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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
V07AB01 STERILE WATER FOR INJECTION G Water for Injection - Water for injection, irrigation 188,772 L.L
V07AB01 STERILE WATER FOR INJECTION G Water for Injection - Water for injection, irrigation 203,481 L.L
V07AB01 STERILE WATER FOR INJECTION G Water for injection - Water for injection, irrigation 264,311 L.L
V07AB01 STERILE WATER FOR INJECTION USP G Water for injection - Water for injection, irrigation 203,405 L.L
V07AB01 STERILE WATER FOR INJECTION USP G Water for injection - Water for injection, irrigation 264,311 L.L
V07AB01 STERILE WATER FOR IRRIGATION G Water for Irrigation - Water for injection, irrigation 203,481 L.L
V03AE02 SEVELAMER CARBONATE ARROW G Sevelamer carbonate - 800mg 800mg Tablet, film coated 8,645,754 L.L
V03AE02 SEVELAMER CARBONATE ARROW G Sevelamer - 2.4g 2.4g Powder for suspension 12,969,932 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
S03AA30 SULFACHLOR G Sulfacetamide sodium - 110mg/ml, Chloramphenicol - 5mg/ml Drops solution 202,216 L.L
S02AA15 SEPTOCIPRO OTICO B Ciprofloxacine (HCl) - 1mg/0.5ml 1mg/0.5ml Solution 473,033 L.L
S01EC54 SIMBRINZA B Brinzolamide - 1%, Brimonidine tartrate - 0.2% Drops suspension 1,706,680 L.L
R07AA01 SURVANTA B Colfosceril palmitate - 200mg/8ml 200mg/8ml Suspension 36,957,499 L.L
R07AA SURFACTANTE B RICHET G Pulmonary surfactant, bovine - 200mg/8ml 200mg/8ml Suspension 26,568,472 L.L
R05DB13 SINECOD B Butamirate dihydrogenocitrate - 15mg/10ml 15mg/10ml Syrup, sugar free 521,411 L.L
R05DB13 SINECOD B Butamirate dihydrogenocitrate - 5mg/ml 5mg/ml Drops 287,582 L.L
R05CB06 SOLVAMUC SR G Ambroxol - 75mg 75mg Capsule 276,448 L.L
R05C SULDEX G Caffein anyhdrous - 0.216g, Antipyrine - 0.972g, Potassium sulfaguaiacolate - 1.44g Syrup 152,302 L.L
R03DC03 SINGULAIR (PEDIATRIC) B Montelukast (sodium) - 5mg 5mg Tablet, chewable 1,217,521 L.L
R03DC03 SINGULAIR B Montelukast (sodium) - 10mg 10mg Tablet, film coated 1,248,430 L.L
R03DC03 SINGULAIR PEDIATRIC B Montelukast (sodium) - 4mg 4mg Tablet, chewable 1,217,521 L.L
R03DC03 SINGULAIR PAEDIATRIC B Montelukast (sodium) - 4mg 4mg Granules 1,248,430 L.L
R03BB06 SEEBRI BREEZHALER B Glycopyronium Bromide - 50mcg 50mcg Capsule, inhalation 2,687,685 L.L
R03BB04 SPIRIVA WITH HANDIHALER B Tiotropium bromide - 18mcg 18mcg Capsule, inhalation 3,179,531 L.L
R03BB04 SPIRIVA RESPIMAT B Tiotropium bromide - 2.5mcg/dose 2.5mcg/dose Inhalation solution 3,000,800 L.L
R03AL06 SPIOLTO RESPIMAT B Olodaterol HCl - 2.5mcg/puff, Tiotropium bromide monohydrate - 2.5mcg/puff Inhalation solution 5,087,788 L.L
R03AK07 SYMBICORT B Formoterol fumarate dihydrate - 4.5mcg/Inhalation, Budesonide - 160mcg/Inhalation Inhalation powder 3,378,420 L.L
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