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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
G03GA02 MENOPUR BioHuman Menotropin - 600IU 600IU Injectable powder for solution+diluent 13,907,829 L.L
B01AB05 ENOXAPARIN LEDRAXEN BioTech Enoxaparin sodium - 6000UI (60mg)/0.6ml 6000UI (60mg)/0.6ml Injectable solution 854,684 L.L
B01AB05 LOVENOX BioTech Enoxaparin sodium - 6000UI (60mg)/0.6ml 6000UI (60mg)/0.6ml Injectable solution 1,085,825 L.L
B01AB05 ENOMEX BioTech Enoxaparin sodium - 6000U Anti-Xa/0.6ml 6000U Anti-Xa/0.6ml Injectable solution 922,772 L.L
B01AB05 ENOXAMED BioTech Enoxaparin sodium - 6000IU Anti-XA/0.6ml 6000IU Anti-XA/0.6ml Injectable solution 765,990 L.L
B01AB05 ENOXAMED BioTech Enoxaparin sodium - 6000IU Anti-XA/0.6ml 6000IU Anti-XA/0.6ml Injectable solution 3,637,782 L.L
B01AB05 PARINOX 60 BioTech Enoxaparin sodium - 6000IU (60mg)/0.6ml 6000IU (60mg)/0.6ml Injectable solution 438,989 L.L
A06AD11 DUPHALAC B Lactulose - 6.7g/10ml 6.7g/10ml Solution 454,219 L.L
C07AG02 DILATREND B Carvedilol - 6.25mg 6.25mg Tablet, scored 364,181 L.L
C07AG02 CARVEDILOL ARROW G Carvedilol - 6.25mg 6.25mg Tablet, film coated, scored 364,181 L.L
B01AB05 ENOXA MEDIS BioTech Enoxaparin sodium - 6,000U Anti-Xa/0.6ml 6,000U Anti-Xa/0.6ml Injectable solution 765,990 L.L
B05AA07 VOLUVEN B Starch poly(O-2-Hydroxyethyl) - 6% 6% Injectable solution 987,724 L.L
G01AX ENTEROGERMINA B Bacillus clausii spores - 6 Billions/2g 6 billions/2g Powder for suspension 1,493,009 L.L
G01AX ENTEROGERMINA B Bacillus clausii spores - 6 Billions/2g 6 billions/2g Powder for suspension 1,343,843 L.L
P02CA03 ANDAZOL G Albendazole - 200mg 6 Tablet, film coated 302,365 L.L
N03AB02 ? PHENYTOIN SODIUM 5% USP G Phenytoin (sodium) - 250mg/5ml 5ml Injectable solution 276,448 L.L
R03AC02 VENTOLIN B Salbutamol (sulfate) - 5mg/ml 5mg/ml Solution 403,153 L.L
J01MA12 LEVOFLOXACIN- HAMELN G Levofloxacin - 500mg/100ml 5mg/ml Injectable solution 1,632,769 L.L
J01MA12 LEVOFLOXACIN NORMON G Levofloxacin - 500mg/100ml 5mg/ml Injectable solution 27,147,388 L.L
J01MA12 LEVOFLOXACINA BASI G Levofloxacin - 5mg/ml 5mg/ml Injectable solution 56,572,950 L.L
S01AE07 MOXITEC G Moxifloxacin (HCl) - 5mg/ml 5mg/ml Drops solution 464,970 L.L
S01AE07 VIGAMOX G Moxifloxacin (HCl) - 5mg/ml 5mg/ml Drops solution 670,577 L.L
L01XA03 OXALIPLATIN HOSPIRA G Oxaliplatin - 100mg/20ml 5mg/ml Injectable concentrated solution 8,471,583 L.L
L01XA03 OXALIPLATIN HOSPIRA G Oxaliplatin - 50mg/10ml 5mg/ml Injectable concentrated solution 3,450,988 L.L
L01CD01 ABRAXANE BioTech Paclitaxel Albumin- bound - 5mg/ml 5mg/ml Injectable powder for dispersion 17,850,751 L.L
C08CA05 NIFE-PAR G Nifedipine - 5mg/ml 5mg/ml Solution 36,667,942 L.L
R05DB13 SINECOD B Butamirate dihydrogenocitrate - 5mg/ml 5mg/ml Drops 287,582 L.L
N05CD08 HIKMA MIDAZOLAM G Midazolam (HCl) - 5mg/ml 5mg/ml Injectable solution 679,984 L.L
N05CD08 IPNODIS MEDIS G Midazolam - 5mg/ml 5mg/ml Injectable solution 565,758 L.L
N05CD08 MIDAZOLAM HAMELN G Midazolam (HCl) - 5mg/ml 5mg/ml Injectable solution 561,726 L.L
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