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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
A04AA05 PALONAN G Palonosetron HCl - 250mcg/5ml 250mcg/5ml Injectable solution 2,194,495 L.L
A10BD11 INAGLIMET G Metformin - 850mg, Linagliptin - 2.5mg Tablet, film coated 1,670,844 L.L
B05BB02 DEXTROSE 5% & SODIUM CHLORIDE 0.3% G Sodium chloride - 0.3g/100ml, Dextrose, H2O - 5g/100ml Injectable solution 220,643 L.L
C01EB15 CARMETADIN G Trimetazidine - 35mg 35mg Tablet, film coated, modified release 631,606 L.L
C09AA05 ACURIL G Ramipril - 10mg 10mg Tablet 810,337 L.L
C10AA05 ATOR MEDIS G Atorvastatin - 10mg 10mg Tablet, film coated 305,052 L.L
G04BD08 ASOLFENA G Solifenacin succinate - 10mg 10mg Tablet, film coated 971,598 L.L
J01CR02 JULMENTIN 2X G Amoxicillin (trihydrate) - 400mg/5ml, Clavulanic Acid (potassium) - 57mg/5ml 457mg/5ml Powder for suspension 278,175 L.L
J01FF01 DANALLI G Clindamycin HCl - 300mg 300mg Capsule 267,425 L.L
L01EB02 TARESSA 150 G Erlotinib (HCl) - 150mg 150mg Tablet, film coated 98,617,813 L.L
L02BX03 ABREMIA G Abiraterone acetate - 250mg 250mg Tablet 77,478,802 L.L
M01AE01 PEDIAFEN G Ibuprofen - 100mg/5ml 100mg/5ml Suspension 200,936 L.L
N03AX16 GABRIKA 100 G Pregabalin - 100mg 100mg Capsule 798,626 L.L
R06AX13 APOTHECARE LORATADINE G Loratadine - 10mg 10mg Tablet 495,878 L.L
L01BA04 PEMETREXED NEAPOLIS G Pemetrexed (disodium) - 500mg Injectable powder L.L
A04AA05 VONAXI G Palonosetron HCl - 250mcg/5ml 250mcg/5ml Injectable solution 1,490,321 L.L
B05BC01 MANNITOL G Mannitol - 20g/100ml 20g/100ml Injectable solution 406,810 L.L
C09AA05 APO-RAMIPRIL G Ramipril - 10mg 10mg Capsule 1,178,550 L.L
C10AA05 ATORLIP 10 G Atorvastatin (calcium) - 10mg 10mg Tablet, film coated 1,052,037 L.L
G04BD08 SOLIFAS G Solifenacin succinate - 10mg 10mg Tablet, film coated 971,598 L.L
J01CR02 KLAVOX G Amoxicillin (trihydrate) - 400mg/5ml, Clavulanic Acid (potassium) - 57mg/5ml 457mg/5ml Powder for suspension 278,175 L.L
J01FF01 CLINDAMYCIN VIANEX BA FREE G Clindamycin (phosphate) - 600mg/4ml 600mg/4ml Injectable solution 201,576 L.L
M01AE01 PROFINAL G Ibuprofen - 100mg/5ml 100mg/5ml Suspension 208,296 L.L
N03AX16 PREGAFORTE 100 G Pregabalin - 100mg 100mg Capsule 998,283 L.L
R06AX13 CLARA G Loratadine (micronised) - 10mg 10mg Tablet 131,697 L.L
B05BC01 MANNITOL G Mannitol - 20g/100ml 20g/100ml Injectable solution 579,064 L.L
C01EB17 BRAVIGO G Ivabradine (HCl) - 5mg 5mg Tablet, film coated 1,237,679 L.L
C09AA05 NORMOPRIL G Ramipril - 10mg 10mg Tablet 599,354 L.L
C10AA05 ATORVA TAD G Atorvastatin - 10mg 10mg Tablet, film coated 677,297 L.L
D07AC01 BETASONE G Betamethasone (valerate) - 1mg/g 1mg/g Cream 120,306 L.L
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