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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
C09AA01 APO-CAPTO G Captopril - 50mg 50mg Tablet, scored 1,752,371 L.L
C10AA01 SIMVASTATIN NORMON G Simvastatin - 10mg 10mg Tablet, film coated 264,737 L.L
J01CA01 ANTALPEN G Ampicillin (trihydrate) - 125mg/5ml 125mg/5ml Powder for suspension 174,060 L.L
J05AP08 NUCLEOBUVIR G Sofosbuvir - 400mg 400mg Tablet, film coated 50,670,440 L.L
L01EA01 APO-IMATINIB G Imatinib - 100mg 100mg Tablet 38,330,537 L.L
M01AB05 DOLONIL G Diclofenac sodium - 75mg/3ml 75mg/3ml Injectable solution 337,880 L.L
N01AH03 SUFENTANIL RENAUDIN G Sufentanil (citrate) - 250mcg/5ml 250mcg/5ml Injectable solution 3,524,899 L.L
N03AX12 GABANET 400 G Gabapentin - 400mg 400mg Capsule 1,607,236 L.L
N05BA08 ANXYL G Bromazepam - 3mg 3mg Tablet, scored 167,660 L.L
P01BA02 DOLQUINE G Hydroxychloroquine sulfate - 200mg 200mg Tablet, coated 1,191,988 L.L
R05X CODOPALM EXPECTORANT G Ipeca Tincture - 3mg, Promethazine HCl - 100mg, Potassium guaiacosulfonate - 0.9g Syrup 291,806 L.L
V03AE01 RESINCALCIO G Calcium Polystyrene Sulphonate - 99.75g/100g 99.75% w/w Powder for suspension 1,673,084 L.L
A04AA01 VOMITRON G Ondansetron (HCl) - 4mg/5ml 4mg/5ml Solution 858,779 L.L
A10BD08 VILDIAB M 50/1000 G Metformin HCl - 1000mg, Vildagliptin - 50mg Tablet, film coated 1,029,383 L.L
B01AC06 ASPICOT G Acetylsalicylic acid - 100mg 100mg Tablet, enteric coated 134,384 L.L
B05BB02 DEXTROSE 2.5% & SODIUM CHLORIDE 0.45% G Sodium chloride - 0.45g/100ml, Dextrose, H2O - 2.5g/100ml Injectable solution 176,974 L.L
C01CA26 EPHEDRINE RENAUDIN G Ephedrine HCl - 30mg/ml 3% Injectable solution 693,423 L.L
C09AA01 CAPTACE G Captopril - 50mg 50mg Tablet, scored 652,724 L.L
C10AA01 STAVINE G Simvastatin - 10mg 10mg Tablet 207,336 L.L
D06AX01 FUCIKALT G Fusidic acid (sodium salt) - 2% 2% Ointment 209,895 L.L
J01CA01 AMPICILLIN G Ampicillin (trihydrate) - 250mg/5ml 250mg/5ml Powder for suspension 206,056 L.L
L01EA01 CEMIVIL G Imatinib - 100mg 100mg Tablet, film coated 12,763,090 L.L
M01AB05 DOLONIL G Diclofenac sodium - 75mg/3ml 75mg/3ml Injectable solution 3,801,155 L.L
N01AH03 SUFENTANIL RENAUDIN G Sufentanil (citrate) - 5mcg/ml 10mcg/2ml Injectable solution 755,239 L.L
N03AX12 GABAPENTINE ARROW GENERIQUES G Gabapentin - 400mg 400mg Capsule 1,342,499 L.L
V03AE01 RESINSODIO G Sodium polystyrene sulphonate - 99.75g/100g 99.75g/100g Powder for suspension 1,534,668 L.L
A04AA01 VOMITRON G Ondansetron (HCl) - 4mg/5ml 4mg/5ml Solution 304,604 L.L
A10BD08 VLUDIN MET G Metformin HCl - 1000mg, Vildagliptin - 50mg Tablet, film coated 735,914 L.L
B01AC06 ASPIPHAR G Acetylsalicylic acid - 100mg 100mg Tablet, enteric coated 134,384 L.L
B05BB02 DEXTROSE 2.5% & SODIUM CHLORIDE 0.45% G Sodium chloride - 0.45g/100ml, Dextrose, H2O - 2.5g/100ml Injectable solution 198,578 L.L
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