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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
A11EX BECOZYM FORTE B Nicotinamide - 50mg, Calcium Pantothenate - 25mg, Biotin - 0.15mg, Vitamin B12 - 10mcg, Vitamin B6 - 10mg, Vitamin B2 - 15mg, Vitamin B1 - 15mg Capsule 290,270 L.L
H01CB03 SOMATULINE AUTOGEL B Lanreotide (acetate) - 120mg 120mg Injectable solution 57,492,826 L.L
M03AC11 NIMBEX B Cisatracurium (besylate) - 20mg/10ml 20mg/10ml Injectable solution 2,010,388 L.L
N02BE51 PANADOL COLD & FLU VAPOUR RELEASE + DECONGESTANT B Paracetamol - 600mg, Phenylephrine HCl - 10mg Powder for solution 524,099 L.L
N06DA02 ARICEPT B Donepezil HCl - 10mg 10mg Tablet, film coated 3,776,197 L.L
A02BX13 GAVISCON DOUBLE ACTION B Sodium alginate - 500mg, Sodium bicarbonate - 213mg, Calcium (carbonate) - 325mg Suspension 517,379 L.L
A11GA01 REDOXON EFF.ORANGE B Ascorbic acid (vit C) - 1g 1g Tablet, effervescent 366,869 L.L
G01AC05 FLUOMIZIN B Dequalinium chloride - 10mg 10mg Tablet 775,397 L.L
H01CB05 SIGNIFOR B Pasireotide (diaspartate) - 0.3mg/ml 0.3mg/ml Injectable solution 168,719,438 L.L
R03DC03 SINGULAIR (PEDIATRIC) B Montelukast (sodium) - 5mg 5mg Tablet, chewable 1,217,521 L.L
A03A SPASMOBROM B Pipethanate Ethobromide - 20mg 20mg Tablet, coated 705,517 L.L
C07AB07 CONCOR B Bisoprolol fumarate - 10mg 10mg Tablet, film coated 1,131,843 L.L
C09DA04 CO APROVEL B Irbesartan - 300mg, Hydrochlorothiazide - 12.5mg Tablet, film coated 658,483 L.L
H01CB05 SIGNIFOR B Pasireotide (diaspartate) - 0.6mg/ml 0.6mg/ml Injectable solution 180,355,261 L.L
A03AA04 DUSPATALIN RETARD B Mebeverine HCl - 200mg 200mg Capsule 861,466 L.L
A11GB CAL-C-VITA EFFERVESCENT B Vitamin B6 - 15mg, Vitamin D - 300IU, Calcium carbonate - 625mg, Ascorbic acid - 1000mg Tablet, effervescent 494,534 L.L
C09DA04 CO APROVEL B Irbesartan - 300mg, Hydrochlorothiazide - 12.5mg Tablet, film coated 658,483 L.L
C10BA05 ATOZET B Atorvastatin - 20mg, Ezetimibe - 10mg Tablet, film coated 2,046,672 L.L
G01AF01 FLAGYL B Metronidazole - 500mg 500mg Ovule 249,955 L.L
H01CB05 SIGNIFOR B Pasireotide (diaspartate) - 0.9mg/ml 0.9mg/ml Injectable solution 183,846,008 L.L
N02BE51 PANADOL EXTRA WITH OPTIZORB B Paracetamol - 500mg, Caffeine - 65mg Tablet, film coated 524,099 L.L
A11JC CYSTINE B6 BAILLEUL B Pyridoxine HCl - 50mg, L-Cystine - 500mg Tablet, coated 862,747 L.L
C10BA05 ATOZET B Atorvastatin - 20mg, Ezetimibe - 10mg Tablet, film coated 2,046,672 L.L
H01CC01 ORGALUTRAN B Ganirelix - 0.25mg/0.5ml 0.25mg/0.5ml Injectable solution 2,383,977 L.L
J02AC01 DIFLUCAN B Fluconazole - 50mg 50mg Capsule 622,199 L.L
N02BE51 PANADOL EXTRA WITH OPTIZORB B Paracetamol - 500mg, Caffeine - 65mg Tablet, film coated 252,642 L.L
G01AF02 CANESTEN B Clotrimazole - 0.1g 0.1g Tablet 408,528 L.L
H01CC01 ORGALUTRAN B Ganirelix - 0.25mg/0.5ml 0.25mg/0.5ml Injectable solution 2,383,977 L.L
S01ED51 XALACOM B Timolol (maleate) - 6.8mg/ml, Latanoprost - 50?g/ml Drops solution 510,660 L.L
A03AB02 GLYCOPYRROLATE B Glycopyronium Bromide - 0.2mg/ml 0.2mg/ml Injectable solution 7,238,185 L.L
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