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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
B05ZA CONCENTRATE SOLUTION FOR HEMODIALYSIS LS3 G Potassium chloride - K+:2.00 mmol/l, Magnesium chloride - Mg++:0.75 mmol/l, Calcium chloride - Ca++:1.60 mmol/l, Sodium acetate - Cl-:112 mmol/l, Sodium chloride - Na+:140 mmol/l Injectable solution L.L
C09DB07 CANDAM G Candesartan cilexetil - 16mg, Amlodipine - 5mg Capsule, hard 1,376,095 L.L
N07X CEREBROLYSIN G Cerebrolysin - 215.2mg/ml 215.2mg/ml Injectable concentrated solution 2,303,346 L.L
B05ZA CONCENTRATE SOLUTION FOR HEMODIALYSIS R G Potassium chloride - K+:1.00 mmol/l, Magnesium chloride - Mg++:0.75 mmol/l, Calcium chloride - Ca++:1.40 mmol/l, Sodium acetate - Cl-:105.8 mmol/l, Sodium chloride - Na+:140.5 mmol/l Injectable solution L.L
C09DB07 CORONOPINE G Candesartan cilexetil - 16mg, Amlodipine - 5mg Capsule, hard 1,638,144 L.L
N07X CEREBROLYSIN G Cerebrolysin - 215.2mg/ml 215.2mg/ml Injectable concentrated solution 3,886,393 L.L
B05ZA CONCENTRATE SOLUTIONFOR HEMODIALYSIS TYPE A G Hemodialytics, concentrates - Injectable solution L.L
C09DB07 CANDAM G Candesartan cilexetil - 16mg, Amlodipine - 10mg Capsule, hard 1,376,095 L.L
L01CD04 CABAZITAXEL EVER PHARMA G Cabazitaxel - 60mg/6ml 10mg/ml Injectable concentrate for solution 54,531,485 L.L
A03FA08 CINITREX G Cinitapride - 1mg 1mg Tablet 636,981 L.L
B05ZA CONCENTRATE SOLUTION FOR HEMODIALYSIS TYPE B+ G Hemodialytics, concentrates - Injectable solution L.L
C09DB07 CORONOPINE G Candesartan cilexetil - 16mg, Amlodipine - 10mg Capsule, hard 1,540,044 L.L
B05ZA CONCENTRATE SOLUTION FOR HEMODIALYSIS TYPE J G Hemodialytics, concentrates - Injectable solution L.L
C09DB07 CORONOPINE G Candesartan cilexetil - 8mg, Amlodipine - 10mg Capsule, hard 1,368,032 L.L
L01XX05 CUREAML G Hydroxycarbamide (or Hydroxyurea) - 500mg 500mg Capsule 1,228,272 L.L
L01XX05 CYTODROX G Hydroxycarbamide (or Hydroxyurea) - 500mg 500mg Capsule 3,301,821 L.L
B01AC04 CERUVIN G Clopidogrel (Bisulfate) - 75mg 75mg Tablet 240,548 L.L
G03DA04 CYCLOGEST G Progesterone - 400mg 400mg Pessary 1,546,763 L.L
B01AC04 CLODOR G Clopidogrel (Bisulfate) - 75mg 75mg Tablet 1,148,025 L.L
B01AC04 CLOPI TAD G Clopidogrel (Bisulfate) - 75mg 75mg Tablet, film coated 911,125 L.L
B01AC04 CLOPIDOGREL ARROW G Clopidogrel besylate - 75mg 75mg Tablet, film coated 658,483 L.L
B01AC04 CLOPIKEY G Clopidogrel (Bisulfate) - 75mg 75mg Tablet 748,520 L.L
B01AC04 CLOTRIX 75 G Clopidogrel (hydrogenosulfate) - 75mg 75mg Tablet, film coated 1,109,630 L.L
B01AC04 CLOTRIX 75 G Clopidogrel (hydrogenosulfate) - 75mg 75mg Tablet, film coated 1,035,399 L.L
J01DH51 CELLABAXIN G Imipenem (monohydrate) - 500mg, Cilastatin (sodium) - 500mg Injectable solution 10,699,559 L.L
J01DH51 CILANEM G Imipenem anhydrous - 500mg, Cilastatin (sodium) - 500mg Injectable solution 850,652 L.L
R05X COFEX G Paracetamol - 33.3mg/5ml, Guaifenesin - 33.3mg/5ml, Oxomemazine HCl - 1.65mg/5ml Syrup 154,542 L.L
L01EA01 CEMIVIL G Imatinib - 400mg 400mg Tablet, film coated 41,106,321 L.L
M01AB05 CLOREN ADULTS G Diclofenac sodium - 100mg 100mg Suppository 598,970 L.L
R05X COLDIN G Caffeine - 30mg, Noscapine - 10mg, Pseudoephedrine HCl - 30mg, Pyrilamine maleate (Mepyramine) - 15mg, Paracetamol - 300mg Capsule 386,515 L.L
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