IBSA UK & Ireland has announced the licensed availability of Lubion® PFS (progesterone 25 mg, solution for subcutaneous injection) in the Republic of Ireland, providing a new option for luteal support during Assisted Reproductive Technology (ART) treatments. The launch marks the company’s first directly supplied fertility medicine in the country, offering a structured supply route for Irish IVF clinics.
Lubion® PFS is indicated for women undergoing ART who are unable to use or tolerate vaginal progesterone preparations. Progesterone plays a critical role in the luteal phase of ART and subcutaneous administration offers an alternative delivery method for these patients, according to IBSA. The product is a ready-to-use formulation delivered in a pre-filled syringe for once-daily subcutaneous injection.
Previously, access to subcutaneous progesterone 25mg in Ireland was limited to EU parallel-import under branding such as Prolutex and Lubion. The licensed availability of Lubion® PFS now allows prescribers to access the medication as a GMS reimbursable item under the HSE primary care reimbursement service, ensuring a consistent supply and distribution network. This change likewise provides direct medical information and support from IBSA.
The product is the first and only licensed aqueous progesterone for subcutaneous injection in Ireland. It is designed for self-administration after professional instruction or can be administered by a healthcare professional. IBSA is providing tailored patient materials, including leaflets, videos, and injection guidance, alongside resources for healthcare professionals.
Melissa Mark, Nurse Manager at Therapie Fertility, Ireland, stated that the clinic has incorporated Lubion® into IVF treatment plans for years and that IBSA’s support provides reassurance regarding the continued supply and availability of the product for their patients.
Lubion contains the active ingredient Progesterone, a naturally occurring female sex hormone that works on the lining of the womb to support pregnancy. It is not indicated for use in cases of vaginal bleeding of unknown origin, miscarriage with suspected retained tissue, ectopic pregnancy, severe liver problems, or known or suspected cancers of the breast or reproductive tract. It is also contraindicated for individuals with a history of blood clots or porphyria disorders.
IBSA announced the licensing on December 4, 2025, and the product received authorisation from the HPRA (Health Products Regulatory Authority) on November 22, 2024, under licence number PA1104/006/001. IBSA Farmaceutici Italia S.r.l. Is the licence holder.
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