At Flextem Biopharma, we develop pharma-grade cannabis-based products that help people to improve their health and life quality. We're not only committed to produce according to the highest quality and safety standards, but also developing a strategy of evidence-generation and active pharmacovigilance along the entire cycle of our products.
This effort allows us to access in a reliable and timely manner to:
1. Added data on prescribing practices of health results achieved by patients, systematizing info on types of pathologies, doses indicated according to pathology and population group, and demographics and health profiles of those who receive treatment with Flextem Biopharma's products.
2. Info on potential adverse effects may be associated with dosis administration of any of our products. Data is proactively collected and any situation that may require an alert to a Health Authority are identified earlier, complemented by our spontaneous notification of passive pharmacovigilance system.
What is a reaction or an adverse effect?
It's any undesirable reaction of effect attributable to the administration of a drug or medical product in commonly used dosis by humans. Any medication can cause an adverse reaction in certain patients, so we believe it's essential to have continuous communication with health personnel, patients, care institutions and health authorities to detect them and act accordingly.
Who can report it?
Any person, family member, close friend or health personnel who becomes aware of an adverse event potentially attributable to the use of any of our products.
How can I report it?
Sending an email to This email address is being protected from spambots. You need JavaScript enabled to view it. with the following information:
– Name of the person who reports.
– Telephone number.
– First name or initials, age, gender, weight and approximate height of the patient.
– Basic description of the identified adverse effect
(symptoms, date of occurrence, etc.).
– Product of Flextem Biopharma used.
Once notified, the Medical Department of Flextem Biopharma will evaluate the information received and will establish the corresponding action plan together with the Technical Directorate of the company.
In the event of detecting a quality problem with any of our products, among other measures, the recall procedure for the corresponding batch may be activated.
