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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
J01CR02 AMOCLAN FORTE G Amoxicillin (trihydrate) - 250mg/5ml, Clavulanic Acid (potassium) - 62.5mg/5ml 312mg/5ml Powder for suspension 288,926 L.L
J01FA10 AZICIN 500 BENTA G Azithromycin - 500mg 500mg Tablet, film coated 573,373 L.L
L01EB01 APO-GEFITINIB G Gefitinib - 250mg 250mg Tablet 87,345,820 L.L
G04BD08 ASOLFENA G Solifenacin succinate - 10mg 10mg Tablet, film coated 971,598 L.L
J01FA10 AZIFAST 500 G Azithromycin - 500mg 500mg Tablet, film coated 573,373 L.L
N01BB58 ARTICAINE MEDIS ADRENALINE G Articaine HCl - 40mg/ml, Adrenaline - 0.07mg/ml Injectable solution 1,881,380 L.L
J01CR02 AMOCLAN BID G Amoxicillin (trihydrate) - 200mg/5ml, Clavulanic Acid (potassium) - 28.5mg/5ml 228.5mg/5ml Powder for suspension 345,368 L.L
J01FA10 AZM-500 G Azithromycin - 500mg 500mg Tablet, film coated 448,843 L.L
L01EB02 APO-ERLOTINIB G Erlotinib (HCl) - 100mg 100mg Tablet 79,672,726 L.L
J01CR02 AMOCLAN BID G Amoxicillin (trihydrate) - 400mg/5ml, Clavulanic Acid (potassium) - 57.1mg/5ml 457mg/5ml Powder for suspension 278,175 L.L
L01EB02 APO-ERLOTINIB G Erlotinib (HCl) - 150mg 150mg Tablet 91,523,229 L.L
C10AA05 APO-ATORVASTATIN G Atorvastatin (calcium) - 20mg 20mg Tablet 1,088,378 L.L
J01CR02 AMOCLAN BID G Amoxicillin (trihydrate) - 600mg/5ml, Clavulanic Acid (potassium) - 42.9mg/5ml 642.9mg/5ml Powder for suspension 507,972 L.L
L02BX03 ABIRATERONE ACETATE NEAPOLIS G Abiraterone acetate - 250mg 250mg Tablet 75,418,662 L.L
C10AA05 ASCOVA G Atorvastatin (calcium) - 20mg 20mg Tablet 1,356,641 L.L
L02BX03 ABIRATERONE ACETATE SPC G Abiraterone acetate - 250mg 250mg Tablet, film coated 92,278,660 L.L
C10AA05 ATOR MEDIS G Atorvastatin - 20mg 20mg Tablet, film coated 591,291 L.L
L02BX03 ABLAX 250 G Abiraterone acetate - 250mg 250mg Tablet 45,056,853 L.L
C10AA05 ATORLIP 20 G Atorvastatin (calcium) - 20mg 20mg Tablet, film coated 1,279,850 L.L
J01GB06 AMICINE G Amikacin (sulfate) - 500mg/2ml 500mg/2ml Injectable solution 1,749,683 L.L
L02BX03 ABREMIA G Abiraterone acetate - 250mg 250mg Tablet 77,478,802 L.L
C10AA05 ATORVA TAD G Atorvastatin - 20mg 20mg Tablet, film coated 1,087,169 L.L
J01GB06 AMIKACIN SULPHATE G Amikacin (sulfate) - 500mg/2ml 500mg/2ml Injectable solution 372,244 L.L
N06AB05 APO-PAROXETINE G Paroxetine (HCl) - 20mg 20mg Tablet 1,099,263 L.L
R01AD09 AVOCOM G Mometasone furoate - 0.05% 0.05% Spray 419,279 L.L
C10AA05 ATORVAKEY-20 G Atorvastatin (calcium) - 20mg 20mg Tablet 362,837 L.L
J01CR02 AMOCLAN G Amoxicillin (trihydrate) - 250mg, Clavulanic Acid (potassium) - 125mg 375mg Tablet 259,362 L.L
L02BX03 ABLAX 500 G Abiraterone acetate - 500mg 500mg Tablet 45,056,853 L.L
C10AA05 ATORVASTATIN PHARMADEX G Atorvastatin - 20mg 20mg Tablet 769,190 L.L
L02BX03 APO-ABIRATERONE G Abiraterone acetate - 500mg 500mg Tablet, film coated 46,110,590 L.L
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