Cosmetovigilance and Pharmacovigilance

Pharmacovigilance and cosmetovigilance aim to ensure the safety and efficacy of its products that are already sold, therefore, it constantly assesses several sources of reports of adverse events.

The information is treated confidentially and will not be used for any legal questioning and is directed to Cosmetovigilance and Pharmacovigilance of TheraSkin.

What is Pharmacovigilance?

Any undesirable medical occurrence in a patient during treatment with a drug, but not necessarily causally related to such treatment.

An adverse event can be considered as a suspected adverse reaction to a drug.

For cosmetics, the definition is similar, that is, an adverse event is any undesirable effect in humans due to the use of a cosmetic.

Cosmetovigilance:

A set of activities that aim to detect, assess, understand and prevent adverse events with the use of cosmetics.

What is an adverse event?

Any undesirable medical occurrence to a patient during treatment with a drug but which does not necessarily have a causal relationship to this treatment. An adverse event can be considered as a suspected adverse reaction to a drug.

For cosmetics, the definition is similar, that is, an adverse event is any undesirable effect in humans due to the use of a cosmetic.

What to report?

Any suspected adverse event with one of TheraSkin’s medicines or cosmetics, this includes:

  • Lack of efficacy or treatment failure;
  • Misuse, accidental ingestion or abuse (with or without symptoms);
  • Interactions between medications or cosmetics;
  • Overdosage (with or without symptoms);
  • Exposure during pregnancy (with or without symptoms);
  • Exposure during breastfeeding (with or without symptoms).

Who can report?

Anyone can report the occurrence of an adverse event, the patient, family member of a patient, friend, doctor, pharmacist or you!

The information is treated confidentially and is directed to Pharmacovigilance or Cosmetovigilance.

How to report?

The notification can be made through the TheraSkin Service Center (COT) by calling 0800 019 6660, by e-mail cot@theraskin.com.br or by the form below.

 

Cosmetovigilance » Patient















Comectovigilance » Product















Cosmetovigilance » Physician







Cosmetovigilance » Adverse Event






Cosmetovigilance » Additional Data








Pharmacovigilance » Patient















Pharmacovigilance » Product















Pharmacovigilance » Physician







Pharmacovigilance » Adverse Event






Pharmacovigilance » Treatment