Alternative OCP approved to address shortages


TGA grants approval for import and supply of two alternative products to address the Brevinor and Norimin shortages

The TGA advised health professionals and consumers in August that there was 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.

Pfizer advised the TGA the shortage of these products was due to manufacturing issues and expected to continue until mid-October 2020 and early December 2020, depending on the product.

To ease the effects of the shortage of these products, the TGA has now granted approval to Medsurge Healthcare to import and supply two alternative products, it said in a Friday update.

The two 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

The approval has been provided under section 19A of the Therapeutic Goods Act 1989.

Health professionals can contact Medsurge Healthcare on 1300 788 261 for further information or to arrange supply.

The TGA requested health professionals or consumers to please report any adverse events involving these alternative products to Medsurge Healthcare or to the TGA.

See more information here

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