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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
S02AA15 CETRAXAL OTICO G Ciprofloxacine (HCl) - 3mg/ml 3mg/ml Drops 821,088 L.L
S02AA15 SEPTOCIPRO OTICO B Ciprofloxacine (HCl) - 1mg/0.5ml 1mg/0.5ml Solution 473,033 L.L
S02AA16 OFLOMED G Ofloxacin - 3mg/ml 3mg/ml Drops solution 317,403 L.L
S02AA30 TYOTOCIN B Hexylresorcinol - 0.1%, Antipyrine - 5%, Benzocaine - 1.25%, Tyrothricin - 0.05% Drops solution 409,552 L.L
S02AA30 OTOCOL G Chloramphenicol - 50mg/ml, Benzocaine - 50mg/ml Drops 163,949 L.L
S02CA02 VIOCORTENE B Clioquinol - 10mg/ml, Flumetasone pivalate - 0.2mg/ml Drops 568,253 L.L
S02CA05 CETRAXAL PLUS G Ciprofloxacine HCl monohydrate - 3mg/ml, Fluocinolone acetonide - 0.25mg/ml Drops solution 795,555 L.L
S02CA06 POLYDEXA G Dexamethasone sodium metasulfobenzoate - 1.000.000IU/100ml, Polymyxin B sulfate - 100mg/100ml, Neomycin sulfate - 650.000IU/100ml Drops solution 231,141 L.L
S02CA06 AURICULARUM G Dexamethasone (sodium phosphate) - 10mg, Nystatin - 1,000,000IU, Oxytetracycline HCl - 90,000IU, Polymyxin B sulfate - 100,000IU Powder for suspension + solvent 755,239 L.L
S02CA07 PAROTICIN G Fludrocortisone acetate - 1mg/ml, Polymyxin B (sulfate) - 10.000IU/ml, Lidocaine - 50mg/ml Drops solution 319,835 L.L
S02D CERULYSE B Xylene - 5g/100g 5g/100g Drops solution 339,992 L.L
S02DA01 OTIPAX B Lidocaine HCl - 1g/100g, Phenazone - 4g/100g Drops 236,516 L.L
S02DC WAXSOL B Docusate sodium - 0.5% 0.5% Drops solution 157,230 L.L
S03AA07 API-CIPROCIN G Ciprofloxacine (HCl) - 3mg/ml 3mg/ml Drops 530,818 L.L
S03AA30 SULFACHLOR G Sulfacetamide sodium - 110mg/ml, Chloramphenicol - 5mg/ml Drops solution 202,216 L.L
S03CA04 MYCICORT G Hydrocortisone acetate - 5mg, Neomycin sulfate - 5mg Drops suspension 166,381 L.L
V01AA STALORAL B Allergen extracts - 2 x 100IR ou IC/ml Solution 8,449,319 L.L
V01AA STALORAL B Allergen extracts - 300 IR ou IC/ml Solution 6,598,267 L.L
V01AA STALORAL B Allergen extracts - 10-100-100 IR ou IC/ml 10-100-100 IR ou IC/ml Solution 9,129,688 L.L
V01AA STALORAL B Allergen extracts - 10-300 IR ou IC/ml 10-300 IR ou IC/ml Solution 7,206,963 L.L
V01AA DIATER B Allergen extracts - Spray 26,856,672 L.L
V01AA DIATER B Allergen extracts - Spray 34,962,083 L.L
V01AA DIATER B Allergen extracts - Spray 35,697,531 L.L
V01AA DIATER B Allergen extracts - Spray 26,856,672 L.L
V01AA ACARIZAX 12 SQ-HDM ORAL LYOPHILISATE B Allergen extracts - 12 SQ-HDM Tablet, lyophilised 9,366,451 L.L
V03AB14 PROSULF 1% B Protamine sulfate - 50mg/5ml 1% Injectable solution 8,216,459 L.L
V03AB35 BRIDION B Sugammadex - 100mg/ml 100mg/ml Injectable solution 54,230,830 L.L
V03AB37 PRAXBIND BioTech Idarucizumab - 50mg/ml 50mg/ml Injectable solution 287,986,627 L.L
V03AC03 DIFIRAX G Deferasirox - 250mg 250mg Tablet, dispersible 23,213,276 L.L
V03AC03 DEFIROX G Deferasirox - 500mg 500mg Tablet, dispersible 38,502,953 L.L
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