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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
C01BC04 FLECAINIDE BIOGARAN L.P. G Flecainide acetate - 50mg 50mg Capsule, extended release 1,154,361 L.L
J01AA08 VULGA XR G Minocycline - 55mg 55mg Tablet, film coated 1,983,512 L.L
L01EA01 IMATINIB SPC G Imatinib - 400mg 400mg Tablet, film coated 62,161,280 L.L
M01AB05 DICLOGESIC 12.5 CHILDREN G Diclofenac sodium - 12.5mg 12.5mg Suppository 83,318 L.L
N01AX10 DORMIFOR G Propofol - 1% 1% Injectable emulsion 1,081,473 L.L
N03AX14 LEVETIRACETAM BIOGARAN G Levetiracetam - 250mg 250mg Tablet, coated, scored 1,350,562 L.L
N05BA25 SEDOXIL G Mexazolam - 1mg 1mg Tablet 1,705,336 L.L
P02CB01 VERMIFUGE G Piperazine citrate - 1g/5ml 1g/5ml Syrup 148,463 L.L
V07AB01 EAU POUR PREPARATION INJECTABLE PROAMP G Water for injection - Water for injection, irrigation 1,240,367 L.L
A10BB12 ORBIDE G Glimepiride - 4mg 4mg Tablet 357,078 L.L
B01AB12 HIBOR G Bemiparin Sodium - 3,500IU 3,500IU Injectable solution 1,029,383 L.L
B05BB02 DEXTROSE 5% SODIUM CHLORIDE 0.9% INJECTION, USP G Sodium chloride - 0.9%, Glucose - 5% Injectable solution 186,167 L.L
C09DX01 ARBITEN AM PLUS G Valsartan - 160mg, Amlodipine - 5mg, Hydrochlorothiazide - 12.5mg Tablet 857,372 L.L
D06AX DERMOTRACIN G Neomycin sulfate - 165.000IU/150ml, Bacitracin - 15.500IU/150ml Powder 737,770 L.L
J01EE01 PAEDIATRIC CO-TRIMOXAZOLE MIXTURE G Trimethoprim - 40mg/5ml, Sulfamethoxazole - 200mg/5ml Suspension 190,698 L.L
L01EA01 SAGITTA G Imatinib - 400mg 400mg Capsule, hard 51,723,840 L.L
L02BA01 TAMOXIFENE BIOGARAN G Tamoxifen (citrate) - 10mg 10mg Tablet 415,247 L.L
N01AX10 PROPOFOL 1% MCT/LCT FRESENIUS G Propofol - 1% 1% Injectable emulsion 847,965 L.L
N03AX14 LEVIPRAM 250 G Levetiracetam - 250mg 250mg Tablet, film coated 1,087,873 L.L
N05CD08 MIDAZOLAM HAMELN G Midazolam (HCl) - 5mg/5ml 5mg/5ml Injectable solution 529,474 L.L
P02CB01 PIPERAZINE CITRATE G Piperazine citrate - 750mg/5ml 750mg/5ml Elixir 113,907 L.L
R06AB02 HISTAMED G Dexchlorpheniramine maleate - 1% 1% Gel 477,384 L.L
V07AB01 EAU POUR PREPARATION INJECTABLE PROAMP G Water for injection - Water for injection, irrigation 1,034,759 L.L
A10BB12 JOSWE GLEMAX 6 G Glimepiride - 6mg 6mg Caplet 663,858 L.L
B01AB12 HIBOR G Bemiparin Sodium - 5,000IU 5,000IU Injectable solution 1,466,132 L.L
B05BB02 MIXTE SIMPLE (2) G Sodium chloride - 0.9g/100ml, Dextrose, H2O - 5g/100ml Injectable solution 182,720 L.L
C01BD01 AMIODARONE BIOGARAN G Amiodarone (HCl) - 200mg 200mg Tablet 345,368 L.L
C09DX01 LOTEVAN PLUS G Valsartan - 160mg, Amlodipine - 5mg, Hydrochlorothiazide - 12.5mg Tablet, film coated 857,372 L.L
D06AX PENICILLIN DERMIC OINTMENT G Penicillin - 5,000IU 5,000IU Ointment 80,631 L.L
J01AA12 TAGIX G Tigecycline - 50mg 50mg Injectable lyophilised powder for solution 2,436,386 L.L
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