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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
P01AB01 PHOSVIT G Metronidazole benzoate - 125mg/5ml 125mg/5ml Suspension 207,336 L.L
R05DA20 ALGOMIEL COUGH SYRUP G Dextromethorphan HBr - 5mg, Carbinoxamine maleate - 2mg Syrup 639,925 L.L
A03BB01 SCOBUREN G Butylscopolamine bromide - 20mg/ml 20mg/ml Injectable solution 370,901 L.L
A10BA02 METFORKEY G Metformin HCl - 850mg 850mg Tablet, extended release 357,462 L.L
A16AX BICANORM G Sodium bicarbonate - 1000mg 1000mg Tablet, gastroresistant 2,623,181 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 - 10% 10% Injectable solution 5,779,226 L.L
C09DB01 LOTEVAN G Amlodipine - 10mg, Valsartan - 160mg Tablet, film coated 857,372 L.L
D01BA02 TERAFAN G Terbinafine HCl - 250mg 250mg Tablet, scored 725,675 L.L
J01DE01 CEFIPEX 1000 BENTA G Cefepime - 1,000mg 1,000mg Injectable dry powder+diluent 703,918 L.L
L01CD02 DOCETAXEL ACCORD G Docetaxel - 20mg/ml 20mg/1ml Injectable concentrate for solution 4,110,814 L.L
L01XG01 VELZOME G Bortezomib - 3.5mg 3.5mg Injectable powder for solution 17,462,517 L.L
M01AB01 INDOMEL G Indometacin - 25mg 25mg Capsule 170,220 L.L
M05BA07 PMS-RISEDRONATE G Risedronate sodium - 150mg 150mg Tablet 806,306 L.L
P01AB01 PHOZOLE G Metronidazole benzoate - 125mg/5ml 125mg/5ml Suspension 207,336 L.L
A03BB01 SCOPINAL G Butylscopolamine bromide - 20mg/ml 20mg/ml Injectable solution 178,731 L.L
A10BB01 GLIBENCLAMIDE G Glibenclamide - 5mg 5mg Tablet, scored 340,440 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
B05XA03 SODIUM CHLORIDE G Sodium chloride - 20% 20% Injectable solution 5,675,800 L.L
C09DB01 POVAM G Amlodipine (besylate) - 10mg, Valsartan - 160mg Tablet, film coated 857,372 L.L
D02 TRIO-CID G Salicylic acid - 24% 24% Film forming solution 870,298 L.L
H02B PREDALONE PLUS G Prednisolone sodium phosphate - 10mg/5ml, Dexchlorpheniramine maleate - 2mg/5ml Syrup 890,776 L.L
J01DE01 CEFIPEX 1000 BENTA G Cefepime (hydrochloride) - 1,000mg 1,000mg Injectable solution 703,918 L.L
L01CD02 DOCETAXEL EBEWE G Docetaxel - 20mg/2ml 20mg/2ml Injectable solution 5,313,553 L.L
P01AB01 METROGYL G Metronidazole benzoate - 200mg/5ml 200mg/5ml Powder for suspension 481,788 L.L
R05DB13 RAPICOD G Butamirate citrate - 0.15% 0.15% Syrup 296,989 L.L
A03BB01 ? HYOSCINE BUTYLBROMIDE G Hyoscine butylbromide - 20mg/ml 20mg/ml Injectable solution 70,392 L.L
A10BB01 GLIBENCLAMIDE G Glibenclamide - 5mg 5mg Tablet 326,362 L.L
B01AB01 HEPARINE MEDIS G Heparin sodium - 25,000UI/5ml 25,000UI/5ml Injectable solution 6,853,597 L.L
B05BB01 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 158,587 L.L
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