Pharmacovigilance

image9

  

We Sudair Pharma care with the Health practitioners to put the patient safety in our first priorities to provide Integrated health care based on high quality throw concept of the Pharmacovigilance Which Seeks to monitoring, evaluation & Prevent any side effects or any other drug problems throw by reporting.

The Food & Drug Authorities (FDA) & Ministry of Health (MoH) in Saudi Arabia & other Supervisory authority in Gulf Country & All the World have some Legal requirements that control how to deal with the Pharmaceutical Complaints & the Health Care In various products.

للإبلاغ عن الاعراض الجانبية باللغة العربية

نرجو من الراغبين بالإبلاغ عن الاعراض الجانبية باللغة العربية الضغط على الرابط التالي 

الضغط هنا

How to report side effects


If you wish to report a side effect, which you suspect is related to one of our products, you can contact us by phone or email.If you use email, please write “Reporting of adverse reaction” in the email header

Reporting of side effects

  • What is a suspected side effect?
  • Why should you report side effects؟
  • What specific information should you include when your report a side effect?
  • How does Sudair Pharma handle privacy in connection with reported side effects?

What is a suspected side effect?

  • A side effect (also called an adverse reaction) is an unwanted symptom or effect caused by a medicine.
  • This side effect can be from inside or outside product indications that mentioned in the Patient Information Leaflet.

Why should you report side effects?

Reporting on the side effects provide to us a very important reaction that help to make the right procedure & provide a better guidance to how to use our products knowing that these reports will be sheared with the authorities which they make their own analyst for the data In order to provide the best protection for patients, regard that the company and the authorities seeking to be sure there are no new side effects, So that patients and health practitioners aware of them

What specific information should you include when your report a side effect?

When you report a suspected side effect, please include as much as possible of information.

Patient details:

  • Initials of the person experiencing the side effect.
  • Age, date of birth .
  • Age group (e.g. child, adolescent, adult, elderly).
  • Gender (male or female).
  • Country of residence

Products details:

  • The product name (brand name).
  • The dose of the product used when the side effect appeared.
  • How long have you used the product?
  • What disease is the product used for?
  • Are you still taking the product?
  • Information about any other products you have taken around the same time (including non-prescription products, herbal remedies and contraceptives)

Side effect details:

  • Description of the suspected side effect including whether you have recovered from the event.
  • When did the side effect occur?
  • Are you experiencing other medical conditions?
  • If YES please provide the contact details of your Doctor.

How does Sudair Pharma handle privacy in connection with reported side effects?

  • All personal information related to the reporting of a side effect is processed in accordance with the data protection legislation.
  • Your report is used solely for the scientific evaluation of the medicine.
  • After careful evaluation of each report received, side effects are filed in our safety database and regularly used to look for overall patterns. Sudair Pharma may share the details of reported side effects with Health Authorities as mandated by law.

To Report Side effects

The National Pharmacovigilance and Drug Safety Centre (NPC), Saudi Arabia

Sudair Company Pharmacovigilance