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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 - 0.1% 0.1% Drops 241,892 L.L
R01AA07 OTRIVIN MENTHOL 0.1% B Xylometazoline HCl - 0.1% 0.1% Drops 387,027 L.L
R01AA07 OTRIVIN B Xylometazoline HCl - 0.05% 0.05% Solution 260,705 L.L
R01AA07 OTRIVIN B Xylometazoline HCl - 0.05% 0.05% Drops 181,419 L.L
R01AB06 OTRIVIN DUAL RELIEF B Xylometazoline HCl - 0.5mg/ml, Ipratropium bromide - 0.6mg/ml Solution 563,070 L.L
R01AD08 OTRIALLERGY B Fluticasone propionate - 50mcg/actuation 50mcg/actuation Spray, suspension 675,953 L.L
R01BA52 ORADUS P G Pseudoephedrine sulfate - 120mg, Desloratadine - 2.5mg Tablet, extended release 746,153 L.L
R01BA52 ORADUS P G Pseudoephedrine sulfate - 120mg, Desloratadine - 2.5mg Tablet, extended release 255,970 L.L
R03AC18 ONBREZ BREEZHALER B Indacaterol maleate - 150mcg 150mcg Capsule, inhalation 2,284,532 L.L
R06AX ORADUS BETA G Desloratadine - 1mg/ml, Betamethasone - 0.05mg/ml Solution 639,925 L.L
R06AX ORADUS BETA G Desloratadine - 5mg, Betamethasone - 0.6mg Tablet, film coated 497,862 L.L
R06AX27 ORADUS G Desloratadine - 5mg 5mg Tablet, film coated 383,955 L.L
R06AX27 ORADUS G Desloratadine - 0.5mg/ml 0.5mg/ml Solution 199,657 L.L
S01AA13 OPTIFUCIN VISCOUS G Fusidic acid - 1% 1% Drops 208,296 L.L
S01AE01 OFLOX B Ofloxacin - 3mg/ml 0.3% Drops solution 366,869 L.L
S01AE01 OFLOX B Ofloxacin - 0.3% 0.3% Drops solution 366,869 L.L
S01AE01 OPTIFLOX G Ofloxacin - 3mg/ml 3mg/ml Drops suspension 143,791 L.L
S01BA01 OZURDEX B Dexamethasone - 700mcg 700mcg Implant 80,696,540 L.L
S01BA01 OZURDEX B Dexamethasone - 700mcg 700mcg Implant 80,696,540 L.L
S01BA07 OPTILONE G Fluorometholone - 0.1% 0.1% Solution 309,084 L.L
S01CA01 OPTIDEX T G Dexamethasone - 1mg/ml, Tobramycin - 3mg/ml Drops suspension 266,081 L.L
S01GX09 OLOPAT G Olopatadine (HCl) - 0.1% 0.1% Drops solution 524,099 L.L
S01GX09 OLOPAT UD G Olopatadine (HCl) - 0.1% 0.1% Drops solution 1,523,917 L.L
S02AA16 OFLOMED G Ofloxacin - 3mg/ml 3mg/ml Drops solution 317,403 L.L
S02AA30 OTOCOL G Chloramphenicol - 50mg/ml, Benzocaine - 50mg/ml Drops 163,949 L.L
S02DA01 OTIPAX B Lidocaine HCl - 1g/100g, Phenazone - 4g/100g Drops 236,516 L.L
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