Hydralazine Hydrochloride Injection Section 19A Approval – Now Available from Pro Pharmaceuticals Group

Dear Healthcare Professional,

Pro Pharmaceuticals Group wishes to advise that the Australian registered product APRESOLINE® hydralazine hydrochloride 20 mg powder for injection ampoule (AUST R: 43190) is currently in shortage, as listed on the TGA Medicines Shortage Database.

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:

Hydralazine Hydrochloride Injection, USP 20 mg per mL, 1 mL single-dose vial(Eugia, USA)

This product is registered and marketed in the United States of America and is approved for import and supply in Australia until 30 April 2026, for use in:

• Hypertensive crises, especially during late pregnancy (pre-eclampsia and eclampsia).

Key Details

• Same active ingredient and strength as the Australian registered product (hydralazine 20 mg/mL)

• Registered in the USA (ANDA 215147)

• Supplied as a ready-to-use solution for injection (no reconstitution required)

• Suitable for intravenous or intramuscular administration

• Supplied in cartons of 25 single-dose vials

• Labelled in English with TGA-approved labelling and Dear Healthcare Professional Letter

• Manufactured by Eugia Pharma Specialities Limited (FDA-registered manufacturing site)

Pro Pharmaceuticals Group has commenced supply to Australian public hospitals and can support ongoing requirements while the Australian registered product remains unavailable.

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