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اين يمكنك التبليغ عن الاحداث الجانية للأدوية واللقاحات

 
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
L04AA36 OCREVUS BioTech Ocrelizumab - 300mg/10ml 300mg/10ml Injectable concentrate for solution L.L
A05AA04 OCALIVA B Obeticholic acid - 5mg 5mg Tablet, film coated 224,503,943 L.L
A05AA04 OCALIVA B Obeticholic acid - 10mg 10mg Tablet, film coated 224,503,943 L.L
L01FF01 OPDIVO BioTech Nivolumab - 40mg/4ml 40mg/4ml Injectable solution 51,234,726 L.L
L01FF01 OPDIVO BioTech Nivolumab - 40mg/4ml 40mg/4ml Injectable solution L.L
L01FY02 OPDUALAG BioTech Nivolumab - 240mg/20ml, Relatlimab - 80mg/20ml Injectable solution 764,283,658 L.L
L01FF01 OPDIVO BioTech Nivolumab - 100mg/10ml 100mg/10ml Injectable solution 117,224,380 L.L
L01FF01 OPDIVO BioTech Nivolumab - 100mg/10ml 100mg/10ml Injectable solution L.L
L01EX09 OFEV B Nintedanib - 150mg 150mg Capsule, soft 209,943,871 L.L
L01EX09 OFEV B Nintedanib - 150mg 150mg Capsule, soft L.L
L01EX09 OFEV B Nintedanib - 100mg 100mg Capsule, soft 104,970,726 L.L
G01AX OVUMIX G Metronidazole - 300mg, Miconazole - 100mg, Neomycin (sulfate) - 48.8mg, Gotu Kola - 15mg, Polymixin sulfate - 4.4mg Suppository 395,090 L.L
A10BD02 ORBIZIDE M FORTE G Metformin HCl - 500mg, Gliclazide - 80mg Tablet 771,750 L.L
B05BC01 OSMITOL G Mannitol - 20g/100ml 20g/100ml Injectable solution 579,064 L.L
C02KX04 OPSUMIT B Macitentan - 10mg 10mg Tablet, film coated 201,006,231 L.L
C02KX04 OPSUMIT B Macitentan - 10mg 10mg Tablet, film coated L.L
S02DA01 OTIPAX B Lidocaine HCl - 1g/100g, Phenazone - 4g/100g Drops 236,516 L.L
J01MA12 OXALEV G Levofloxacin - 500mg 500mg Tablet, film coated 791,523 L.L
J01MA12 OXALEV G Levofloxacin - 500mg 500mg Tablet, film coated 565,758 L.L
R03AC18 ONBREZ BREEZHALER B Indacaterol maleate - 150mcg 150mcg Capsule, inhalation 2,284,532 L.L
J06BA02 OCTAGAM BioHuman Human normal immunoglobulin G - 50mg/ml 2.5g/50ml Injectable solution 19,540,934 L.L
J06BA02 OCTAGAM BioHuman Human normal immunoglobulin G - 50mg/ml 5g/100ml Injectable solution 37,672,334 L.L
J06BA02 OCTAGAM BioHuman Human normal immunoglobulin G - 50mg/ml 10g/200ml Injectable solution 74,515,099 L.L
J06BA02 OCTAGAM 10% BioHuman Human normal immunoglobulin G - 10% 5g/50ml Injectable solution 37,672,334 L.L
B05BA10 OLIMEL N9E B Glucose solution - 27.5%, Amino acids solution - 14.2%, Lipid emulsion - 20%, Sodium - 70mmol/2l, Potassium - 60mmol/2l, Magnesium - 8mmol/2l, Calcium - 7mmol/2l, Phosphate - 30mmol/2l, Acetate - 107mmol/2l, Chloride - 90mmol/2l, Azote - 18g/2l Injectable emulsion 4,711,512 L.L
A10BB12 ORBIDE G Glimepiride - 4mg 4mg Tablet 357,078 L.L
A10BB12 ORBIDE G Glimepiride - 3mg 3mg Tablet 351,959 L.L
A10BB12 ORBIDE G Glimepiride - 2mg 2mg Tablet 209,895 L.L
A10BB12 ORBIDE G Glimepiride - 1mg 1mg Tablet 207,336 L.L
H01CC01 ORGALUTRAN B Ganirelix - 0.25mg/0.5ml 0.25mg/0.5ml Injectable solution 2,383,977 L.L
    5
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