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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
B02BD08 NOVOSEVEN RT BioTech Eptacog alfa (activated) recombinant - 1mg 1mg (50KIU) Injectable powder for solution+diluent L.L
B02BD02 NOVOEIGHT BioTech Turoctocog Alfa - 500IU 500IU Injectable powder for solution+diluent 29,783,973 L.L
B02BD02 NUWIQ BioTech Coagulation Factor VIII recombinant, human (Simoctogog alfa) - 500IU 500IU Injectable powder for solution+diluent 47,418,699 L.L
B01AC06 NU-SEALS G Acetylsalicylic acid - 75mg 75mg Tablet, enteric coated 403,153 L.L
B01AC04 NORMIGORE G Clopidogrel (Bisulfate) - 75mg 75mg Tablet, film coated 1,184,117 L.L
A11DB NEUROBION B Vitamin B12 - 1000mcg, Vitamin B6 - 100mg, Vitamin B1 - 100mg Injectable solution 545,600 L.L
A11DB NEUROBION B Vitamin B12 - 1000mcg, Vitamin B6 - 100mg, Vitamin B1 - 100mg Injectable solution 287,582 L.L
A11DB NEURORUBINE G Vitamin B12 - 1mg, Vitamin B6 - 100mg, Vitamin B1 - 100mg Injectable solution 302,365 L.L
A11DB NEUROBION B Vitamin B12 - 200mcg, Vitamin B6 - 200mg, Vitamin B1 - 100mg Tablet, coated 364,181 L.L
A11DB NEUROBION B Vitamin B12 - 200mcg, Vitamin B6 - 200mg, Vitamin B1 - 100mg Tablet, coated 550,975 L.L
A11DB NEUROMED G Vitamin B12 - 200mcg, Vitamin B6 - 200mg, Vitamin B1 - 100mg Tablet, coated 257,250 L.L
A11DB NEURORUBINE-FORTE G Vitamin B12 - 1mg, Vitamin B6 - 50mg, Vitamin B1 - 200mg Tablet, film coated 262,049 L.L
A10BX02 NOVONORM B Repaglinide - 2mg 2mg Tablet 666,546 L.L
A10BX02 NOVONORM B Repaglinide - 0.5mg 0.5mg Tablet 475,720 L.L
A10BX02 NOVONORM B Repaglinide - 1mg 1mg Tablet 571,133 L.L
A10AD05 NOVOMIX 30 BioTech Insulin aspart - 30%, Insulin aspart protamine - 70% 100IU/ml Injectable suspension 4,264,012 L.L
A10AD05 NOVOMIX 30 BioTech Insulin aspart - 30%, Insulin aspart protamine - 70% 100IU/ml Injectable suspension 4,264,012 L.L
A10AD05 NOVOMIX 30 BioTech Insulin aspart - 30%, Insulin aspart protamine - 70% 100IU/ml Injectable suspension 4,264,012 L.L
A10AB05 NOVORAPID FLEXPEN BioTech Insulin aspart - 100IU/ml 100IU/ml Injectable solution 3,123,090 L.L
A10AB05 NOVORAPID FLEXPEN BioTech Insulin aspart - 100IU/ml 100IU/ml Injectable solution 3,123,090 L.L
A10AB05 NOVORAPID FLEXPEN BioTech Insulin aspart - 100IU/ml 100IU/ml Injectable solution 3,123,090 L.L
A07AX03 NIFUNAL G Nifuroxazide - 200mg 200mg Capsule, hard 217,702 L.L
A07AA11 NORMIX TAB B Rifaximin alpha - 200mg 200mg Tablet, film coated 827,807 L.L
A07AA11 NORMIX SIROP B Rifaximin alpha - 100mg/5ml 100mg/5ml Granules for suspension 477,064 L.L
A04AA02 NEOSET G Granisetron (HCl) - 3mg/3ml 3mg/3ml Injectable solution 405,840 L.L
A04AA01 NAUSETRON G Ondansetron (HCl dihydrate) - 8mg 8mg Tablet, scored 1,023,880 L.L
A04AA01 NOZENTRIX G Ondansetron - 8mg 8mg Tablet, film coated 1,151,865 L.L
A04AA01 NOZAMET G Ondansetron - 8mg 8mg Film, orodispersible 6,075,448 L.L
A04AA01 NAUSETRON G Ondansetron - 4mg/5ml 4mg/5ml Solution 958,608 L.L
A04AA01 NAUSETRON G Ondansetron - 4mg/5ml 4mg/5ml Solution 802,466 L.L
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