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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
C05AX05 PROCTO GLYVENOL B Lidocaine HCl - 2g/100g, Tribenoside - 5g/100g Cream 405,840 L.L
D10AD51 CLINIDERM T G Tretinoin - 0.05%, Clindamycin (phosphate) - 1% Gel 890,776 L.L
J07AX BRONCHO-VAXOM CHILDREN B Lyophilized bacterial lysates of Haemophilus influenzae, Diplococcus pneumoniae, Klebsiella pneumoniae and ozaenae, Staphylococcus aureus, Streptococcus pyogenes and viridans, Neisseria catarrhalis - 3.5mg Capsule 1,988,887 L.L
M01AB55 DIFEN PLUS G Diclofenac potassium - 50mg, Betamethasone - 0.3mg Tablet, coated 503,941 L.L
R05X FERVEX ADULTS B Paracetamol - 500mg, Ascorbic acid - 200mg, Pheniramine maleate - 25mg Granules for solution 425,998 L.L
C05AX05 PILOCIN G Tribenoside - 5%, Lidocaine HCl - 2% Cream 271,456 L.L
D10AD51 MEDCLINIDERM-T G Tretinoin - 0.05%, Clindamycin (phosphate) - 1% Gel 890,776 L.L
J07AX BRONCHO-VAXOM ADULTS B Lyophilized bacterial lysates of Haemophilus influenzae, Diplococcus pneumoniae, Klebsiella pneumoniae and ozaenae, Staphylococcus aureus, Streptococcus pyogenes and viridans, Neisseria catarrhalis - 7mg Capsule 2,746,814 L.L
M01AB55 DIFEN B12 G Diclofenac potassium - 50mg, Betamethasone - 0.3mg, Cyanocobalamin - 5mg Tablet 503,941 L.L
R05X COLDIN-H G Paracetamol - 300mg, Mepyramine maleate - 15mg, Noscapine - 10mg Capsule 386,515 L.L
C05BA53 CONTRACTUBEX B Allantoin - 1g/100g, Cepae - 10g/100g, Heparin - 5000IU/100g Gel 498,566 L.L
D10AD53 EPIDUO B Adapalene - 0.1%, Benzoyl peroxide - 2.5% Gel 2,088,331 L.L
M01AB55 DIOXAFLEX B12 G Diclofenac sodium - 75mg, Betamethasone (sodium phosphate) - 2mg, Hydroxocobalamin sulphate - 10mg Injectable solution 1,104,639 L.L
B05D PERITONEAL DIALYSIS SOLUTION WITH 4 1/4% DEXTROSE G Sodium lactate - 0.392g%, Calcium chloride, 2H2O - 0.0257g%, Magnesium chloride, 6H2O - 0.0153g%, Sodium chloride - 0.567g%, Dextrose, H2O - 4.25g% Injectable solution 498,744 L.L
C05BA53 CONTRACTUBEX B Allantoin - 1g/100g, Cepae - 10g/100g, Heparin - 5,000IU/100g Gel 1,183,925 L.L
D10AD53 EPIDUO FORTE B Adapalene - 0.3%, Benzoyl peroxide - 2.5% Gel 2,201,214 L.L
J07BB01 INFLUVAC TETRA B Influenza virus surface antigens inactivated (haemagglutinin and neuraminidase) - 15mcg/4strains/0.5ml Injectable suspension 970,254 L.L
M01AB55 DIOXAFLEX B12 G Diclofenac sodium - 75mg, Betamethasone (sodium phosphate) - 2mg, Hydroxocobalamin sulphate - 10mg Injectable solution 620,855 L.L
R06AA52 AMYDRAMINE G Diphenhydramine HCl - 13.5mg/5ml, Sodium citrate - 57mg/5ml, Ammonium chloride - 131.5mg/5ml, Menthol - 1mg/5ml Syrup, sugar free 133,040 L.L
B05D PERITONEAL DIALYSIS SOLUTION WITH 1 1/2% DEXTROSE G Sodium lactate - 0.392g%, Calcium chloride, 2H2O - 0.0257g%, Magnesium chloride, 6H2O - 0.0153g%, Sodium chloride - 0.567g%, Dextrose, H2O - 1.5g% Injectable solution 490,807 L.L
J07BB01 VAXIGRIPTETRA, VACCIN GRIPPAL QUADRIVALENT (INACTIVE A VIRION FRAGMENTE) B Influenza vaccine virus (inactivated, split) - 15mcg/4strains/0.5ml Injectable suspension 970,254 L.L
M01AB55 PANCLO B12 G Diclofenac sodium - 75mg, Betamethasone disodium phosphate - 2mg, Hydroxocobalamin sulphate - 10mg Injectable solution 1,158,392 L.L
R06AA52 PULMONAL EXPECTORANT G Diphenhydramine HCl - 0.015g/5ml, Ammonium HCl - 0.1g/5ml Syrup 177,899 L.L
B05D CAPD/DPCA 17Solution for peritoneal dialysis stay safe G Sodium chloride - 5.786g/l, Sodium-(S)-lactate - 3.925g/l, Calcium chloride 2H2O - 0.1838g/l, Magnesium chloride, 6H2O - 0.1017g/l, Anhydrous glucose - 15g/l, Fructose , - up to 0.75g/l Injectable solution 629,916 L.L
J07BB01 GC FLU QUADRIVALENT INFLUENZA VACCINE G Influenza vaccine inactivated (split virion, purified, quadrivalent) (H1N1, H3N2,BVR-26, B/Phuket/3073/2013) - 15mcg/4strains/0.5ml Injectable suspension 791,523 L.L
M01AB55 DIFEN B12 G Diclofenac sodium - 75mg, Prednisolone sodium phosphate - 10.08mg, Hydroxocobalamin acetate - 10.44mg Injectable solution 978,317 L.L
R06AA52 HISTALIX G Diphenhydramine HCl - 14mg/5ml, Ammonium chloride - 135mg/5ml, Menthol - 1.1mg/5ml Syrup 405,840 L.L
B05D CAPD/DPCA 19Solution for peritoneal dialysis stay safe G Sodium chloride - 5.786g/l, Sodium-(S)-lactate - 3.925g/l, Calcium chloride 2H2O - 0.1838g/l, Magnesium chloride, 6H2O - 0.1017g/l, Anhydrous glucose - 22.73g/l, Fructose , - up to 1.1g/l Injectable solution 769,337 L.L
J07BB02 INFLUVAC B Grippal virus surface antigen 3strains - 15mcgx3strains/0.5ml Injectable suspension 573,821 L.L
R06AA52 MENTEX G Diphenhydramine HCl - 12.5mg/5ml, Dextrometorphan HBr - 15mg/5ml, Pseudoephedrine HCl - 30mg/5ml Syrup 323,866 L.L
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