A.MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
Name and address of the manufacturer responsible for batch release
Passauer Pharma GmbH
Eiderstedter Weg 3
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
- Myfenax - mycophenolate mofetil
- Cellcept - mycophenolate mofetil
- Mycophenolate mofetil teva - mycophenolate mofetil
Prescription drugs listed. Substance: "Mycophenolate mofetil"
D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
Risk Management Plan (RMP) Not applicable.
Additional risk minimisation measures
Prior to the use of Myclausen in each Member State (MS) the Marketing Authorisation Holder (MAH) must agree about the content and format of the educational programme and a
The educational programme is aimed at ensuring that the health professionals and patients are aware of the teratogenicity and mutagenicity, the need for pregnancy tests before starting therapy with mycophenolate mofetil, the contraceptive requirements for both male and female patients and what to do in case of pregnancy during treatment with Myclausen.
The MAH shall ensure that in each MS where Myclausen is marketed, all healthcare professionals and patients who are expected to prescribe, dispense or use Myclausen are provided with the following educational package:
·Physician educational material
·Patient information pack
The health professional educational material should contain:
·The Summary of Product Characteristics
·Guide for healthcare professionals
The patient information pack should contain:
·The Package Leaflet
·Guide for patients
The educational materials should be implemented within four months after completion of this procedure and shall contain the following key elements:
Separate guides for healthcare professionals and patients should be provided. For patients, the text should be appropriately separated for men and women. The following areas should be covered in these guides:
An introduction in each guide will inform the reader that the purpose of the guide is to tell them that a foetal exposure must be avoided and how to minimize the risk of birth defects and miscarriage associated with mycophenolate mofetil. It will explain that although this guide is very important it does not provide full information on mycophenolate mofetil and that the SmPC (healthcare professionals) and package leaflet (patients) supplied with the medicine must also be read carefully.
Background information on mycophenolate mofetil teratogenicity and mutagenicity in humans. This section will provide important background information concerning the teratogenicity and mutagenicity of mycophenolate mofetil. It will provide details about the nature and magnitude of the risk, in line with the information provided in the SmPC. The information provided in this section will facilitate a correct understanding of the risk and explain the rationale for the following pregnancy prevention measures. Guides should also mention that patients should not to give this drug to any other person.
Counselling of patients: This section will emphasise the importance of a thorough, informative and ongoing dialogue between patient and healthcare professional about the pregnancy risks associated with mycophenolate mofetil and the relevant minimisation strategies including alternative treatment choices, if applicable. The need to plan a pregnancy will be highlighted.
The need to avoid foetal exposure: Contraceptive requirements for patients of reproductive potential prior to, during and after treatment with mycophenolate mofetil. Contraceptive requirements for sexually active male patients (including vasectomised men) and female patients of childbearing potential will be explained. The need for contraception prior to, during and after treatment with mycophenolate mofetil, including details of the duration of time for which contraception must be continued after cessation of therapy, will be clearly stated.
In addition, the text relating to women should explain the pregnancy test requirements prior to and during therapy with mycophenolate mofetil; including the advice for two negative pregnancy tests prior to starting therapy and the importance of the timing of these tests. The need for subsequent pregnancy tests during treatment will also be explained.
Advice that patients should not donate blood during therapy or for at least 6 weeks following discontinuation of mycophenolate. Furthermore, men should not donate semen during therapy or for 90 days following discontinuation of mycophenolate.
Advice on action if a pregnancy occurs or is suspected during or shortly after being treated with mycophenolate mofetil. Patients will be informed that they should not stop taking mycophenolate mofetil but must contact their doctor immediately. It will be explained that the correct course of action, based on an assessment of the individual
In addition, a pregnancy