Mesalazine 800 mg tablets (Asacol): Supply issue

Last Updated: 23 April 2024

Supply issue Active

Chiesi, the supplier, has reported a supply constraint of 800 mg Asacol tabs from late February until July 2024.

23 April 2024 update

Stock of the s29 alternative has been briefly delayed. The supplier advises it should be available for wholesalers to order by early May. Once it arrives, we are asking that people use the section 29 alternative of the 800 mg tablet, to preserve stock of the 400 mg tablet for those who need it.

We have had a report from a pharmacist that they were having difficulty getting the 400 mg. We have checked and there is currently enough supply of the 400 mg available.

Affected product

Chiesi, the supplier, has reported a supply constraint of 800 mg Asacol tabs from late February until July 2024.

Chemical: Mesalazine
Brand: Asacol
Pharmacode: 2470616 and 2536552
Subsidy: $85.50
Measure / Qty: per 90

Schedule listing for mesalazine(external link)

This supply constraint only affects the 800 mg tablet of mesalazine, other presentations remain available.

Demand for mesalazine may also be affected by the supply issue for olsalazine

Alternative products

Pharmac and Chiesi are working to ensure continuity of supply of mesalazine.

Section 29 alternative sourced

To ensure a product remains available, Chiesi are bringing Australian branded Asacol. While the packaging is similar, it will still need to be prescribed and supplied as an unapproved medicine.

Chiesi letter to prescribers about the alternative product [PDF, 106 KB]

It was listed from 1 April 2024. The supplier advises that it should be available for wholesalers to order by early May 2024.

Please use the section 29 product

We would normally encourage people to use an approved product (in this case 2 x 400 mg tablets) rather than an unapproved product.

However, to manage this supply issue, we encourage prescribers and pharmacists to use the section 29 800 mg Asacol product because we need to preserve stock of the approved 400 mg tablets for those who need them.

Thank you for your patience while we manage this supply issue.

If the section 29 800 mg is not available, we have received clinical advice that people can take two 400 mg tablets of mesalazine.

Prescribing and supplying an unapproved medicine

Section 29 of the Medicines Act 1981 allows for medicines that are not Medsafe approved to be prescribed and supplied to people. The medicine must be prescribed by someone registered with the Medical Council of New Zealand – such as, a doctor.

We know supplying a medicine under section 29 is not ideal. In this case, however, this will allow patients to be able to access an appropriate treatment.

We apologise for any inconvenience this causes.

Advice for prescribing under section 29 – BPAC website(external link)

Prescriber and pharmacist requirements for section 29 medicines – Medsafe website (external link)

Medsafe’s section 29 Declaration / Notification Form [DOC](external link)

What patients need to know about unapproved medicines – Healthify website(external link)

Who to contact

If you have questions about this issue, email enquiry@pharmac.govt.nz

Please include as much information as you can about the product (presentation, brand, pharmacode) and who your wholesaler is.