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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
N05AX08 PMS-RISPERIDONE G Risperidone - 1mg/ml 1mg/ml Solution 604,729 L.L
R05C PULMONAL SIROP G Belladona tincture - 0.5g/5ml, Drosera tincture - 2g/5ml, Ammonium bromide - 2g/5ml, Sodium benzoate - 2g/5ml Syrup 148,463 L.L
S01GX08 BRUNISTILL G Ketotifen - 250mcg/ml 250mcg/ml Drops solution 940,690 L.L
A03CA02 BIPAX G Clidinium bromide - 2.5mg, Chlordiazepoxide - 5mg Tablet, sugar coated 363,477 L.L
A10BB09 GLYZIDE G Gliclazide - 80mg 80mg Tablet 534,849 L.L
B01AB01 HEPARINE MEDIS G Heparin sodium - 25,000UI/5ml 25,000UI/5ml Injectable solution 6,853,597 L.L
B05BA10 SMOFKABIVEN PERIPHERAL G Glucose monohydrate - 143mg, Soya-bean oil, refined - 60mg, Triglycerides, Medium Chain - 60mg, Olive oil, refined - 50mg, Fish oil, rich in omega-3-acids - 30mg, Alanine - 14mg, Arginine - 12mg, Proline - 11.2mg, Glycine - 11mg, Lysine acetate - 9.3mg, Leucine - 7.4mg, Serine - 6.5mg, Valine - 6.2mg, Sodium acetate, 3H2O - 5.62mg, Phenylalanine - 5.1mg, Isoleucine - 5mg, Potassium chloride - 4.48mg, Threonine - 4.4mg, Methionine - 4.3mg, Sodium glycerophosphate, anhydrous - 4.18mg, Histidine - 3mg, Magnesium sulfate, 7H2O - 2.47mg, Tryptophan - 2mg, Taurine - 1mg, Calcium chloride 2H2O - 0.74mg, Tyrosine - 0.40mg, Zinc sulfate heptahydrate - 23mcg Injectable emulsion 4,571,752 L.L
B05XA03 SODIUM CHLORIDE G Sodium chloride - 0.45% 0.45% Injectable solution 161,805 L.L
C09DB01 LOTEVAN G Amlodipine - 5mg, Valsartan - 160mg Tablet, film coated 857,372 L.L
G02CB03 NOSTIFIX G Cabergoline - 0.5mg 0.5mg Tablet 248,611 L.L
J01DD13 CEFODOX G Cefpodoxime (proxetil) - 200mg 200mg Tablet 851,996 L.L
L01CB01 ETOPOSIDE EBEWE G Etoposide - 100mg/5ml 100mg/5ml Injectable concentrated solution 768,678 L.L
L01XA01 CISPLATINE VIATRIS 1MG/ML G Cisplatin - 50mg/50ml 50mg/50ml Injectable concentrated solution 1,134,720 L.L
L04AX04 LENALIDOMIDE SPC G Lenalidomide - 5mg 5mg Capsule, hard 71,647,217 L.L
M04AA01 ALURIC G Allopurinol - 300mg 300mg Tablet, scored 175,339 L.L
N02CX01 APIZINE G Pizotifen - 0.25mg/5ml 0.25mg/5ml Syrup 505,541 L.L
N07BB03 ACAMPROSATE BIOGARAN G Acamprosate - 333mg 333mg Tablet, gastroresistant 3,641,813 L.L
R05C SULDEX G Caffein anyhdrous - 0.216g, Antipyrine - 0.972g, Potassium sulfaguaiacolate - 1.44g Syrup 152,302 L.L
A03CA02 LIBROCOL G Chlordiazepoxide - 5mg, Clidinium bromide - 2.5mg Tablet 338,648 L.L
B01AB01 HEPARINE SODIQUE PANPHARMA G Heparin sodium - 25,000IU/5ml 25,000IU/5ml Injectable solution 6,134,641 L.L
B05BB01 LACTATED RINGER'S G Sodium lactate - 0.31g/100ml, Calcium chloride, 2H2O - 0.02g/100ml, Potassium chloride - 0.03g/100ml, Sodium chloride - 0.598g/100ml Injectable solution 147,095 L.L
B05XA03 SODIUM CHLORIDE 0.45% INJECTION, USP G Sodium chloride - 0.45% 0.45% Injectable solution 161,314 L.L
C07BB07 BISCORDEX PLUS G Bisoprolol fumarate - 5mg, Hydrochlorothiazide - 12.5mg Tablet 723,115 L.L
C09DB01 POVAM G Amlodipine (besylate) - 5mg, Valsartan - 160mg Tablet, film coated 857,372 L.L
D01AE15 TERAFAN G Terbinafine HCl - 1% 1% Solution 355,798 L.L
G02CB03 PROCTIN G Cabergoline - 0.5mg 0.5mg Tablet 350,679 L.L
H02AB06 PEDIACORT G Prednisolone sodium phosphate - 15mg/5ml 15mg/5ml Solution 417231.1 L.L
J01DD13 CEFODOX G Cefpodoxime (proxetil) - 100mg/5ml 100mg/5ml Powder for suspension 735,082 L.L
L01CB01 ETOPOSIDE VIATRIS 20MG/ML G Etoposide - 100mg/5ml 100mg/5ml Injectable concentrated solution 1,485,634 L.L
L01XA02 CARBOPLATIN VIANEX G Carboplatin - 150mg/15ml 150mg/15ml Injectable solution 1,277,994 L.L
    ...
    139
    ...
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