Availability of Apresoline® Ampoules

HPS Pharmacies wish to advise that Amdipharm Mercury Australia is anticipating a supply interruption for Apresoline^® Ampoules as follows:

Apresoline^® Ampoules
Hydralazine hydrochloride 20mg
ARTG 43190 

This supply interruption is expected to occur between mid-August 2025 and end-March 2026.

An internationally registered alternative has been approved for supply under Section 19A of the Therapeutic Goods Act 1989. This stock is expected to be available from wholesalers from the second week of August 2025.

The S19A product is registered in Spain and labelling is in Spanish. Some of the other differences between the Australian registered product and the S19A alternative are shown in the table below.

The S19A product contains information on IM administration. Healthcare professionals are advised to ignore the reference to IM use and refer to the Australian Product Information (PI) for dosing and administration instructions. The Australian PI is supplied with the pack and also available here.

Please note that S19A products may have a longer lead time as they must be sourced internationally.

Retain this notice in a prominent position, including in other related business units until supplies return to normal. Report any problems identified with medicines, vaccines or medical devices to the TGA.

Should you require further information regarding this matter, please contact Amdipharm Mercury Australia on 1800 627 680, or your pharmacist at HPS Pharmacies.
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