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Roche medicines must be effective and reliable. But in addition, consumers of our medicines
must be confident that every effort is being made to ensure their safety through rigorous testing, ongoing
monitoring and risk management.
There is always
an element of risk involved
when introducing a medicine into your body. Hence, there can never be a guarantee that a medicine is
completely safe. All medicines can cause side effects in some patients – our commitment is to provide
highly effective medicines that will improve quality of life, while minimising potential risks. This
means we must continually collect information on the adverse effects of our medicines,
then assess and
manage the risks of those adverse effects.
Our product information clearly
describes potential risks but, if necessary, we also provide advice to reduce these risks. This information
is available from many sources. The most important information is contained in the Summary of
Product Characteristics (SmPC) which is available to all prescribers. In addition, patient information
is included in all medicine packaging. SmPC and patient information must be approved by regulatory
authorities. This helps doctors and patients to decide whether the benefits of taking a particular medicine
outweigh the risks in each individual case and if specific actions are required to reduce any risk.
We
re-evaluate the benefit–risk profile of each of our products based on monitoring reports
of adverse
events and, if necessary, update our SmPC and patient information accordingly. This process of detection,
assessment and prevention of adverse events to medicines is known as pharmacovigilance.
However,
in the ideal world, every patient should have exactly the treatment that is right for him or her and
be prescribed the medication that is individually suited to his or her specific condition. Therapies
should show precisely the effect that is intended, and have few if any effects on the patient’s quality
of life. With this in mind, Roche is leading in the drive towards Personalised Healthcare
and customised therapies. Our aim is to enable healthcare to be tailored more closely to patients’ individual
needs, thereby offering more cost-efficient, differentiated and targeted medicines to patients.
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