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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
N03AX14 LEVIPRAM 250 G Levetiracetam - 250mg 250mg Tablet, film coated 1,087,873 L.L
N06AB03 PMS-FLUOXETINE G Fluoxetine (HCl) - 20mg 20mg Capsule 592,635 L.L
R06AE07 RINALGIT G Cetirizine (dihydrochloride) - 10mg/ml 10mg/ml Drops solution 237,860 L.L
V07AB01 STERILE WATER FOR INJECTION USP G Water for injection - Water for injection, irrigation 203,405 L.L
A02BC05 METAPRO G Esomeprazole - 40mg 40mg Tablet, gastroresistant 639,669 L.L
A11CC05 MEGAVIT-D 25 G Vitamin D3 - 25000IU 25000IU Capsule 1,130,108 L.L
B03AE02 ELEVIT PRONATAL G Vitamin A, palmitate - 1080mcg, Vitamin B1 - 1.6mg, Vitamin B2 - 1.8mg, Vitamin B6 - 2.6mg, Vitamin B12 - 4mcg, Vitamin C - 100mg, Vitamin D3 - 12.5mcg, Vitamin E - 15mg, Biotin - 0.2mg, Calcium Pantothenate - 10mg, Folic acid - 0.8mg, Nicotinamide - 19mg, Calcium - 125mg, Magnesium - 100mg, Phosphorous - 125mg, Iron - 60mg, Copper - 1mg, Manganese - 1mg, Zinc - 7.5mg Tablet, film coated 893,655 L.L
B05XA02 SODIUM BICARBONATE G Sodium bicarbonate - 1.4g/100ml 1.4g/100ml Injectable solution 258,887 L.L
C07AA05 PROBETOL G Propranolol HCl - 40mg 40mg Tablet 159,981 L.L
D10BA01 CURACNE G Isotretinoin - 5mg 5mg Capsule, soft gelatin 856,028 L.L
G04CA04 SILODOSINE ARROW G Silodosine - 4mg 4mg Capsule 732,394 L.L
J01MA12 FLOBIOX G Levofloxacin - 750mg 750mg Tablet, film coated 945,809 L.L
L01EJ01 CELEZON G Ruxolitinib - 5mg 5mg Tablet 95,532,998 L.L
L03AX13 GLITAXON G Glatiramer acetate - 20mg/ml 20mg/ml Injectable solution 10,146,988 L.L
N02AA01 ACTISKENAN G Morphine sulfate - 5mg 5mg Capsule, immediate release 233,829 L.L
N06AB03 PROXETIN G Fluoxetine (HCl) - 20mg 20mg Capsule 374,996 L.L
V07AB01 STERILE WATER FOR INJECTION USP G Water for injection - Water for injection, irrigation 264,311 L.L
A02BC05 PRIMAZOL 40 G Esomeprazole (magnesium dihydrate) - 40mg 40mg Capsule, gastro-resistant 639,925 L.L
A11CC05 MEGAVIT-D 25 G Vitamin D3 - 25000IU 25000IU Capsule 2,147,588 L.L
B05XA03 0.9% SODIUM CHLORIDE INJECTION USP G Sodium chloride - 0.9% 0.9% Injectable solution 145,946 L.L
C07AA07 SOTALOL BIOGARAN G Sotalol hydrochloride - 160mg 160mg Tablet, scored 357,462 L.L
C10AB05 FENOFIBRATE ARROW G Fenofibrate - 160mg 160mg Tablet 639,669 L.L
D10BA01 ISOSUPRA LIDOSE G Isotretinoin - 16mg 16mg Capsule, hard 1,826,282 L.L
G04CA04 SILODOSINE BIOGARAN G Silodosine - 4mg 4mg Capsule 555,007 L.L
J01DC10 CEFPROZ G Cefprozil - 500mg 500mg Tablet, film coated 1,737,588 L.L
J01MA12 JOSWE AVOXIN 750 G Levofloxacin - 750mg 750mg Tablet, film coated 1,550,794 L.L
M01AE01 PROFINAL G Ibuprofen - 600mg 600mg Tablet 302,365 L.L
N03AX14 KEPCITAM G Levetiracetam - 500mg 500mg Tablet, film coated 2,933,608 L.L
N06AB03 FLUTIN G Fluoxetine (HCl) - 20mg 20mg Capsule 362,837 L.L
R06AE07 CETIMED G Cetirizine (dihydrochloride) - 5mg/5ml 5mg/5ml Solution 415,951 L.L
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