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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
B02BD02 OCTANATE BioHuman Coagulation Factor VIII - 250IU 250IU Injectable lyophilised powder for solution+diluent 13,247,110 L.L
B02BD02 OCTANATE BioHuman Coagulation Factor VIII - 500IU 500IU Injectable lyophilised powder for solution+diluent 26,495,478 L.L
B02BD02 OCTANATE BioHuman Coagulation Factor VIII - 1,000IU 1,000IU Injectable lyophilised powder for solution+diluent 46,817,511 L.L
B02BD04 OCTANINE F BioHuman Plasma coagulation factor IX, human - 500IU 500IU Injectable freeze dried powder + diluent 31,425,075 L.L
G03GA08 OVITRELLE BioHuman Choriogonadotropin Alfa - 250mcg/0.5ml 250mcg/0.5ml Injectable solution 4,145,754 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 10% BioHuman Human normal immunoglobulin G - 10% 5g/50ml Injectable solution 37,672,334 L.L
J06BA02 OCTAGAM BioHuman Human normal immunoglobulin G - 50mg/ml 10g/200ml Injectable solution 71,676,672 L.L
L01FF01 OPDIVO BioTech Nivolumab - 100mg/10ml 100mg/10ml Injectable solution L.L
L01FF01 OPDIVO BioTech Nivolumab - 40mg/4ml 40mg/4ml Injectable solution L.L
L04AA36 OCREVUS BioTech Ocrelizumab - 300mg/10ml 300mg/10ml Injectable concentrate for solution 547,517,314 L.L
L01FD01 OGIVRI BioTech Trastuzumab - 440mg 440mg Injectable lyophilised powder 80,027,615 L.L
H01AC01 OMNITROPE BioTech Somatropin recombinant - 5mg/1.5ml 5mg/1.5ml Injectable solution 26,295,375 L.L
H01AC01 OMNITROPE BioTech Somatropin recombinant - 10mg/1.5ml 10mg/1.5ml Injectable solution 45,388,478 L.L
L01FF01 OPDIVO BioTech Nivolumab - 100mg/10ml 100mg/10ml Injectable solution 117,224,380 L.L
L01FF01 OPDIVO BioTech Nivolumab - 40mg/4ml 40mg/4ml Injectable solution 51,234,726 L.L
H05AA02 OSTEOFORTIL BioTech Teriparatide - 250mcg/ml 250mcg/ml Injectable solution 16,963,499 L.L
R06AX27 ORADUS G Desloratadine - 5mg 5mg Tablet, film coated 383,955 L.L
C10AA05 ORBALIP G Atorvastatin (calcium) - 20mg 20mg Tablet 1,091,712 L.L
R06AX27 ORADUS G Desloratadine - 0.5mg/ml 0.5mg/ml Solution 199,657 L.L
C10AA05 ORVASTA G Atorvastatin - 20mg 20mg Tablet, film coated 920,532 L.L
S01AA13 OPTIFUCIN VISCOUS G Fusidic acid - 1% 1% Drops 208,296 L.L
A02BC01 OMEDAR G Omeprazole - 20mg 20mg Tablet, enteric coated 18,087,352 L.L
A02BC01 OMEPRAL G Omeprazole - 20mg 20mg Capsule, delayed release 213,735 L.L
A02BC01 OMEPRAZOLE PHARMADEX G Omeprazole - 20mg 20mg Capsule 415,951 L.L
C10AA05 ORBALIP G Atorvastatin (calcium) - 40mg 40mg Tablet 1,405,275 L.L
A02BC01 OMEPRAZOLE PHARMADEX G Omeprazole - 20mg 20mg Capsule 15,757,784 L.L
C10AA05 ORVASTA G Atorvastatin - 40mg 40mg Tablet, film coated 1,170,487 L.L
S01AE01 OPTIFLOX G Ofloxacin - 3mg/ml 3mg/ml Drops suspension 143,791 L.L
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