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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
A07EC02 SALOFALK B Mesalazine - 1g 1g Suppository 3,948,209 L.L
A07EC02 SALOFALK B Mesalazine - 4g/60ml 4g/60ml Enema 3,796,355 L.L
A07EC02 SALOFALK B Mesalazine - 1.5g 1.5g Granules, gastro-resistant, prolonged release 6,150,767 L.L
A07EC02 SALOFALK B Mesalazine - 3g 3g Granules, gastro-resistant, prolonged release 11,256,652 L.L
A10AE54 SULIQUA BioTech Insulin glargine - 100IU/ml, Lixisenatide - 50mcg/ml Injectable solution 11,286,573 L.L
A10AE54 SULIQUA BioTech Insulin glargine - 100IU/ml, Lixisenatide - 33mcg/ml Injectable solution 7,975,793 L.L
A10BA02 SIOFOR G Metformin HCl - 850mg 850mg Tablet, film coated 174,700 L.L
A10BD07 SAGIMET G Metformin HCl - 1000mg, Sitagliptin (HCl monohydrate) - 50mg Tablet, film coated 1,551,690 L.L
A10BD07 SITAMET G Metformin - 1000mg, Sitagliptin - 50mg Tablet, film coated 2,444,896 L.L
A10BD07 SITAVITEA G Metformin - 1000mg, Sitagliptin - 50mg Tablet, film coated 1,079,106 L.L
A10BD07 SAGIMET G Metformin HCl - 500mg, Sitagliptin (HCl monohydrate) - 50mg Tablet, film coated 1,432,536 L.L
A10BD07 SAGIMET G Metformin HCl - 850mg, Sitagliptin (HCl monohydrate) - 50mg Tablet, film coated 1,463,892 L.L
A10BD07 SITAMET G Metformin - 850mg, Sitagliptin - 50mg Tablet, film coated 2,301,079 L.L
A10BD07 SITAVITEA G Metformin - 850mg, Sitagliptin - 50mg Tablet, film coated 1,079,106 L.L
A10BD20 SYNJARDY B Empagliflozin - 5mg, Metformin HCl - 1000mg 5mg/1000mg Tablet, film coated 3,156,820 L.L
A10BD20 SYNJARDY B Empagliflozin - 12.5mg, Metformin HCl - 1000mg 12.5mg/1000mg Tablet, film coated 3,156,820 L.L
A10BD20 SYNJARDY B Empagliflozin - 12.5mg, Metformin HCl - 1000mg 12.5mg/1000mg Tablet, film coated 3,156,820 L.L
A10BD20 SYNJARDY B Empagliflozin - 12.5mg, Metformin HCl - 850mg 12.5mg/850mg Tablet, film coated 3,052,874 L.L
A10BD20 SYNJARDY B Empagliflozin - 5mg, Metformin HCl - 850mg 5mg/850mg Tablet, film coated 3,052,874 L.L
A10BH01 SAGIFOR G Sitagliptin (HCl monohydrate) - 100mg 100mg Tablet, film coated 1,242,606 L.L
A10BH01 SITAGLIPTINE ARROW G Sitagliptin - 100mg 100mg Tablet, coated 1,154,361 L.L
A10BH01 SITAGLIPTINE ARROW G Sitagliptin - 50mg 50mg Tablet, coated 1,139,578 L.L
A10BJ02 SAXENDA BioTech Liraglutide - 6mg/ml 6mg/ml Injectable solution 16,747,035 L.L
A11CC05 SUN-D3 G Vitamin D3 - 10,000IU 10,000IU Capsule 935,570 L.L
B01AA07 SINTROM B Acenocoumarol - 4mg 4mg Tablet 490,183 L.L
B05 SOLUFLEX POTASSIUM CHLORIDE 40meq/l SODIUM CHLORIDE 0.9% INJECTION USP G Sodium chloride - 0.9%, Potassium chloride - 40meq/l Injectable solution 293,041 L.L
B05 SOLUFLEX POTASSIUM CHLORIDE 20meq/l SODIUM CHLORIDE 0.9% INJECTION USP G Sodium chloride - 0.9%, Potassium chloride - 20meq/l Injectable solution 232,134 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
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
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
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