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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
J05AF10 ENTECAVIR ARROW G Entecavir - 1mg 1mg Tablet, coated L.L
A03AX HEPABYL G Sorbitol - 2.5g/5ml, Diisopromine - 0.02g/5ml Liquid 238,052 L.L
A10BA02 GLYSTOR G Metformin HCl - 850mg 850mg Tablet, film coated 454,347 L.L
B05XA03 SODIUM CHLORIDE G Sodium chloride - 0.9% 0.9% Injectable solution 174,553 L.L
C07AB07 BISCORDEX G Bisoprolol fumarate - 10mg 10mg Tablet 789,667 L.L
D11AX18 ALMIRAL G Diclofenac sodium - 1% w/w 1% w/w Gel 396,434 L.L
H01BA02 NICTUR G Desmopressin acetate - 360mcg/ml 360mcg/ml Solution 5,270,550 L.L
J01DD04 LEBACEF G Ceftriaxone (sodium) - 1g 1g Injectable powder for solution+diluent 643,765 L.L
J01XA01 VANCO MEDIS G Vancomycin - 1g 1g Injectable lyophilisate for solution 1,276,650 L.L
L01AX03 TEMOZOLOMIDE PHARMINICIO G Temozolomide - 20mg 20mg Capsule, hard 920,532 L.L
L04AA29 TRIJAN G Tofacitinib - 10mg 10mg Tablet, film coated 84,793,962 L.L
N03AX18 LACOSAMIDE/GENEPHARM G Lacosamide - 200mg 200mg Tablet 8,284,105 L.L
N06AB10 CITOLES G Escitalopram (oxalate) - 10mg 10mg Tablet, film coated 511,940 L.L
R06AX13 CLARA G Loratadine (micronised) - 5mg/5ml 5mg/5ml Syrup 215,015 L.L
J05AF10 ENTECAVIR ARROW G Entecavir - 0.5mg 0.5mg Tablet, coated L.L
A10BA02 METFORMINE ARROW LAB G Metformin - 850mg 850mg Tablet, film coated 237,860 L.L
A12AA04 CALPEROS G Calcium (carbonate) - 500mg 500mg Tablet 630,262 L.L
B05XA03 SODIUM CHLORIDE G Sodium chloride - 0.9% 0.9% Injectable solution 188,772 L.L
C07AB07 BISOCOR 10 G Bisoprolol fumarate - 10mg 10mg Tablet, film coated 460,746 L.L
C10BA05 OTOREZA 10MG/40MG G Atorvastatin - 40mg, Ezetimibe - 10mg Tablet, film coated 1,144,954 L.L
D11AX18 LABDIC RELIEF G Diclofenac sodium - 1%w/w, Methyl salicylate - 8%w/w, Menthol - 2%w/w Gel 263,393 L.L
J01DD04 LEBACEF G Ceftriaxone (sodium) - 1g, Lidocaine (ampoule) - 1g Injectable powder for solution+diluent 568,253 L.L
J01XA01 ZERMACIN G Vancomycin (HCl) - 1g 1g Injectable lyophilised powder for solution 1,066,115 L.L
L01AX03 TEMOZOLOMIDE ACCORD G Temozolomide - 20mg 20mg Capsule, hard 1,153,017 L.L
N03AX18 TREPADIO G Lacosamide - 200mg 200mg Tablet, film coated 8,876,013 L.L
N06AB10 CITOXAL G Escitalopram (oxalate) - 10mg 10mg Tablet, film coated 1,410,395 L.L
R06AX13 LORINE G Loratadine (micronised) - 5mg/5ml 5mg/5ml Syrup 215,015 L.L
L01EB01 GEFITINIB ARROW G Gefitinib - 250mg 250mg Tablet, coated L.L
A10BA02 METFORMINE ARROW LAB G Metformin - 850mg 850mg Tablet, film coated 689,391 L.L
B05XA03 SODIUM CHLORIDE G Sodium chloride - 0.9% 0.9% Injectable solution 209,151 L.L
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