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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
H02AB02 DECADRON B Dexamethasone - 0.5mg/5ml 0.5mg/5ml Elixir 449,227 L.L
J02AC01 DIFLUCAN B Fluconazole - 150mg 150mg Capsule 286,238 L.L
L04AD02 PROGRAF 1MG B Tacrolimus - 1mg 1mg Capsule 25,241,922 L.L
M03BA03 LUMIRELAX B Methocarbamol - 500mg 500mg Tablet 667,890 L.L
A03AX12 SPASFON B Phloroglucinol hydrate - 80mg, Trimethylphloroglucinol - 80mg Tablet, coated 278,175 L.L
A10BA02 GLUCOPHAGE B Metformin HCl - 1,000mg 1,000mg Tablet, film coated 601,157 L.L
A12AX DECALCIT B Vitamin D3 - 500IU, Calcium - 600mg Tablet 912,469 L.L
B05 20 MEQ POTASSIUM OF 5% DEXTROSE AND 0.45% SODIUM CHLORIDE INJECTION USP B Dextrose, H2O - 5%, Sodium chloride - 0.45%, Potassium chloride - 20meq Injectable solution 229,959 L.L
C10BA06 LIPOCOMB B Rosuvastatin (calcium) - 20mg, Ezetimibe - 10mg Capsule, hard 2,701,123 L.L
J01DD08 SUPRAX 100 B Cefixime (trihydrate) - 100mg/5ml 100mg/5ml Powder for suspension 1,166,455 L.L
L01BC06 XELODA B Capecitabine - 500mg 500mg Tablet, film coated 17,946,398 L.L
L04AD02 PROGRAF 1MG B Tacrolimus - 1mg 1mg Capsule 25,241,922 L.L
N02BE51 PANADOL MIGRAINE B Paracetamol - 250mg, Acetylsalicylic acid - 250mg, Caffeine - 65mg Caplet 604,729 L.L
A12AX DECALCIT B Vitamin D3 - 500IU, Calcium - 600mg Tablet 348,055 L.L
B05 20 MEQ POTASSIUM OF 0.9% SODIUM CHLORIDE INJECTION USP B Sodium chloride - 0.9%, Potassium chloride - 20meq Injectable solution 278,102 L.L
C10BA06 ZYMPASS B Rosuvastatin (calcium) - 20mg, Ezetimibe - 10mg Tablet, film coated 2,482,077 L.L
J01DD08 SUPRAX 100 B Cefixime (trihydrate) - 100mg/5ml 100mg/5ml Powder for suspension 1,166,455 L.L
A03AX13 OVOL B Simethicone - 40mg/ml 40mg/ml Drops 233,829 L.L
B05 20 MEQ POTASSIUM OF 0.9% SODIUM CHLORIDE INJECTION USP B Sodium chloride - 0.9%, Potassium chloride - 20mEq Injectable solution 229,959 L.L
C10BA06 ZYMPASS B Rosuvastatin (calcium) - 40mg, Ezetimibe - 10mg Tablet, film coated 2,482,077 L.L
L04AD02 PROGRAF 5MG B Tacrolimus - 5mg 5mg Capsule 94,286,686 L.L
S01EE01 XALATAN B Latanoprost - 50mcg/ml 50mcg/ml Drops solution 704,173 L.L
A12AX DECALCIT B Vitamin D3 - 750IU, Calcium - 600mg Powder 1,075,074 L.L
C09DA06 ATACAND PLUS B Candesartan cilexetil - 16mg, Hydrochlorothiazide - 12.5mg Tablet 705,517 L.L
G01AF12 LOMEXIN B Fenticonazole nitrate - 200mg 200mg Ovule 779,490 L.L
L04AD02 PROGRAF 5MG B Tacrolimus - 5mg 5mg Capsule 94,286,686 L.L
N06DA03 EXELON TRANSDERMAL PATCH 10 B Rivastigmine - 9.5mg/24h 9.5mg/24h Patch 2,457,888 L.L
A03AX13 MOSAR PLUS B Mosapride citrate - 5mg, Simethicone - 200mg Tablet, coated 865,435 L.L
A12AX CALPEROS D3 A SUCER B Vitamin D3 - 400IU, Calcium - 500mg Tablet, chewable 667,890 L.L
C09DA06 BLOPRESS PLUS 16MG B Candesartan cilexetil - 16mg, Hydrochlorothiazide - 12.5mg Tablet 1,257,837 L.L
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