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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
L01BA04 SUKUBA G Pemetrexed (disodium) - 500mg 500mg Injectable lyophilised powder 34,786,563 L.L
A03AX12 SPASFON B Phloroglucinol hydrate - 80mg, Trimethylphloroglucinol - 80mg Tablet, coated 278,175 L.L
A03A SPASMOBROM B Pipethanate Ethobromide - 20mg 20mg Tablet, coated 705,517 L.L
J07AL02 SYNFLORIX B Polysaccharide from each of 10 capsular types of pneumococcus (conjugated to carrier proteins) adsorbed onto aluminium phosphate - 1mcg/0.5ml, Polysaccharide of serotypes 41,2, 18C1,3 and 19F1,4 - 3mcg/0.5ml, 1 adsorbed onto aluminium phosphate - 0.5mg Al3+, 2 conjugated to protein D (derived from NTHi) carrier protein - ~ 13mcg, 3 conjugated to tetanos toxoid carrier protein - ~ 8mcg, 4 conjugated to diphteria toxoid carrier protein - ~ 5mcg Injectable suspension 4,675,228 L.L
N04BC05 SIFROL B Pramipexole (dihydrochloride monohydrate) - 0.18mg 0.18mg Tablet 631,606 L.L
N04BC05 SIFROL ER B Pramipexole (dihydrochloride monohydrate) - 0.375mg 0.375mg Tablet, extended release 473,033 L.L
N04BC05 SIFROL ER B Pramipexole (dihydrochloride monohydrate) - 0.75mg 0.75mg Tablet, extended release 942,034 L.L
N04BC05 SIFROL B Pramipexole (dihydrochloride monohydrate) - 0.7mg 0.7mg Tablet 2,478,046 L.L
N04BC05 SIFROL ER B Pramipexole (dihydrochloride monohydrate) - 1.5mg 1.5mg Tablet, extended release 1,847,783 L.L
C10AA03 STAVACOR G Pravastatin sodium - 10mg 10mg Tablet, scored 1,695,801 L.L
C10AA03 STAVACOR G Pravastatin sodium - 20mg 20mg Tablet, scored 725,419 L.L
C10AA03 STAVACOR G Pravastatin sodium - 40mg 40mg Tablet, scored 891,799 L.L
R07AA SURFACTANTE B RICHET G Pulmonary surfactant, bovine - 200mg/8ml 200mg/8ml Suspension 26,568,472 L.L
N05AH04 SEROPINE 100 G Quetiapine fumarate - 100mg 100mg Tablet, film coated 1,996,950 L.L
N05AH04 SEROPINE 25 G Quetiapine fumarate - 25mg 25mg Tablet, film coated 1,233,647 L.L
N05AH04 SEROPINE XR 300 G Quetiapine fumarate - 300mg 300mg Tablet, extended release 4,744,660 L.L
L01EX05 STIVARGA B Regorafenib - 40mg 40mg Tablet, film coated L.L
L01EX05 STIVARGA B Regorafenib - 40mg 40mg Tablet, film coated 272,778,486 L.L
L04AC18 SKYRIZI BioTech Risankizumab - 150mg 150mg Injectable solution 194,911,251 L.L
C10AA07 SINLIP G Rosuvastatin (calcium) - 10mg 10mg Tablet, film coated 563,070 L.L
C10AA07 SUPERSTAT G Rosuvastatin (calcium) - 10mg 10mg Tablet, coated 517,379 L.L
C10AA07 SINLIP G Rosuvastatin (calcium) - 20mg 20mg Tablet, film coated 563,070 L.L
C10AA07 SUPERSTAT G Rosuvastatin (calcium) - 20mg 20mg Tablet, coated 517,379 L.L
C10AA07 SINLIP G Rosuvastatin (calcium) - 5mg 5mg Tablet, film coated 387,027 L.L
R03AC02 SALBUTAMOL SULFATE G Salbutamol (sulfate) - 2mg 2mg Tablet, scored 401,873 L.L
R03AK06 SEROFLO-S 125 G Salmeterol (xinafoate) - 25mcg/inhalation, Fluticasone propionate - 125mcg/inhalation Inhalation suspension 1,212,146 L.L
R03AK06 SEROFLO-S 250 G Salmeterol (xinafoate) - 25mcg/inhalation, Fluticasone propionate - 250mcg/inhalation Inhalation suspension 1,725,494 L.L
R03AK06 SERETIDE DISKUS 100 B Salmeterol (xinafoate) - 50mcg/inhalation, Fluticasone propionate - 100mcg/inhalation Inhalation powder 2,276,469 L.L
R03AK06 SERETIDE DISKUS 250 B Salmeterol (xinafoate) - 50mcg/inhalation, Fluticasone propionate - 250mcg/inhalation Inhalation powder 2,830,132 L.L
R03AK06 SEROFLO 250 G Salmeterol (xinafoate) - 50mcg/inhalation, Fluticasone propionate - 250mcg/inhalation Inhalation suspension 1,580,359 L.L
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