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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 KLAVOX G Amoxicillin (trihydrate) - 400mg/5ml, Clavulanic Acid (potassium) - 57mg/5ml 457mg/5ml Powder for suspension 278,175 L.L
J01CR02 KLAVOX G Amoxicillin (trihydrate) - 875mg, Clavulanic Acid (potassium) - 125mg 1g Tablet, film coated 338,648 L.L
C07AB05 KERLONE B Betaxolol HCl - 20mg 20mg Tablet, film coated, scored 575,165 L.L
V06DD KETOSTERIL B Calcium - 0.05g, Total nitrogen - 36mg, L-Tyrosine - 30mg, L-Histidine - 38mg, L-Tryptophan - 23mg, L-Threonine - 53mg, L-Lysine Monoacetate - 105mg, Alpha Hydroxyanalogue-DL-Methionine, Calcium Salt - 59mg, Alpha Ketoanalogue-Valine,Calcium Salt - 86mg, Alpha Ketoanalogue-Phenylalanine,Calcium Salt - 68mg, Alpha-Ketoanalogue- Leucine,Calcium Salt - 101mg, Alpha-Ketoanalogue-DL-isoleucine,Calcium Salt - 67mg Tablet, film coated 3,950,897 L.L
L01XA02 KARBOTEEN G Carboplatin - 150mg/15ml 150mg/15ml Injectable solution 2,080,268 L.L
L01XG02 KYPROLIS B Carfilzomib - 60mg 60mg Injectable powder for solution L.L
L01XG02 KYPROLIS B Carfilzomib - 60mg 60mg Injectable powder for solution 96,642,005 L.L
J01DB01 KEFLEX B Cefalexin (monohydrate) - 250mg/5ml 250mg/5ml Granules for suspension 477,384 L.L
J01DB01 KEFLEX B Cefalexin (monohydrate) - 500mg 500mg Capsule 659,123 L.L
J01FA09 KLACID B Clarithromycin - 125mg/5ml 125mg/5ml Granules for suspension 575,165 L.L
J01FA09 KLACID B Clarithromycin - 250mg/5ml 250mg/5ml Granules for suspension 1,698,617 L.L
J01FA09 KLACID B Clarithromycin - 500mg 500mg Tablet, film coated 1,329,060 L.L
J01FA09 KLERIMED G Clarithromycin - 500mg 500mg Tablet 686,704 L.L
J01FA09 KLACID B Clarithromycin - 500mg 500mg Injectable powder for solution 1,428,505 L.L
J01FA09 KLACID RM B Clarithromycin - 500mg 500mg Tablet, modified release 1,173,175 L.L
M01AE17 KETESSE B Dexketoprofen (trometamol) - 25mg 25mg Tablet, film coated 399,121 L.L
M01AE17 KETESSE B Dexketoprofen (trometamol) - 50mg/2ml 50mg/2ml Injectable concentrated solution 435,405 L.L
M01AE17 KETESSE B Dexketoprofen (trometamol) - 50mg/2ml 50mg/2ml Injectable solution 435,405 L.L
N05BA01 KRATIUM G Diazepam - 10mg/2ml 10mg/2ml Injectable solution 537,537 L.L
A04AA02 KYTRIL B Granisetron (HCl) - 1mg 1mg Tablet, film coated 2,765,628 L.L
A04AA02 KYTRIL B Granisetron (HCl) - 3mg/3ml 3mg/3ml Injectable solution 3,711,693 L.L
J06BA02 KIOVIG BioHuman Human normal immunoglobulin G - 10g/100ml 10g/100ml Injectable solution 54,343,313 L.L
J06BA02 KIOVIG BioHuman Human normal immunoglobulin G - 5g/50ml 5g/50ml Injectable solution L.L
J06BA02 KIOVIG BioHuman Human normal immunoglobulin G - 5g/50ml 5g/50ml Injectable solution 35,639,835 L.L
N01AX03 KETAMINE PANPHARMA G Ketamine HCl - 250mg/5ml 250mg/5ml Injectable solution 1,534,668 L.L
D01AC08 KETOCONAZOLE KORHISPANA G Ketoconazole - 2% 2% Gel 599,354 L.L
M01AE03 KETOPROFENE MACOPHARMA G Ketoprofen - 100mg/100ml 100mg/100ml Injectable solution 329,241 L.L
M01AB15 KETOLAC G Ketorolac trometamine - 10mg 10mg Tablet 106,164 L.L
M01AB15 KETOLAC G Ketorolac trometamine - 30mg/2ml 30mg/2ml Injectable solution 106,164 L.L
M01AB15 KETO-AVI G Ketorolac tromethamine - 30mg/ml 30mg/ml Injectable solution 106,164 L.L
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