Scottish Medicines Consortium (SMC) acceptance of use of Prometrium® (progesterone) 400mg soft vaginal capsules

FOR MEDICAL & PHARMA TRADE JOURNALISTS ONLY

Scottish Medicines Consortium (SMC) acceptance of use of Prometrium® (progesterone) 400mg soft vaginal capsules within NHSScotland is welcomed by Besins Healthcare UK Limited 

Decision expands access to the first and only licensed treatment in the UK for the prevention of miscarriage in women presenting with bleeding in the first trimester of pregnancy and have a history of recurrent miscarriages^[i]

LONDON, England. Monday 8 December 2025. Today, Besins Healthcare UK Limited is pleased to announce that following its assessment and review, the Scottish Medicines Consortium (SMC) has accepted Prometrium (progesterone) 400mg soft vaginal capsules^[i] for use in NHSScotland for the prevention of miscarriage in early pregnancy bleeding when the woman has a history of recurrent miscarriage. This decision allows women, deemed clinically eligible, to have access to a licensed treatment option in Scotland.

A threatened miscarriage describes a pregnancy that may continue when vaginal bleeding, with or without lower abdominal pain, occurs within the first 24 weeks of gestation.^[ii] Recurrent miscarriage, defined as the loss of three or more pregnancies, affects around 1% of couples trying to conceive.^[iii] For women with no history of miscarriage, the risk of miscarriage is approximately 11%, but this increases significantly with each successive pregnancy loss - rising to 42% after three or more miscarriages.^[iv]

The medicine will now be available for the first time for use in NHSScotland, marking another milestone in the advancement of women’s health. This move supports healthcare professionals in offering evidence-based care and reflects the Scottish governments commitment to improving women’s health and wellbeing across the country.

Scotland’s graded model of care ‘Delivery Framework for Miscarriage Care’ was published in September 2025 by the Scottish Government and is dedicated to ensuring that women experiencing miscarriage receive the care and support they deserve, no matter where they live.^[v]

Irina Spirieva, General Manager, Besins Healthcare UK Limited, expressed the company’s pride at this milestone:

“We are extremely pleased that the Scottish Medicines Consortium has recognised the value of Prometrium (progesterone) 400mg for the prevention of miscarriage in women presenting with bleeding in the first trimester of pregnancy and have a history of recurrent miscarriages.^[i] As a company dedicated to hormone health including women’s reproductive health, this decision is a testament to our ongoing commitment and to supporting families through some of their most challenging moments. We are proud to play our part in making a meaningful difference to improve access, awareness, and health outcomes for women in Scotland.”

-ENDS-

Notes to Editors

About the Scottish Medicines Consortium (SMC):

• The Scottish Medicines Consortium provides advice to NHS Scotland on newly licensed medicines to ensure the best possible outcomes for patients.
• The SMC’s advice on Prometrium was issued following an abbreviated submission, see website: https://scottishmedicines.org.uk/medicines-advice/progesterone-prometrium-abb-smc2869/
• Journalists and members of the press can contact the SMC media team, available Monday to Friday, during office hours at: media@nhs.scot

About Besins Healthcare UK Limited

Besins Healthcare is a specialist pharmaceutical company with a strong family heritage that specialises in producing the highest quality hormone therapies for the patients that need them. Our hormone replacement therapies are trusted by patients and physicians worldwide for conditions including menopause, endometriosis, reproductive health, and testosterone deficiency.

By working with passion and commitment, we develop and deliver hormone therapies to people with hormone imbalance in the UK and Ireland. Our aim is to empower those with life-impacting hormonal conditions, enabling them to lead fulfilling lives both now and in the future. Our patient-centric ethos is: “By your side, for life.” www.besinshealthcare.co.uk

 About Prometrium (progesterone) 400mg soft vaginal capsules

• It is a prescription only medicine indicated for the prevention of miscarriage in women presenting with bleeding in the first trimester (up to the 16th week) of pregnancy and who have a history of recurrent miscarriage.^[i]
• Further information can be found in the Summary of Product Characteristics.

References

^[i] Prometrium 400 mg soft vaginal capsules - Summary of Product Characteristics (SmPC) - (emc) [Online]. www.medicines.org.uk. 2024. Available from: https://www.medicines.org.uk/emc/product/16016/smpc. Accessed December 2025.

^[ii] Miscarriage. What is it? CKS Health topics A to Z. National Institute for Health and Care Excellence website: https://cks.nice.org.uk/topics/miscarriage/background-information/definition/#:~:text=Threatened%2520miscarriage%2520%E2%80%94%2520when%2520vaginal%2520bleeding,from%2520within%2520the%2520uterine%2520cavity. Accessed December 2025.

^[iii] Rai R, Regan L. Recurrent miscarriage. Lancet. 2006;368(9535):601-11. doi:10.1016/S0140-6736(06)69204-0.

^[iv] Quenby S, Gallos ID, Dhillon-Smith RK, et al. Miscarriage matters: the epidemiological, physical, psychological, and economic costs of early pregnancy loss. Lancet. 2021;397(10285):1658-67. doi:10.1016/S0140-6736(21)00682-6.

^[v] Scottish Government. Delivery Framework for Miscarriage Care in Scotland. https://www.gov.scot/publications/delivery-framework-miscarriage-care-scotland/documents/. Accessed December 2025.

MAT-BHUK-NP-0695. December 2025.