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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
B05BB02 DEXTROSE 5% SODIUM CHLORIDE 0.45% INJECTION, USP G Sodium chloride - 0.45%, Glucose - 5% Injectable solution 193,062 L.L
C01CA03 NORADRENALINE HIKMA G Noradrenaline bitartrate - 4mg/4ml 4mg/4ml Injectable solution 1,279,338 L.L
C08DB01 ZALDEM G Diltiazem HCl - 60mg 60mg Tablet, scored 199,657 L.L
C09DX03 OLMENOR TRIPLE G Olmesartan medoxomil - 40mg, Amlodipine (besylate) - 10mg, Hydrochlorothiazide - 12.5mg Tablet, film coated 1,067,011 L.L
J01AA07 TETRACYCLINE G Tetracycline HCl - 250mg 250mg Capsule 1,247,086 L.L
J01DH51 IMILASTIN G Imipenem - 500mg, Cilastatin - 500mg Injectable powder for solution 5,869,189 L.L
J05AF10 ENTECAVIR BIOGARAN G Entecavir - 0.5mg 0.5mg Tablet, coated 19,080,319 L.L
M01AB05 DICLO-DENK 100 RETARD G Diclofenac sodium - 100mg 100mg Tablet, sustained release 1,756,402 L.L
M09AX NUCLEO C.M.P. FORTE G UTP+UDP+UMP - 3mg, CMP - 5mg Capsule 448,843 L.L
N03AX11 TOPIRATE 200 BENTA G Topiramate - 200mg 200mg Tablet, film coated 7,039,175 L.L
R05X MUCOTAL PROMETHAZINE G Promethazine HCl - 2.5mg/5ml, Carbocysteine - 100mg/5ml Syrup 243,172 L.L
V03AC03 DIFIRAX G Deferasirox - 500mg 500mg Tablet, dispersible 38,637,010 L.L
A04AA01 ONDANSETRON VIANEX G Ondansetron (HCl) - 8mg/4ml 8mg/4ml Injectable solution 387,027 L.L
B01AC04 PIDOGREL MEDIS G Clopidogrel - 75mg 75mg Tablet, film coated 810,337 L.L
B05BB02 DEXTROSE 5% SODIUM CHLORIDE 0.45% INJECTION, USP G Sodium chloride - 0.45%, Glucose - 5% Injectable solution 180,421 L.L
C01CA04 DOPAMINE FRESENIUS G Dopamine HCl - 200mg/5ml 200mg/5ml Injectable concentrated solution 713,580 L.L
C08DB01 ZALDEM CR G Diltiazem HCl - 180mg 180mg Capsule, controlled release 966,287 L.L
J01AA07 TETRAN G Tetracycline HCl - 250mg 250mg Capsule 168,940 L.L
J01DH51 IMIPENEM-CILASTATIN LABATEC G Imipenem (monohydrate) - 500mg, Cilastatin (sodium) - 500mg Injectable powder for solution 8,922,845 L.L
J05AF10 ENTRILIV G Entecavir - 0.5mg 0.5mg Tablet, film coated 19,165,898 L.L
L01DB07 MITOXANTRON EBEWE G Mitoxantrone - 20mg/10ml 20mg/10ml Injectable concentrated solution 11,064,120 L.L
M01AB05 DICLOGESIC RETARD G Diclofenac sodium - 100mg 100mg Tablet, film coated 233,829 L.L
N03AX12 APO-GABAPENTIN G Gabapentin - 300mg 300mg Capsule 2,527,768 L.L
P01AB01 METROLAG G Metronidazole - 500mg 500mg Tablet 389,714 L.L
R05X COFEX G Paracetamol - 33.3mg/5ml, Guaifenesin - 33.3mg/5ml, Oxomemazine HCl - 1.65mg/5ml Syrup 154,542 L.L
V03AC03 ENFEROX G Deferasirox - 500mg 500mg Tablet, dispersible 37,720,158 L.L
A04AA01 TRONDAMET G Ondansetron (HCl) - 8mg/4ml 8mg/4ml Injectable solution 2,027,858 L.L
A10BD07 SAGIMET G Metformin HCl - 500mg, Sitagliptin (HCl monohydrate) - 50mg Tablet, film coated 1,432,536 L.L
B01AC04 PLAVINOR-75 G Clopidogrel - 75mg Tablet, film coated Tablet, film coated 1,112,702 L.L
B05BB02 DEXTROSE 5% SODIUM CHLORIDE 0.45% INJECTION, USP G Sodium chloride - 0.45%, Glucose - 5% Injectable solution 148,566 L.L
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