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اين يمكنك التبليغ عن الاحداث الجانية للأدوية واللقاحات

 
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
A07XA04 HIDRASEC INFANTS B Racecadotril - 10mg 10mg Granules for suspension 858,715 L.L
A11BA VITALIPID N INFANT B Vitamin A - 230IU/ml, Vitamin D2 - 40IU/ml, Vitamin E - 0.7IU/ml, Vitamin K1 - 20mcg/ml Injectable concentrate for solution 2,448,481 L.L
C05A ANTROLIN B Nifedipine - 0.3%, Lidocaine - 1.5% Cream 1,333,092 L.L
J07AL01 PNEUMOVAX 23 B Polysaccharides from each of 23 capsular types of Streptococcus pneumoniae - 25mcgx23serotypes/0.5ml Injectable solution 2,378,601 L.L
A07XA04 HIDRASEC B Racecadotril - 100mg 100mg Capsule, hard 411,216 L.L
A11CC03 ONE-ALPHA B Alfacalcidol - 2mcg/ml 2mcg/ml Injectable solution 2,218,684 L.L
B02BX01 DICYNONE B Etamsylate - 250mg/2ml 250mg Injectable solution 482,439 L.L
D10AD03 DIFFERIN B Adapalene - 0.1g/100g 0.1% Gel 503,941 L.L
J07AL02 PREVENAR 13 B Polysaccharide for serotypes 1, 3, 4, 5 , 6A, 7F, 9V,14, 18C, 19A, 19F, 23F (2.2mcg)Polysaccharide for serotypes 6B (4.4mcg)Conjugated to CRM197 carrier protein and adsorbed on aluminium phosphate (0.125mg aluminium) - Injectable suspension 6,352,343 L.L
A11CC03 ONE-ALPHA B Alfacalcidol - 2mcg/ml 2mcg/ml Injectable solution 4,219,665 L.L
B02BX01 DICYNONE B Etamsylate - 500mg 500mg Capsule 1,311,590 L.L
J07AL02 SYNFLORIX B Polysaccharide from each of 10 capsular types of pneumococcus (conjugated to carrier proteins) adsorbed onto aluminium phosphate - 1mcg/0.5ml, Polysaccharide of serotypes 41,2, 18C1,3 and 19F1,4 - 3mcg/0.5ml, 1 adsorbed onto aluminium phosphate - 0.5mg Al3+, 2 conjugated to protein D (derived from NTHi) carrier protein - ~ 13mcg, 3 conjugated to tetanos toxoid carrier protein - ~ 8mcg, 4 conjugated to diphteria toxoid carrier protein - ~ 5mcg Injectable suspension 4,675,228 L.L
L01ED01 XALKORI B Crizotinib - 250mg 250mg Capsule 347,644,061 L.L
P02CA01 VERMOX B Mebendazole - 100mg/5ml 100mg/5ml Suspension 223,078 L.L
A11CC03 ONE-ALPHA B Alfacalcidol - 1mcg 1mcg Capsule 3,735,882 L.L
D10AD04 ROACCUTANE B Isotretinoin - 0.05% 0.05% Gel 932,627 L.L
L01ED01 XALKORI B Crizotinib - 200mg 200mg Capsule 347,644,061 L.L
M01AB16 AIRTAL 100MG 20 B Aceclofenac - 100mg 100mg Tablet, film coated 471,689 L.L
N03AX09 LAMICTAL B Lamotrigine - 50mg 50mg Tablet 1,753,895 L.L
P02CA01 VERMOX B Mebendazole - 500mg 500mg Tablet 106,164 L.L
B02BX05 REVOLADE B Eltrombopag Olamine - 25mg 25mg Tablet, film coated 75,701,015 L.L
D10AD06 AKLIEF B Trifarotene - 50mcg/g 50mcg/g Cream 4,359,425 L.L
J07AL02 PREVENAR 20 B Pneumococcal polysaccharide for serotypes 1, 3, 4, 5 , 6A, 7F,8, 9V,10A, 11A, 12F, 14, 15B, 18C, 19A, 19F,22F, 23F, 33F (2.2mcg) Pneumococcal polysaccharide for serotypes 6B (4.4mcg)Conjugated to CRM197 carrier protein (approximately 51mcg) adsorbed on aluminium phosphate (0.125mg aluminium) - Injectable suspension 7,415,107 L.L
L01ED03 ALECENSA B Alectinib - 150mg 150mg Capsule, hard 490,837,809 L.L
N03AX11 TOPAMAX 25 B Topiramate - 25mg 25mg Tablet, film coated 858,715 L.L
P02CA01 VERMOX B Mebendazole - 100mg 100mg Tablet 190,826 L.L
V03AC03 JADENU B Deferasirox - 180mg 180mg Tablet, film coated 27,151,164 L.L
A08AA01 LOMAIRA B Phentermine Hydrochloride - 8mg 8mg Tablet 6,138,673 L.L
A11CC03 ONE-ALPHA B Alfacalcidol - 0.25mcg 0.25mcg Capsule 1,138,235 L.L
J07AL02 VAXNEUVANCE B Pneumococcal polysaccharide for serotypes 1, 3, 4, 5 , 6A, 7F, 9V,14, 18C, 19A, 19F, 22F, 23F,33F (2mcg) Pneumococcal polysaccharide for serotypes 6B (4.4mcg) Conjugated to CRM197 carrier protein and adsorbed on aluminium phosphate adjuvant - Injectable suspension 6,988,413 L.L
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