Shortage of Brevinor and Norimin (ethinylestradiol/norethisterone) | Therapeutic Goods Administration (TGA)

Press Release

By:

Ref: TGA

Published: 08/13/2020

Shortage of Brevinor and Norimin (ethinylestradiol/norethisterone) | Therapeutic Goods Administration (TGA)
13 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.

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.

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.

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 3 blister:
28 x 30 mcg ethinyloestradiol +
7 x 10 mcg ethinyloestradiol

Month 1 & 2 blisters:
28 x 150 mcg levonorgestrel
Month 3 blister:
28 x 150 mcg levonorgestrel

 Not PBS listed
Microgynon 50 ED 50 mcg ethinyloestradiol 125 mcg levonorgestrel PBS listed

Logynon ED
Trifeme 28
Triphasil 28
Triquilar ED

6 x 30 mcg ethinyloestradiol
5 x 40 mcg ethinyloestradiol
10 x 30 mcg ethinyloestradiol

6 x 50 mcg levonorgestrel
5 x 75 mcg levonorgestrel
10 x 125 mcg levonorgestrel

 All brands PBS listed

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
5 x 2 mg oestradiol valerate
17 x 2 mg oestradiol valerate
2 x 1 mg oestradiol valerate

-
5 x 2 mg dienogest
17 x 3 mg dienogest
-

 Not PBS listed
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

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.