romosozumab
Evenity · ATC code M05BX06
- Key facts
- Active substance
- romosozumab
- ATC code
- M05BX06
- Authorisation
- centrally authorised across the EU (EMA)
- Dosage forms
- EVENITY 105 mg solution for injection in pre-filled pen / EVENITY 105 mg solution for injection in pre-filled syringe
- Marketing authorisation holder
- UCB Pharma S.A.
- Information as of
- 2026-10-27
Key facts
Romosozumab is a monoclonal antibody against sclerostin that increases bone formation and decreases bone resorption. It is used for severe osteoporosis in postmenopausal women at high risk of fracture.
What it is used for
- Severe osteoporosis in postmenopausal women at high risk of fracture
Dosing
- 210 mg (two subcutaneous injections of 105 mg each) once monthly for 12 months
- Adequate calcium and vitamin D supplementation before and during treatment
- After completion, transition to antiresorptive therapy is recommended
- A missed dose is given as soon as feasible; the next dose not earlier than one month later
- No dose adjustment in the elderly or in renal impairment; monitor serum calcium in severe renal impairment or dialysis
Contraindications
- Hypersensitivity to the active substance or excipients
- Hypocalcaemia
- History of myocardial infarction or stroke
Important warnings
- Increase in serious cardiovascular events (myocardial infarction, stroke); weigh fracture risk against cardiovascular risk and discontinue if an event occurs
- Hypocalcaemia; correct before starting
- Rare osteonecrosis of the jaw
- Rare atypical femoral fractures; evaluate new thigh, hip or groin pain
Side effects
- Most common: nasopharyngitis and arthralgia
- Hypersensitivity-related reactions; hypocalcaemia uncommonly
- Myocardial infarction and stroke
Interactions
- No interaction studies; no pharmacokinetic interactions expected
Pregnancy and breastfeeding
- Not indicated in women of child-bearing potential, in pregnancy or during breast-feeding
Summary of the official product information, written with AI (Claude, Anthropic) on 2026-10-28. Every number was checked automatically against the original text. Not reviewed by a physician – the full official text is authoritative.
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For patients
Package leaflet, verbatim
Authorisation and brand names by country
Medicines with exactly this active-substance composition, as listed in the national registers – alphabetical and without ranking. Whether a product is currently available is not shown here.
EU – centrally authorised (all member states)
- EvenityUCB Pharma S.A. · EMEA/H/C/004465
Source: European Medicines Agency (EMA), product information
Turkey
- EvenityAMGEN İLAÇ TİC. LTD. ŞTİ. · 1 register entry
Source: TİTCK – Ruhsatlı Beşeri Tıbbi Ürünler Listesi, as of 2026-10-16
Brand names in 3 more European countries
- Iceland
- Evenity
- Liechtenstein
- Evenity
- Norway
- Evenity
EMA – Article 57 product data (EU/EEA), 2026-10-28
Medelix receives no money from pharmaceutical companies. Brand names are listed alphabetically and without ranking.
Other substances in the same group
Another question about this substance?
Medelix answers clinical questions from guidelines, studies and product information – every claim with its source.
Sources
- European Medicines Agency. Evenity – EPAR, Product Information (OF THE TEXT Detailed information on this medicinal product i). 2026-10-27. https://www.ema.europa.eu/en/documents/product-information/evenity-epar-product-information_en.pdf
- TİTCK – Ruhsatlı Beşeri Tıbbi Ürünler Listesi, 2026-10-16. https://www.titck.gov.tr/dinamikmodul/85
Editorial: Medelix editorial team · last updated 2026-10-27 · How these pages are made · Report an error
Source: European Medicines Agency (EMA), product information. Not advertising, not a treatment recommendation. For questions about your own treatment, ask your doctor or pharmacist.