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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
J01CA01 ANTALPEN FORTE G Ampicillin (trihydrate) - 250mg/5ml 250mg/5ml Powder for suspension 206,056 L.L
J01FA09 CLAREM 250 G Clarithromycin - 250mg 250mg Tablet, film coated 467,657 L.L
J05AR01 LAMIVUDINE/ ZIDOVUDINE ARROW G Lamivudine - 150mg, Zidovudine - 300mg Tablet, coated, scored 15,643,319 L.L
L01EA01 IMATINIB NEAPOLIS G Imatinib - 100mg 100mg Tablet, film coated 31,085,276 L.L
L02BB03 BICALUTAMIDE ACCORD G Bicalutamide - 50mg 50mg Tablet, film coated 1,382,814 L.L
M01AB15 ALGIKEY G Ketorolac trometamine - 30mg/ml 30mg/ml Injectable solution 873,498 L.L
N01BB02 LIDOCAINE ARWAN G Lidocaine (HCl) - 1% 1% Injectable solution 1,995,158 L.L
N03AX14 LEVIPRAM 500 G Levetiracetam - 500mg 500mg Tablet, film coated 1,663,805 L.L
P03AB02 GAMMA BENZENE HEXACHLORIDE G Lindane - 1% 1% Shampoo 195,817 L.L
R06AD02 PROMETAL G Promethazine - 25mg 25mg Tablet 8,003,607 L.L
V07AB01 STERILE WATER FOR INJECTION USP G Water for injection - Water for injection, irrigation 264,311 L.L
B01AC04 CERUVIN G Clopidogrel (Bisulfate) - 75mg 75mg Tablet 240,548 L.L
B05BB02 5% DEXTROSE 0.45% SODIUM CHLORIDE INJECTION G Dextrose,H2O - 5g/100ml, Sodium chloride - 0.45g/100ml Injectable solution 224,090 L.L
C01CA03 ? NORADRENALINE G Norepinephrine tartrate - 8mg/4ml 8mg/4ml Injectable solution 330,201 L.L
C08DB01 ZALDEM G Diltiazem HCl - 60mg 60mg Tablet, scored 199,657 L.L
C09DX03 OLMENOR TRIPLE G Olmesartan medoxomil - 40mg, Amlodipine (besylate) - 10mg, Hydrochlorothiazide - 12.5mg Tablet, film coated 1,067,011 L.L
D06AX01 DERMOFUCIN G Fusidic acid - 2% 2% Cream 290,270 L.L
J01CA01 ANTALPEN G Ampicillin (trihydrate) - 250mg 250mg Capsule 218,854 L.L
J01FA09 ERACID 250 G Clarithromycin - 250mg 250mg Tablet, film coated 446,156 L.L
L01EA01 IMATINIB NEAPOLIS G Imatinib - 100mg 100mg Tablet, film coated 16,360,672 L.L
L02BB03 BICALUTAMIDE BIOGARAN G Bicalutamide - 50mg 50mg Tablet, coated 4,315,078 L.L
M01AB15 KETO-AVI G Ketorolac tromethamine - 30mg/ml 30mg/ml Injectable solution 106,164 L.L
N01BB02 CHLORHYDRATE DE LIDOCAINE RENAUDIN G Lidocaine (HCl) - 10mg/ml 1% Injectable solution 591,291 L.L
N03AX14 ZITERA G Levetiracetam - 500mg 500mg Tablet, film coated 2,203,902 L.L
N05CF04 INDUCTAL G Eszopiclone - 2mg 2mg Tablet, film coated 1,411,035 L.L
P03AB02 GAMMAPHARM G Lindane - 1% 1% Shampoo 195,817 L.L
V07AB01 STERILE WATER FOR IRRIGATION G Water for Irrigation - Water for injection, irrigation 203,481 L.L
A04AA01 ODNATRON G Ondansetron (HCl dihydrate) - 4mg/2ml 4mg/2ml Injectable solution 880,217 L.L
A10BD02 ORBIZIDE M FORTE G Metformin HCl - 500mg, Gliclazide - 80mg Tablet 771,750 L.L
B01AC04 CLODOR G Clopidogrel (Bisulfate) - 75mg 75mg Tablet 1,148,025 L.L
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