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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
L01XA03 OXALIPLATINO GP PHARM G Oxaliplatin - 100mg 100mg Injectable lyophilised powder for solution 6,199,145 L.L
L01XA03 OXALTIE G Oxaliplatin - 100mg 100mg Injectable lyophilised powder for solution 5,915,595 L.L
M01AB05 OLFEN-100 SR G Diclofenac sodium - 100mg 100mg Capsule, prolonged release 503,941 L.L
L01FF01 OPDIVO BioTech Nivolumab - 100mg/10ml 100mg/10ml Injectable solution L.L
L01FF01 OPDIVO BioTech Nivolumab - 100mg/10ml 100mg/10ml Injectable solution 117,224,380 L.L
J06BA02 OCTAGAM BioHuman Human normal immunoglobulin G - 50mg/ml 10g/200ml Injectable solution 71,676,672 L.L
G02AX OXYTOCIN 10 PANPHARMA 10 UI-1ML G Oxytocin - 10IU/ml 10IU/ml Injectable solution 525,442 L.L
G02AX OXYTOCIN 10 PANPHARMA 10 UI-1ML G Oxytocin - 10IU/ml 10IU/ml Injectable solution 525,442 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
A02BC01 OMEPRAL G Omeprazole - 10mg 10mg Powder for suspension 890,776 L.L
C09CA08 OLMETEC B Olmesartan medoxomil - 10mg 10mg Tablet, film coated 710,893 L.L
N05AH03 OLANZAX 10 G Olanzapine - 10mg 10mg Tablet, mouth dissolving 2,329,327 L.L
N05AH03 OLIZAX 10 G Olanzapine - 10mg 10mg Tablet, mouth dissolving 2,598,096 L.L
C09CA08 OLMENOR G Olmesartan medoxomil - 10mg 10mg Tablet, film coated 526,786 L.L
N05AH03 OLANZAMED G Olanzapine - 10mg 10mg Tablet 902,294 L.L
N05AH03 OLANZAPINE ARROW G Olanzapine - 10mg 10mg Tablet 822,432 L.L
N02AA05 OXYNORM B Oxycodone HCl - 10mg 10mg Capsule, hard 3,988,525 L.L
A05AA04 OCALIVA B Obeticholic acid - 10mg 10mg Tablet, film coated 224,503,943 L.L
C10AA05 ORBALIP G Atorvastatin (calcium) - 10mg 10mg Tablet 966,287 L.L
C10AA05 ORVASTA G Atorvastatin - 10mg 10mg Tablet, film coated 834,526 L.L
H01AC01 OMNITROPE BioTech Somatropin recombinant - 10mg/1.5ml 10mg/1.5ml Injectable solution 45,388,478 L.L
N02AA05 OXYCODONE RENAUDIN G Oxycodone HCl - 10mg/10ml 10mg/10ml Injectable solution 2,432,355 L.L
N02AA05 OXYNORM B Oxycodone HCl - 10mg/ml 10mg/ml Injectable solution 1,584,390 L.L
A08AB01 ONLEFIT G Orlistat - 120mg 120mg Capsule 1,537,356 L.L
A08AB01 ORLISTAT-SIGMA G Orlistat - 120mg 120mg Capsule 847,965 L.L
A08AB01 ORLY SLIM G Orlistat - 120mg 120mg Capsule 1,174,518 L.L
M04AA03 OXUBAT 120 G Febuxostat - 120mg 120mg Tablet, film coated 1,549,002 L.L
J01DD15 OMNICEF B Cefdinir - 125mg/5ml 125mg/5ml Powder for suspension 1,189,301 L.L
J01DD15 OMNICEF B Cefdinir - 125mg/5ml 125mg/5ml Powder for suspension 2,025,171 L.L
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