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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
C01CA06 PHENYLEPHRINE AGUETTANT G Phenylephrine - 500mcg/10ml 500mcg/10ml Injectable solution 11,464,796 L.L
B05XA01 POTASSIUM CHLORIDE G Potassium chloride - 7.46g/100ml 7.46g/100ml Injectable solution 2,822,386 L.L
B05XA01 POTASSIUM CHLORIDE G Potassium chloride - 7.46g/100ml 7.46g/100ml Injectable solution 663,077 L.L
B05XA01 POTASSIUM CHLORIDE G Potassium chloride - 10g/100ml 10g/100ml Injectable solution 3,023,493 L.L
B05XA01 POTASSIUM CHLORIDE G Potassium chloride - 15g/100ml 15g/100ml Injectable solution 5,688,441 L.L
B05XA01 POTASSIUM CHLORIDE G Potassium chloride - 11.2g/100ml 11.2g/100ml Injectable solution 789,487 L.L
B05XA PEDITRACE B Sodium selenite 5H2O (anhydrous) - 6.66mcg/ml, Sodium fluoride - 126mcg/ml, Potassium iodide - 1.31mcg/ml, Zinc chloride - 521mcg/ml, Copper chloride - 53.7mcg/ml, Manganese chloride 4H2O - 3.6mcg/ml Injectable concentrated solution 4,749,139 L.L
B05D PERITONEAL DIALYSIS SOLUTION WITH 4 1/4% DEXTROSE G Sodium lactate - 0.392g%, Calcium chloride, 2H2O - 0.0257g%, Magnesium chloride, 6H2O - 0.0153g%, Sodium chloride - 0.567g%, Dextrose, H2O - 4.25g% Injectable solution 498,744 L.L
B05D PERITONEAL DIALYSIS SOLUTION WITH 1 1/2% DEXTROSE G Sodium lactate - 0.392g%, Calcium chloride, 2H2O - 0.0257g%, Magnesium chloride, 6H2O - 0.0153g%, Sodium chloride - 0.567g%, Dextrose, H2O - 1.5g% Injectable solution 490,807 L.L
B05BA10 PERIOLIMEL N4E B Olive oil + Soja oil - 45.00g, Alanine - 5.50g, Arginine - 3.72g, Aspartic Acid - 1.10g, Glutamic Acid - 1.90g, Glycine - 2.63g, Histidine - 2.26g, Isoleucine - 1.90g, Leucine - 2.63g, Lysine - 2.99g, Methionine - 1.90g, Phenylalanine - 2.63g, Proline - 2.26g, Serine - 1.50g, Threonine - 1.90g, Tryptophan - 0.64g, Tyrosine - 0.10g, Valine - 2.43g, Sodium acetate, 3H2O - 1.73g, Sodium glycerophosphate, H2O - 2.87g, Potassium chloride - 1.79g, Magnesium chloride, 6H2O - 0.67g, Calcium chloride 2H2O - 0.44g, Glucose monohydrate - 123.75g Injectable emulsion 5,288,020 L.L
B05AA01 PLASBUMIN-20 ALBUMIN (HUMAN) BioHuman Albumin human - 20% 20% Injectable solution 3,641,813 L.L
B03AA07 PEDIAFER G Ferrous (sulfate) - 15mg/ml 15mg/ml Drops 550,975 L.L
B02BA01 PHYTOMENADIONE (VITAMINE K1) PANPHARMA G Phytomenadione - 10mg/ml 10mg/ml Solution 740,457 L.L
B01AE07 PRADAXA B Dabigatran etexilate (mesilate) - 75mg 75mg Capsule, hard 3,205,064 L.L
B01AE07 PRADAXA B Dabigatran etexilate (mesilate) - 75mg 75mg Capsule, hard 1,603,204 L.L
B01AE07 PRADAXA B Dabigatran etexilate (mesilate) - 110mg 110mg Capsule, hard 1,603,204 L.L
B01AE07 PRADAXA B Dabigatran etexilate (mesilate) - 110mg 110mg Capsule, hard 3,205,064 L.L
B01AE07 PRADAXA B Dabigatran etexilate (mesilate) - 150mg 150mg Capsule, hard 3,031,709 L.L
B01AC04 PLAVIX B Clopidogrel (hydrogenosulfate) - 75mg 75mg Tablet, film coated 1,350,562 L.L
B01AC04 PLAVIX B Clopidogrel (hydrogenosulfate) - 75mg 75mg Tablet, film coated 1,350,562 L.L
B01AC04 PEDOVEX G Clopidogrel (Bisulfate) - 75mg 75mg Tablet, film coated 808,993 L.L
B01AC04 PIDOGREL MEDIS G Clopidogrel - 75mg 75mg Tablet, film coated 810,337 L.L
B01AC04 PLAVINOR-75 G Clopidogrel - 75mg Tablet, film coated Tablet, film coated 1,112,702 L.L
B01AB05 PARINOX 40 BioTech Enoxaparin sodium - 4000IU (40mg)/0.4ml 4000IU (40mg)/0.4ml Injectable solution 358,358 L.L
B01AB05 PARINOX 80 BioTech Enoxaparin sodium - 8000IU (80mg)/0.8ml 8000IU (80mg)/0.8ml Injectable solution 494,022 L.L
B01AB05 PARINOX 60 BioTech Enoxaparin sodium - 6000IU (60mg)/0.6ml 6000IU (60mg)/0.6ml Injectable solution 438,989 L.L
B01AB05 PARINOX 20 BioTech Enoxaparin sodium - 2000IU (20mg)/0.2ml 2000IU (20mg)/0.2ml Injectable solution 188,138 L.L
A13A POTENCIATOR G Arginine Aspartate - 5g/10ml 5g Solution 1,402,972 L.L
A12CX PHOSPHATE DIPOTASSIQUE RENAUDIN G Phosphate dipotassique - 174.20mg/ml 174.20mg/ml Injectable solution 1,189,301 L.L
A11CC05 PEDIAVIT D G Vitamin D3 - 400IU 400IU Liquid 550,975 L.L
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