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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
J01CR02 MOXICLAV BIS G Amoxicillin (trihydrate) - 400mg/5ml, Clavulanic Acid (potassium) - 57mg/5ml 457mg/5ml Powder for suspension 309,084 L.L
J01FA10 ZEVLEN G Azithromycin (dihydrate) - 250mg 250mg Tablet, film coated 409,552 L.L
L01EA01 SAGITTA G Imatinib - 100mg 100mg Capsule, hard 25,170,264 L.L
M01AB05 EPARDEX G Diclofenac sodium - 50mg 50mg Tablet, enteric coated 223,974 L.L
M05BA08 ZOLEDRA G Zoledronic acid - 4mg 4mg Injectable powder for solution 6,368,470 L.L
N05AX12 JOSWE ARIPAL 15 G Aripiprazole - 15mg 15mg Tablet 2,413,541 L.L
N07CA01 VERTINEX G Betahistine dihydrochloride - 24mg 24mg Tablet, scored 921,492 L.L
R05CB03 MUCOTAL ADULTE G Carbocysteine - 250mg/5ml 250mg/5ml Syrup 308,444 L.L
A02BC01 OMEPRAL G Omeprazole - 20mg 20mg Capsule, delayed release 213,735 L.L
B05CX01 5% DEXTROSE INJECTION USP G Glucose - 5% 5% Injectable solution 148,244 L.L
C03BA11 RAWEL SR G Indapamide - 1.5mg 1.5mg Tablet, prolonged release 362,837 L.L
C09CA01 LACINE 50 G Losartan potassium - 50mg 50mg Tablet, film coated 671,921 L.L
C10AA05 ORBALIP G Atorvastatin (calcium) - 20mg 20mg Tablet 1,091,712 L.L
D07AD01 DECLOBAN G Clobetasol (propionate) - 0.05% 0.05% Ointment 302,045 L.L
J01FA10 ZIMAX G Azithromycin (dihydrate) - 250mg 250mg Capsule 360,150 L.L
M01AB05 EPARDEX G Diclofenac sodium - 50mg 50mg Tablet, enteric coated 3,246,979 L.L
M05BA08 ZOLEDRO-DENK G Zoledronic acid - 4mg/5ml 4mg/5ml Injectable concentrate for solution 4,388,990 L.L
N05AX12 PIRIFY G Aripiprazole - 15mg 15mg Tablet 795,555 L.L
N07CA02 CINARIN G Cinnarizine - 75mg 75mg Capsule 490,183 L.L
R05CB06 API-MUCOL G Ambroxol HCl - 15mg/5ml 15mg/5ml Syrup 326,554 L.L
S01XA18 DRYFREE G Ciclosporin - 0.05% 0.05% Drops 2,257,655 L.L
A02BC01 OMEPRAZOLE PHARMADEX G Omeprazole - 20mg 20mg Capsule 415,951 L.L
B05CX01 5% DEXTROSE INJECTION USP G Glucose - 5% 5% Injectable solution 148,244 L.L
C09CA01 LOSANET G Losartan potassium - 50mg 50mg Tablet 395,474 L.L
C10AA05 ORVASTA G Atorvastatin - 20mg 20mg Tablet, film coated 920,532 L.L
D07CA01 HYDROMYCINE G Neomycin sulfate - 0.005g/g, Hydrocortisone acetate - 0.01g/g Cream 238,052 L.L
G04BE03 DEGRA G Sildenafil - 50mg 50mg Tablet, film coated 330,585 L.L
J01CR02 AMOCLAN BID G Amoxicillin (trihydrate) - 600mg/5ml, Clavulanic Acid (potassium) - 42.9mg/5ml 642.9mg/5ml Powder for suspension 507,972 L.L
J01FA10 ZOMAX G Azithromycin (dihydrate) - 250mg 250mg Capsule 360,150 L.L
L01EA02 APO-DASATINIB G Dasatinib - 70mg 70mg Tablet 71,323,688 L.L
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