A. MANUFACTURER(S) RESPONSIBLE FOR BATCH
Name and address of the manufacturers responsible for batch release
Concentrate for solution for infusion
- Bondronat - ibandronic acid
- Ibandronic acid sandoz - ibandronic acid
- Ibandronic acid teva - ibandronic acid
- Bonviva - ibandronic acid
- Bondenza (ibandronic acid roche) - ibandronic acid
Prescription drugs listed. Substance: "Ibandronic acid"
Pharmathen International S.A. Industrial Park Sapes, Street block 5 69300 Sapes, Prefecture of Rodopi Greece
The printed package leaflet of the medicinal product must state the name and address of the manufacturer responsible for the release of the concerned batch
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
Periodic safety update reports
At the time of granting the marketing authorisation, the submission of periodic safety update reports is not required for this medicinal product. However, the marketing authorisation holder shall submit periodic safety update reports for this medicinal product if the product is included in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and 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 minimisation) milestone being reached.
If the dates for submission of a PSUR and the update of a RMP coincide, they can be submitted at the same time.