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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
R06AE07 CETIMED G Cetirizine (dihydrochloride) - 10mg 10mg Tablet, scored 360,918 L.L
A10BD07 SAGIMET G Metformin HCl - 1000mg, Sitagliptin (HCl monohydrate) - 50mg Tablet, film coated 1,551,690 L.L
B01AC04 GREPID G Clopidogrel (Bisulfate) - 75mg 75mg Tablet, film coated 1,248,335 L.L
B05BB02 DEXTROSE 5% SODIUM CHLORIDE 0.45% INJECTION, USP G Sodium chloride - 0.45%, Glucose - 5% Injectable solution 148,566 L.L
C01CA07 DOBUTAMINE PANPHARMA G Dobutamine (HCl) - 250mg/20ml 250mg/20ml Injectable concentrated solution 2,701,123 L.L
C09AA01 CAPTACE G Captopril - 25mg 25mg Tablet, scored 486,343 L.L
D06AX08 TYROSUR G Tyrothricin - 1mg/g 1mg/g Gel 510,660 L.L
J01CA04 AMOXIDREX G Amoxicillin (trihydrate) - 500mg 500mg Capsule 7,332,097 L.L
L01EA02 ELPIDA G Dasatinib - 70mg 70mg Tablet, film coated 127,364,905 L.L
M01AB55 DIFEN FLEX G Diclofenac sodium - 75mg, Pridinol mesylate - 2.2mg Injectable solution 1,131,515 L.L
N01BB03 SCANDINIBSA G Mepivacaine HCl - 3% 3% Injectable solution 1,191,988 L.L
N03AX14 ZITERA G Levetiracetam - 1,000mg 1,000mg Tablet, film coated 3,225,222 L.L
R01AA07 DECOZAL G Xylometazoline HCl - 0.1% 0.1% Drops 145,135 L.L
R06AE07 CETRAK G Cetirizine (dihydrochloride) - 10mg 10mg Tablet 147,823 L.L
A04AA01 ODNATRON G Ondansetron (HCl dihydrate) - 8mg/4ml 8mg/4ml Injectable solution 952,784 L.L
A10BD07 SITAMET G Metformin - 1000mg, Sitagliptin - 50mg Tablet, film coated 2,444,896 L.L
B01AC04 NORMIGORE G Clopidogrel (Bisulfate) - 75mg 75mg Tablet, film coated 1,184,117 L.L
B05BB02 MIXTE SIMPLE (1) G Sodium chloride - 0.45g/100ml, Dextrose, H2O - 5g/100ml Injectable solution 182,720 L.L
C01CA24 ADRENALINE 1 MG I.V. G Adrenaline - 1mg/ml 1mg/ml Injectable solution 2,239,738 L.L
C09AA01 CAPTOPRIL G Captopril - 25mg 25mg Tablet, scored 4,453,878 L.L
D06AX09 AVALON AVOBAN G Mupirocin - 2% w/w 2% Ointment 460,938 L.L
J01CA04 AMOXYCILLIN G Amoxicillin (trihydrate) - 500mg 500mg Capsule 4,073,187 L.L
J01FA09 CLARIDAR DAR AL DAWA G Clarithromycin - 125mg/5ml 125mg/5ml Suspension 295,645 L.L
M01AB55 DIFEN PLUS G Diclofenac potassium - 50mg, Betamethasone - 0.3mg Tablet, coated 503,941 L.L
N01BB09 ROPIVACAINA MOLTENI G Ropivacaine HCl - 75mg/10ml 7.5mg/ml Injectable solution 2,332,911 L.L
N03AX14 LEPITAM G Levetiracetam - 100mg/ml 100mg/ml Solution 1,336,163 L.L
R06AE07 FINALLERG G Cetirizine (dihydrochloride) - 10mg 10mg Tablet, film coated 342,680 L.L
A04AA01 ONDANSETRON HIKMA G Ondansetron (HCl dihydrate) - 8mg/4ml 8mg/4ml Injectable solution 4,018,089 L.L
A10BD07 SITAVITEA G Metformin - 1000mg, Sitagliptin - 50mg Tablet, film coated 1,079,106 L.L
B01AC04 PEDOVEX G Clopidogrel (Bisulfate) - 75mg 75mg Tablet, film coated 808,993 L.L
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