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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
J05AH02 FLUMIVIR G Oseltamivir - 75mg 75mg Capsule 1,384,158 L.L
L02BA01 TAMOXIFEN SANDOZ G Tamoxifen (citrate) - 20mg 20mg Tablet, film coated 497,222 L.L
N01BB01 BUPIVACAINE AGUETTANT for spinal anaesthesia G Bupivacaine HCl - 20mg/4ml 20mg/4ml Injectable solution 1,554,826 L.L
N05CD08 MIDAZOLAM NORMON. G Midazolam - 5mg/5ml 5mg/5ml Injectable solution 618,168 L.L
P02CF01 IVERMECTINE BIOGARAN G Ivermectin - 3mg 3mg Tablet 1,075,074 L.L
R06AB52 HISTAMED-F G Dexchlorpheniramine - 2mg/5ml, Dexamethasone - 0.25mg/5ml Syrup 712,876 L.L
V07AB01 EAU POUR PREPARATION INJECTABLE PROAMP G Water for injection - Water for injection, irrigation 795,555 L.L
A04AA01 APO-ONDANSETRON G Ondansetron - 8mg 8mg Tablet 1,491,665 L.L
B01AB12 HIBOR G Bemiparin Sodium - 7,500IU 7,500IU Injectable solution 2,198,526 L.L
B05BB02 MIXTE SIMPLE (2) G Sodium chloride - 0.9g/100ml, Dextrose, H2O - 5g/100ml Injectable solution 207,894 L.L
C09DX01 VIOSTAN AM PLUS 160/5/12.5 G Valsartan - 160mg, Amlodipine - 5mg, Hydrochlorothiazide - 12.5mg Tablet, film coated 1,196,020 L.L
J01BA01 CHLORAMPHENICOL PALMITATE G Chloramphenicol (palmitate) - 125mg/5ml 125mg/5ml Suspension 159,981 L.L
J01EE01 CO-TRIMOXAZOLE G Trimethoprim - 160mg, Sulfamethoxazole - 800mg Tablet 7,529,090 L.L
J05AH02 VIRIFLU G Oseltamivir - 75mg 75mg Capsule 1,371,615 L.L
L01EA01 APO-IMATINIB G Imatinib - 100mg 100mg Tablet 38,330,537 L.L
L02BA01 TAMOXIFENE BIOGARAN G Tamoxifen (citrate) - 20mg 20mg Tablet 858,715 L.L
M01AB05 DILO G Diclofenac potassium - 50mg 50mg Tablet 223,974 L.L
N01BB01 BUPIVACAINE HEAVY PANPHARMA G Bupivacaine HCl - 20mg/4ml 20mg/4ml Injectable solution 2,586,897 L.L
N03AX14 KEPCITAM G Levetiracetam - 500mg 500mg Tablet, film coated 2,933,608 L.L
N05CD08 MIDAZOLAM PANPHARMA G Midazolam - 5mg/5ml 5mg/5ml Injectable solution 697,454 L.L
P02CF01 IVER G Ivermectin - 6mg 6mg Tablet 431,373 L.L
R06AB52 HISTAMED-F G Dexchlorpheniramine maleate - 2mg, Dexamethasone - 0.25mg, Fluphenazine HCl - 0.25mg Tablet, coated 579,772 L.L
V07AB01 EAU POUR PREPARATIONS INJECTABLES RENAUDIN G Water for injection - Water for injection, irrigation 266,081 L.L
A04AA01 NAUSETRON G Ondansetron (HCl dihydrate) - 8mg 8mg Tablet, scored 1,023,880 L.L
A10BD02 GLYSTOR PLUS G Metformin HCl - 500mg, Glibenclamide - 2.5mg Tablet, film-scored 533,697 L.L
B05BB02 SERUFLEX DEXTROSE 5% SODIUM CHLORIDE 0.9% INJECTION, USP G Sodium chloride - 0.9%, Glucose - 5% Injectable solution 194,211 L.L
C09DX01 ANGIOSAR PLUS G Valsartan - 320mg, Amlodipine - 10mg, Hydrochlorothiazide - 25mg Tablet, film coated 1,689,210 L.L
J01BA01 CHLORAMPHENICOL G Chloramphenicol - 250mg 250mg Capsule 166,381 L.L
J01EE01 CO-TRIMOXAZOLE G Trimethoprim - 160mg, Sulfamethoxazole - 800mg Tablet 183,019 L.L
J05AP08 NUCLEOBUVIR G Sofosbuvir - 400mg 400mg Tablet, film coated 50,670,440 L.L
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