A.MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE
Name and address of the manufacturer responsible for batch release
FERRER INTERNACIONAL, S.A.
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 marketing authorisation holder shall submit the first periodic safety update report for this product within 6 months following authorisation. Subsequently, the marketing authorisation holder shall submit periodic safety update reports for this product in accordance with the requirements set out 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 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 shall be submitted annually until renewal.
When the submission of a PSUR and the update of a RMP coincide, they should be submitted at the same time.
In addition, 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) mileston being reached.
Addtional risk minimisation measures
Prior to launch in each Member State the Marketing Authorisation Holder (MAH) shall agree an educational programme with the National Competent Authority.
The MAH shall ensure that, following discussion and agreement with the National Competent Authorities in each Member State where ADASUVE is marketed, at launch and after launch, all healthcare professionals who are expected to use ADASUVE are provided with an information pack containing the following items:
Summary of Product Characteristics (SmPC) and Package Leaflet and Labelling
Educational material for the healthcare professionals
Key elements to be included in the educational materials:
Introductory statement on the purpose of the educational material
Statement on acute setting of indication
Risk of bronchospasm:
A clear recommendation not to start ADASUVE treatment in patients with a respiratory medical history
Treatment with ADASUVE to be limited to a hospital setting
Availabilty of rescue medicatins (short acting beta agonist bronchodilator) during treatment
Observation of patients for 1 hour after each dose of ADASUVE
Risk of QT prolongation:
Administration of a maximum of 2 doses
Caution to be exercised when ADASUVE is administered in patients with known cardiovascular disease or a family history of QT prolongation, and in cases of concomitant use with other medicial products known to prolong the QT interval