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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 ORBACE G Captopril - 50mg 50mg Tablet 949,649 L.L
C10AA01 VASCOR G Simvastatin - 10mg 10mg Tablet, scored 284,127 L.L
D06AX08 TYROSUR G Tyrothricin - 1mg/g 1mg/g Gel 510,660 L.L
J01CA01 ANTALPEN FORTE G Ampicillin (trihydrate) - 250mg/5ml 250mg/5ml Powder for suspension 206,056 L.L
J01FA09 CLAMYCIN G Clarithromycin - 250mg 250mg Tablet, film coated 641,205 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
N05BA08 BROMAZEPAM BIOGARAN G Bromazepam - 6mg 6mg Tablet, scored 180,075 L.L
A04AA01 NOZAMET G Ondansetron - 4mg 4mg Film, orodispersible 3,234,181 L.L
B05BB02 DEXTROSE 2.5% & SODIUM CHLORIDE 0.45% G Sodium chloride - 0.45g/100ml, Dextrose, H2O - 2.5g/100ml Injectable solution 224,090 L.L
C01CE02 MILRINONE G Milrinone - 1mg/ml 1mg/ml Injectable concentrate for solution 28,486,446 L.L
D06AX09 AVALON AVOBAN G Mupirocin - 2% w/w 2% Ointment 460,938 L.L
J01CA01 ANTALPEN G Ampicillin (trihydrate) - 250mg 250mg Capsule 218,854 L.L
J01FA09 CLAREM 250 G Clarithromycin - 250mg 250mg Tablet, film coated 467,657 L.L
J05AR01 CONDINE G Lamivudine - 150mg, Zidovudine - 300mg Tablet, film coated 5,818,474 L.L
L01EA01 GLIMATINIB BENTA G Imatinib (mesylate) - 100mg 100mg Tablet, film coated 17,619,185 L.L
L02BA01 TAMOXIFENE BIOGARAN G Tamoxifen (citrate) - 10mg 10mg Tablet 415,247 L.L
M01AB05 OLFEN 75MG G Diclofenac sodium - 75mg 75mg Injectable solution 334,617 L.L
N01AH06 REMIFENTANIL MEDIS G Remifentanil (HCl) - 1mg 1mg Injectable powder 1,101,951 L.L
N03AX12 GABATREX G Gabapentin - 400mg 400mg Capsule 1,846,440 L.L
V03AE02 FOSEAL-800 G Sevelamer HCl - 800mg 800mg Tablet, film coated 470,345 L.L
A04AA01 ZONETRON ODT G Ondansetron - 4mg 4mg Tablet, orodispersible 972,686 L.L
A10BD08 GLUNORM M G Metformin HCl - 850mg, Vildagliptin - 50mg Tablet, film coated 1,089,856 L.L
B01AC17 TIROPREST G Tirofiban - 12.5mg/50ml 12.5mg/50ml Injectable concentrate for solution 18,279,605 L.L
B05BB02 DEXTROSE 2.5% & SODIUM CHLORIDE 0.45% G Sodium chloride - 0.45g/100ml, Dextrose, H2O - 2.5g/100ml Injectable solution 212,598 L.L
C10AA01 SIMVAKEY G Simvastatin - 20mg 20mg Tablet, film coated 716,268 L.L
D06BA01 SILVEDERMA G Silver sulfadiazine - 1% 10mg/g Cream 1,220,209 L.L
J01CA01 ANTALPEN G Ampicillin (trihydrate) - 500mg 500mg Capsule 285,407 L.L
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