A.MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE
Name and address of the manufacturer responsible for batch release
Roche Pharma AG
- Bondenza (ibandronic acid roche) - ibandronic acid
- Ibandronic acid accord - ibandronic acid
- Ibandronic acid teva - ibandronic acid
- Bondronat - ibandronic acid
- Ibandronic acid sandoz - ibandronic acid
Prescription drugs listed. Substance: "Ibandronic acid"
Solution for injection in
Roche Pharma AG
- Bondronat - Roche Registration Ltd.
- Bondenza (ibandronic acid roche) - Roche Registration Ltd.
- Viracept - Roche Registration Ltd.
- Cellcept - Roche Registration Ltd.
- Zenapax - Roche Registration Ltd.
Prescription drugs listed. Manufacturer: "Roche Registration Ltd."
B.CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE
Medicinal product subject to medical prescription.
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:
•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 minisation) milestone being reached.
Additional risk minimisation measures
The MAH shall ensure that a patient reminder card regarding osteonecrosis of the jaw is implemented.