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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
B03AC FERINJECT B Iron trivalent (ferric carboxymaltose) - 500mg/10ml 500mg/10ml Injectable solution 10,212,033 L.L
B05DB DIANEAL PD4 CYCLER 3.86% GLUCOSE B Sodium lactate - 4.48g/l, Magnesium chloride - 0.051g/l, Calcium chloride - 0.184g/l, Sodium chloride - 5.38g/l, Anhydrous glucose - 38.6g/l Injectable solution 1,150,329 L.L
C05CX TANAKAN B Ginkgo biloba - 40mg 40mg Tablet, film coated 600,698 L.L
C09CA08 OLMETEC B Olmesartan medoxomil - 20mg 20mg Tablet, film coated 888,280 L.L
L01AX03 TEMODAL B Temozolomide - 100mg 100mg Capsule 7,731,224 L.L
L04AA44 RINVOQ B Upadacitinib - 15mg 15mg Tablet, prolonged release 45,469,094 L.L
N05AD01 HALDOL B Haloperidol - 5mg 5mg Tablet 231,141 L.L
S01AE03 CILOXAN B Ciprofloxacine (HCl) - 3mg/ml 3mg/ml Drops solution 348,055 L.L
B05XA PEDITRACE B Sodium selenite 5H2O (anhydrous) - 6.66mcg/ml, Sodium fluoride - 126mcg/ml, Potassium iodide - 1.31mcg/ml, Zinc chloride - 521mcg/ml, Copper chloride - 53.7mcg/ml, Manganese chloride 4H2O - 3.6mcg/ml Injectable concentrated solution 4,749,139 L.L
C05CX TANAKAN B Ginkgo biloba - 40mg 40mg Tablet, film coated 1,662,333 L.L
C09CA08 VOTUM B Olmesartan medoxomil - 20mg 20mg Tablet, film coated 954,128 L.L
J01MA17 KINODROX B Prulifloxacin - 600mg 600mg Tablet, film coated 1,407,835 L.L
B03AD MALTOFER FOL B Folic acid - 0.35mg, Iron trivalent (hydroxide polymaltose) - 100mg Tablet, chewable 854,684 L.L
C09CA08 VOTUM B Olmesartan medoxomil - 20mg 20mg Tablet, film coated 954,128 L.L
J01MA23 BAXDELA B Delafloxacin - 450mg 450mg Tablet 93,777,847 L.L
N05AD01 HALDOL DECANOAS B Haloperidol (Decanoate) - 50mg/ml 50mg/ml Injectable solution 444,812 L.L
R03AL03 ANORO ELLIPTA B Vilanterol - 25mcg, Umeclidinium bromide - 62.5mcg Inhalation powder 5,367,774 L.L
L01XX41 HALAVEN B Eribulin mesylate - 0.88mg/2ml 0.88mg/2ml Injectable solution L.L
J01MA23 BAXDELA B Delafloxacin - 300mg 300mg Injectable concentrate for solution 78,349,010 L.L
R03AL04 ULTIBRO BREEZHALER B Indacaterol - 110mcg, Glycopyronium - 50mcg Capsule, inhalation 4,031,528 L.L
L01ED03 ALECENSA B Alectinib - 150mg 150mg Capsule, hard L.L
C05CX REPARIL B Aescine - 20mg 20mg Tablet, sugar coated 510,660 L.L
C09CA08 OLMETEC B Olmesartan medoxomil - 40mg 40mg Tablet, film coated 920,532 L.L
C10AA07 CRESTOR B Rosuvastatin (calcium) - 5mg 5mg Tablet 589,947 L.L
G04CA04 SILOSIN B Silodosine - 4mg 4mg Capsule 1,251,693 L.L
L01AX03 TEMODAL B Temozolomide - 20mg 20mg Capsule 1,612,611 L.L
R03AL06 SPIOLTO RESPIMAT B Olodaterol HCl - 2.5mcg/puff, Tiotropium bromide monohydrate - 2.5mcg/puff Inhalation solution 5,087,788 L.L
B03AD03 GYNO-TARDYFERON B Folic acid - 0.35mg, Ferrous (sulfate) - 80mg Tablet, sugar coated, slow release 682,672 L.L
C09CA08 VOTUM B Olmesartan medoxomil - 40mg 40mg Tablet, film coated 1,032,071 L.L
N02BE01 TYLENOL B Paracetamol - 350mg 350mg Suppository 239,204 L.L
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