Source: Australian Department of Health
Alternative product approved to address discontinuation
Consumers and health professionals are advised that the Therapeutic Goods Administration (TGA) has authorised two sponsors to supply an overseas-registered brand of phenelzine under Section 19A of the Therapeutic Goods Act 1989.
This action has been taken to ease the effects of the discontinuation of the only phenelzine product registered in Australia, which was marketed under the brand name Nardil. Phenelzine is used to treat major depression.
The TGA published a joint statement about the discontinuation of Nardil on 29 June 2020.
Due to the uncertainty of ongoing supply of phenelzine, prescribers are reminded that they should not initiate any new patients on phenelzine treatment.
The overseas-registered brand of phenelzine is named Phenelzine Sulfate USP 15 mg tablets (Lupin Pharmaceuticals). The two Section 19A approved sponsors are:
- Barwon Pharma Pty Ltd (0427 902599)
- Generic Health Pty Ltd (03 9809 7900)
The Section 19A product is not currently subsidised through the Pharmaceutical Benefits Scheme (PBS).
Health professionals should contact the Section 19A approved sponsors on the above phone numbers for further information or to arrange supply.
Information for consumers
If you or someone you provide care for takes phenelzine tablets, the overseas-registered brand Phenelzine Sulfate USP 15 mg tablets has been approved for supply in Australia.
This medicine contains the same active ingredient as Nardil and should work in the same way as your normal medicine. However, it is not currently subsidised through the PBS and therefore may cost significantly more.
Please be aware that supply of phenelzine has been a global issue and you may wish to discuss potential alternative treatments with your prescribing doctor.
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 phenelzine or a pharmacist, please be aware of this issue and advise patients accordingly if they seek advice.
You can contact Barwon Pharma on 0427 902 599 or Generic Health on 03 9809 7900 for further information.
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.