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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
H01CC01 ORGALUTRAN B Ganirelix - 0.25mg/0.5ml 0.25mg/0.5ml Injectable solution 2,383,977 L.L
J01DD15 OMNICEF B Cefdinir - 125mg/5ml 125mg/5ml Powder for suspension 1,189,301 L.L
A03AX13 OVOL B Simethicone - 40mg/ml 40mg/ml Drops 233,829 L.L
J01DD15 OMNICEF B Cefdinir - 125mg/5ml 125mg/5ml Powder for suspension 2,025,171 L.L
J01DD15 OMNICEF B Cefdinir - 125mg/5ml 125mg/5ml Powder for suspension 2,025,171 L.L
J01DD15 OMNICEF B Cefdinir - 125mg/5ml 125mg/5ml Powder for suspension 1,189,301 L.L
A03AX13 OVOL FOR GAZ B Simethicone - 180mg 180mg Capsule, liquid gel 241,892 L.L
S02DA01 OTIPAX B Lidocaine HCl - 1g/100g, Phenazone - 4g/100g Drops 236,516 L.L
J01DD15 OMNICEF B Cefdinir - 300mg 300mg Capsule 2,238,842 L.L
J01DD15 OMNICEF 300 B Cefdinir - 300mg 300mg Capsule 2,238,842 L.L
J01DD15 OMNICEF B Cefdinir - 250mg/5ml 250mg/5ml Powder for suspension 3,670,034 L.L
B05BA10 OLIMEL N9E B Glucose solution - 27.5%, Amino acids solution - 14.2%, Lipid emulsion - 20%, Sodium - 70mmol/2l, Potassium - 60mmol/2l, Magnesium - 8mmol/2l, Calcium - 7mmol/2l, Phosphate - 30mmol/2l, Acetate - 107mmol/2l, Chloride - 90mmol/2l, Azote - 18g/2l Injectable emulsion 5,496,316 L.L
G03CA03 OESTRODOSE B Estradiol (17 bêta estradiol anhydre) - 0.06% 0.06% Gel 642,357 L.L
M05BX OSSOPAN B Osseine-hydroxyapatite complex - 800mg 800mg Tablet, film coated 1,142,266 L.L
L01XX24 ONCASPAR B Pegaspargase - 750U/ml 750U/ml Injectable powder for solution 172,758,585 L.L
R01AA07 OTRIVIN B Xylometazoline HCl - 0.1% 0.1% Solution 260,705 L.L
R01AA07 OTRIVIN B Xylometazoline HCl - 0.1% 0.1% Drops 241,892 L.L
R01AA07 OTRIVIN MENTHOL 0.1% B Xylometazoline HCl - 0.1% 0.1% Drops 387,027 L.L
R01AA07 OTRIVIN B Xylometazoline HCl - 0.05% 0.05% Solution 260,705 L.L
R01AA07 OTRIVIN B Xylometazoline HCl - 0.05% 0.05% Drops 181,419 L.L
R01AB06 OTRIVIN DUAL RELIEF B Xylometazoline HCl - 0.5mg/ml, Ipratropium bromide - 0.6mg/ml Solution 563,070 L.L
R01AD08 OTRIALLERGY B Fluticasone propionate - 50mcg/actuation 50mcg/actuation Spray, suspension 675,953 L.L
N02AA05 OXYNORM B Oxycodone HCl - 5mg 5mg Capsule, hard 1,991,575 L.L
L01XX24 ONCASPAR B Pegaspargase - 750U/ml 750U/ml Injectable powder for solution L.L
N02AA05 OXYNORM B Oxycodone HCl - 10mg 10mg Capsule, hard 3,988,525 L.L
N02AA05 OXYNORM B Oxycodone HCl - 20mg 20mg Capsule, hard 7,634,958 L.L
N02AA05 OXYNORM B Oxycodone HCl - 10mg/ml 10mg/ml Injectable solution 1,584,390 L.L
A05AA04 OCALIVA B Obeticholic acid - 10mg 10mg Tablet, film coated 224,503,943 L.L
A05AA04 OCALIVA B Obeticholic acid - 5mg 5mg Tablet, film coated 224,503,943 L.L
B02BD01 OCTAPLEX BioHuman Prothrombin complex, human (PPSB) - 500IU 500IU Injectable powder for solution+diluent 37,682,862 L.L
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