Imipramine 10 mg Tablets – Section 19A Approval (Australia)

Pro Pharmaceuticals Group has received approval from the Therapeutic Goods Administration (TGA) under Section 19A of the Therapeutic Goods Act 1989 to import and supply Imipramine 10 mg tablets in Australia to support continuity of supply during the current shortage of the Australian registered product Tofranil® 10 mg.

Imipramine 10 mg tablets are currently in shortage in Australia. Pro Pharmaceuticals Group has received TGA Section 19A approval to import and supply an alternative product during the Tofranil® 10 mg shortage.

Import and supply approved until 31 August 2026

Background – Medicine Shortage

Imipramine 10 mg tablets are currently experiencing a shortage in Australia due to supply disruption of Tofranil® 10 mg tablets.

To support patient access during this shortage period, the TGA has granted Section 19A approval to Pro Pharmaceuticals Group to import and supply an overseas registered alternative product.

Product Details

Product: Imipramine HCL Tablets USP 10 mgPack size: 100 tabletsManufacturer: Leading Pharma LLC – United StatesMarket authorisation number: NDC 69315-133-01 (USA)

Indications

Major depression

Nocturnal enuresis (from 5 years of age after exclusion of organic causes)

PBS Status

PBS listing: TBC

Ordering Information

Orders can be placed via Symbion wholesalers using the PDE numbers below.

PDE: TBC

Alternatively orders can be placed directly with Pro Pharmaceuticals Group.

Website: www.propg.com.auEmail: orders@propg.com.auPhone: 1300 077 674

Pro Pharmaceuticals Group continues to work with international manufacturers to secure supply of essential medicines for Australian patients during periods of shortage.

of essential medicines for Australian patients during periods of shortage.