Pharmacovigilance
What is Pharmacovigilance?

The pharmacovigilance is the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other drug related problems.

What is Adverse Drug Reactions (ADRs)?

ADR is a response to a medicine which is noxious and unintended, and which occurs at doses normally used in man.

Why do we report Adverse Drug Reactions?

Reporting of an adverse drug reactions is important because as a pharmaceutical company, we have a responsibility to detect early and report promptly suspected adverse drug reactions and other safety information which occurred in association with Axantia medicinal products to the competent authorities. This is done to minimize the risk of their occurrence and to ensure patient care and safety to the use of our products.

What Safety Information needs to be reported?

Any of the following safety information shall be reported:
• Lack of efficacy
• Overdose, abuse, misuse, off-label use
• Use of drug during pregnancy and breastfeeding
• Transmission of an infectious agent via a medicinal drug
• Quality defects, or counterfeits
• Medication errors
• Drug interactions
• Occupational exposure

Who can report?

All society members can report ADRs.

How to report Adverse Drug Reaction?

If you wish to report an adverse drug reaction, which you suspect is related to Axantia products, fill ADR reporting form either handwritten and send it the below contact details. Alternatively, call us and we will fill the form on your behalf.

To report any adverse drug reaction:


Please contact:

Jordan

Pharmacovigilance Department in Axantia/Jordan:

  • Tel: +9624792222
  • Fax: +962 5154783
  • Email: pharmacovigilance@axantia.com
  • Mobile: +96277840 6066

Saudi Arabia

The National Pharmacovigilance and Drug Safety Center

  • SFDA call center: 19999
  • Toll free phone: 8002490000
  • Email: npc.drug@sfda.gov.sa
  • Website: http://ade.sfda.gov.sa/

Pharmacovigilance Department in Axantia/KSA

  • Fax: +966126358138
  • Tel: +966920003288
  • Email: pharmacovigilance-ksa@axantia.com
  • Mobile: +966533314875