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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 - 0.05% 0.05% Drops 181,419 L.L
G03CA03 OESTRODOSE B Estradiol (17 bêta estradiol anhydre) - 0.06% 0.06% Gel 642,357 L.L
S01BA07 OPTILONE G Fluorometholone - 0.1% 0.1% Solution 309,084 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
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
A11CC03 ONE-ALPHA B Alfacalcidol - 0.25mcg 0.25mcg Capsule 1,138,235 L.L
A10BJ06 OZEMPIC B Semaglutide - 0.25mg 0.25mg Injectable solution 10,927,526 L.L
H01CC01 ORGALUTRAN B Ganirelix - 0.25mg/0.5ml 0.25mg/0.5ml Injectable solution 2,383,977 L.L
H01CC01 ORGALUTRAN B Ganirelix - 0.25mg/0.5ml 0.25mg/0.5ml Injectable solution 2,383,977 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
G04CA02 OMNIC OCAS B Tamsulosin HCl - 0.4mg 0.4mg Tablet, film coated, prolonged release 866,778 L.L
A11CC03 ONE-ALPHA B Alfacalcidol - 0.5mcg 0.5mcg Capsule 943,377 L.L
A11CC03 ONE-ALPHA B Alfacalcidol - 0.5mcg 0.5mcg Capsule 942,034 L.L
A10BJ06 OZEMPIC B Semaglutide - 0.5mg 0.5mg Injectable solution 10,927,526 L.L
R06AX27 ORADUS G Desloratadine - 0.5mg/ml 0.5mg/ml Solution 199,657 L.L
G03CA03 OESTRACLIN G Estradiol - 0.6mg/g 0.6mg/g Gel 448,843 L.L
S01AA13 OPTIFUCIN VISCOUS G Fusidic acid - 1% 1% Drops 208,296 L.L
M02AA15 OLFEN G Diclofenac sodium (diethylamine) - 1% 1% Gel 268,769 L.L
B02BD02 OCTANATE BioHuman Coagulation Factor VIII - 1,000IU 1,000IU Injectable lyophilised powder for solution+diluent 46,817,511 L.L
J01CA04 OSPAMOX G Amoxicillin (trihydrate) - 1g 1,000mg Tablet, film coated 657,246 L.L
A11CC05 ONE BIG-D 10.000 G Vitamin D3 - 10,000IU 10,000IU Capsule 895,895 L.L
A11CC05 ORAVIL G Vitamin D3 - 100,000IU/2ml 100,000IU Solution 618,168 L.L
A11CC05 OSTEODYN VITAMINE D3 G Vitamin D3 - 100000IU/2ml 100000IU/2ml Solution 618,168 L.L
L01EX09 OFEV B Nintedanib - 100mg 100mg Capsule, soft 100,972,184 L.L
L01XA03 OXALIPLATIN MEDAC G Oxaliplatin - 100mg 100mg Injectable powder for solution 7,841,801 L.L
L01XA03 OXALIPLATINE VIATRIS 5MG/ML G Oxaliplatin - 100mg 100mg Injectable powder for solution 6,932,000 L.L
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