A.MANUFACTURER(S)RESPONSIBLE FOR BATCH RELEASE
Name and address of the manufacturer(s) responsible for batch release
Les Laboratoires Servier Industrie 905, route de Saran
45520 Gidy France
B.CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE
Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2).
C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION
•Periodic Safety Update Reports
The requirements for submission of periodic safety update reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines
D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
•Risk Management Plan (RMP)
The MAH shall perform the required pharmacovigilance activities and interventions detailed in the agreed RMP presented in Module 1.8.2 of the Marketing Authorisation and any agreed subsequent updates of the RMP.
An updated RMP should be submitted:
- Protelos - strontium ranelate
Prescription drugs listed. Substance: "Strontium ranelate"
•At the request of the European Medicines Agency;
•Whenever the risk management system is modified, especially as the result of new information being received that may lead to a significant change to the benefit/risk profile or as the result of an important (pharmacovigilance or risk minimisation) milestone being reached.
•Obligation to conduct
The MAH shall complete, within the stated timeframe, the below measures:
After approval of the protocol, annual reports from this study shall be provided within the PSUR until submission of the final study report, which is due by December 2017.
Additional risk minimisation measures
In each Member State where OSSEOR is marketed, the Marketing Authorisation Holder (MAH) shall agree the final educational programme with the National Competent Authority.
The MAH shall ensure that, following discussion and agreement with the National Competent Authority in each Member State where OSSEOR is marketed, all physicians who are expected to prescribe OSSEOR are provided with the following educational package:
•Prescriber guide and checklist
•Patient alert card
The prescriber guide and checklist shall contain the following key messages:
•OSSEOR is only indicated for use in patients with severe osteoporosis 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.
•The initiation of treatment with OSSEOR should be based on an assessment of the individual patient’s overall risk.
•All patients should be fully informed that cardiovascular risks should be monitored on a regular basis generally every
•The patient alert card should be given to every patient.
•OSSEOR is contraindicated and must not be used in patients with :
oEstablished, current or past history of ischaemic heart disease, peripheral arterial disease and/or cerebrovascular disease.
o Uncontrolled hypertension.
oCurrent or previous venous thromboembolic events (VTE), including deep vein thrombosis and pulmonary embolism.
oTemporary or permanent immobilisation due to e.g.
oHypersensitivity to the active substance (strontium ranelate) or any of the excipients.
•OSSEOR should only be used with caution in:
- Protelos - M05BX03
Prescription drugs listed. ATC Code: "M05BX03"
oPatients with significant risk factors for cardiovascular events such as hypertension, hyperlipidaemia, diabetes mellitus or smoking.
oPatients at risk of VTE. When treating patients over 80 years at risk of VTE, the need for continued treatment with OSSEOR should be
•The treatment should be either discontinued or stopped in the following situations:
oIf the patient develops ischaemic heart disease, peripheral arterial disease, cerebrovascular disease or if hypertension is uncontrolled, the treatment
should be stopped.
oAs soon as possible in the event of an illness or a condition leading to immobilization, the treatment should be discontinued.
oIf symptoms or signs of
patient has developed SJS, TEN or DRESS with the use of OSSEOR, OSSEOR must not be
•Within the prescriber guide there will be a
The patient alert card shall contain the following key messages:
•Importance of showing the patient alert card to any Health Care Professional involved in their treatment.
•The contraindications to the treatment with OSSEOR.
•Key signs and symptoms of myocardial infarction, VTE and serious skin reactions.
•When to seek urgent medical advice.
•Importance of regularly monitoring cardiovascular risk.