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Source: Australian Department of Health

Alternative product approved to address expected shortage

Consumers and health professionals are advised that the Therapeutic Goods Administration (TGA) has authorised the supply of an overseas-registered brand of tranylcypromine to address an expected shortage of the Australian-registered product in late 2020.

Tranylcypromine is marketed in Australia under the brand name Parnate and is used to treat symptoms of depression.

Amdipharm Mercury (Australia) Pty Ltd has notified the TGA that Parnate 10 mg tablets will be in short supply from 1 November 2020 to 7 December 2020 due to manufacturing issues.

To support continuity of supply for patients using this medicine, the TGA has authorised Amdipharm to supply an overseas-registered brand of tranylcypromine under Section 19A of the Therapeutic Goods Act 1989.

The Section 19A product can be subsidised through the Pharmaceutical Benefits Scheme (PBS).

While stock of the Australian-registered and overseas-registered products are expected to be available during the period of the shortage, Amdipharm are reserving an emergency supply of tranylcypromine for patients unable to access the medicine through their pharmacy. Pharmacists may contact Amdipharm on 0294316333 or 1800 627 680 to enquire about access to the emergency supply.

Additionally, dispensing limits of one month’s supply at the prescribed dose will help to ensure equitable access to the medicine. These limits have been in place for certain prescription medicines since March 2020 to prevent panic-buying or stockpiling, which can cause supply disruptions that can affect consumers’ access to medicines.

The TGA is working closely with Amdipharm Mercury (Australia) to monitor supply of tranylcypromine. Refer to the Medicine Shortages Reports Database for up to date information.

Information for consumers

If you or someone you provide care for takes tranylcypromine (Parnate) 10 mg tablets, please be aware of the anticipated shortage.

You should still be able to fill prescriptions for tranylcypromine at your local pharmacy, but you may be dispensed an overseas-registered alternative product. This medicine contains the same active ingredients as Parnate and should work in the same way as your normal medicine.

The alternative product can also be subsidised through the PBS and should therefore cost the same as your normal medicine.

Please note that under normal circumstances, you will only be allowed to purchase one month’s supply of your medicine at the prescribed dose.

If your pharmacy cannot obtain stock of tranylcypromine during the shortage period, you can ask them to contact Amdipharm Mercury (Australia) directly.

If you have any questions or concerns about this issue, speak to your health professional.

Information for health professionals

If you are a prescriber treating patients with tranylcypromine or a pharmacist, please be aware of the anticipated shortage and advise patients accordingly if they seek advice. In particular, advise them that they should still be able to fill prescriptions for tranylcypromine at their local pharmacy, but may be dispensed an overseas-registered alternative product.

Please note that a dispensing limit of one month’s supply of tranylcypromine at the prescribed dose is currently in place to support fair and equitable access.

The Section 19A product may be dispensed under the existing listing and lawfully subsidised through the PBS.

Pharmacists can contact Amdipharm Mercury (Australia) on 02 9431 6333 or 1800 627 680 for further information or to request emergency supply.

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.

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