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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
M01AB55 DIFEN FLEX G Diclofenac sodium - 50mg, Pridinol mesylate - 4mg Tablet, film coated 575,165 L.L
M01AB55 DIFEN FLEX G Diclofenac sodium - 75mg, Pridinol mesylate - 2.2mg Injectable solution 1,131,515 L.L
M01AB55 DIFEN PLUS G Diclofenac potassium - 50mg, Betamethasone - 0.3mg Tablet, coated 503,941 L.L
M01AB55 DIFEN B12 G Diclofenac potassium - 50mg, Betamethasone - 0.3mg, Cyanocobalamin - 5mg Tablet 503,941 L.L
M01AB55 DIOXAFLEX B12 G Diclofenac sodium - 75mg, Betamethasone (sodium phosphate) - 2mg, Hydroxocobalamin sulphate - 10mg Injectable solution 1,104,639 L.L
M01AB55 DIOXAFLEX B12 G Diclofenac sodium - 75mg, Betamethasone (sodium phosphate) - 2mg, Hydroxocobalamin sulphate - 10mg Injectable solution 620,855 L.L
M01AB55 DIFEN B12 G Diclofenac sodium - 75mg, Prednisolone sodium phosphate - 10.08mg, Hydroxocobalamin acetate - 10.44mg Injectable solution 978,317 L.L
M01AE01 DIMIDON G Ibuprofen - 20mg/ml 20mg/ml Suspension 483,783 L.L
M01AE01 DOLORAZ 400 G Ibuprofen - 400mg 400mg Capsule 295,645 L.L
M01AE17 DEXKEVITAE G Dexketoprofen (trometamol) - 25mg 25mg Tablet, film coated 486,471 L.L
M01AE17 DEXON G Dexketoprofen - 25mg 25mg Tablet, film coated 239,204 L.L
M01AE17 DEXIREN G Dexketoprofen - 50mg/2ml 50mg/2ml Injectable solution 467,657 L.L
M01AX DORIXINA B Lysine clonixinate - 125mg 125mg Tablet 326,554 L.L
M01AX05 DONA G Glucosamine hemisulfate - 1500mg 1500mg Powder for solution 1,615,299 L.L
M01BX DORIXINA B1B6B12 B Lysine clonixinate - 125mg, Vitamin B1 - 50mg, Vitamin B6 - 30mg, Vitamin B12 - 50mcg Tablet, film coated 804,962 L.L
M02AA15 DICLOGESIC G Diclofenac sodium (diethylamine) - 10mg/g 1% Gel 135,728 L.L
M02AA15 DILO G Diclofenac sodium - 2% 2% Gel 267,489 L.L
M03AX01 DYSPORT BioTech Clostridium botulinum type A neurotoxin complex - 300units 300units Injectable powder for solution 14,625,182 L.L
M03AX01 DYSPORT BioTech Clostridium botulinum type A neurotoxin complex - 500units 500units Injectable powder for solution 42,726,155 L.L
M03BA53 DISTEM G Paracetamol - 300mg, Methocarbamol - 380mg Tablet 978,317 L.L
M03BX DORIXINA RELAX B Lysine clonixinate - 125mg, Cyclobenzaprine HCl - 5mg Tablet, film coated 581,884 L.L
M05BA07 DRONEL 35 G Risedronate sodium - 35mg 35mg Tablet, film coated 511,940 L.L
M05BA08 DROMEZON G Zoledronic acid - 4mg/5ml 4mg/5ml Injectable concentrate for solution 4,577,128 L.L
N01AX10 DORMIFOR G Propofol - 1% 1% Injectable emulsion 1,081,473 L.L
N01BB52 DILOCAIN 2% G Lidocaine HCl - 20mg/1.7ml, Epinephrine (bitartrate) - 0.0125mg/1.7ml Injectable solution 2,768,316 L.L
N02AA59 DOLOSPASMINE COMP B Codeine phosphate - 40 mg, Hexahydro-adipenine HCl - 50 mg, Propyphenazone - 500 mg Suppository 267,489 L.L
N02AB03 DUROGESIC B Fentanyl - 16.8mg 100mcg/h Patch 5,911,563 L.L
N02AB03 DUROGESIC B Fentanyl - 8.4mg 50mcg/h Patch 3,019,614 L.L
N02AB03 DUROGESIC B Fentanyl - 4.2mg 25mcg/h Patch 1,509,135 L.L
N02BE01 DOLIPRANE B Paracetamol - 500mg 500mg Tablet 120,946 L.L
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