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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
C09DX04 ENTRESTO B Valsartan - 26mg, Sacubitril - 24mg Tablet, film coated 6,029,821 L.L
J05AR20 BIKTARVY B Bictegravir - 50mg, Emtricitabine - 200mg, Tenofovir alafenamide - 25mg Tablet, film coated 73,652,468 L.L
L01EA02 ELPIDA G Dasatinib - 70mg 70mg Tablet, film coated 127,364,905 L.L
L02BB05 ERLEADA B Apalutamide - 60mg 60mg Tablet, film coated 254,089,146 L.L
N03AX14 ZITERA G Levetiracetam - 1,000mg 1,000mg Tablet, film coated 3,225,222 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
C09DX04 ENTRESTO B Valsartan - 51mg, Sacubitril - 49mg Tablet, film coated 6,029,821 L.L
J05AR24 DELSTRIGO B Lamivudine - 300mg, Tenofovir disoproxil - 300mg, Doravirine - 100mg Tablet, film coated 48,879,793 L.L
L02BB05 ERLEADA B Apalutamide - 60mg 60mg Tablet, film coated 254,089,146 L.L
R06AE07 FINALLERG G Cetirizine (dihydrochloride) - 10mg 10mg Tablet, film coated 342,680 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
C09DX04 ENTRESTO B Valsartan - 103mg, Sacubitril - 97mg Tablet, film coated 11,674,240 L.L
L02BB06 NUBEQA B Darolutamide - 300mg Tablet, film coated 452,633,527 L.L
B01AC04 PIDOGREL MEDIS G Clopidogrel - 75mg 75mg Tablet, film coated 810,337 L.L
J01CA04 OSPAMOX G Amoxicillin (trihydrate) - 750mg 750mg Tablet, film coated 480,350 L.L
J05AX12 TIVICAY B Dolutegravir - 50mg 50mg Tablet, film coated 54,508,037 L.L
L01EA02 DALEUBIN G Dasatinib - 50mg 50mg Tablet, film coated 97,680,409 L.L
L02BG03 ARIMIDEX B Anastrozole - 1mg 1mg Tablet, film coated 3,202,377 L.L
B01AC04 PLAVINOR-75 G Clopidogrel - 75mg Tablet, film coated Tablet, film coated 1,112,702 L.L
C10AA01 SIMVASTATIN NORMON G Simvastatin - 10mg 10mg Tablet, film coated 264,737 L.L
J05AX18 PREVYMIS B Letermovir - 240mg 240mg Tablet, film coated 460,943,945 L.L
L01EA02 DASATINIB NEAPOLIS G Dasatinib - 50mg 50mg Tablet, film coated 127,364,905 L.L
L02BG03 ANASTROZOL GP PHARM G Anastrozole - 1mg 1mg Tablet, film coated 1,181,238 L.L
A10BD07 SAGIMET G Metformin HCl - 500mg, Sitagliptin (HCl monohydrate) - 50mg Tablet, film coated 1,432,536 L.L
B01AC04 THROMBO G Clopidogrel - 75mg 75mg Tablet, film coated 764,646 L.L
J05AX18 PREVYMIS B Letermovir - 480mg 480mg Tablet, film coated 961,233,292 L.L
L01EA02 ELPIDA G Dasatinib - 50mg 50mg Tablet, film coated 127,364,905 L.L
B01AC04 TROKEN G Clopidogrel (Bisulfate) - 75mg 75mg Tablet, film coated 1,148,985 L.L
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