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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
N03AF01 APO-CARBAMAZEPINE G Carbamazepine - 200mg 200mg Tablet 727,019 L.L
B05CX01 ALDEX G Dextrose, H2O - 5g/100ml 5g/100ml Injectable solution 174,062 L.L
C10AA05 ASCOVA G Atorvastatin (calcium) - 40mg 40mg Tablet 1,612,611 L.L
L01EA02 APO-DASATINIB G Dasatinib - 20mg 20mg Tablet 57,771,855 L.L
B05CX01 ALDEX G Dextrose, H2O - 5g/100ml 5g/100ml Injectable solution 170,630 L.L
C10AA05 ATOR MEDIS G Atorvastatin - 40mg 40mg Tablet, film coated 694,767 L.L
S02CA06 AURICULARUM G Dexamethasone (sodium phosphate) - 10mg, Nystatin - 1,000,000IU, Oxytetracycline HCl - 90,000IU, Polymyxin B sulfate - 100,000IU Powder for suspension + solvent 755,239 L.L
B05CX01 ALDEX G Dextrose, H2O - 5g/100ml 5g/100ml Injectable solution 182,720 L.L
C10AA05 ATORLIP 40 G Atorvastatin (calcium) - 40mg 40mg Tablet, film coated 1,484,626 L.L
B05CX01 ALDEX G Dextrose, H2O - 5g/100ml 5g/100ml Injectable solution 205,933 L.L
C10AA05 ATORVA TAD G Atorvastatin - 40mg 40mg Tablet, film coated 1,405,659 L.L
C10AA05 ATORVASTATINE ARROW GENERQUES G Atorvastatin - 40mg 40mg Tablet, coated 564,414 L.L
J01CR02 AMOCLAN BID G Amoxicillin (trihydrate) - 875mg, Clavulanic Acid (potassium) - 125mg 1g Tablet 456,906 L.L
J01GB06 AMICINE G Amikacin (sulfate) - 500mg/2ml 500mg/2ml Injectable solution 1,749,683 L.L
C09CA03 ANGINET G Valsartan - 160mg 160mg Tablet, film coated 544,256 L.L
C10AA05 ATORVASTATINE ARROW GENERQUES G Atorvastatin - 40mg 40mg Tablet, coated 564,414 L.L
J01CR02 AMOKLAVIN BID G Amoxicillin (trihydrate) - 875mg, Clavulanic Acid (potassium) - 125mg 1000mg Tablet, film coated 448,843 L.L
J01GB06 AMIKACIN SULPHATE G Amikacin (sulfate) - 500mg/2ml 500mg/2ml Injectable solution 372,244 L.L
M01AB05 ALMIRAL G Diclofenac sodium - 75mg/3ml 75mg/3ml Injectable solution 415,247 L.L
C09CA03 ARBITEN 160 G Valsartan - 160mg 160mg Tablet 544,256 L.L
G04BE08 APO-TADALAFIL G Tadalafil - 20mg 20mg Tablet 1,111,358 L.L
J01CR02 ARDINECLAV G Amoxicillin (trihydrate) - 875mg, Clavulanic Acid (potassium) - 125mg 1g Tablet 431,309 L.L
R05DA20 ALGOMIEL COUGH SYRUP G Dextromethorphan HBr - 5mg, Carbinoxamine maleate - 2mg Syrup 639,925 L.L
S03AA07 API-CIPROCIN G Ciprofloxacine (HCl) - 3mg/ml 3mg/ml Drops 530,818 L.L
J01CR02 AYECLAV-T G Amoxicillin - 875mg, Clavulanic Acid - 125mg Tablet 338,648 L.L
D07XC04 AZONIT - D G Diflucortolone valerate - 1mg/g, Isoconazole nitrate - 10mg/g Cream 225,766 L.L
J01CR02 AMOCLAN BID G Amoxicillin (trihydrate) - 400mg/5ml, Clavulanic Acid (potassium) - 57.1mg/5ml 457mg/57mg Tablet, chewable 892,311 L.L
L01EB01 APO-GEFITINIB G Gefitinib - 250mg 250mg Tablet 87,345,820 L.L
L02BG03 ANASTROZOL GP PHARM G Anastrozole - 1mg 1mg Tablet, film coated 1,181,238 L.L
C09CA04 ANDARAN G Irbesartan - 150mg 150mg Tablet, film coated 940,435 L.L
    4
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