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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
L01AA09 RIBOMUSTIN B Bendamustine HCl - 100mg 100mg Injectable powder for concentrate for solution 31,939,807 L.L
L01AA09 RIBOMUSTIN B Bendamustine HCl - 100mg 100mg Injectable powder for concentrate for solution 31,939,807 L.L
J07BH01 ROTATEQ ROTAVIRUS VACCINE, LIVE, ORAL, PENTAVALENT B Rotavirus G1, live attenuated - ?2.2x106 IU, Rotavirus G2, live attenuated - ?2.8x106 IU, Rotavirus G3, live attenuated - ?2.2x106 IU, Rotavirus G4, live attenuated - ?2.0x106 IU, Rotavirus P1, live attenuated - ?2.3x106 IU Suspension 4,508,592 L.L
J07BH01 ROTARIX ORAL B Rota virus human RIX4414, live attenuated - ?106 CCID50 Suspension 5,167,074 L.L
J07BH01 ROTASIIL, ROTAVIRUS VACCINE, LIVE ATTENUATED (ORAL FREEZE-DRIED) BioTech Rotavirus bovine-human , live attenuated - Suspension 2,822,069 L.L
J07BH01 ROTASIIL, ROTAVIRUS VACCINE, LIVE ATTENUATED (ORAL LIQUID) BioTech Rotavirus bovine-human , live attenuated - Liquid 2,822,069 L.L
J07BG01 RABIVAX-S (RABIES VACCINE INACTIVATED) BioTech Freeze dried inactivated purified rabies antigen (Pitman Moore PM3218 as virus strain) - Injectable freeze dried material 1,552,138 L.L
J06BB05 RABISHIELD-100 (RABIES HUMAN MONOCLONAL ANTIBODY rDNA) BioHuman Rabies, Human IgG1 Monoclonal Antibody - 100IU/2.5ml 100IU/2.5ml 8,455,824 L.L
J06BB01 RHOPHYLAC 300 BioHuman Human anti-D (rh) immunoglobulin - 300mcg/2ml 300mcg/2ml Injectable solution 5,939,784 L.L
J06BB01 RHESONATIV BioHuman Human anti-D (rh) immunoglobulin - 625IU/ml 625IU/ml Injectable solution 12,281,758 L.L
J05AF01 REVODINE G Zidovudine - 300mg 300mg Tablet, film coated 7,771,552 L.L
J01FA09 RITHROCID G Clarithromycin - 500mg 500mg Tablet, film coated 686,704 L.L
J01FA02 ROVAMYCINE B Spiramycin - 3MIU 3MIU Tablet, film coated 649,076 L.L
J01FA02 ROVAMYCINE B Spiramycin - 1.5MIU 1.5MIU Tablet, film coated 256,674 L.L
J01DH02 ROPENEM 1000 BENTA G Meropenem (trihydrate) - 1000mg 1g Injectable powder for solution 995,723 L.L
J01DD04 ROCEPHIN IV B Ceftriaxone (sodium) - 1g 1g Injectable lyophilised powder for solution+diluent 757,927 L.L
J01DD04 ROCEPHIN IM B Ceftriaxone (sodium) - 1g 1g Injectable lyophilised powder for solution+diluent 731,050 L.L
J01DD04 ROCICARE G Ceftriaxone - 1g 1g Injectable powder for solution 9,382,061 L.L
J01DB05 ROXIL G Cefadroxil (monohydrate) - 250mg/5ml 250mg/5ml Powder for suspension 459,594 L.L
J01DB05 ROXIL G Cefadroxil (monohydrate) - 500mg 500mg Capsule 869,466 L.L
J01AA02 RETADOX G Doxycycline (hyclate) - 100mg 100mg Capsule 209,895 L.L
H02AB02 RADOLINE G Dexamethasone sodium phosphate - 8mg/2ml 8mg/2ml Injectable solution 3,711,565 L.L
G04BX ROWATINEX B Olive oil - 33mg, Cineol - 3mg, Fenchone - 4mg, Anethol - 4mg, Borneol - 10mg, Camphene - 15mg, ?-Pinene - 6.2mg, ?-Pinene - 24.8mg Capsule 255,330 L.L
G04BE08 RAVANA G Tadalafil - 20mg 20mg Tablet 500,421 L.L
G04BE08 RAVANA G Tadalafil - 5mg 5mg Tablet 1,501,264 L.L
G03XC01 RALOXIFENE ARROW G Raloxifene HCl - 60mg 60mg Tablet, coated 1,425,817 L.L
D11AX01 REGAINE FOAM FOR MEN B Minoxidil - 5% Foam 1,370,719 L.L
D11AX01 REGAINE FOAM FOR MEN B Minoxidil - 5% Foam 3,090,838 L.L
D10AD51 RETINOMYCIN G Tretinoin - 0.025%, Erythromycin - 4% Gel 662,962 L.L
D10AD04 ROACCUTANE B Isotretinoin - 0.05% 0.05% Gel 932,627 L.L
    5
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