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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
R06AB54 ALERGICAL EXPECTORANT B Chlorpheniramine maleate - 50mg/100ml, Guaifenesin - 2000mg/100ml, Dihydroxypropyltheophylline - 500mg/100ml, Paracetamol - 2000mg/100ml Syrup 485,127 L.L
R06AD02 PROMETHAZINE HYDROCHLORIDE G Promethazine HCl - 5mg/5ml 5mg/5ml Syrup 204,776 L.L
R06AD08 TOPLEXIL B Oxomemazine HCl - 0.33mg/ml 0.33mg/ml Syrup 615,480 L.L
R06AD52 FLUISEDAL G Promethazine HCl - 2.5g/5ml, Meglumine benzoate - 130mg/5ml, Polysorbate 20 - 15mg/5ml Syrup 393,746 L.L
R06AD52 FLUISEDAL G Promethazine HCl - 2.5g/5ml, Meglumine benzoate - 130mg/5ml, Polysorbate 20 - 15mg/5ml Syrup 550,821 L.L
R06AD52 CODOPALM G Promethazine HCl - 5mg/5ml, Sodium gentisate - 0.5mg/5ml Syrup 149,742 L.L
N02BE01 PANADOL B&I B Paracetamol - 120mg/5ml 120mg/5ml Suspension, sugar free, alcohol free 210,983 L.L
N02BE01 ADOL G Paracetamol - 250mg/5ml 250mg/5ml Suspension, alcohol free 192,169 L.L
J01CR02 MEGAMOX-JPI G Amoxicillin (trihydrate) - 400mg/5ml, Clavulanic Acid (potassium) - 57mg/5ml 457mg/5ml Suspension 435,405 L.L
A02AF02 ACTONORM B Aluminium hydroxide - 220mg/5ml, Magnesium hydroxide - 200mg/5ml, Simethicone - 25mg/5ml Suspension 425,998 L.L
A02AF02 MAALOX PLUS B Simethicone - 25mg/5ml, Aluminium hydroxide - 175mg/5ml, Magnesium hydroxide - 200mg/5ml Suspension 438,093 L.L
M01AE01 CHILDREN'S ADVIL B Ibuprofen - 100mg/5ml 100mg/5ml Suspension 370,901 L.L
M01AE01 CAPTAIN G Ibuprofen - 100mg/5ml 100mg/5ml Suspension 335,321 L.L
M01AE01 DIMIDON G Ibuprofen - 20mg/ml 20mg/ml Suspension 483,783 L.L
M01AE01 FEVERAL G Ibuprofen - 100mg/5ml 100mg/5ml Suspension 309,724 L.L
A07AA02 MEDISTAN G Nystatin - 500,000IU/5ml 500,000IU/5ml Suspension 415,951 L.L
M01AE01 IBUSOL G Ibuprofen - 100mg/5ml 100mg/5ml Suspension 309,724 L.L
M01AE01 PEDIAFEN G Ibuprofen - 100mg/5ml 100mg/5ml Suspension 200,936 L.L
M01AE01 PROFINAL G Ibuprofen - 100mg/5ml 100mg/5ml Suspension 208,296 L.L
R01AD12 AVAMYS B Fluticasone furoate - 27.5mcg/dose 27.5mcg/dose Suspension 722,987 L.L
R01AD12 AVAMYS B Fluticasone furoate - 27.5mcg/dose 27.5mcg/dose Suspension 722,987 L.L
M01AE01 ALGIFAST PEDIATRIC B Ibuprofen Lysine - 20mg/ml 20mg/ml Suspension 393,746 L.L
J07BH01 ROTATEQ ROTAVIRUS VACCINE, LIVE, ORAL, PENTAVALENT B Rotavirus G1, live attenuated - ?2.2x106 IU, Rotavirus G2, live attenuated - ?2.8x106 IU, Rotavirus G3, live attenuated - ?2.2x106 IU, Rotavirus G4, live attenuated - ?2.0x106 IU, Rotavirus P1, live attenuated - ?2.3x106 IU Suspension 4,508,592 L.L
J07BH01 ROTARIX ORAL B Rota virus human RIX4414, live attenuated - ?106 CCID50 Suspension 5,167,074 L.L
J07BH01 ROTASIIL, ROTAVIRUS VACCINE, LIVE ATTENUATED (ORAL FREEZE-DRIED) BioTech Rotavirus bovine-human , live attenuated - Suspension 2,822,069 L.L
R07AA SURFACTANTE B RICHET G Pulmonary surfactant, bovine - 200mg/8ml 200mg/8ml Suspension 26,568,472 L.L
R07AA01 SURVANTA B Colfosceril palmitate - 200mg/8ml 200mg/8ml Suspension 36,957,499 L.L
B03AA02 FERRATE G Ferrous fumarate - 20mg/ml (iron element) 20mg/ml Suspension 667,890 L.L
A02BX13 GAVISCON ADVANCE ANISEED FLAVOR B Sodium alginate - 1000mg/10ml, Potassium hydrogen carbonate - 200mg/10ml Suspension 514,692 L.L
A02BX13 GAVISCON DOUBLE ACTION MINT B Sodium alginate - 500mg/10ml, Sodium bicarbonate - 213mg/10ml, Calcium (carbonate) - 325mg/10ml Suspension 542,912 L.L
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