A.MANUFACTURERS RESPONSIBLE FOR BATCH RELEASE
Name and address of the manufacturers responsible for batch release
Takeda Ireland Limited
Bray Business Park
Delpharm Novara S.r.l.
Via Crosa 86,
28065 Cerano (NO)
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 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 minimisation) milestone being reached.
Additional risk minimisation measures
The MAH shall provide an educational pack targeting all physicians who are expected to prescribe/use Pioglitazone. Prior to distribution of the prescriber guide in each Member State, the MAH agreed the content and format of the educational material, together with a communication plan, with the national competent authority.
•This educational pack is aimed at strengthening awareness of important identified risks of bladder cancer and heart failure and the overall recommendations intended to optimise the
•The physician educational pack should contain: The Summary of Product Characteristics, package leaflet, and a Prescriber Guide.
The Prescriber Guide highlights the following:
•Patient selection criteria including that Pioglitazone should not be used as first line therapy and emphasising the need for regular review of treatment benefit.
•The risk of bladder cancer and relevant risk minimisation advice.
•The risk of heart failure and relevant risk minimisation advice.
•Caution in use in the elderly in light of age related risks (in particular bladder cancer, fractures and heart failure).