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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
B05BB02 DEXTROSE 5% & SODIUM CHLORIDE 0.45% G Sodium chloride - 0.45g/100ml, Dextrose, H2O - 5g/100ml Injectable solution 205,933 L.L
C01CA03 NORADRENALINE HIKMA G Noradrenaline bitartrate - 4mg/4ml 4mg/4ml Injectable solution 1,279,338 L.L
C08DB01 ZALDEM CR G Diltiazem HCl - 180mg 180mg Capsule, controlled release 966,287 L.L
D06AX01 FUTASOLE G Fusidic acid - 20mg/g 2% Cream 145,135 L.L
J01CA01 ANTALPEN G Ampicillin (trihydrate) - 500mg 500mg Capsule 285,407 L.L
J05AR03 EMZAVIR G Emtricitabine - 200mg, Tenofovir disoproxil fumarate - 300mg Tablet, film coated 18,701,506 L.L
L01EA01 IMATINIB SPC G Imatinib - 100mg 100mg Tablet, film coated 29,473,181 L.L
L02BB03 BICALUTAMIDE GP PHARM G Bicalutamide - 50mg 50mg Tablet, film coated 1,306,215 L.L
M01AB15 KETOLAC G Ketorolac trometamine - 30mg/2ml 30mg/2ml Injectable solution 106,164 L.L
N01BB02 LIDOCAINE- ORBUCELL G Lidocaine HCl - 1% 1% Injectable solution 1,787,950 L.L
N05CF04 INDUCTAL G Eszopiclone - 3mg 3mg Tablet, film coated 1,693,242 L.L
P03AB02 GAMMA BENZENE HEXACHLORIDE G Lindane - 1% 1% Lotion 167,660 L.L
R06AD52 FLUISEDAL G Promethazine HCl - 2.5g/5ml, Meglumine benzoate - 130mg/5ml, Polysorbate 20 - 15mg/5ml Syrup 393,746 L.L
V07AB01 WATER FOR INJECTION G Water for Injection - Water for injection, irrigation 2,706,319 L.L
A04AA01 ONDANSETRON HIKMA G Ondansetron (HCl dihydrate) - 4mg/2ml 4mg/2ml Injectable solution 2,228,091 L.L
B01AC04 CLOPI TAD G Clopidogrel (Bisulfate) - 75mg 75mg Tablet, film coated 911,125 L.L
B05BB02 DEXTROSE 5% & SODIUM CHLORIDE 0.45% G Sodium chloride - 0.45g/100ml, Dextrose, H2O - 5g/100ml Injectable solution 182,720 L.L
C01CA04 DOPAMINE FRESENIUS G Dopamine HCl - 200mg/5ml 200mg/5ml Injectable concentrated solution 713,580 L.L
C08DB01 ZALDEM CR G Diltiazem HCl - 120mg 120mg Capsule, controlled release 517,059 L.L
C09DX03 OLMENOR TRIPLE G Olmesartan medoxomil - 20mg, Amlodipine (besylate) - 5mg, Hydrochlorothiazide - 12.5mg Tablet, film coated 1,037,446 L.L
D06AX01 ZETA G Fusidic acid - 20mg/g 20mg/g Cream 178,731 L.L
J01CA01 AMPICILLINE PANPHARMA G Ampicillin (sodium) - 500mg 500mg Injectable powder for solution 1,944,540 L.L
J01FA09 CLAREM 500 G Clarithromycin - 500mg 500mg Tablet, film coated 686,704 L.L
J05AR06 VITRICOMB G Emtricitabine - 200mg, Tenofovir disoproxil fumarate - 300mg, Efavirenz - 600mg Tablet, film coated 22,191,783 L.L
L01EA01 SAGITTA G Imatinib - 100mg 100mg Capsule, hard 25,170,264 L.L
L02BB03 BICAMIDE G Bicalutamide - 50mg 50mg Tablet, film coated 1,451,753 L.L
N01BB02 LIDOCAINE- ORBUCELL G Lidocaine HCl - 2% 2% Injectable solution 1,787,950 L.L
N03AX14 KEPCITAM G Levetiracetam - 1000mg 1000mg Tablet, film coated 3,119,058 L.L
P03AC04 PERMACARE G Permethrin - 1% 1% Lotion 590,011 L.L
R06AD52 FLUISEDAL G Promethazine HCl - 2.5g/5ml, Meglumine benzoate - 130mg/5ml, Polysorbate 20 - 15mg/5ml Syrup 550,821 L.L
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