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EU & UK Conclude Decentralised Procedure Approval for Bijuva® (Estradiol & Progesterone) Capsules for Hormone Replacement Therapy

March 3, 2021 Off By BusinessWire

LONDON–(BUSINESS WIRE)–Theramex, a global company specialised in women’s health, announced today the Decentralised Procedure approval in several EU countries and the UK of BIJUVA® (1 mg estradiol / 100 mg progesterone) capsules for the indication of continuous combined hormone replacement therapy (HRT) for estrogen deficiency symptoms in postmenopausal women with intact uterus and with at least 12 months since last menses.

“Up to 80% of women experience vasomotor symptoms during their menopause transition,1, 2 and these lasted more than 7 years for more than half of the women. 3 With Bijuva, Theramex aims to help these patients with an oral combination of low dose estradiol and progesterone which have the same chemical and molecular structure as the hormones produced naturally in a woman’s body”, says Robert Stewart, CEO of the company.

Bijuva is the first and only oral combined HRT with bio-identical hormones, made available to patients across Europe through the license agreement that TherapeuticsMD (Nasdaq: TXMD) and Theramex signed in June 2019 granting Theramex the exclusive license and supply agreement to commercialize BIJUVA outside the United States, Canada and Israel.

About Theramex

Theramex is a leading, global specialty pharmaceutical company dedicated to women and their health. With a broad portfolio of innovative and established brands covering contraception, fertility, menopause and osteoporosis, Theramex supports women at every stage of their lives. Theramex’s commitment is to understand its patients, serve their needs, and offer healthcare solutions to help improve their lives. Theramex’s vision is to be a lifetime partner for women and the healthcare professionals who treat them by providing innovative, effective solutions that care for and support women as they advance through each stage of their lives. To learn more about Theramex, please visit www.theramex.com.

References:

  1. Woods NF, Mitchell ES. Am J Med. 2005;118(suppl 12B):14–24.
  2. Gold EB, Colvin A, Avis N, et al. Am J Public Health. 2006;96(7):1226–1235.
  3. Avis NE et al JAMA Intern Med. 2015 Apr 1; 175(4): 531–539. 

Contacts

For any enquiries, please contact:

Nicholas Saunders, Director – Global Menopause Franchise

[email protected]