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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
J07BC01 ENGERIX-B 20 B Hepatitis B, purified antigen - 20mcg/ml 20mcg/ml Injectable suspension 1,652,926 L.L
L01EF01 IBRANCE B Palbociclib - 100mg 100mg Tablet, film coated 172,164,216 L.L
R06AA59 CARIBAN B Pyridoxine HCl - 10mg, Doxylamine succinate - 10mg Capsule, hard, modified release 1,701,305 L.L
A09AA02 CREON 10,000 B Pancreatin protease - 600FIP-U, Pancreatin amylase - 8,000FIP-U, Pancreatin lipase - 10,000FIP-U Capsule 1,835,689 L.L
C05BX01 DOXIUM B Calcium dobesilate - 500mg 500mg Capsule 1,323,685 L.L
D10AF02 ERYFLUID B Erythromycin base - 40mg/ml 4% Lotion 542,912 L.L
G04BE30 LIF-DOL B Yohimbin HCl - 3.3mg, Thiamine - 5.5mg, Cyanocobalamine - 0.015mg, Ferrous fumarate - 50mg, Sildenafil citrate - 10mg Tablet, coated 231,653 L.L
J07BC01 ENGERIX-B 10 B Hepatitis B, surface antigen - 10mcg/0.5ml 10mcg/0.5ml Injectable suspension 1,042,822 L.L
A09AA02 CREON 25,000 B Pancreatin protease - 1000FIP-U, Pancreatin amylase - 18000FIP-U, Pancreatin lipase - 25000FIP-U Capsule 4,598,629 L.L
B03AB02 FERRICURE B Iron (polysaccharide complex) - 150mg 150mg Capsule 1,001,163 L.L
C05BX51 DOXIPROCT B Calcium dobesilate - 4%, Lidocaine HCl - 2% Ointment 610,104 L.L
C09CA07 MICARDIS B Telmisartan - 40mg 40mg Tablet 760,615 L.L
D10AF02 ERYFLUID B Erythromycin base - 4% 4% Lotion 542,912 L.L
G04BX ROWATINEX B Olive oil - 33mg, Cineol - 3mg, Fenchone - 4mg, Anethol - 4mg, Borneol - 10mg, Camphene - 15mg, ?-Pinene - 6.2mg, ?-Pinene - 24.8mg Capsule 255,330 L.L
M01AC01 BRUXICAM B Piroxicam - 0.5% Drops solution 530,818 L.L
N05CM18 PRECEDEX (DEXMEDETOMIDINE) B Dexmedetomidine HCl - 200mcg/2ml 200mcg/2ml Injectable solution 19,441,512 L.L
C05BX51 DOXIPROCT PLUS B Calcium dobesilate - 4%, Dexamethasone acetate - 0.0025%, Lidocaine HCl - 2% Ointment 489,159 L.L
G04BX14 PRILIGY B Dapoxetine (hydrochloride) - 30mg 30mg Tablet, film coated 1,957,979 L.L
J07BC02 HAVRIX '1440' B Hepatitis A, inactivated, whole virus - 1,440 ELISA units/ml 1,440 ELISA units/ml Injectable suspension 2,215,996 L.L
M01AC01 BREXIN B Piroxicam-?-cyclodextrin - 20mg 20mg Tablet, scored 487,815 L.L
N01BB54 EMLA B Prilocaine - 25mg/g, Lidocaine - 25mg/g 5% Cream 1,763,121 L.L
V03AE03 FOSRENOL B Lanthanum Carbonate - 500mg 500mg Tablet, chewable 18,751,847 L.L
A02BC05 NEXIUM B Esomeprazole (magnesium trihydrate) - 20mg 20mg Tablet, gastroresistant 1,005,194 L.L
B03AB09 FERPLEX B Iron trivalent (ferric proteinsuccinylate) - 800mg 800mg Solution 1,202,739 L.L
B05DA EXTRANEAL (ICODEXTRIN 7.5%) TWIN BAG B Sodium lactate - 4.5g/l, Magnesium Chloride - 0.051g/l, Calcium chloride - 0.257g/l, Sodium chloride - 5.4g/l, Icodextrin - 75.0 g/l Injectable solution 1,998,025 L.L
C05CA03 DIOVENOR 600 B Diosmin - 600mg 600mg Tablet, film coated 1,089,856 L.L
J01DC02 ZINNAT B Cefuroxime (axetil) - 250mg 250mg Tablet, film coated 349,399 L.L
J07BC02 HAVRIX JUNIOR 720 B Hepatitis A, inactivated, whole virus - 720 ELISA units/0.5ml 720 ELISA units/0.5ml Injectable suspension 1,491,665 L.L
L01EF01 IBRANCE B Palbociclib - 125mg 125mg Capsule 172,164,216 L.L
R06AB54 ALERGICAL EXPECTORANT B Chlorpheniramine maleate - 50mg/100ml, Guaifenesin - 2000mg/100ml, Dihydroxypropyltheophylline - 500mg/100ml, Paracetamol - 2000mg/100ml Syrup 485,127 L.L
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