Substitution instrument to address shortage of Imdur Durules and Monodur Durules isosorbide mononitrate extended to 30 June 2023

This extension relates to the Substitution instrument to address shortage of Imdur Durules and Monodur Durules isosorbide mononitrate 120 mg modified release tablets

The Serious Scarcity Substitution Instrument (SSSI) for isosorbide mononitrate has been extended until 30 June 2023 as the shortages have been extended. The shortages are expected to continue until 31 May 2023.

The PBS subsidy arrangements will remain in force for the same duration as the SSSI.

Imdur Durules and Monodur Durules tablets are indicated for the prophylactic treatment of angina pectoris.

The TGA has extended this Serious Scarcity Substitution Instrument (SSSI) to:

• assist patients to access their medicine from their pharmacist without delay
• ensure treatment is not interrupted
• relieve workload pressure on prescribers and pharmacists.

The SSSI is now in force from 18 September 2021 until 30 June 2023. The TGA may, however, revoke the SSSI before its end date if the serious scarcity is resolved, or safety concerns are identified.

Specific information for pharmacists, prescribers and patients is available in our 28 September 2021 Substitution instrument to address shortage of Imdur Durules and Monodur Durules isosorbide mononitrate 120 mg modified release tablets.

More information about SSSIs

• Substituting scarce medicines
• Serious Scarcity Substitution Instruments (SSSIs).

Read the SSSI at the Federal Register of Legislation Therapeutic Goods (Serious Scarcity and Substitutable Medicine) (Isosorbide Mononitrate) Instrument 2021.