Dear Healthcare Professional Letter concerning introduction of a pregnancy risk reduction plan for patients using CellCept
24.06.2009
On 24 June 2009, in cooperation with the Agency for Medicinal Products and Medical Devices, Roche d.o.o. sent a Dear Healthcare Professional Letter to prescribing physicians concerning implementation of the pregnancy risk reduction measures during use of CellCept (mofetilmycophenolate).
Basic goals are to present and describe in more detail the risks of possible adverse effect on foetus in pregnant women using CellCept in combination with other immunosuppressants, and to provide adequate educational materials and preventive actions on the global level. The letters are meant once more to remind physicians of the special precautionary measures aimed at the use of CellCept in connection with the pregnancy and the importance of communication with the patients of reproductive age for which a special Medication Guide has been prepared. Physicians are invited to cooperate and comply with proposed measures in order to ensure a safe use of CellCept.
The Agency for Medicinal Products and Medical Devices supports implementation of this risk reduction plan and emphasises that the same instructions are valid for all medicinal products containing the active substance mofetilmycophenolate. In the Republic of Croatia, in addition to CellCept, there is also the medicinal product Trixin pills 500 mg of the marketing authorisation holder Pliva Hrvatska d.o.o. containing the active substance mofetilmycophenolate which is also approved for marketing.
The text of the letter can be found at the following link: "Information to physicians concerning CellCept and pregnancy".
The Medication Guide for patients can be found at the following link: "CellCept-What You Need to Know"
