A.MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE
Name and address of the manufacturer(s) responsible for batch release
Roche Pharma AG
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 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 set up a
The MAH must ensure that at launch all physicians who are expected to prescribe Esbriet are provided with a physician information pack containing the following:
●Product information (SPC)
●Physician information (safety checklists)
●Patient information (PIL)
The safety checklist about Esbriet should contain the following key elements related to liver function and photosensitivity:
●Esbriet is contraindicated in patients with severe hepatic impairment or end stage liver disease.
●Elevations of serum transaminases can occur during treatment with Esbriet.
●There is a need to monitor liver function tests prior to initiation of treatment with Esbriet and at regular intervals thereafter.
●Close monitoring is required of any patients who develop liver enzyme elevation with appropriate dose adjustment or discontinuation.
●Patients should be informed that Esbriet is known to be associated with photosensitivity reactions and that preventative measures have to be taken.
●Patients are advised to avoid or reduce exposure to direct sunlight (including sunlamps).
●Patients should be instructed to use a sunblock daily, to wear clothing that protects against sun exposure, and to avoid other medications known to cause photosensitivity.
The physician information should encourage the prescribers to report serious adverse reactions and clinically significant ADRs of special interest including:
●Photosensitivity reactions and skin rashes
●Abnormal liver function tests
●Any other clinically significant ADRs based on the judgment of the prescriber
●Obligation to conduct
The MAH shall complete, within the stated timeframe, the below measures:
Observational Registry to Evaluate
Safety updates to coincide with PSUR timetable. Final PASS report