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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
L01FF02 KEYTRUDA BioTech Pembrolizumab - 100mg/4ml 100mg/4ml Injectable solution 241,744,802 L.L
L04AC10 COSENTYX BioTech Secukinumab - 150mg/ml 150mg/ml Injectable solution 70,463,329 L.L
M03AC11 NIMBEX B Cisatracurium (besylate) - 20mg/10ml 20mg/10ml Injectable solution 2,010,388 L.L
B03XA01 ALPEEN BioTech Erythropoietin recombinant human (Epoetin alfa) - 4000IU 4000IU Injectable solution 8,728,144 L.L
B05XA03 SODIUM CHLORIDE G Sodium chloride - 0.9% 0.9% Injectable solution 5,566,628 L.L
H01CB03 SOMATULINE AUTOGEL B Lanreotide (acetate) - 120mg 120mg Injectable solution 57,492,826 L.L
J02AC01 STABILANOL G Fluconazole - 2mg/ml 2mg/ml Injectable solution 1,242,583 L.L
L01FF03 IMFINZI BioTech Durvalumab - 500mg/10ml 500mg/10ml Injectable solution 227,939,689 L.L
L04AC13 TALTZ BioTech Ixekizumab - 80mg/ml 80mg/ml Injectable solution 85,080,792 L.L
M03AC11 NIMBEX B Cisatracurium (besylate) - 20mg/10ml 20mg/10ml Injectable solution 2,010,388 L.L
B03XA01 ALPEEN BioTech Erythropoietin recombinant human (Epoetin alfa) - 4000IU 4000IU Injectable solution 1,127,036 L.L
B05XA03 SODIUM CHLORIDE G Sodium chloride - 0.9% 0.9% Injectable solution 519,736 L.L
H01CB05 SIGNIFOR B Pasireotide (diaspartate) - 0.3mg/ml 0.3mg/ml Injectable solution 168,719,438 L.L
J02AC01 UNIZOL MS G Fluconazole - 200mg/100ml 200mg/100ml Injectable solution 1,419,098 L.L
L01FF03 IMFINZI BioTech Durvalumab - 500mg/10ml 500mg/10ml Injectable solution 227,939,689 L.L
L04AC16 TREMFYA BioTech Guselkumab - 100mg/ml 100mg/ml Injectable solution 190,195,151 L.L
M03AC11 SISACURE G Cisatracurium (besylate) - 20mg/10ml 20mg/10ml Injectable solution 1,408,347 L.L
A11GA01 VITAMIN C S.A.L.F. G Ascorbic acid (vit C) - 500mg/5ml 500mg/5ml Injectable solution 498,566 L.L
B03XA01 ALPEEN BioTech Erythropoietin recombinant human (Epoetin alfa) - 4000IU 4000IU Injectable solution 4,748,244 L.L
B05XA03 SODIUM CHLORIDE G Sodium chloride - 0.9% 0.9% Injectable solution 167,780 L.L
H01CB05 SIGNIFOR B Pasireotide (diaspartate) - 0.6mg/ml 0.6mg/ml Injectable solution 180,355,261 L.L
L01FF03 IMFINZI BioTech Durvalumab - 120mg/2.4ml 120mg/2.4ml Injectable solution 59,776,110 L.L
L04AC16 TREMFYA BioTech Guselkumab - 100mg/ml 100mg/ml Injectable solution 190,195,151 L.L
B03XA01 EPOTIN BioTech Erythropoietin recombinant human (Epoetin alfa) - 4,000IU/ml 4,000IU/ml Injectable solution 11,317,795 L.L
B05XA03 SODIUM CHLORIDE G Sodium chloride - 0.9% 0.9% Injectable solution 167,780 L.L
H01CB05 SIGNIFOR B Pasireotide (diaspartate) - 0.9mg/ml 0.9mg/ml Injectable solution 183,846,008 L.L
L01FF03 IMFINZI BioTech Durvalumab - 120mg/2.4ml 120mg/2.4ml Injectable solution 59,776,110 L.L
L04AC18 SKYRIZI BioTech Risankizumab - 75mg 75mg Injectable solution 194,911,251 L.L
B05XA03 SODIUM CHLORIDE G Sodium chloride - 0.9% 0.9% Injectable solution 166,708 L.L
H01CC01 ORGALUTRAN B Ganirelix - 0.25mg/0.5ml 0.25mg/0.5ml Injectable solution 2,383,977 L.L
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