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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
L04AX04 SOTIRA G Lenalidomide - 5mg 5mg Capsule 68,908,116 L.L
N05AX08 DEPIA G Risperidone - 2mg 2mg Tablet, scored 307,164 L.L
N07BC01 BUPRENORPHINE ARROW G Buprenorphine - 8mg 8mg Tablet 1,671,740 L.L
R05CA03 MUCINEX G Guaifenesin - 600mg 600mg Tablet, extended release 749,864 L.L
S01GX09 OLOPAT G Olopatadine (HCl) - 0.1% 0.1% Drops solution 524,099 L.L
A03CA02 ULCEDEX G Clidinium bromide - 2.5mg, Chlordiazepoxide - 5mg Tablet 222,694 L.L
B05BB01 SOLUFLEX LACTATED RINGER'S INJECTION, USP G Sodium lactate - 3.1g/l, Calcium chloride, 2H2O - 0.2g/l, Potassium chloride - 0.3g/l, Sodium chloride - 6g/l Injectable solution 236,731 L.L
B05XA03 SODIUM CHLORIDE 0.45% INJECTION, USP G Sodium chloride - 0.45% 0.45% Injectable solution 148,566 L.L
C07BB07 PRESCOR 5 PLUS G Bisoprolol - 5mg, Hydrochlorothiazide - 12.5mg Tablet, film coated 678,321 L.L
D01AE16 AMOROLFINE BGR G Amorolfine - 5% 5% Nail lacquer 753,896 L.L
G02CB03 PROCTINMED G Cabergoline - 0.5mg 0.5mg Tablet 473,545 L.L
H02AB06 PREDO G Prednisolone sodium phosphate - 15mg/5ml 15mg/5ml Syrup 1,018,633 L.L
J01DD13 CEFODOX G Cefpodoxime (proxetil) - 50mg/5ml 50mg/5ml Powder for suspension 604,729 L.L
L01CD01 PATAXEL G Paclitaxel - 300mg/50ml 300mg/50ml Injectable concentrate for solution 17,809,220 L.L
L01XA02 CARPLATU G Carboplatin - 150mg/15ml 150mg/15ml Injectable solution 1,277,994 L.L
M04AA03 FEBUXOSTAT ARROW G Febuxostat - 120mg 120mg Tablet, film coated 1,084,481 L.L
N03AB02 PHENTOLEP INJECTION G Phenytoin (sodium) - 250mg/5ml 250mg/5ml Injectable solution 1,447,318 L.L
N05AX08 PMS-RISPERIDONE G Risperidone - 2mg 2mg Tablet 931,283 L.L
N07BC01 BUPRENORPHINE ARROW G Buprenorphine - 2mg 2mg Tablet 563,070 L.L
R05CA12 HEDERAL G Dried Ivy leaf extract (Hedera Helix) - 99mg/5ml 99mg/5ml Drops solution 384,339 L.L
S01GX09 OLOPAT UD G Olopatadine (HCl) - 0.1% 0.1% Drops solution 1,523,917 L.L
A10BB12 AMEPRIDE G Glimepiride - 1mg 1mg Tablet 137,072 L.L
B05BB01 RINGER'S INJECTION USP G Calcium chloride, 2H2O - 0.033%, Potassium chloride - 0.03%, Sodium chloride - 0.86% Injectable solution 199,957 L.L
B05XA03 SOLUFLEX SODIUM CHLORIDE 0.45% INJECTION, USP G Sodium chloride - 0.45% 0.45% Injectable solution 383,826 L.L
C09DB01 AMLODIPINE/VALSARTAN ARROW G Amlodipine (besylate) - 10mg, Valsartan - 160mg Tablet, coated 923,220 L.L
G02CB03 PROCTINMED G Cabergoline - 0.5mg 0.5mg Tablet 1,689,402 L.L
H02AB06 PREDOXONE G Prednisolone sodium phosphate - 15mg/5ml 15mg/5ml Solution 417,231 L.L
J02AX04 CANDIGARD G Caspofungin (acetate) - 70mg 70mg Injectable powder for concentrate for solution 22,127,179 L.L
L01CD01 EBETAXEL G Paclitaxel - 30mg/5ml 30mg/5ml Injectable concentrated solution 2,983,330 L.L
L01XA02 KARBOTEEN G Carboplatin - 150mg/15ml 150mg/15ml Injectable solution 2,080,268 L.L
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