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Update - Alternative products approved to address shortages
22 October 2020
The Therapeutic Goods Administration (TGA) is advising consumers and health professionals of an update to the below information about the shortage of oral contraceptive pills containing the combination ethinylestradiol and norethisterone.
To ease the effects of the shortage of these products, the TGA has granted approval to Medsurge Healthcare Pty Ltd to import and supply two alternative products under section 19A of the Therapeutic Goods Act 1989. The two Section 19A approved products are:
- Necon 0.5/35 - norethisterone 0.5 mg and ethinylestradiol 35 micrograms
- Pirmella 1/35 - norethisterone 1 mg and ethinylestradiol 35 micrograms.
Health professionals can contact Medsurge Healthcare on 1300 788 261 for further information or to arrange supply.
Please report any adverse events involving these alternative products to Medsurge Healthcare or to the TGA.
Medicine shortage alert
25 August 2020
Consumers and health professionals are advised that there is a shortage of oral contraceptive pills containing the combination ethinylestradiol and norethisterone. The affected products are:
- Brevinor - norethisterone 0.5 mg and ethinylestradiol 35 micrograms
- Norimin - norethisterone 0.5 mg and ethinylestradiol 35 micrograms
- Brevinor-1 - norethisterone 1 mg and ethinylestradiol 35 micrograms
- Norimin-1 - norethisterone 1 mg and ethinylestradiol 35 micrograms.
All four products are sponsored by Pfizer Australia Pty Ltd.
Pfizer has advised the Therapeutic Goods Administration (TGA) the shortage of these products is due to manufacturing issues and is expected to continue until mid-October 2020 and early December 2020, depending on the product. Further information about the shortage is available on the TGA's Medicine Shortage Reports Database.
Although the TGA have sought interest for supply of an overseas alternative under Section 19A of the Therapeutic Goods Act 1989, to date, no applications have been received.
Individuals may also be able to arrange access to overseas registered norethisterone and ethinylestradiol combination products via the TGA's Special Access Scheme (SAS). The SAS refers to arrangements that allow for the import and/or supply of an unapproved therapeutic good for a single patient, on a case-by-case basis. Further information regarding the SAS and the relevant application forms are available from our website.
Information for consumers
If you have been prescribed Brevinor, Brevinor-1, Norimin or Norimin-1, please speak to your doctor or other prescriber as soon as possible for advice on alternative products that may be suitable for you.
Information for health professionals
There are currently no exact alternatives for these products. If your patient has been prescribed Brevinor, Brevinor-1, Norimin or Norimin-1, you may wish to consider an alternative combined oral contraceptive pill or methods of contraception.
Advice on the appropriateness of certain alternatives to ethinyloestradiol/ norethistoerone containing pills (pdf,143kb) has been published by SPHERE (NHMRC Centre of Research Excellence in Sexual and Reproductive Health for Women in Primary Care).
Table 1 below lists the combined oral contraceptive pills currently marketed in Australia. Table 2 and Table 3 provide other goods on the Australian Register of Therapeutic Goods available for contraception. The benefits and risks of each option will need to be considered according to the individual needs and preferences of the patient, as well as their age and any co-morbidities.
You can search the TGA Product Information and Consumer Medicines Information database for information to assist you with counselling patients on the suitability of the medicine for their medical and personal circumstances.
Information about whether an alternative product is in shortage can be found on the TGA's Medicine Shortage Reports Database.
| Brand name | Oestrogen | Progestogen | PBS listing |
|---|---|---|---|
| Femme-Tab ED 20/100 Microgynon 20 ED Loette Micronelle 20 ED Lenest 20 ED | 20 mcg ethinyloestradiol | 100 mcg levonorgestrel | Only Femme-Tab ED 20/100 PBS listed |
| Femme-Tab ED 30/150 Levlen ED Microgynon 30 ED Monofeme 28 Nordette 28 Evelyn 150/30 ED Eleanor 150/30 ED Micronelle 30 ED Lenest 30 ED | 30 mcg ethinyloestradiol | 150 mcg levonorgestrel | All brands PBS listed except Microgynon 30 ED |
| Seasonique | Month 1 & 2 blisters: 28 x 30 mcg ethinyloestradiol | Month 1 & 2 blisters: 28 x 150 mcg levonorgestrel | Not PBS listed |
| Month 3 blister: 28 x 30 mcg ethinyloestradiol + 7 x 10 mcg ethinyloestradiol | Month 3 blister: 28 x 150 mcg levonorgestrel | ||
| Microgynon 50 ED | 50 mcg ethinyloestradiol | 125 mcg levonorgestrel | PBS listed |
| Logynon ED Trifeme 28 Triphasil 28 Triquilar ED | 6 x 30 mcg ethinyloestradiol | 6 x 50 mcg levonorgestrel | All brands PBS listed |
| 5 x 40 mcg ethinyloestradiol | 5 x 75 mcg levonorgestrel | ||
| 10 x 30 mcg ethinyloestradiol | 10 x 125 mcg levonorgestrel | ||
| Brevinor 28 Day Norimin 28 Day | 35 mcg ethinyloestradiol | 500 mcg norethisterone | All brands PBS listed |
| Brevinor-1 28 Day Norimin-1 28 Day | 35 mcg ethinyloestradiol | 1000 mcg norethisterone | All brands PBS listed |
| Norinyl-1 28 Day | 50 mcg mestranol | 1000 mcg norethisterone | PBS listed |
| Marvelon 28 Madeline | 30 mcg ethinyloestradiol | 150 mcg desogestrel | Not PBS listed |
| Minulet | 30 mcg ethinyloestradiol | 75 mcg gestodene | Not PBS listed |
| Yaz | 20 mcg ethinyloestradiol | 3 mg drospirenone | Not PBS listed |
| Petibelle Yasmin | 30 mcg ethinyloestradiol | 3 mg drospirenone | Not PBS listed |
| Valette | 30 mcg ethinyloestradiol | 2 mg dienogest | Not PBS listed |
| Qlaira | 2 x 3 mg oestradiol valerate | - | Not PBS listed |
| 5 x 2 mg oestradiol valerate | 5 x 2 mg dienogest | ||
| 17 x 2 mg oestradiol valerate | 17 x 3 mg dienogest | ||
| 2 x 1 mg oestradiol valerate | - | ||
| Zoely | 1.5 mg oestradiol | 2.5 mg nomegestrol acetate | Not PBS listed |
Note: Brenda-35 ED, Diane-35 ED, Estelle-35 ED, Jene-35 ED and Juliet-35 ED are registered for use in women with hyperandrogenism, and are not indicated for women who desire contraception who do not have co-morbid hyperandrogenism.
| Brand name | Oestrogen | Progestogen | PBS listing |
|---|---|---|---|
| Nuvaring | ethinylestradiol 2.7mg | etonogestrel 11.7 mg | Not PBS listed |
| Implanon NXT | - | etonogestrel 68 mg | PBS listed |
| Mirena | - | levonorgestrel 52 mg | PBS listed |
| Kyleena | - | levonorgestrel 19.5 mg | PBS listed |
| Brand name | Progestogen | PBS listing |
|---|---|---|
| Microlut | 30 mcg levonorgestrel | PBS listed |
| Noriday 28 Day | 350 mcg norethisterone | PBS listed |
Reporting problems
Consumers and health professionals are encouraged to report problems with medicines or vaccines. Your report will contribute to the TGA's monitoring of these products.
The TGA cannot give advice about an individual's medical condition. You are strongly encouraged to talk with a health professional if you are concerned about a possible adverse event associated with a medicine or vaccine.