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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
R05DB13 SINECOD B Butamirate dihydrogenocitrate - 5mg/ml 5mg/ml Drops 287,582 L.L
V01AA STALORAL B Allergen extracts - 10-100-100 IR ou IC/ml 10-100-100 IR ou IC/ml Solution 9,129,688 L.L
V01AA STALORAL B Allergen extracts - 10-300 IR ou IC/ml 10-300 IR ou IC/ml Solution 7,206,963 L.L
A07EC02 SALOFALK B Mesalazine - 1g 1g Suppository 3,948,209 L.L
A07EC02 SALOFALK B Mesalazine - 4g/60ml 4g/60ml Enema 3,796,355 L.L
N03AG04 SABRIL B Vigabatrin - 500mg 500mg Tablet, film coated 2,988,706 L.L
A07EC02 SALOFALK B Mesalazine - 1.5g 1.5g Granules, gastro-resistant, prolonged release 6,150,767 L.L
A07EC02 SALOFALK B Mesalazine - 3g 3g Granules, gastro-resistant, prolonged release 11,256,652 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
N01BB03 SCANDONEST 3% sans vasoconstricteur B Mepivacaine - 54mg/1.8ml 3% Injectable solution 1,670,396 L.L
N05CF02 STILNOX B Zolpidem (tartrate) - 10mg 10mg Tablet, film coated, scored 96,757 L.L
N01BB58 SEPTANEST ADRENALINEE B Articaine HCl - 72mg/1.8ml, Adrenaline (tartrate) - 0.033mg/1.8ml 1/100,000 Injectable solution 2,945,703 L.L
D10AX03 SKINOREN B Azelaic acid - 0.2g/g 0.2g/g Cream 722,987 L.L
M01AE01 SPIDIFEN B Ibuprofen alginate - 400mg 400mg Tablet, film coated 330,585 L.L
G04CA04 SILOSIN B Silodosine - 4mg 4mg Capsule 1,251,693 L.L
G04CA04 SILOSIN B Silodosine - 8mg 8mg Capsule 1,927,454 L.L
N06AB05 SEROXAT B Paroxetine (HCl) - 20mg 20mg Tablet, film coated 1,586,205 L.L
L01EX05 STIVARGA B Regorafenib - 40mg 40mg Tablet, film coated L.L
L01EX01 SUTENT B Sunitinib maleate - 12.5mg 12.5mg Capsule 54,006,801 L.L
N06AB05 SEROXAT CR B Paroxetine (HCl) - 12.5mg 12.5mg Tablet, controlled release 2,371,608 L.L
N06AB05 SEROXAT CR B Paroxetine (HCl) - 25mg 25mg Tablet, controlled release 2,845,587 L.L
L01EX01 SUTENT B Sunitinib maleate - 25mg 25mg Capsule 98,852,769 L.L
L01EX01 SUTENT B Sunitinib maleate - 50mg 50mg Capsule 197,706,574 L.L
A03A SPASMOBROM B Pipethanate Ethobromide - 20mg 20mg Tablet, coated 705,517 L.L
L01EX01 SUTENT B Sunitinib maleate - 12.5mg 12.5mg Capsule L.L
L01EX01 SUTENT B Sunitinib maleate - 50mg 50mg Capsule L.L
L01EX05 STIVARGA B Regorafenib - 40mg 40mg Tablet, film coated 272,778,486 L.L
M01AE11 SURGAM B Tiaprofenic acid - 300mg 300mg Tablet 849,308 L.L
A03AB06 SPASMOMEN B Otilonium bromide - 40mg 40mg Tablet, film coated 438,093 L.L
A03AX SPASMO-DIGESTIN B Simethicone - 30mg, Dicyclomine HCl - 5mg, Sodium dihydrocholate - 10mg, Sanzyme 3500 - 36mg, Papain - 100mg Tablet, enteric coated 260,705 L.L
    ...
    11
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