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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
B05XA03 SOLUFLEX SODIUM CHLORIDE 0.45% INJECTION, USP G Sodium chloride - 0.45% 0.45% Injectable solution 383,826 L.L
B05XA03 SODIUM CHLORIDE G Sodium chloride - 10% 10% Injectable solution 4,129,004 L.L
B05XA03 SODIUM CHLORIDE G Sodium chloride - 10% 10% Injectable solution 5,779,226 L.L
B05XA03 SODIUM CHLORIDE G Sodium chloride - 20% 20% Injectable solution 5,675,800 L.L
M04AA03 STABURIC G Febuxostat - 120mg 120mg Tablet, film coated 1,420,889 L.L
B05XA03 SODIUM CHLORIDE G Sodium chloride - 20% 20% Injectable solution 784,890 L.L
J01DD15 SEFARIN G Cefdinir - 125mg/5ml 125mg/5ml Suspension 1,695,929 L.L
J01DD15 SEFARIN G Cefdinir - 125mg/5ml 125mg/5ml Suspension 939,346 L.L
B05XA05 SULFATE DE MAGNESIUM PROAMP G Magnesium sulfate - 0.15g/ml 0.15g/ml Injectable solution 1,400,284 L.L
B05XA05 SULFATE DE MAGNESIUM RENAUDIN G Magnesium sulfate - 1.5g/10ml 15% Injectable solution 434,061 L.L
N07BC51 SUBOXONE G Buprenorphine HCl - 2mg, Naloxone HCl - 0.5mg Tablet, sublingual 1,473,590 L.L
B05BB01 SERUFLEX LACTATED RINGER'S INJECTION, USP G Sodium lactate - 3.1g/l, Calcium chloride, 2H2O - 0.2g/l, Potassium chloride - 0.3g/l, Sodium chloride - 6g/l Injectable solution 216,046 L.L
L04AX04 SOTIRA G Lenalidomide - 10mg 10mg Capsule 72,248,183 L.L
M04AA03 STABURIC G Febuxostat - 80mg 80mg Tablet, film coated 1,355,489 L.L
N07BC51 SUBOXONE G Buprenorphine HCl - 8mg, Naloxone HCl - 2mg Tablet, sublingual 7,382,584 L.L
N07BC51 SUBOXONE G Buprenorphine HCl - 16mg, Naloxone HCl - 4mg Tablet, sublingual 14,284,125 L.L
M04AA03 STABURIC G Febuxostat - 40mg 40mg Tablet, film coated 1,081,345 L.L
J01DD15 SEFARIN G Cefdinir - 300mg 300mg Capsule 1,494,353 L.L
B05BB01 SERUFLEX LACTATED RINGER'S INJECTION, USP G Sodium lactate - 3.1g/l, Calcium chloride, 2H2O - 0.2g/l, Potassium chloride - 0.3g/l, Sodium chloride - 6g/l Injectable solution 232,134 L.L
B05BB01 SOLUFLEX LACTATED RINGER'S INJECTION, USP G Sodium lactate - 3.1g/l, Calcium chloride, 2H2O - 0.2g/l, Potassium chloride - 0.3g/l, Sodium chloride - 6g/l Injectable solution 264,311 L.L
L04AX04 SOTIRA G Lenalidomide - 15mg 15mg Capsule 76,208,289 L.L
M05BA04 STRONDEX 70 G Alendronate sodium - 70mg 70mg Tablet 1,305,447 L.L
J01DE01 SALAPIME G Cefepime - 1g 1g Injectable powder for solution 618,168 L.L
B05BB01 SERUFLEX RINGER'S INJECTION, USP G Calcium chloride, 2H2O - 0.33g/l, Potassium chloride - 0.3g/l, Sodium chloride - 8.6g/l Injectable solution 204,554 L.L
B05BB01 SOLUFLEX RINGER'S INJECTION, USP G Calcium chloride, 2H2O - 0.33g/l, Potassium chloride - 0.3g/l, Sodium chloride - 8.6g/l Injectable solution 221,792 L.L
D03BA SERODASE G Serratiopeptidase - 5mg 5mg Tablet, enteric coated 460,938 L.L
L04AX04 SOTIRA G Lenalidomide - 25mg 25mg Capsule 76,719,234 L.L
R05CB06 SOLVAMUC SR G Ambroxol - 75mg 75mg Capsule 276,448 L.L
S03AA30 SULFACHLOR G Sulfacetamide sodium - 110mg/ml, Chloramphenicol - 5mg/ml Drops solution 202,216 L.L
N03AX09 SEIZET 25 G Lamotrigine - 25mg 25mg Tablet, dispersible/ chewable 573,821 L.L
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