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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
H02AB09 HYDROCORTISON VUAB G Hydrocortisone hydrogenosuccinate - 100mg 100mg Injectable dry powder for solution 147,823 L.L
J02AC02 ITRAZOL G Itraconazole - 100mg 100mg Capsule 149,167 L.L
L01BC06 DIROGIT G Capecitabine - 500mg 500mg Tablet, film coated 11,330,804 L.L
M02AA15 DICLOGESIC G Diclofenac sodium (diethylamine) - 10mg/g 1% Gel 135,728 L.L
N02BE01 KIDOL-OR G Paracetamol - 240mg/5ml 240mg/5ml Elixir 314,843 L.L
R03BA02 BUDESONIDE ARROW G Budesonide - 1mg/2ml 1mg/2ml Inhalation suspension for nebuliser 1,342,499 L.L
S01AE07 MOXITEC G Moxifloxacin (HCl) - 5mg/ml 5mg/ml Drops solution 464,970 L.L
A10BB12 ORBIDE G Glimepiride - 4mg 4mg Tablet 357,078 L.L
B01AB11 ANGIOFLUX G Sulodexide - 250LRU 250LRU Capsule, soft 2,026,514 L.L
B05BB02 5% DEXTROSE 0.9% SODIUM CHLORIDE INJECTION G Dextrose,H2O - 5g/100ml, Sodium chloride - 0.9g/100ml Injectable solution 153,990 L.L
B05ZA CONCENTRATE SOLUTION FOR HEMODIALYSIS R G Potassium chloride - K+:1.00 mmol/l, Magnesium chloride - Mg++:0.75 mmol/l, Calcium chloride - Ca++:1.40 mmol/l, Sodium acetate - Cl-:105.8 mmol/l, Sodium chloride - Na+:140.5 mmol/l Injectable solution L.L
C08CA01 TORANS G Amlodipine (besylate) - 5mg 5mg Tablet 518,339 L.L
C09DB07 CANDAM G Candesartan cilexetil - 16mg, Amlodipine - 5mg Capsule, hard 923,220 L.L
D04AA32 HISTAFEN G Diphenhydramine HCl - 2% 2% Solution 362,837 L.L
G03AD01 PURPLE LINE G Levonorgestrel - 1.5mg 1.5mg Tablet, film coated 1,071,570 L.L
H02AB09 HYDROCORTISONE ORBUCELL G Hydrocortisone (sodium succinate) - 100mg 100mg Injectable powder 1,091,712 L.L
J02AC02 ITRAZOL G Itraconazole - 100mg 100mg Capsule 559,038 L.L
L01BC06 CAPECITABINE SPC G Capecitabine - 150mg 150mg Tablet, film coated 4,094,240 L.L
M02AA15 GROFENAC G Diclofenac sodium - 1% Emulsion Gel 314,459 L.L
N02BE01 PAROL CHILDREN G Paracetamol - 240mg/5ml 240mg/5ml Elixir 314,843 L.L
N05AH02 CLOZAPINE PANPHARMA G Clozapine - 100mg 100mg Tablet, scored 808,993 L.L
R03BA02 BUDESONIDE ARROW G Budesonide - 1mg/2ml 1mg/2ml Inhalation suspension for nebuliser 1,342,499 L.L
S01AE07 VIGAMOX G Moxifloxacin (HCl) - 5mg/ml 5mg/ml Drops solution 670,577 L.L
A04AA01 APO-ONDANSETRON G Ondansetron - 8mg 8mg Tablet 1,491,665 L.L
A10BB12 JOSWE GLEMAX 6 G Glimepiride - 6mg 6mg Caplet 663,858 L.L
B01AB12 HIBOR G Bemiparin Sodium - 2,500IU 2,500IU Injectable solution 704,173 L.L
B05BB02 DEXTROSE 5% & SODIUM CHLORIDE 0.9% G Sodium chloride - 0.9g/100ml, Dextrose, H2O - 5g/100ml Injectable solution 189,262 L.L
B05ZA CONCENTRATE SOLUTIONFOR HEMODIALYSIS TYPE A G Hemodialytics, concentrates - Injectable solution L.L
C08CA01 AMLINE G Amlodipine - 10mg 10mg Tablet 662,962 L.L
C09DB07 CORONOPINE G Candesartan cilexetil - 16mg, Amlodipine - 5mg Capsule, hard 1,638,144 L.L
    ...
    163
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