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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
B05BA02 LIPIDEM G Triglycerides, Medium Chain - 100g/500ml, Soya bean oil - 80g/500ml, Omega-3 acid triglicerides - 20g/500ml Injectable emulsion 2,486,109 L.L
C09DA08 OLMENOR PLUS G Olmesartan medoxomil - 20mg, Hydrochlorothiazide - 12.5mg Tablet, film coated 628,918 L.L
G01AF20 MICOGYL G Metronidazole - 500mg, Miconazole nitrate - 100mg Suppository 362,198 L.L
R03AK06 SEROFLO-S 250 G Salmeterol (xinafoate) - 25mcg/inhalation, Fluticasone propionate - 250mcg/inhalation Inhalation suspension 1,725,494 L.L
A03CA02 LIBROCOL G Chlordiazepoxide - 5mg, Clidinium bromide - 2.5mg Tablet 338,648 L.L
B05BA10 OLIMEL N9E B Glucose solution - 27.5%, Amino acids solution - 14.2%, Lipid emulsion - 20%, Sodium - 70mmol/2l, Potassium - 60mmol/2l, Magnesium - 8mmol/2l, Calcium - 7mmol/2l, Phosphate - 30mmol/2l, Acetate - 107mmol/2l, Chloride - 90mmol/2l, Azote - 18g/2l Injectable emulsion 4,711,512 L.L
C09DA09 EDARBYCLOR B Azilsartan medoxomil - 40mg, Chlortalidone - 12.5mg Tablet, film coated 1,846,440 L.L
G01AX OVUMIX G Metronidazole - 300mg, Miconazole - 100mg, Neomycin (sulfate) - 48.8mg, Gotu Kola - 15mg, Polymixin sulfate - 4.4mg Suppository 395,090 L.L
R03AK07 SYMBICORT B Formoterol fumarate dihydrate - 4.5mcg/Inhalation, Budesonide - 160mcg/Inhalation Inhalation powder 3,378,420 L.L
A03CA02 PRIMAX G Clidinium bromide - 2.5mg, Chlordiazepoxide - 5mg Tablet 222,694 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
C09DA09 EDARBYCLOR B Azilsartan medoxomil - 40mg, Chlortalidone - 25mg Tablet, film coated 1,846,440 L.L
G01AX ENTEROGERMINA B Bacillus clausii spores - 2 Billions/5ml Suspension 1,131,515 L.L
R03AK07 SYMBICORT TURBUHALER B Formoterol fumarate dihydrate - 4.5mcg/inhalation, Budesonide - 160mcg/inhalation Inhalation powder 1,689,210 L.L
A03CA02 ULCEDEX G Clidinium bromide - 2.5mg, Chlordiazepoxide - 5mg Tablet 222,694 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
C07BB03 ATONIUM PLUS G Chlortalidone - 25mg, Atenolol - 50mg Tablet 738,473 L.L
C09DB01 EXFORGE B Amlodipine - 5mg, Valsartan - 160mg Tablet, film coated 1,333,092 L.L
G01AX ENTEROGERMINA B Bacillus clausii spores - 2 Billions/5ml Suspension 595,322 L.L
R03AK07 BUFOMIX EASYHALER G Formoterol fumarate dihydrate - 4.5mcg/inhalation, Budesonide - 160mcg/inhalation Metered dose inhaler 2,365,163 L.L
A03CB01 RESTROPINAL PEDIATRIC B Butobarbital - 2mg/ml, Methyl hyoscine nitrate - 0.1mg/ml Drops 197,097 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
C07BB03 TENORETIC B Chlortalidone - 25mg, Atenolol - 100mg Tablet, film coated 291,614 L.L
C09DB01 AMLODIPINE/VALSARTAN ARROW G Amlodipine (besylate) - 5mg, Valsartan - 160mg Tablet, coated 923,220 L.L
G01AX ENTEROGERMINA B Bacillus clausii spores - 2 Billions Capsule 831,839 L.L
R03AK07 BUFOMIX EASYHALER G Formoterol fumarate dihydrate - 4.5mcg/inhalation, Budesonide - 160mcg/inhalation Metered dose inhaler 1,182,581 L.L
A03DB04 PANADOL WOMAN B Paracetamol - 500mg, Hyoscine butylbromide - 10mg Tablet, coated 436,749 L.L
B05BB01 LACTATED RINGER'S G Sodium lactate - 0.31g/100ml, Calcium chloride, 2H2O - 0.02g/100ml, Potassium chloride - 0.03g/100ml, Sodium chloride - 0.598g/100ml Injectable solution 147,095 L.L
C07BB03 ATONIUM PLUS G Chlortalidone - 25mg, Atenolol - 100mg Tablet 738,473 L.L
C09DB01 ARBITEN AM 5/160 G Amlodipine - 5mg, Valsartan - 160mg Caplet, film coated 857,372 L.L
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