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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
R02A TRACHISAN G Lidocaine HCl - 1mg, Tyrothricin - 0.5mg, Chlorhexidine gluconate - 1mg Lozenge 228,453 L.L
B02BC30-V03AK TISSEEL LYO B Fibrinogen, human (clottable protein) (I) - 91mg/ml, Aprotinin, synthetic (I) - 3000KIU/ml, Thrombin, Human (II) - 500IU/ml, Calcium chloride (II) - 40?mol/ml Injectable powder for solution + solution 24,369,850 L.L
D07XC01 LOTRIDERM B Betamethasone (dipropionate) - 0.5mg/g, Clotrimazole - 10mg/g Cream 408,528 L.L
J01CR05 PIPERACILINA/TAZOBACTAM SALA G Piperacillin (sodium) - 4g, Tazobactam (sodium) - 0.5g Injectable powder for solution 913,813 L.L
J07BB01 INFLUVAC TETRA B Influenza virus surface antigens inactivated (haemagglutinin and neuraminidase) - 15mcg/4strains/0.5ml Injectable suspension 970,254 L.L
L03AX03 BCG-MEDAC G BCG seed RIVM derived from seed 1173-P2 - 2x10? to 3x10? viable units Injectable powder for suspension+diluent 13,873,850 L.L
R02A CHLORASEPTIC TOTAL SORE THROAT + COUGH LOZENGES WILD CHERRY G Benzocaine - 6mg, Dextromethorphan - 5mg, Menthol - 10mg Lozenge 537,537 L.L
B02BC30-V03AK TISSEEL LYO B Fibrinogen, human (clottable protein) (I) - 91mg/ml, Aprotinin, synthetic (I) - 3000KIU/ml, Thrombin, Human (II) - 500IU/ml, Calcium chloride (II) - 40?mol/ml Injectable powder for solution + solution 13,394,024 L.L
D07XC01 BETA-MICOTER G Betamethasone (dipropionate) - 0.5mg/g, Clotrimazole - 10mg/g Cream 415,951 L.L
J01CR05 PIPERACILLIN/TAZOBACTAM PANPHARMA G Piperacillin (sodium) - 4g, Tazobactam (sodium) - 0.5g Injectable powder for solution 8,851,296 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
R02AA05 GOLASEPTINE-LIDOCAINE G Chlorhexidine HCl - 5mg, Lidocaine HCl - 1mg Tablet, chewable 736,426 L.L
D07XC01 DIPROSALIC B Salicylic acid - 30mg/g, Betamethasone (dipropionate) - 0.5mg/g Ointment 352,087 L.L
J01CR05 PIPERACILLIN/TAZOBACTAM SANDOZ G Piperacillin (sodium) - 4g, Tazobactam (sodium) - 0.5g Injectable powder for solution 913,813 L.L
J07BB02 INFLUVAC B Grippal virus surface antigen 3strains - 15mcgx3strains/0.5ml Injectable suspension 573,821 L.L
R02AA20 ANGINOVA G Lidocaine HCl - 1mg, Dequalinium HCl - 0.25mg Lozenge 349,399 L.L
D07XC03 ELICA M G Mometasone furoate - 0.1%, Miconazole nitrate - 2% Cream 459,594 L.L
J01CR05 PIPERACILLIN/TAZOBACTAM STRAGEN G Piperacillin (sodium) - 4g, Tazobactam (sodium) - 0.5g Injectable powder for solution 897,687 L.L
D07XC03 ELICASAL G Mometasone furoate - 1mg/g, Salicylic acid - 50mg/g Ointment 462,282 L.L
J01CR05 PIPERACILLIN/TAZOBACTAM STRAGEN G Piperacillin (sodium) - 4g, Tazobactam (sodium) - 0.5g Injectable powder for solution 7,820,986 L.L
D07XC04 TRAVOCORT B Diflucortolone valerate - 0.1%, Isoconazole nitrate - 1% Cream 435,405 L.L
J01CR05 PIPTAZ-ORBUCELL G Piperacillin (sodium) - 4g, Tazobactam (sodium) - 0.5g Injectable powder for solution 1,087,873 L.L
L01FD01 TRASTUREL BioTech Trastuzumab - 440mg L.L
D07XC04 AZONIT - D G Diflucortolone valerate - 1mg/g, Isoconazole nitrate - 10mg/g Cream 225,766 L.L
J01CR05 PRIZMA G Piperacillin (sodium) - 4g, Tazobactam (sodium) - 0.5g Injectable powder for solution 913,813 L.L
D08AC52 CYTEAL Solution Antiseptique G Chlorhexidine digluconate - 0.5ml/100ml, Hexamidine - 0.1g/100ml, Chlorocresol - 0.3g/100ml Solution 362,420 L.L
J01CR05 YANOVEN G Piperacillin (sodium) - 4g, Tazobactam (sodium) - 0.5g Injectable powder for solution 997,259 L.L
D08AC52 CYTEAL Solution Antiseptique G Chlorhexidine digluconate - 0.5ml/100ml, Hexamidine - 0.1g/100ml, Chlorocresol - 0.3g/100ml Solution 616,977 L.L
J01CR05 YANOVEN G Piperacillin (sodium) - 4g, Tazobactam (sodium) - 0.5g Injectable powder for solution 10,860,623 L.L
J01CR05 PIPERACILLINE/ TAZOBACTAM ARROW Piperacillin (sodium) - 4g, Tazobactam (sodium) - 500mg 7,378,682 L.L
    5
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