ADVERSE EVENT REPORTING

At humanova, we identify, collect, assess, and prevent adverse events that may occur during the use of our products to safeguard patient well-being and continuously monitor their benefit-risk profile.

Frequently Asked Questions (FAQs)

1 What Is an Adverse Event?

Any undesirable clinical occurrence in a patient who has been administered a product (medication, medical device, and/or cosmetic) that does not necessarily have a causal relationship with its use¹. In this context, the key consideration is the temporal association, without any suspicion of a causal relationship.

2 What Is Pharmacovigilance?

The World Health Organization (WHO) defines pharmacovigilance as the science and activities relating to the detection, assessment, understanding, and prevention of adverse events or any other health-related problems associated with medicines or vaccines².

3 ¿Qué es la Tecnovigilancia?

The Pan American Health Organization (PAHO) defines medical device vigilance as a set of methods and observations used to detect adverse events during the use of a medical device that may cause harm to the patient, the operator, or their surroundings. Problems, malfunctions, risks, or potential risks arising from the use of medical devices may be classified as adverse incidents.³.

4 What Is Cosmetovigilance?

Cosmetovigilance is defined as the practice of collecting, assessing, and monitoring information on undesirable effects observed as a result of the normal or reasonably foreseeable use of cosmetic products, as well as implementing measures and disseminating information related to such effects.⁴.

5 References

1. Uppsala Monitoring Centre. Glossary [Internet]. Uppsala: Uppsala Monitoring Centre; [citado 17 Jul 2026]. Available at: https://who-umc.org/pharmacovigilance-communications/glossary/
2. Organización Mundial de la Salud. Farmacovigilancia [Internet]. Ginebra: OMS; [citado 17 Jul 2026]. Available at: https://www.who.int/teams/regulation-prequalification/regulation-and-safety/pharmacovigilance.
3. Organización Panamericana de la Salud. Buenas prácticas de farmacovigilancia para las Américas [Internet]. Washington, D.C.: OPS; 2011 [citado 17 Jul 2026]. 78 p. (Red PARF Documento Técnico, No. 5). Disponible en: https://www.paho.org/sites/default/files/Technical-Doc-5-web.pdf.
4. Agencia Española de Medicamentos y Productos Sanitarios. Cosmetovigilancia [Internet]. Madrid: AEMPS; 14 May 2025 [citado 17 Jul 2026]. Available at: https://www.aemps.gob.es/cosmeticos/cosmetovigilancia/#.

REPORT YOUR ADVERSE EVENT!

To report an adverse event related to any of our products, please contact us using the form below.

Patient Data

Patient Initials (*)

Age (*)

Sex (*)

Weight (Kg)

Height (cm)

Adverse Event Description

Describe the Adverse Event (*)

Adverse Event or Incident Start Date (*)

Adverse Event End Date

Product Data

Product Name (include health registration if possible) (*)

Dose / Frequency (if applicable) (*)

Route of Administration (if applicable) (*)

Product use start date (*)

Product use end date

Product lot or serial number:

Why do you use it?:

You may upload a photo of the medicine or medical device package, including lot or serial number information if visible or available.

Notifier Data

Iniciales del Notifier (*)

Phone (*)

Email (*)

Are you a healthcare professional? YesNo

Profession

Professional Registration

I have read and agree to the Pharmacovigilance and Technovigilance Policy and the Data Privacy Policy

Dear user, based on your notification, it may be necessary to collect additional information for proper follow-up of your case. Do you authorize Humanova to contact you, including by phone, for this purpose?

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