A.MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
Name and address of the manufacturer responsible for batch release
Production Site Oranienburg
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 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 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.
Additional risk minimisation measures
The Marketing Authorisation Holder shall agree the content and format of the updated educational material with the national competent authority.
The Marketing Authorisation Holder (MAH) should ensure that all Healthcare Professionals who are expected to prescribe Libertek are provided with an updated Educational pack.
The educational pack should contain the following:
Summary of Product Characteristics and Patient Information Leaflet for Libertek
Educational material for the physician.
Copies of the patient card to be given to patients or caregivers before they receive Libertek The educational material for the prescriber should include information on the following key elements:
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The specific indication approved.
The fact that Libertek is not indicated for the treatment of COPD patients outside of the approved indication, nor for use in patients with asthma or
The need to inform patients about the risks of Libertek and the precautions for safe use including:
The risk of weight decrease in underweight patients and the need to monitor the body weight at each visit and to stop the treatment in the event of an unexplained and clinically concerning weight decrease. Patients should be advised to weigh themselves at regular intervals and record the weight in the patient card.
The risk of psychiatric disorders such as insomnia, anxiety, depression in patients receiving Libertek and the potential risk of suicide. Rare instances of suicidal ideation and behaviour, including completed suicide, have been observed in patients with and without a history of depression, usually in the first weeks of treatment. Physicians should carefully assess the benefit risk balance of this treatment in patients with existing psychiatric symptoms or with history of depression. Libertek is not recommended in patients with a history of depression associated with suicidal ideation or behaviour. If patients suffer from new or worsening psychiatric symptoms, or suicidal ideation or suicidal attempt, it is recommended to discontinue treatment with Libertek.
Patients and caregivers should be requested to report any changes in the patient`s behaviour or mood or suicidal ideation.
The potential risk of malignant tumours and the lack of experience in patients with past history of cancer. Libertek should not be initiated or should be stopped in patients with cancers (except basal cell carcinoma).
That increased exposure might occur in certain populations and increase the risk of persistent
oSpecial populations who have increased PDE4 inhibition such as black non smoking females;
oPatients concomitantly treated with CYP1A2/2C19/3A4 inhibitors (such as fluvoxamine and cimetidine) or CYP1A2/3A4 inhibitors (such as enoxacin).
The potential risk of infections: Libertek should not be initiated, or treatment should be stopped, in patients with severe acute infectious diseases. The limited experience in patients with latent infections such as tuberculosis, viral hepatitis or herpes infections.
The lack of experience in patients with HIV infection or active hepatitis, with severe immunological diseases (e.g..multiple sclerosis, lupus erythematosus, multifocal leukoencephalopathy) or treated with immunosuppressive therapy (other than
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The potential cardiac risk: Libertek has not been studied in patients in congestive heart failure (NYHA grade 3 and 4); hence, it is not recommended in this population.
The limited or missing information in patients with liver impairment. Libertek is contraindicated in patients with moderate or severe liver impairment
The lack of clinical data to support the combination with theophylline and that such combination is not recommended.
The patient card should contain the following key elements:
That they should tell their doctor if they have a history of any of the following conditions
insomnia, anxiety, depression, suicidal ideation or behaviour
multiple sclerosis or SLE
infection with tuberculosis, herpes, hepatitis, HIV
That patients or their caregivers should tell their doctor if the patient develops symptoms indicative of:
insomnia, anxiety, depression, changes in behaviour or mood, suicidal ideation or behaviour
That patients should tell their doctor if they are taking any other medicines.
That Libertek may cause weight loss and patients should weigh themselves regularly and record their weight on the patient card.
The patient card should include an area where patients can record their weight and the date they weighed themselves and they should be asked to bring the patient card with them at each visit.
Obligation to conduct
The MAH shall complete, within the stated timeframe, the below measures:
ANX 2.1 - The MAH commits to conduct a
observational safety study. This study should be appropriate to compare
Reports - with each
the incidences of
diagnosis of cancer,
respiratory disease, suicide or hospitalisation for suicide attempt, and new
Final study report
diagnosis of depression, tuberculosis or viral hepatitis B or C in
roflumilast treated COPD patients compared with COPD patients not
treated with roflumilast.