The European Commission adopted the CHMP opinion to maintain Protelos®/Osseor® available in Europe.

07/05/2014

The European Commission adopted on April 15 2014, the CHMP opinion to maintain Protelos®/Osseor® available in Europe, with further restrictions.

  • Protelos®/Osseor® is now indicated for the treatment of severe osteoporosis in postmenopausal women and adult men, at high risk of fracture, for whom treatment with other medicinal products approved for the treatment of osteoporosis is not possible due to, for example, contraindications or intolerance.
  • During Protelos®/Osseor® treatment, cardiovascular risks should be monitored on a regular basis generally every 6 to 12 months.
  • Servier will provide educational materials for prescribers and patients after approval from the EMA.

With these new conditions of use, Protelos®/Osseor® represents an alternative in the treatment of severe osteoporosis for patients who do not present contra-indications1 and who cannot be treated with other treatments.

For more information, please refer to the Summary of Product Characteristics and to the Direct Healthcare Professional Communication available at www.servier.com.

 

1- Protelos®/Osseor® is contra-indicated in patients with established, current or past history of venous thromboembolic event, ischemic heart disease, peripheral arterial disease, cerebrovascular disease, and/or in case of uncontrolled hypertension or temporary or permanent immobilisation.

Previous article: The European Medicines Agency recommends that PROTELOS®/OSSEOR® remain available with further restrictions (21/02/2014)