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Where Can You Report your Adverse Drug Reactions or Adverse Events Following Immunization

 
Where Can You Report your Adverse Drug Reactions or Adverse Events Following Immunization
 

This section provides a comprehensive overview of the procedures and tools available to Healthcare Professionals, Market Authorization Holders and the General Public to report adverse events associated with medicinal products and vaccines in Lebanon.
 
How to report

You can send the case reports using the following tools:
 
  1. For Healthcare Professionals and the Public
The Lebanese National Pharmacovigilance Program has adapted two user-friendly tools: one for Adverse Drug Reactions (Vigimobile e-Reporting e-Form) and another for reporting Adverse Events Following Immunization (Vigimobile e-Form). Both tools may be accessed by healthcare professionals and the general public.
 
  1. The VigiMobile e-Form and e-Reporting e-Form:
The VigiMobile e-Form and e-Reporting e-Form are the latest tools launched in January 2025 by the Lebanese National Pharmacovigilance Program. These digital platforms were introduced to enhance the reporting process, with the e-Reporting e-Form designed for Adverse Drug Reactions (ADRs) and the VigiMobile e-Form specifically for Adverse Events Following Immunization (AEFIs).

How to Download on Android Phones
 
  1. Scan the QR Code by pressing the link
  2. Click the three dots in the top-right corner
  3. Choose Install app
  4. VigiMobile e-Form/e-Reporting e-Form now appears as an app
 
How to Download on Apple IOS Phones
 
  1. Scan the QR Code by pressing the link
  2. Click on the share button
  3. Add VigiMobile to the home screen
  4. VigiMobile e-Form/e-Reporting e-Form now appears as an app

How to Download on Windows
  1. Press on the link
  2. Install from the Browser menu
  3. VigiMobile e-Form/e-Reporting e-Form is now installed 
 
Scan QR Codes to Report:
  1. ADRs Following Medication Use
  1. AEFIs Following Vaccine Use
Or use the following link: LNPVP: e-Reporting eForm Or use the following link: LNPVP: VigiMobile eForm
 
  1. Direct Contact with the Lebanese National Pharmacovigilance Program:
You may contact the Lebanese National Pharmacovigilance Program through:
  • Email Address:
  • Phone number of the Quality Assurance of Pharmaceutical Products Program: 01-830254   
 
  1.  For Market Authorization Holders:
Based on the Ministerial Resolution MR #181 issued in 2021, MAHs should adhere to the internationally agreed ICH guidelines and standards and send the reports in XML format as specified in ICH E2B (R2 or R3) guidelines

(https://www.moph.gov.lb/userfiles/files/Quality%26Safety/PharmacovigilanceSystemInLebanon/Karar%20181-2021.pdf).

All XML files should be sent to the following emails: pv@moph.gov.lb, and pv.moph@gmail.com.
 
As for what to report or report type, you can refer to Module VI:
https://moph.gov.lb/en/Pages/4/44742/pharmacovigilance-system-lebanon#/en/view/70479/lebanese-guideline-on-good-pharmacovigilance-practices-lgvp-
 
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ATC Name B/G Ingredients Dosage Form Price
P02CA03 ZENTEL B Albendazole - 400mg 400mg Tablet 169,324 L.L
J01DI54 ZERBAXA B Ceftolozane Sulfate - 1g, Tazobactam (sodium) - 0.5g Injectable powder for concentrate for solution 74,780,802 L.L
A04AA01 ZOFRAN B Ondansetron (HCl dihydrate) - 8mg 8mg Tablet, film coated 6,061,174 L.L
A04AA01 ZOFRAN INJECTION B Ondansetron (HCl dihydrate) - 4mg/2ml 4mg/2ml Injectable solution 6,971,989 L.L
R06AE07 ZYRTEC B Cetirizine (dihydrochloride) - 10mg 10mg Tablet, film coated 593,978 L.L
A04AA01 ZOFRAN INJECTION B Ondansetron (HCl dihydrate) - 8mg/4ml 8mg/4ml Injectable solution 9,338,600 L.L
R06AE07 ZYRTEC B Cetirizine (dihydrochloride) - 1% 1% Drops 170,668 L.L
C10AA01 ZOCOR B Simvastatin - 10mg 10mg Tablet 881,817 L.L
R06AE07 ZYRTEC B Cetirizine (dihydrochloride) - 5mg/5ml Solution 278,175 L.L
C10AA01 ZOCOR B Simvastatin - 20mg 20mg Tablet 976,526 L.L
C09AA03 ZESTRIL B Lisinopril (dihydrate) - 5mg 5mg Tablet 295,645 L.L
J01FA10 ZITHROMAX B Azithromycin (dihydrate) - 300mg/7.5ml 300mg/7.5ml Powder for suspension 489,159 L.L
C09AA03 ZESTRIL B Lisinopril (dihydrate) - 10mg 10mg Tablet 592,635 L.L
J01FA10 ZITHROMAX B Azithromycin (dihydrate) - 250mg 250mg Capsule 591,291 L.L
C09AA03 ZESTRIL B Lisinopril (dihydrate) - 20mg 20mg Tablet 636,981 L.L
C10AA01 ZOCOR B Simvastatin - 40mg 40mg Tablet 1,435,992 L.L
L02BX03 ZYTIGA B Abiraterone acetate - 500mg 500mg Tablet, film coated 69,627,132 L.L
N06AB06 ZOLOFT B Sertraline HCl - 50mg 50mg Tablet, scored 596,666 L.L
L01EC01 ZELBORAF B Vemurafenib - 240mg 240mg Tablet, film coated 142,041,587 L.L
N06AB06 ZOLOFT B Sertraline HCl - 50mg 50mg Tablet, scored 596,666 L.L
C09BA03 ZESTORETIC B Lisinopril (dihydrate) - 20mg, Hydrochlorothiazide - 12.5mg Tablet 663,858 L.L
N02AJ13 ZALDIAR B Paracetamol - 325mg, Tramadol - 37.5mg Tablet, film coated 404,497 L.L
C09BB02 ZANIPRESS B Lercanidipine HCl - 10mg, Enalapril maleate - 20mg Tablet, film coated 2,548,821 L.L
C09BB02 ZANIPRESS B Lercanidipine HCl - 10mg, Enalapril maleate - 10mg Tablet, film coated 2,280,949 L.L
L01FA01 ZYTUX BioTech Rituximab - 100mg/10ml 100mg/10ml Injectable concentrate for solution 16,463,240 L.L
L01FA01 ZYTUX BioTech Rituximab - 500mg/50ml 500mg/50ml Injectable concentrate for solution 27,724,196 L.L
L01FG01 ZIRABEV BioTech Bevacizumab - 400mg/16ml 400mg/16ml Injectable solution 49,965,229 L.L
L01FG01 ZIRABEV BioTech Bevacizumab - 100mg/4ml 100mg/4ml Injectable solution 14,800,115 L.L
L01XX44 ZALTRAP BioTech Aflibercept - 100mg/4ml 100mg/4ml Injectable concentrate for solution 35,658,713 L.L
L01XX44 ZALTRAP BioTech Aflibercept - 100mg/4ml 100mg/4ml Injectable concentrate for solution 35,658,713 L.L
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