EVE Health Clears Regulatory Pathway for Libbo and Dyspro Launch in Australia

EVE Health Group (ASX: EVE) has confirmed it has met all regulatory requirements under the Therapeutic Goods Administration (TGA) medicines access pathways, allowing prescription access to its lead products, Libbo and Dyspro, in Australia. This achievement brings forward the Company’s commercial launch timeline, with first prescriptions expected before the end of calendar year 2025.

Libbo, formulated for erectile dysfunction, and Dyspro, designed to address dysmenorrhoea, are fast-acting oral dissolvable therapies developed with established active pharmaceutical ingredients. Stability data supports a shelf life of two years for Libbo and one year for Dyspro. The Company is conducting ongoing stability testing in line with GMP standards, supporting future regulatory submissions including ARTG registration and global export opportunities. EVE is now focused on completing commercial preparations such as product manufacturing, national distribution, and software integration. A purchase order has already been placed for Dyspro’s first commercial batch. Full rollout in Australia is on track for late 2025, with international expansion to follow.

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