Cessation
of marketing of Protelos/Osseor: Extract of the letter sent to European
Medicine Agency (EMA) and national European Agencies on 10 February 2017
14/03/2017
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:
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.
Servier, founded in 1954, is the
first independent pharmaceutical group. We are present in 140 countries, with
more than 21 000 employees, including close to 3000 in R&D.
My note: Those who will no longer be prescribed strontium ranelate can buy nonprescription strontium citrate.
