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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
B05XA31 NUTRYELT G Zinc (gluconate) - 10000mcg/10ml, Copper (gluconate) - 300mcg/10ml, Manganese (gluconate) - 55mcg/10ml, Sodium fluoride - 950mcg/10ml, Iodine potassium iodide - 130mcg/10ml, Selenium (sodium salt) - 70mcg/10ml, Molybdenum (Sodium molybdate) - 20mcg/10ml, Chrome (chlorure) - 10mcg/10ml, Ferrous (gluconate) - 1000mcg/10ml Injectable concentrate for solution 3,483,240 L.L
C09DB02 VOCADO B Olmesartan medoxomil - 40mg, Amlodipine besylate - 5mg Tablet, film coated 1,103,295 L.L
B05BB01 LR G Sodium lactate - 0.3g/100ml, Calcium chloride, 2H2O - 0.02g/100ml, Potassium chloride - 0.03g/100ml, Sodium chloride - 0.598g/100ml Injectable solution 234,862 L.L
B05XA31 ADDAVEN G Chromic chloride 6H2O - 53mcg/10ml, Copper chloride dihydrate - 1.02mg/10ml, Ferric Chloride hexahydrate - 5.40mg/10ml, Manganese chloride 4H2O - 198mcg/10ml, Potassium iodide - 166mcg/10ml, Sodium fluoride - 2.10mg/10ml Injectable concentrate for solution 4,065,124 L.L
C09DB02 OLMENOR COMBI G Olmesartan medoxomil - 40mg, Amlodipine - 5mg Tablet, film coated 772,709 L.L
D02AF METHYL SALICYLATE COMPOUND UNGUENTUM G Methylsalicylate - 4.5g/30g, Menthol - 1.8g/30g Ointment 165,101 L.L
B05BB01 SERUFLEX 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 232,134 L.L
C09DB02 SEVIKAR B Olmesartan medoxomil - 40mg, Amlodipine - 10mg Tablet, film coated 1,245,742 L.L
S01XA20 LUBRI-TEARS G Carmellose sodium - 2mg Drops solution 792,867 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 264,311 L.L
B05ZA CONCENTRATE SOLUTION FOR HEMODIALYSIS TYPE C G Potassium chloride - 2.611g/l, Magnesium chloride, 6H2O - 5.33g/l, Calcium chloride, 2H2O - 8.99g/l, Sodium acetate, 3H2O - 190.505g/l, Sodium chloride - 204.54g/l Injectable solution L.L
C09DB02 VOCADO B Olmesartan medoxomil - 40mg, Amlodipine besylate - 10mg Tablet, film coated 1,186,613 L.L
D02AF VERRUFILM G Lactic acid - 16.7%, Salicylic acid - 16.7% Solution 861,403 L.L
J01DD52 ZAVICEFTA B Ceftazidime - 2g, Avibactam - 0.5g Injectable powder for concentrate for solution 101,659,975 L.L
B05BB01 RINGER'S INJECTION USP G Calcium chloride, 2H2O - 0.033%, Potassium chloride - 0.03%, Sodium chloride - 0.86% Injectable solution 129,934 L.L
B05ZA CONCENTRATE SOLUTION FOR HEMODIALYSIS TYPE D G Potassium chloride - 5.215g/l, Magnesium chloride, 6H2O - 5.32g/l, Calcium chloride, 2H2O - 8.99g/l, Sodium acetate, 3H2O - 166.7g/l, Sodium chloride - 214.76g/l Injectable solution L.L
C09DB04 TWYNSTA B Telmisartan - 80mg, Amlodipine - 10mg Tablet 991,756 L.L
D02AF REPARIL GEL-N B Diethylamine salicylate - 5g/100g, Ascine - 1g/100g Gel 481,096 L.L
B05BB01 RINGER'S INJECTION USP G Calcium chloride, 2H2O - 0.033%, Potassium chloride - 0.03%, Sodium chloride - 0.86% Injectable solution 205,933 L.L
B05ZA CONCENTRATE SOLUTION FOR HEMODIALYSIS TYPE E G Potassium chloride - 2.611g/l, Magnesium chloride, 6H2O - 5.32g/l, Calcium chloride, 2H2O - 7.00g/l, Sodium acetate, 3H2O - 190.505g/l, Sodium chloride - 205.49g/l Injectable solution L.L
C09DB04 TWINCARD 80/10 G Telmisartan - 80mg, Amlodipine - 10mg Tablet 1,460,309 L.L
B05BB01 RINGER'S INJECTION USP G Calcium chloride, 2H2O - 0.033%, Potassium chloride - 0.03%, Sodium chloride - 0.86% Injectable solution 224,565 L.L
B05ZA CONCENTRATE SOLUTION FOR HEMODIALYSIS TYPE F G Potassium chloride - 3.914g/l, Magnesium chloride, 6H2O - 3.558g/l, Calcium chloride, 2H2O - 7.719g/l, Acetic acid 100% - 6.010ml/l, Sodium chloride - 208.631g/l Injectable solution L.L
C09DB04 TWYNSTA B Telmisartan - 80mg, Amlodipine - 5mg Tablet 1,241,710 L.L
D02AX GLYCERINE G Glycerol - Liquid 163,821 L.L
H02B PREDALONE PLUS G Prednisolone sodium phosphate - 10mg/5ml, Dexchlorpheniramine maleate - 2mg/5ml Syrup 890,776 L.L
S02AA30 TYOTOCIN B Hexylresorcinol - 0.1%, Antipyrine - 5%, Benzocaine - 1.25%, Tyrothricin - 0.05% Drops solution 409,552 L.L
B05BB01 RINGER'S INJECTION, USP G Calcium chloride, 2H2O - 0.33g/l, Potassium chloride - 0.3g/l, Sodium chloride - 8.6g/l Injectable solution 204,554 L.L
B05ZA CONCENTRATE SOLUTION FOR HEMODIALYSIS TYPE SG G Potassium chloride - 3.92g/l, Magnesium chloride, 6H2O - 5.32g/l, Calcium chloride, 2H2O - 8.99g/l, Sodium acetate, 3H2O - 166.7g/l, Sodium chloride - 214.76g/l Injectable solution L.L
C09DB04 TWINCARD 80/5 G Telmisartan - 80mg, Amlodipine - 5mg Tablet 1,372,511 L.L
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    172
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