To make sure Concerta is safe for you, tell your doctor if you have: high blood pressure; a personal or family history of mental illness, psychotic disorder, bipolar illness, depression,.
![Concerta Compassionate Program Concerta Compassionate Program](/uploads/1/2/5/5/125529192/694237423.png)
Is a treatment option that allows the use of an unauthorised medicine. Under strict conditions, products in development can be made available to groups of patients who have a disease with no satisfactory authorised therapies and who cannot enter. Agency RoleThe European Medicines Agency (EMA) provides recommendations through the, but these do not create a legal framework. Programmes are coordinated and implemented by Member States, which set their own rules and procedures.These programmes are only put in place if the medicine is expected to help patients with life-threatening, long-lasting or seriously debilitating illnesses, which cannot be treated satisfactorily with any currently authorised medicine.The medicine must be undergoing or have entered the marketing-authorisation application process and while early studies will generally have been completed, its safety profile and dosage may not be fully established. How to request an opinionNational competent authorities can ask EMA for an opinion on how to administer, distribute and use certain medicines for. The also identifies which patients would benefit, and Member States should take note of these recommendations when making decisions.Manufacturers and marketing-authorisation applicants should not contact EMA to request an opinion, but they may wish to inform the Agency of applications underway at national level.