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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
G03GA04 FOSTIMON BioHuman Urofollitropin - 75IU 75IU Injectable lyophilised powder for solution+diluent 15,744,000 L.L
L01XG01 BORTEZOMIB NEAPOLIS G Bortezomib - 3.5mg 3.5mg Injectable lyophilised powder for solution L.L
J01CR05 TAZOCIN B Piperacillin (sodium) - 4g, Tazobactam (sodium) - 0.5g Injectable lyophilised powder for solution 1,306,215 L.L
A02BC01 ESELAN G Omeprazole (sodium) - 40mg 40mg Injectable lyophilised powder for solution 2,073,549 L.L
A02BC01 RISEK G Omeprazole (sodium) - 40mg 40mg Injectable lyophilised powder for solution 592,635 L.L
A02BC02 LUGANOR G Pantoprazole - 40mg 40mg Injectable lyophilised powder for solution 463,050 L.L
A02BC02 LUGANOR G Pantoprazole - 40mg 40mg Injectable lyophilised powder for solution 4,146,714 L.L
J01DD01 CEFOTAXIME PANPHARMA G Cefotaxime (sodium) - 1g 1g Injectable lyophilised powder for solution 6,127,922 L.L
A16AB02 CEREZYME B Imiglucerase - 400IU 400IU Injectable lyophilised powder for solution L.L
J01XA01 VANCOLON G Vancomycin (HCl) - 0.5g 0.5g Injectable lyophilised powder for solution 1,009,226 L.L
J01XA01 ZERMACIN G Vancomycin (HCl) - 1g 1g Injectable lyophilised powder for solution 1,066,115 L.L
J01XA01 ZERMACIN G Vancomycin (HCl) - 1g 1g Injectable lyophilised powder for solution 6,911,190 L.L
J01DD04 CEFAXONE IM/IV G Ceftriaxone - 1g 1g Injectable lyophilised powder for solution 3,628,375 L.L
L01BC05 GEMTABINE 200 G Gemcitabine HCl - 200mg 200mg Injectable lyophilised powder for solution 1,343,843 L.L
M03AX01 NEURONOX BioTech Clostridium botulinum type A neurotoxin complex - 100units 100units Injectable lyophilised powder for solution 13,011,437 L.L
M03AX01 NEURONOX BioTech Clostridium botulinum type A neurotoxin complex - 200units 200units Injectable lyophilised powder for solution 25,175,058 L.L
M03AX01 NEURONOX BioTech Clostridium botulinum type A neurotoxin complex - 50units 50units Injectable lyophilised powder for solution 8,904,323 L.L
L01BC05 GEMTABINE 1000 G Gemcitabine HCl - 1,000mg 1,000mg Injectable lyophilised powder for solution 4,882,628 L.L
L01BC08 DACOGEN B Decitabine - 50mg 50mg Injectable lyophilised powder for solution 87,048,758 L.L
L01BC08 DACOGEN B Decitabine - 50mg 50mg Injectable lyophilised powder for solution 87,048,758 L.L
A16AB02 CEREZYME B Imiglucerase - 400IU 400IU Injectable lyophilised powder for solution 128,412,818 L.L
J02AX05 MYCAMINE B Micafungin (sodium) - 50mg 50mg Injectable lyophilised powder for solution 13,170,341 L.L
L01XA03 OXALIPLATINO GP PHARM G Oxaliplatin - 100mg 100mg Injectable lyophilised powder for solution 6,197,802 L.L
L01XA03 OXALTIE G Oxaliplatin - 100mg 100mg Injectable lyophilised powder for solution 5,915,595 L.L
J05AB01 ASIMPLEX G Aciclovir - 250mg 250mg Injectable lyophilised powder for solution 278,175 L.L
L01XA03 OXALIPLATINO GP PHARM G Oxaliplatin - 50mg 50mg Injectable lyophilised powder for solution 2,956,454 L.L
L01XA03 OXALTIE G Oxaliplatin - 50mg 50mg Injectable lyophilised powder for solution 2,957,797 L.L
L01XG01 VELCADE B Bortezomib - 3.5mg 3.5mg Injectable lyophilised powder for solution 23,616,000 L.L
L01XG01 BORTEZOMIB NEAPOLIS G Bortezomib - 3.5mg 3.5mg Injectable lyophilised powder for solution 14,169,600 L.L
L01CE01 HYCAMTIN IV B Topotecan HCl - 4mg 4mg Injectable lyophilised powder for solution 52,580,031 L.L
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