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Shortage of Brevinor and Norimin (ethinylestradiol/norethisterone)

Update - Alternative products approved to address shortages

23 October 2020

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.

Table 1 Combined oral contraceptive pills indicated for contraception
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.

Table 2 Non-pill products indicated for contraception
Brand name Oestrogen Progestogen PBS listing

Nuvaring
vaginal drug delivery system

ethinylestradiol 2.7mg etonogestrel 11.7 mg Not PBS listed

Implanon NXT
subcutaneous implant

- etonogestrel 68 mg PBS listed

Mirena
intrauterine drug delivery system

- levonorgestrel 52 mg PBS listed

Kyleena
intrauterine drug delivery system

- levonorgestrel 19.5 mg PBS listed
Table 3 Progestogen-only oral products for contraception
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.