Side effects may include (but are not limited to) symptoms like:
- Nausea (feeling sick)
- Headache
- Itching
- Vomiting
Product Details
An Adverse Event (AE), also known as a side effect, is an unwanted and unintended response in a patient, after receiving a medicinal product, that may or may not have been caused by treatment with this product. This includes all events where harm or unintended and unwanted response in a patient, user or other person as a result of the use of a medical device. The information you provide helps to ensure the safety of our products and our patients.
For which Roche product do you want to report a potential side effect?
Could you please submit additional product details?
Please submit as many product details as possible.
Side effect details
Side effect examples
Side effect description
Please describe the adverse event as accurate as possible and provide as many details as possible, like for example: The [side effect] occured after taking [the product] on [date]. The [side effect] started on [date] and the patient was admitted into hospital. The [side effect] stopped on [date].
Pregnancy-related details
The pregnancy-related questions are meant to collect information about side effects and pregnancy. Thank you for contributing to making our products safer and more efficient.
Describe here the side effect, if this has resolved or is ongoing, how serious this is/was, the outcome and any further information that may be relevant both before, during and after the side effect occurred. For medical devices please also describe the way the device caused or contributed to the event and if relevant clearly describe the device malfunction causing the event.
Please describe the potential side effect that you would like to report:
Pregnancy-related details (optional)
Information about the use of our medicines during pregnancy is valuable to us to increase knowledge of their safety and inform patients. Please note, patients should consult with their healthcare professional to be informed on the safety of taking a medicine during pregnancy.
Was a pregnancy/breastfeeding taking place at the same time as either the side effect was experienced, or the Roche product was consumed?
When did the exposure to the Roche product occur? Select all that apply.
What is the current status of the pregnancy?
Please provide additional information about the abnormalities (e.g. describe the birth defect).
Please provide the estimated date of delivery if known
Information about the patient
To improve the safety of our medication, any information (at least 1 identifying detail) you can provide is very helpful. The data will be stored in accordance with data privacy regulations.
Gender
Reporter details
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Can we contact the treating healthcare professional?
Healthcare professional contact details
If you consent in contacting your healthcare professional, please provide details below.
F. Hoffmann-La Roche Ltd ("Roche") has legal obligations to record and/or report adverse events. Therefore, for such purposes your data will be processed in accordance with specific GVP (pharmacovigilance) legislation, as further described in the Roche Privacy Notice for Pharmacovigilance, medical information and product complaints.
Roche will keep a record of the personal data that you provide for the purpose of responding to your inquiry, to follow up on such requests, to maintain the information in the Roche global pharmacovigilance database for reference and to comply with our legal and regulatory recording and reporting obligations. The retention time of data is in accordance with respective laws and regulations.
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The Privacy Policy provides further detailed information about your rights and how Roche processes personal data.