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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
B03XA01 BINOCRIT BioTech Erythropoietin recombinant human (Epoetin alfa) - 40,000IU/ml 40,000IU/ml Injectable solution 11,726,826 L.L
B03XA01 ALPEEN BioTech Erythropoietin recombinant human (Epoetin alfa) - 4000IU 4000IU Injectable solution 8,728,144 L.L
B03XA01 ALPEEN BioTech Erythropoietin recombinant human (Epoetin alfa) - 4000IU 4000IU Injectable solution 1,127,036 L.L
B03XA01 ALPEEN BioTech Erythropoietin recombinant human (Epoetin alfa) - 4000IU 4000IU Injectable solution 4,748,244 L.L
B01AB05 PARINOX 40 BioTech Enoxaparin sodium - 4000IU (40mg)/0.4ml 4000IU (40mg)/0.4ml Injectable solution 358,358 L.L
B01AB05 ENOXAMED BioTech Enoxaparin sodium - 4000IU Anti-XA/0.4ml 4000IU Anti-XA/0.4ml Injectable solution 755,239 L.L
B01AB05 ENOXAMED BioTech Enoxaparin sodium - 4000IU Anti-XA/0.4ml 4000IU Anti-XA/0.4ml Injectable solution 2,150,148 L.L
B01AB05 ENOMEX BioTech Enoxaparin sodium - 4000U Anti-Xa/0.4ml 4000U Anti-Xa/0.4ml Injectable solution 753,832 L.L
B01AB05 ENOXAPARIN LEDRAXEN BioTech Enoxaparin sodium - 4000UI (40mg)/0.4ml 4000UI (40mg)/0.4ml Injectable solution 841,245 L.L
B03XA01 EPOMAX BioTech Erythropoietin recombinant human (Epoetin alfa) - 4000UI/ml 4000UI/ml Injectable solution 1,243,054 L.L
B03XA01 EPOMAX BioTech Erythropoietin recombinant human (Epoetin alfa) - 4000UI/ml 4000UI/ml Injectable solution L.L
A11CC05 PEDIAVIT D G Vitamin D3 - 400IU 400IU Liquid 550,975 L.L
A16AB02 CEREZYME B Imiglucerase - 400IU 400IU Injectable lyophilised powder for solution 128,412,818 L.L
A16AB02 CEREZYME B Imiglucerase - 400IU 400IU Injectable lyophilised powder for solution L.L
R03BA02 AERONIDE G Budesonide - 400mcg 400mcg Capsule, inhalation 2,116,552 L.L
B01AC27 UPTRAVI B Selexipag - 400mcg 400mcg Tablet, film coated 275,097,581 L.L
N05CM18 DEXMEDETOMIDINE EVER PHARMA G Dexmedetomidine HCl - 400mcg/4ml 400mcg/4ml Injectable concentrate for solution 15,543,897 L.L
N02AB03 PECFENT B Fentanyl (citrate) - 400mcg/spray 400mcg/spray Spray 5,718,050 L.L
J05AP08 NUCLEOBUVIR G Sofosbuvir - 400mg 400mg Tablet, film coated 50,670,440 L.L
L01EA01 CEMIVIL G Imatinib - 400mg 400mg Tablet, film coated 41,106,321 L.L
L01EA01 GLIMATINIB BENTA 400 G Imatinib (mesylate) - 400mg 400mg Tablet, film coated 38,254,090 L.L
L01EA01 IMAREM G Imatinib (mesylate) - 400mg 400mg Tablet, film coated 64,682,117 L.L
L01EA01 IMATINIB GP PHARM G Imatinib - 400mg 400mg Tablet, coated 26,083,945 L.L
L01EA01 GLIMATINIB BENTA 400 G Imatinib (mesylate) - 400mg 400mg Tablet, film coated L.L
L01EA01 IMATINIB NEAPOLIS G Imatinib - 400mg 400mg Tablet, film coated 36,046,335 L.L
L01EA01 IMATINIB SHILPA MESYLATE G Imatinib - 400mg 400mg Tablet, film coated 21,518,059 L.L
L01EA01 IMATINIB SPC G Imatinib - 400mg 400mg Tablet, film coated 53,700,122 L.L
L01EA01 SAGITTA G Imatinib - 400mg 400mg Capsule, hard 51,723,840 L.L
N05AX12 ABILIFY MAINTENA B Aripiprazole - 400mg 400mg Injectable powder for suspension, prolonged release+solvent 29,491,998 L.L
A07EC02 ASACOL B Mesalazine - 400mg 400mg Tablet, enteric coated 5,895,437 L.L
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