Cessation of marketing of Protelos/Osseor: Extract of the letter sent to European Medicine Agency (EMA) and national European Agencies on 10 February 2017
Similar letters, adapted to local regulations, have been sent to all countries worldwide where Protelos/Osseor® is marketed
PROTELOS/OSSEOR® – Cessation of marketing
On 21 September 2004, Protelos/Osseor® (strontium ranelate), centrally authorised medicinal product, was granted a Marketing Authorisation by the European Commission for the European Union (EU).
Protelos/Osseor® is indicated in the treatment of severe osteoporosis in postmenopausal women and in 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.
Les Laboratoires Servier hereby notify the cease of the marketing, permanently, in the European countries where it is currently marketed.
This worldwide and strategic decision is taken for commercial reasons based on the following grounds:
- The restricted indication/limited use of Protelos/Osseor®,
- The continuous decrease of patients treated with Protelos/Osseor®.
Les Laboratoires Servier will cease the distribution of Protelos/Osseor® in August 2017.