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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
R01AA07 OTRIVIN B Xylometazoline HCl - 0.1% 0.1% Solution 260,705 L.L
R01AA07 OTRIVIN B Xylometazoline HCl - 0.05% 0.05% Solution 260,705 L.L
R01AB06 OTRIVIN DUAL RELIEF B Xylometazoline HCl - 0.5mg/ml, Ipratropium bromide - 0.6mg/ml Solution 563,070 L.L
A04AA01 ONDEMED G Ondansetron (HCl) - 4mg/5ml 4mg/5ml Solution 858,779 L.L
R06AX ORADUS BETA G Desloratadine - 1mg/ml, Betamethasone - 0.05mg/ml Solution 639,925 L.L
R01AD08 OTRIALLERGY B Fluticasone propionate - 50mcg/actuation 50mcg/actuation Spray, suspension 675,953 L.L
G01AX OVUMIX G Metronidazole - 300mg, Miconazole - 100mg, Neomycin (sulfate) - 48.8mg, Gotu Kola - 15mg, Polymixin sulfate - 4.4mg Suppository 395,090 L.L
C10AA05 ORBALIP G Atorvastatin (calcium) - 20mg 20mg Tablet 1,091,712 L.L
C10AA05 ORBALIP G Atorvastatin (calcium) - 40mg 40mg Tablet 1,405,275 L.L
N05AG02 ORAP FORTE B Pimozide - 4mg 4mg Tablet 329,241 L.L
N05AH03 OLANZAMED G Olanzapine - 5mg 5mg Tablet 665,522 L.L
N05AH03 OLANZAPINE ARROW G Olanzapine - 5mg 5mg Tablet 670,577 L.L
N05AH03 OLANZAMED G Olanzapine - 20mg 20mg Tablet 3,941,938 L.L
N05AH03 OLANZAMED G Olanzapine - 10mg 10mg Tablet 902,294 L.L
N05AH03 OLANZAPINE ARROW G Olanzapine - 10mg 10mg Tablet 822,432 L.L
N05AH03 OLANZAPINE ARROW G Olanzapine - 7.5mg 7.5mg Tablet 822,432 L.L
A12AX OSTRONG G Vitamin D3 - 500IU, Calcium hydrogen phosphate - 600mg Tablet 435,149 L.L
A10BB12 ORBIDE G Glimepiride - 1mg 1mg Tablet 207,336 L.L
A10BB12 ORBIDE G Glimepiride - 2mg 2mg Tablet 209,895 L.L
A10BB12 ORBIDE G Glimepiride - 3mg 3mg Tablet 351,959 L.L
A10BB12 ORBIDE G Glimepiride - 4mg 4mg Tablet 357,078 L.L
A10BD02 ORBIZIDE M FORTE G Metformin HCl - 500mg, Gliclazide - 80mg Tablet 771,750 L.L
C09AA01 ORBACE G Captopril - 25mg 25mg Tablet 522,179 L.L
C09AA01 ORBACE G Captopril - 50mg 50mg Tablet 949,649 L.L
C10AA05 ORBALIP G Atorvastatin (calcium) - 10mg 10mg Tablet 966,287 L.L
M05BA04 OREK G Alendronate - 70mg 70mg Tablet, coated 2,404,838 L.L
A04AA01 ONDANSETRON BIOGARAN G Ondansetron - 8mg 8mg Tablet, coated 1,307,559 L.L
N06AB03 OXETINE 20 G Fluoxetine (HCl) - 20mg 20mg Tablet, coated 362,837 L.L
A02BC01 OMEDAR G Omeprazole - 20mg 20mg Tablet, enteric coated 18,087,352 L.L
R01BA52 ORADUS P G Pseudoephedrine sulfate - 120mg, Desloratadine - 2.5mg Tablet, extended release 746,153 L.L
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