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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 HEMAX BioTech Erythropoietin recombinant human (Epoetin alfa) - 20,000IU 20,000IU Injectable freeze dried powder + diluent 5,438,531 L.L
B03XA01 ALPEEN BioTech Erythropoietin recombinant human (Epoetin alfa) - 40,000IU 40,000IU Injectable solution 11,210,836 L.L
B03XA01 HEMAX BioTech Erythropoietin recombinant human (Epoetin alfa) - 40,000IU 40,000IU Injectable freeze dried powder + diluent 6,316,060 L.L
B03BB01 ACFOL G Folic acid - 5mg 5mg Tablet 355,798 L.L
B03BB01 FOLICIL G Folic acid - 5mg 5mg Tablet 584,571 L.L
B03BB01 MED-FOLIC ACID G Folic acid - 5mg 5mg Tablet, scored 355,798 L.L
B03BA51 DEPOVEX B Aluminium monostearate - 20mg/ml, Cyanocobalamine - 1mg/ml Injectable oily suspension 423,310 L.L
B03BA05 COBAL G Mecobalamine - 500mcg/ml 500mcg/ml Injectable solution 1,128,828 L.L
B03BA01 COBAL G Vitamin B12 - 500mcg 500mcg Tablet, coated 486,471 L.L
B03BA01 CYNOVIT-JULPHAR G Vitamin B12 - 1mg/ml 1mg/ml Injectable solution 167,980 L.L
B03BA01 JECTIN-12 G Cyanocobalamin - 1000mcg/1ml 1000mcg/1ml Injectable solution 567,102 L.L
B03AE10 TOT'HEMA B Copper (gluconate) - 0.70mg/10ml, Manganese (gluconate) - 1.33mg/10ml, Iron (gluconate) - 50mg/10ml Solution 604,729 L.L
B03AD04 MALTOFER B Iron trivalent (hydroxide polymaltose) - 10mg/ml 50mg/5ml Syrup 589,947 L.L
B03AD04 MALTOFER B Iron trivalent (hydroxide polymaltose) - 10mg/ml 50mg/5ml Syrup 589,947 L.L
B03AD04 MALTOFER B Iron trivalent (hydroxide polymaltose) - 50mg/ml 50mg/ml Drops solution 649,076 L.L
B03AD04 MALTOFER B Iron trivalent (hydroxide polymaltose) - 50mg/ml 50mg/ml Drops solution 649,076 L.L
B03AD03 GYNO-TARDYFERON B Folic acid - 0.35mg, Ferrous (sulfate) - 80mg Tablet, sugar coated, slow release 682,672 L.L
B03AD03 FOLIFER G Folic acid - 1mg, Iron bivalent (as dried ferrous sulfate) - 90mg Tablet, film coated 1,408,347 L.L
B03AD MALTOFER FOL B Folic acid - 0.35mg, Iron trivalent (hydroxide polymaltose) - 100mg Tablet, chewable 854,684 L.L
B03AD EURO-FER CF G Folic acid - 0.5mg, Vitamin C - 200mg, Ferrous fumarate - 300mg Capsule 706,861 L.L
B03AD VITEXFER G Folic acid - 1mg, Ascorbic acid - 200mg, Iron ferrous fumarate - 100mg Tablet, film coated 791,523 L.L
B03AC VENOFER I.V. B Iron (sucrose) - 100mg/5ml 100mg/5ml Injectable concentrated solution 3,594,779 L.L
B03AC FER PANPHARMA G Iron (sucrose) - 100mg/5ml 100mg/5ml Injectable solution 2,315,441 L.L
B03AC FER PANPHARMA G Iron (sucrose) - 100mg/5ml 100mg/5ml Injectable solution 2,315,441 L.L
B03AC FEROMAX G Iron trivalent (hydroxide sucrose complex) - 100mg/5ml 100mg/5ml Injectable solution 2,213,309 L.L
B03AC FERRASIL G Iron (sucrose) - 100mg/5ml 100mg/5ml Injectable solution 2,194,047 L.L
B03AC IVIRON G Iron (sucrose) - 100mg/5ml 100mg/5ml Injectable concentrated solution 1,745,203 L.L
B03AC FERINJECT B Iron trivalent (ferric carboxymaltose) - 500mg/10ml 500mg/10ml Injectable solution 10,212,033 L.L
B03AC FERAPPLIC G Iron trivalent (ferric carboxymaltose) - 500mg/10ml 500mg/10ml Injectable dispersion 34,231,559 L.L
B03AB09 FERPLEX B Iron trivalent (ferric proteinsuccinylate) - 800mg 800mg Solution 1,202,739 L.L
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