Section 19A Approval – Mefloquine Hydrochloride 250 mg Tablets Now Available from Pro Pharmaceuticals Group

Dear Healthcare Professional,

Pro Pharmaceuticals Group wishes to advise that the Australian registered product LARIAM® mefloquine 250 mg (as hydrochloride) tablets blister pack (AUST R: 43321) is currently in shortage, as listed on the TGA Medicines Shortage Database.

Current shortage status:

LARIAM mefloquine 250 mg tablets (AUST R: 43321)

Availability: Limited availability

Expected supply: 20 March 2026

Management action: Sponsor is closely controlling supply and working to expedite next shipment.

To ensure continuity of patient care, the Therapeutic Goods Administration (TGA) has granted approval under Section 19A of the Therapeutic Goods Act 1989 for the importation and supply of the following alternative product:

Mefloquine Hydrochloride Tablets 250 mg

Pack size: 8 tablets

Manufacturer: AA Pharma Inc., Canada

This product is registered and marketed in Canada and is approved for temporary importation and supply in Australia until 30 April 2026.

Approved indications:

In adults and children over 45 kg bodyweight:

• Treatment of acute malaria due to Plasmodium falciparum resistant to conventional antimalarial drugs• Chemoprophylaxis of malaria in travellers to regions with documented chloroquine-resistant P. falciparum• Alternative prophylaxis for travellers hypersensitive to sulphonamides and sulphones

Key details:

Same active ingredient, strength, and dose form as the Australian registered product (mefloquine hydrochloride 250 mg tablets)

Registered and marketed in Canada

English and French labelled packaging

Tablets may be swallowed whole or crushed and suspended for administration where required

Supplied in packs of 8 tablets

TGA-approved Dear Healthcare Professional letter available

Pro Pharmaceuticals Group has commenced supply to Australian healthcare institutions and can support ongoing requirements while the Australian registered product remains in shortage.

We encourage hospital pharmacies and clinical teams to circulate this information internally.

Orders & Enquiries: orders@propg.com.au

Phone: 1300 077 674

Website: www.propg.com.au