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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
J01FA02 ROVAMYCINE B Spiramycin - 1.5MIU 1.5MIU Tablet, film coated 256,674 L.L
J05AP55 EPCLUSA B Sofosbuvir - 400mg, Velpatasvir - 100mg Tablet, film coated 954,137,511 L.L
L02AE04 GONAPEPTYL B Triptorelin acetate - 0.1mg 0.1mg Injectable solution 4,637,600 L.L
N05BA08 LEXOTANIL B Bromazepam - 1.5mg 1.5mg Tablet, scored 299,677 L.L
P02CA01 VERMOX B Mebendazole - 100mg/5ml 100mg/5ml Suspension 196,201 L.L
R05X ACTISOUFRE B Sulfure de Sodium - 13mg, Saccharomyces Cerevisiae - 500mg Solution 740,457 L.L
J05AP56 VOSEVI B Sofosbuvir - 400mg, Velpatasvir - 100mg, Voxilaprevir - 100mg Tablet, film coated 857,670,718 L.L
L02AE04 GONAPEPTYL CR B Triptorelin - 3.75mg 3.75mg Injectable powder for suspension+diluent 12,095,730 L.L
P02CA01 VERMOX B Mebendazole - 100mg/5ml 100mg/5ml Suspension 196,201 L.L
R05X FERVEX CHILDREN SUGAR FREE B Paracetamol - 280mg, Ascorbic acid - 100mg, Pheniramine maleate - 10mg Granules for solution 425,998 L.L
V03AE02 RENVELA B Sevelamer - 800mg 800mg Tablet, film coated 8,386,876 L.L
A10BD08 GALVUS MET B Metformin HCl - 850mg, Vildagliptin - 50mg Tablet, film coated 1,816,875 L.L
B01AC17 AGGRASTAT B Tirofiban hydrochloride monohydrate - 0.25mg/ml 0.25mg/ml Injectable concentrated solution 18,280,324 L.L
C09AA02 RENITEC B Enalapril maleate - 20mg 20mg Tablet 405,840 L.L
C10AA01 ZOCOR B Simvastatin - 20mg 20mg Tablet 976,526 L.L
N05BA12 XANAX B Alprazolam - 0.5mg 0.5mg Tablet 477,064 L.L
P02CA01 VERMOX B Mebendazole - 500mg 500mg Tablet 106,164 L.L
R05X FERVEX ADULTS SUGAR FREE B Paracetamol - 500mg, Ascorbic acid - 200mg, Pheniramine maleate - 25mg Granules for solution 425,998 L.L
C01DA02 NITRODERM TTS 5 B Glyceryl trinitrate - 5mg/24h 5mg/24h Patch 654,183 L.L
C09AA03 ZESTRIL B Lisinopril (dihydrate) - 5mg 5mg Tablet 295,645 L.L
N01AH06 ULTIVA B Remifentanil (HCl) - 5mg 5mg Injectable powder for solution 2,990,050 L.L
P02CA01 VERMOX B Mebendazole - 500mg 500mg Tablet 106,164 L.L
R05X FERVEX ADULTS RASPBERRY B Paracetamol - 500mg, Ascorbic acid - 200mg, Pheniramine maleate - 25mg Granules for solution 425,998 L.L
B01AC24 BRILINTA B Ticagrelor - 90mg 90mg Tablet, film coated 5,544,694 L.L
J01FA09 KLACID B Clarithromycin - 500mg 500mg Tablet, film coated 1,329,060 L.L
J05AR03 TRUVADA B Emtricitabine - 200mg, Tenofovir disoproxil - 245mg Tablet, film coated 20,507,286 L.L
P02CA01 VERMOX B Mebendazole - 100mg 100mg Tablet 129,009 L.L
R05X FERVEX ADULTS B Paracetamol - 500mg, Ascorbic acid - 200mg, Pheniramine maleate - 25mg Granules for solution 425,998 L.L
C09AA03 ZESTRIL B Lisinopril (dihydrate) - 10mg 10mg Tablet 592,635 L.L
L02BA03 FASLODEX B Fulvestrant - 250mg/5ml 250mg/5ml Injectable solution 46,628,557 L.L
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