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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
B05BB02 SOLUFLEX DEXTROSE 5% SODIUM CHLORIDE 0.9% INJECTION, USP G Sodium chloride - 0.9%, Glucose - 5% Injectable solution 222,941 L.L
V07AB01 STERILE WATER FOR INJECTION G Water for injection - Water for injection, irrigation 264,311 L.L
B05BB02 SOLUFLEX DEXTROSE 5% SODIUM CHLORIDE 0.9% INJECTION, USP G Sodium chloride - 0.9%, Glucose - 5% Injectable solution 158,587 L.L
V07AB01 STERILE WATER FOR INJECTION USP G Water for injection - Water for injection, irrigation 203,405 L.L
V07AB01 STERILE WATER FOR INJECTION USP G Water for injection - Water for injection, irrigation 264,311 L.L
V07AB01 STERILE WATER FOR IRRIGATION G Water for Irrigation - Water for injection, irrigation 203,481 L.L
P03AX01 SPIDOGALE G Benzyl benzoate - 10g/100ml, Sulfur colloïdal - 5g/100ml Lotion 207,336 L.L
A10BD07 SAGIMET G Metformin HCl - 1000mg, Sitagliptin (HCl monohydrate) - 50mg Tablet, film coated 1,551,690 L.L
A10BD07 SITAMET G Metformin - 1000mg, Sitagliptin - 50mg Tablet, film coated 2,444,896 L.L
A10BD07 SITAVITEA G Metformin - 1000mg, Sitagliptin - 50mg Tablet, film coated 1,079,106 L.L
B05BB02 SERUFLEX DEXTROSE 5% SODIUM CHLORIDE 0.45% INJECTION, USP G Sodium chloride - 0.45%, Glucose - 5% Injectable solution 193,062 L.L
B05BB02 SERUFLEX DEXTROSE 5% SODIUM CHLORIDE 0.45% INJECTION, USP G Sodium chloride - 0.45%, Glucose - 5% Injectable solution 180,421 L.L
A10BD07 SAGIMET G Metformin HCl - 500mg, Sitagliptin (HCl monohydrate) - 50mg Tablet, film coated 1,432,536 L.L
B05BB02 SOLUFLEX DEXTROSE 5% SODIUM CHLORIDE 0.45% INJECTION, USP G Sodium chloride - 0.45%, Glucose - 5% Injectable solution 236,731 L.L
B05BB02 SOLUFLEX DEXTROSE 5% SODIUM CHLORIDE 0.45% INJECTION, USP G Sodium chloride - 0.45%, Glucose - 5% Injectable solution 211,449 L.L
A10BD07 SAGIMET G Metformin HCl - 850mg, Sitagliptin (HCl monohydrate) - 50mg Tablet, film coated 1,463,892 L.L
A10BD07 SITAMET G Metformin - 850mg, Sitagliptin - 50mg Tablet, film coated 2,301,079 L.L
D06BA51 SILVEZ PLUS G Silver sulfadiazine - , Chlorhexidine - Cream 349,399 L.L
A10BD07 SITAVITEA G Metformin - 850mg, Sitagliptin - 50mg Tablet, film coated 1,079,106 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
R01AD09 SINOCORT METERED DOSE G Mometasone furoate - 0.05% 0.05% Spray, suspension 419,279 L.L
B05XA05 SULFATE DE MAGNESIUM PROAMP G Magnesium sulfate - 0.15g/ml 0.15g/ml Injectable solution 1,400,284 L.L
M01AE03 SOLKET INFLAMMATION AND PAIN G Ketoprofen Lysine salt - 0.16% 0.16% Spray 946,065 L.L
N04BC05 SIFROL B Pramipexole (dihydrochloride monohydrate) - 0.18mg 0.18mg Tablet 631,606 L.L
H01CB02 SANDOSTATIN B Octreotide - 0.1mg/ml 0.1mg/ml Injectable solution 1,038,790 L.L
D10AX03 SKINOREN B Azelaic acid - 0.2g/g 0.2g/g Cream 722,987 L.L
N04BC05 SIFROL ER B Pramipexole (dihydrochloride monohydrate) - 0.375mg 0.375mg Tablet, extended release 473,033 L.L
H01CB05 SIGNIFOR B Pasireotide (diaspartate) - 0.3mg/ml 0.3mg/ml Injectable solution 168,719,438 L.L
B05XA03 SODIUM CHLORIDE G Sodium chloride - 0.45% 0.45% Injectable solution 133,856 L.L
B05XA03 SODIUM CHLORIDE G Sodium chloride - 0.45% 0.45% Injectable solution 149,393 L.L
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