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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
A04AA01 ONDANSETRON MEDIS G Ondansetron - 4mg/2ml 4mg/2ml Injectable solution 978,317 L.L
A04AA01 ONDANSETRON RENAUDIN G Ondansetron (HCl dihydrate) - 4mg/2ml 4mg/2ml Injectable solution 2,964,517 L.L
A04AA01 ONDANSETRON VIANEX G Ondansetron (HCl) - 4mg/2ml 4mg/2ml Injectable solution 197,545 L.L
A04AA01 ODNATRON G Ondansetron (HCl dihydrate) - 8mg/4ml 8mg/4ml Injectable solution 952,784 L.L
A04AA01 ONDANSETRON HIKMA G Ondansetron (HCl dihydrate) - 8mg/4ml 8mg/4ml Injectable solution 4,018,089 L.L
G03GA08 OVITRELLE BioHuman Choriogonadotropin Alfa - 250mcg/0.5ml 250mcg/0.5ml Injectable solution 4,145,754 L.L
A04AA01 ONDANSETRON MEDIS G Ondansetron - 8mg/4ml 8mg/4ml Injectable solution 1,919,007 L.L
A04AA01 ONDANSETRON RENAUDIN G Ondansetron (HCl dihydrate) - 8mg/4ml 8mg/4ml Injectable solution 4,345,987 L.L
A04AA01 ONDANSETRON VIANEX G Ondansetron (HCl) - 8mg/4ml 8mg/4ml Injectable solution 387,027 L.L
J06BA02 OCTAGAM BioHuman Human normal immunoglobulin G - 50mg/ml 2.5g/50ml Injectable solution 19,540,934 L.L
N01BB58 ORABLOC G Articaine HCl - 4%, Epinephrine (tartrate) - 1/100.000 Injectable solution 2,308,721 L.L
J06BA02 OCTAGAM BioHuman Human normal immunoglobulin G - 50mg/ml 5g/100ml Injectable solution 37,672,334 L.L
J06BA02 OCTAGAM 10% BioHuman Human normal immunoglobulin G - 10% 5g/50ml Injectable solution 37,672,334 L.L
N02AA05 OXYNORM B Oxycodone HCl - 10mg/ml 10mg/ml Injectable solution 1,584,390 L.L
N02AA05 OXYCODONE RENAUDIN G Oxycodone HCl - 10mg/10ml 10mg/10ml Injectable solution 2,432,355 L.L
J06BA02 OCTAGAM BioHuman Human normal immunoglobulin G - 50mg/ml 10g/200ml Injectable solution 71,676,672 L.L
B05BC01 OSMITOL G Mannitol - 20g/100ml 20g/100ml Injectable solution 579,064 L.L
J01GB06 ORLOBIN G Amikacin (sulfate) - 500mg/2ml 500mg/2ml Injectable solution 329,241 L.L
A02BC01 OMEPRAL G Omeprazole - 20mg 20mg Powder for suspension 712,876 L.L
A02BC01 OMEPRAL G Omeprazole - 10mg 10mg Powder for suspension 890,776 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
J01DD15 OMNICEF B Cefdinir - 125mg/5ml 125mg/5ml Powder for suspension 2,025,171 L.L
J01DD15 OMNICEF B Cefdinir - 125mg/5ml 125mg/5ml Powder for suspension 1,189,301 L.L
J01DD15 OMNICEF B Cefdinir - 250mg/5ml 250mg/5ml Powder for suspension 3,670,034 L.L
J01CA04 OSPAMOX G Amoxicillin (trihydrate) - 250mg/5ml 250mg/5ml Powder for suspension 223,078 L.L
R06AX27 ORADUS G Desloratadine - 0.5mg/ml 0.5mg/ml Solution 199,657 L.L
S01BA07 OPTILONE G Fluorometholone - 0.1% 0.1% Solution 309,084 L.L
A11CC05 OSTEODYN VITAMINE D3 G Vitamin D3 - 100000IU/2ml 100000IU/2ml Solution 618,168 L.L
A11CC05 ORAVIL G Vitamin D3 - 100,000IU/2ml 100,000IU Solution 618,168 L.L
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