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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
V07AB01 WATER FOR INJECTION/ DEMO G Water for injection - Water for injection, irrigation 1,339,811 L.L
A04AA01 ONDANSETRON VIANEX G Ondansetron (HCl) - 4mg/2ml 4mg/2ml Injectable solution 197,545 L.L
B01AC04 CLOTRIX 75 G Clopidogrel (hydrogenosulfate) - 75mg 75mg Tablet, film coated 1,109,630 L.L
B05BB02 DEXTROSE 5% SODIUM CHLORIDE 0.45% INJECTION, USP G Sodium chloride - 0.45%, Glucose - 5% Injectable solution 193,062 L.L
C01CA06 PHENYLEPHRINE RENAUDIN G Phenylephrine - 100mcg/ml 100mcg/ml Injectable solution 5,955,910 L.L
C08DB01 ZALDEM CR G Diltiazem HCl - 240mg 240mg Capsule, controlled release 1,002,123 L.L
J01CA04 AMOXICILLINE ARROW LAB G Amoxicillin (trihydrate) - 500mg 500mg Capsule 564,414 L.L
J01FA09 RITHROCID G Clarithromycin - 500mg 500mg Tablet, film coated 686,704 L.L
L01EA02 DALEUBIN G Dasatinib - 70mg 70mg Tablet, film coated 98,514,698 L.L
M01AB16 LOFLAM G Aceclofenac - 100mg 100mg Tablet 767,334 L.L
N01BB02 ? 2% LIDOCAINE HCL USP G Lidocaine HCl - 2% 2% Injectable solution 255,970 L.L
N03AX14 LEVIPHAR G Levetiracetam - 1000mg 1000mg Tablet, film coated 2,212,861 L.L
N05CM18 DEXMEDETOMIDINE EVER PHARMA G Dexmedetomidine HCl - 400mcg/4ml 400mcg/4ml Injectable concentrate for solution 15,543,897 L.L
R06AE07 CETALLERG G Cetirizine (dihydrochloride) - 10mg 10mg Tablet, film coated 180,075 L.L
V07AB01 WATER FOR INJECTION/ DEMO G Water for injection - Water for injection, irrigation 1,103,295 L.L
A04AA01 TRONDAMET G Ondansetron (HCl) - 4mg/2ml 4mg/2ml Injectable solution 2,027,858 L.L
B01AC04 CLOTRIX 75 G Clopidogrel (hydrogenosulfate) - 75mg 75mg Tablet, film coated 1,035,399 L.L
B05BB02 DEXTROSE 5% SODIUM CHLORIDE 0.45% INJECTION, USP G Sodium chloride - 0.45%, Glucose - 5% Injectable solution 180,421 L.L
C01CA06 PHENYLEPHRINE AGUETTANT G Phenylephrine - 500mcg/10ml 500mcg/10ml Injectable solution 11,464,796 L.L
C09AA01 APO-CAPTO G Captopril - 25mg 25mg Tablet, scored 1,132,859 L.L
C09DX03 OLMENOR TRIPLE G Olmesartan medoxomil - 40mg, Amlodipine (besylate) - 5mg, Hydrochlorothiazide - 12.5mg Tablet, film coated 1,067,011 L.L
D06AX01 FUCIKALT G Fusidic acid (sodium salt) - 2% 2% Ointment 209,895 L.L
J01CA04 AMOXIDREX G Amoxicillin (trihydrate) - 500mg 500mg Capsule 254,690 L.L
L01EA02 DASATINIB NEAPOLIS G Dasatinib - 70mg 70mg Tablet, film coated 127,364,905 L.L
L02BB04 ENZASTIK 40 G Enzalutamide - 40mg 40mg Capsule 82,838,963 L.L
M01AB55 DIFEN FLEX G Diclofenac sodium - 50mg, Pridinol mesylate - 4mg Tablet, film coated 575,165 L.L
N01BB03 MEDICAINE 3% SANS VASOCONSTRICTEUR G Mepivacaine HCl - 3% 3% Injectable solution 954,128 L.L
N03AX14 LEVIPRAM 1000 G Levetiracetam - 1000mg 1000mg Tablet, film coated 1,663,805 L.L
N06AA01 DESIPRAMINE G Desipramine (HCl) - 50mg 50mg Tablet, scored 656,563 L.L
R01AA07 DECOZAL G Xylometazoline HCl - 0.1% 0.1% Metered dose spray 147,823 L.L
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