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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
A07AA02 MEDISTAN G Nystatin - 200.000IU 200.000IU Lozenge 418,511 L.L
A07AA02 MEDISTAN G Nystatin - 500,000IU 500,000IU Capsule 417,231 L.L
A07AA02 MEDISTAN G Nystatin - 500,000IU/5ml 500,000IU/5ml Suspension 415,951 L.L
R05X TRIMEDIL FORTE G O-(?-hydroxyethyl)-rutosides - 30mg, Ascorbic acid - 80mg, Dimethindene - 0.5mg, Phenylephrine HCl - 2.5mg, Paracetamol - 200mg Capsule 386,515 L.L
A05AA04 OCALIVA B Obeticholic acid - 10mg 10mg Tablet, film coated 224,503,943 L.L
A05AA04 OCALIVA B Obeticholic acid - 5mg 5mg Tablet, film coated 224,503,943 L.L
L01FA03 GAZYVA BioTech Obinutuzumab - 1000mg/40ml 1000mg/40ml Injectable concentrate for solution L.L
L01FA03 GAZYVA BioTech Obinutuzumab - 1000mg/40ml 1000mg/40ml Injectable concentrate for solution 314,437,416 L.L
L04AA36 OCREVUS BioTech Ocrelizumab - 300mg/10ml 300mg/10ml Injectable concentrate for solution 547,517,314 L.L
H01CB02 SANDOSTATIN LAR B Octreotide (acetate) - 20mg 20mg Injectable powder for suspension+diluent L.L
H01CB02 SANDOSTATIN LAR B Octreotide (acetate) - 20mg 20mg Injectable powder for suspension+diluent 36,504,302 L.L
H01CB02 SANDOSTATIN LAR B Octreotide (acetate) - 30mg 30mg Injectable powder for suspension+diluent L.L
H01CB02 SANDOSTATIN LAR B Octreotide (acetate) - 30mg 30mg Injectable powder for suspension+diluent 54,757,132 L.L
H01CB02 SANDOSTATIN B Octreotide - 0.1mg/ml 0.1mg/ml Injectable solution 1,038,790 L.L
L04AA52 KESIMPTA BioTech Ofatumumab - 20mg/0.4ml 20mg/0.4ml Injectable solution 96,542,598 L.L
S01AE01 OFLOX B Ofloxacin - 0.3% 0.3% Drops solution 366,869 L.L
J01MA01 OFLACIN G Ofloxacin - 200mg 200mg Tablet, film-scored 602,041 L.L
J01MA01 OFLOMED G Ofloxacin - 200mg 200mg Tablet, film-scored 601,530 L.L
S01AE01 OFLOX B Ofloxacin - 3mg/ml 0.3% Drops solution 366,869 L.L
S01AE01 FLOXIGEN G Ofloxacin - 3mg/ml 3mg/ml Drops solution 358,806 L.L
S01AE01 OPTIFLOX G Ofloxacin - 3mg/ml 3mg/ml Drops suspension 143,791 L.L
S01AE01 FLOXEDOL G Ofloxacin - 3mg/ml 3mg/ml Gel 339,992 L.L
S02AA16 OFLOMED G Ofloxacin - 3mg/ml 3mg/ml Drops solution 317,403 L.L
N05AH03 ZYPREXA VELOTAB B Olanzapine - 10mg 10mg Tablet, dispersible 5,214,109 L.L
N05AH03 ZYPREXA VELOTAB B Olanzapine - 10mg 10mg Tablet, dispersible 5,214,109 L.L
N05AH03 APO-OLANZAPINE ODT G Olanzapine - 10mg 10mg Tablet, orally disintegrating 3,628,375 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
N05AH03 PRANZA G Olanzapine - 10mg 10mg Tablet, orodispersible 3,553,120 L.L
N05AH03 VAINCOR G Olanzapine - 10mg 10mg Tablet, coated, scored 1,209,458 L.L
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