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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
G03GA30 PERGOVERIS BioHuman Follitropin alfa - 150IU, Lutropin Alfa - 75IU Injectable powder for solution+diluent 6,523,011 L.L
B01AD11 METALYSE BioTech Tenecteplase - 10,000IU 10,000IU Injectable powder for solution+diluent 74,851,424 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 53,437,592 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
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
G03GA02 MENO-CLAIR HP-HMG BioHuman Human Menopausal Gonadotrophin, Highly purified - 75IU 75IU Injectable powder for solution + solution 1,045,509 L.L
G03GA02 MENO-CLAIR HP-HMG BioHuman Human Menopausal Gonadotrophin, Highly purified - 150IU 150IU Injectable powder for solution + solution 2,005,013 L.L
L01XX24 ONCASPAR B Pegaspargase - 750U/ml 750U/ml Injectable powder for solution L.L
B02BB01 HAEMOCOMPLETTAN P BioHuman Fibrinogen, human - 1g 1g Injectable powder for solution 39,933,692 L.L
B02BB01 HAEMOCOMPLETTAN P BioHuman Fibrinogen, human - 2g 2g Injectable powder for solution 73,094,026 L.L
J01CR05 YANOVEN G Piperacillin (sodium) - 2g, Tazobactam (sodium) - 0.25g Injectable powder for solution 830,623 L.L
J01CR05 PIPERACILINA/TAZOBACTAM SALA G Piperacillin (sodium) - 4g, Tazobactam (sodium) - 0.5g Injectable powder for solution 913,813 L.L
J01CR05 PIPERACILLIN/TAZOBACTAM PANPHARMA G Piperacillin (sodium) - 4g, Tazobactam (sodium) - 0.5g Injectable powder for solution 8,851,296 L.L
J01CR05 PIPERACILLIN/TAZOBACTAM SANDOZ G Piperacillin (sodium) - 4g, Tazobactam (sodium) - 0.5g Injectable powder for solution 913,813 L.L
J01CR05 PIPERACILLIN/TAZOBACTAM STRAGEN G Piperacillin (sodium) - 4g, Tazobactam (sodium) - 0.5g Injectable powder for solution 897,687 L.L
J01CR05 PIPERACILLIN/TAZOBACTAM STRAGEN G Piperacillin (sodium) - 4g, Tazobactam (sodium) - 0.5g Injectable powder for solution 7,820,986 L.L
J01CR05 PIPTAZ-ORBUCELL G Piperacillin (sodium) - 4g, Tazobactam (sodium) - 0.5g Injectable powder for solution 1,087,873 L.L
L04AA04 THYMOGLOBULINE 5mg/ml BioTech Rabbit anti-human thymocyte immunoglobulin - 25mg/5ml 25mg/5ml Injectable powder for solution 21,092,764 L.L
J01CR05 PRIZMA G Piperacillin (sodium) - 4g, Tazobactam (sodium) - 0.5g Injectable powder for solution 913,813 L.L
J01CR05 YANOVEN G Piperacillin (sodium) - 4g, Tazobactam (sodium) - 0.5g Injectable powder for solution 997,259 L.L
J01CR05 YANOVEN G Piperacillin (sodium) - 4g, Tazobactam (sodium) - 0.5g Injectable powder for solution 10,860,623 L.L
A02BC01 LOZICARE G Omeprazole - 40mg 40mg Injectable powder for solution 12,446,972 L.L
A02BC01 OMEPRAZOLE ARROW G Omeprazole - 40mg 40mg Injectable powder for solution 454,219 L.L
J01DB04 CEFAZOLIN PANPHARMA G Cefazolin (sodium) - 1g 1g Injectable powder for solution 5,521,849 L.L
J01DB04 CEFAZOLINA G Cefazolin (sodium) - 1g 1g Injectable powder for solution 18,574,396 L.L
J01DC02 AXETINE G Cefuroxime sodium - 750mg 750mg Injectable powder for solution 1,193,332 L.L
B02BX04 NPLATE BioTech Romiplostim - 250mcg 250mcg Injectable powder for solution L.L
J01DC02 CEFUROXIME – PANPHARMAPOUDRE POUR SOLUTION INJ. IM/IV G Cefuroxime (sodium) - 750mg 750mg Injectable powder for solution 1,651,582 L.L
L01AA01 ENDOXAN B Cyclophosphamide (monohydrate) - 500mg 500mg Injectable powder for solution 764,646 L.L
A02BC02 PANTONIX-JULPHAR G Pantoprazole - 40mg 40mg Injectable powder for solution 260,705 L.L
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