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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
B05XA03 SOLUFLEX SODIUM CHLORIDE 0.9% INJECTION USP G Sodium chloride - 0.9% 0.9% Injectable solution 180,421 L.L
A03BB01 SCOPINAL G Butylscopolamine bromide - 10mg 10mg Tablet, film coated 162,605 L.L
B05XA03 SOLUFLEX SODIUM CHLORIDE 0.9% INJECTION USP G Sodium chloride - 0.9% 0.9% Injectable solution 180,421 L.L
A03BB01 SCOPINAL G Butylscopolamine bromide - 5mg/5ml 5mg/5ml Syrup 210,983 L.L
B05XA03 SOLUFLEX SODIUM CHLORIDE 0.9% INJECTION, USP G Sodium chloride - 0.9% 0.9% Injectable solution 218,344 L.L
L01BA04 SUKUBA G Pemetrexed (disodium) - 500mg 500mg Injectable lyophilised powder 34,786,563 L.L
B05XA03 SOLUFLEX SODIUM CHLORIDE 0.9% INJECTION, USP G Sodium chloride - 0.9% 0.9% Injectable solution 203,405 L.L
B05XA03 SOLUFLEX SODIUM CHLORIDE 0.9% INJECTION, USP G Sodium chloride - 0.9% 0.9% Injectable solution 179,272 L.L
A03BB01 SCOBUREN G Butylscopolamine bromide - 20mg/ml 20mg/ml Injectable solution 370,901 L.L
A03BB01 SCOPINAL G Butylscopolamine bromide - 20mg/ml 20mg/ml Injectable solution 178,731 L.L
R03AK06 SEROFLO 500 G Salmeterol (xinafoate) - 50mcg/inhalation, Fluticasone propionate - 500mcg/inhalation Inhalation suspension 2,031,890 L.L
R03AK06 SEROFLO-S 125 G Salmeterol (xinafoate) - 25mcg/inhalation, Fluticasone propionate - 125mcg/inhalation Inhalation suspension 1,212,146 L.L
B05BA02 SMOFLIPID G Soya oil - 6%, Olive oil - 5%, Fish oil - 3%, Medium chain triglycerides - 6% 20% Injectable emulsion 1,424,473 L.L
R03AK06 SEROFLO 250 G Salmeterol (xinafoate) - 50mcg/inhalation, Fluticasone propionate - 250mcg/inhalation Inhalation suspension 1,580,359 L.L
R03AK06 SEROFLO-S 250 G Salmeterol (xinafoate) - 25mcg/inhalation, Fluticasone propionate - 250mcg/inhalation Inhalation suspension 1,725,494 L.L
B05XA03 SODIUM CHLORIDE G Sodium chloride - 0.45% 0.45% Injectable solution 133,856 L.L
B05XA03 SODIUM CHLORIDE G Sodium chloride - 0.45% 0.45% Injectable solution 149,393 L.L
B05BA10 SMOFKABIVEN G Glucose monohydrate - 462mg, Soya-bean oil, refined - 60mg, Triglycerides, Medium Chain - 60mg, Olive oil, refined - 50mg, Fish oil, rich in omega-3-acids - 30mg, Alanine - 14mg, Arginine - 12mg, Proline - 11.2mg, Glycine - 11mg, Lysine acetate - 9.3mg, Leucine - 7.4mg, Serine - 6.5mg, Valine - 6.2mg, Sodium acetate, 3H2O - 5.62mg, Phenylalanine - 5.1mg, Isoleucine - 5mg, Potassium chloride - 4.48mg, Threonine - 4.4mg, Methionine - 4.3mg, Sodium glycerophosphate, anhydrous - 4.18mg, Histidine - 3mg, Magnesium sulfate, 7H2O - 2.47mg, Tryptophan - 2mg, Taurine - 1mg, Calcium chloride 2H2O - 0.74mg, Tyrosine - 0.40mg, Zinc sulfate heptahydrate - 23mcg Injectable emulsion 3,835,326 L.L
B05XA03 SODIUM CHLORIDE G Sodium chloride - 0.45% 0.45% Injectable solution 163,184 L.L
J02AC01 STABILANOL G Fluconazole - 2mg/ml 2mg/ml Injectable solution 1,291,789 L.L
B05BA10 SMOFKABIVEN PERIPHERAL G Glucose monohydrate - 143mg, Soya-bean oil, refined - 60mg, Triglycerides, Medium Chain - 60mg, Olive oil, refined - 50mg, Fish oil, rich in omega-3-acids - 30mg, Alanine - 14mg, Arginine - 12mg, Proline - 11.2mg, Glycine - 11mg, Lysine acetate - 9.3mg, Leucine - 7.4mg, Serine - 6.5mg, Valine - 6.2mg, Sodium acetate, 3H2O - 5.62mg, Phenylalanine - 5.1mg, Isoleucine - 5mg, Potassium chloride - 4.48mg, Threonine - 4.4mg, Methionine - 4.3mg, Sodium glycerophosphate, anhydrous - 4.18mg, Histidine - 3mg, Magnesium sulfate, 7H2O - 2.47mg, Tryptophan - 2mg, Taurine - 1mg, Calcium chloride 2H2O - 0.74mg, Tyrosine - 0.40mg, Zinc sulfate heptahydrate - 23mcg Injectable emulsion 4,571,752 L.L
B05XA03 SODIUM CHLORIDE G Sodium chloride - 0.45% 0.45% Injectable solution 176,974 L.L
B05XA03 SODIUM CHLORIDE G Sodium chloride - 0.45% 0.45% Injectable solution 161,805 L.L
R07AA SURFACTANTE B RICHET G Pulmonary surfactant, bovine - 200mg/8ml 200mg/8ml Suspension 26,568,472 L.L
B05XA03 SODIUM CHLORIDE 0.45% INJECTION, USP G Sodium chloride - 0.45% 0.45% Injectable solution 161,314 L.L
N02BE01 SICADOL G Paracetamol - 1000mg 1000mg Tablet 423,310 L.L
B05BB01 SOLUFLEX LACTATED RINGER'S INJECTION, USP G Sodium lactate - 3.1g/l, Calcium chloride, 2H2O - 0.2g/l, Potassium chloride - 0.3g/l, Sodium chloride - 6g/l Injectable solution 236,731 L.L
B05XA03 SODIUM CHLORIDE 0.45% INJECTION, USP G Sodium chloride - 0.45% 0.45% Injectable solution 149,393 L.L
B05XA03 SODIUM CHLORIDE 0.45% INJECTION, USP G Sodium chloride - 0.45% 0.45% Injectable solution 148,566 L.L
N02BE01 SULDEX B G Paracetamol - 150mg 150mg Suppository 117,746 L.L
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