |
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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.
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ESTRADOT 75 (Estradiol, transdermal patches 1.17 mg, 8)
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ESTRADIOL TRANSDERMAL SYSTEM (SANDOZ, USA) (Estradiol, transdermal patches 1.17 mg, 8) |
Sandoz Pty Ltd |
1 June 2024 |
This product is a-flagged* to Estradot 75 and may be substituted at the pharmacy level. |
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ESTRADOT 100 (Estradiol, transdermal patches 1.17 mg, 8)
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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.
