Adverse event(s) notification

Who are you ? *

(Please select your profile)

Member of public (yourself, a patient, a friend, a parent)

Health professionnal (a doctor, a pharmacist, a nurse)

What is your email address ? *

Product 1

What is the name of the Biocodex product you suspect to be linked to the adverse event(s) ? *

Why the Biocodex product is used?

When did the patient start and stop the Biocodex product, if applicable ?

What is the daily dose of the Biocodex product ?

What is the administration route ?

What action was taken with the product as result of the adverse event ?

Do you know the batch number of the Biocodex product ? If yes, please specify

Is there any other product(s) used at the same time as the suspected Biocodex product ? If yes, which product(s) is it ?

Do you consider other product as suspect to be linked to the adverse event ?

Yes

No

What is the patient’s gender ? *

Male

Female

Unknown

What are the patient's initials ?

What is the patient’s date of birth ?

Unknown

Could you please provide any information regarding the patient's medical history?

Indicate if the patient has a usual treatment(s) or treatment(s) administered during the adverse event but not considered as linked to its occurrence

Start date

End date

What is the adverse event experienced by the patient ? *

You can provide further details regarding the adverse and if any corrective treatment was needed

Could you please indicate the chronology of the adverse event ?

What is the evolution of the patient's health status regarding this event ?

Could you please indicate whether the adverse event leads to one or more following situations ?

Death

Life threatening

Hospitalisation or prolongation of existing hospitalisation

Persistent or significant disability/incapacity

Congenital anomaly/birth defect

No

Please, specify any results of tests/labs, other exams supporting the analysis of the adverse event occurrence

Please upload any relevant documents supporting the analysis of the adverse event occurence

Please upload documents to 15Mo maximum and no more than 10 documents.

Thank you, your submission is about to be sent.

Please read and accept our RGPD policy in order to send your submission :

Personal data can be processed, in respect of medical confidentiality, to allow BIOCODEX to follow up the requests for information or quality complaints on the products and to meet its legal obligations in pharmacovigilance, which aims to monitor the risk of adverse reactions resulting from the use of drugs it sells. These data are accessible only to BIOCODEX members and authorized services, and are not intended to be transmitted to other companies or organizations. These data will be kept up to 10 years after the end of the marketing of the product. In accordance with the (EU) General Data Protection Regulation 2016/679 of 27 April 2016 (« GDPR ») on the protection of natural persons with regard to the processing of personal data and on the free movement of such data, you can exercise your right of access to the data concerning you and rectify them, by contacting the Data Protection Officer (« DPO »): dpo@biocodex.com | DPO BIOCODEX – 22 Rue des Aqueducs – 94250 GENTILLY – France . If you are a healthcare professional, be sure to communicate orally to the patient the above mentioned information and inform him that his right to access and correct the data could be exercised only through you, as BIOCODEX has no access to his identity.

I have read and I agree with Biocodex’s terms of use and privacy statement *

Thank you for your notification. This has been registered and has been sent to the relevant department of the Biocodex laboratory. If you have accepted it, our teams will contact you to obtain additional information on your notification. To access the homepage, please click here.

Adverse event(s) notification

Product 1

Product ID

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Adverse event(s) notification