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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
C10AA01 SIMVAKEY G Simvastatin - 20mg 20mg Tablet, film coated 249,955 L.L
D06BA01 SILVEDERMA G Silver sulfadiazine - 1% 10mg/g Cream 1,220,209 L.L
C10AA01 SIMVASTATIN NORMON G Simvastatin - 20mg 20mg Tablet, film coated 264,737 L.L
D06BA01 SILVEDERMA G Silver sulfadiazine - 1% 10mg/g Cream 494,534 L.L
C10AA01 SIMVASTATIN-REMEDICA G Simvastatin - 20mg 20mg Tablet, film coated 542,912 L.L
A04AA02 SANCUSO G Granisetron - 3.1mg/24h 3.1mg/24h Patch 7,590,728 L.L
C10AA01 STAVINE G Simvastatin - 20mg 20mg Tablet 207,336 L.L
D06BA05 SULFANILAMIDE G Sulfanilamide - 12g 12g Powder 151,022 L.L
C10AA01 SIMVASTATIN NORMON G Simvastatin - 40mg 40mg Tablet, film coated 264,737 L.L
C10AA01 SIMVASTATIN-REMEDICA G Simvastatin - 40mg 40mg Tablet, film coated 780,772 L.L
M03BX04 STIFFANO G Tolperisone - 150mg 150mg Tablet 651,764 L.L
C10AA01 STAVINE G Simvastatin - 40mg 40mg Tablet, scored 207,336 L.L
D06BA51 SILVEZ PLUS G Silver sulfadiazine - , Chlorhexidine - Cream 349,399 L.L
N05AH04 SEROPINE XR 300 G Quetiapine fumarate - 300mg 300mg Tablet, extended release 4,744,660 L.L
L04AX04 SOTIRA G Lenalidomide - 5mg 5mg Capsule 68,908,116 L.L
J01DH51 SYNERGIC G Imipenem - 500mg, Cilastatin - 500mg Injectable powder 1,142,266 L.L
C10AA03 STAVACOR G Pravastatin sodium - 40mg 40mg Tablet, scored 891,799 L.L
C10AA03 STAVACOR G Pravastatin sodium - 20mg 20mg Tablet, scored 725,419 L.L
C10AA03 STAVACOR G Pravastatin sodium - 10mg 10mg Tablet, scored 1,695,801 L.L
A06AB02 SUPPOLAX G Bisacodyl - 10mg 10mg Suppository 598,051 L.L
L01XX02 SPECTRILA BioTech Asparaginase, recombinant - 10,000IU 10,000IU Injectable powder for concentrate for solution 21,370,813 L.L
L04AC05 STELARA BioTech Ustekinumab - 45mg 45mg Injectable solution L.L
A10BJ02 SAXENDA BioTech Liraglutide - 6mg/ml 6mg/ml Injectable solution 16,747,035 L.L
J06BD01 SYNAGIS BioTech Palivizumab - 100mg/ml 100mg/ml Injectable solution 57,429,464 L.L
J06BD01 SYNAGIS BioTech Palivizumab - 50mg/0.5ml 50mg/0.5ml Injectable solution 38,316,693 L.L
A10AE54 SULIQUA BioTech Insulin glargine - 100IU/ml, Lixisenatide - 50mcg/ml Injectable solution 11,286,573 L.L
A10AE54 SULIQUA BioTech Insulin glargine - 100IU/ml, Lixisenatide - 33mcg/ml Injectable solution 7,975,793 L.L
L04AB06 SIMPONI BioTech Golimumab - 50mg/0.5ml 50mg/0.5ml Injectable solution 75,598,955 L.L
L04AB06 SIMPONI BioTech Golimumab - 100mg/1ml 100mg/1ml Injectable solution 75,598,955 L.L
L04AC02 SIMULECT BioTech Basiliximab - 20mg 20mg Injectable powder + solvent 137,661,787 L.L
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