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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
L04AC18 SKYRIZI BioTech Risankizumab - 150mg 150mg Injectable solution 194,911,251 L.L
M03BX04 STIFFANO G Tolperisone - 150mg 150mg Tablet 651,764 L.L
J02AC01 STABILANOL G Fluconazole - 150mg 150mg Capsule 254,557 L.L
L04AX04 SOTIRA G Lenalidomide - 15mg 15mg Capsule 76,208,289 L.L
R05DB13 SINECOD B Butamirate dihydrogenocitrate - 15mg/10ml 15mg/10ml Syrup, sugar free 521,411 L.L
C07AA07 SOTALOL BIOGARAN G Sotalol hydrochloride - 160mg 160mg Tablet, scored 357,462 L.L
R03BB04 SPIRIVA WITH HANDIHALER B Tiotropium bromide - 18mcg 18mcg Capsule, inhalation 3,179,531 L.L
A07EC02 SALCROZINE G Mesalazine - 1g 1g Tablet, gastroresistant 4,073,187 L.L
A07EC02 SALOFALK B Mesalazine - 1g 1g Suppository 3,948,209 L.L
J01DD01 STOPAREN G Cefotaxime (sodium) - 1g 1g Injectable lyophilised powder for solution+diluent 213,671 L.L
A02BX02 SUCRATE GEL G Sucralfate - 1g 1g Gel 636,981 L.L
H02AB04 SOLU MEDROL B Methylprednisolone sodium succinate - 1g 1g Injectable powder for solution 1,444,631 L.L
J01DE01 SALAPIME G Cefepime - 1g 1g Injectable powder for solution 618,168 L.L
N02BE01 STOPALGIC G Paracetamol - 1g/100ml 1g/100ml Injectable solution 1,536,012 L.L
N02BE01 SOLUFLEX PARACETAMOL G Paracetamol - 1g/100ml 1g/100ml Injectable solution 211,175 L.L
L04AA10 SIROMUNE G Sirolimus - 1mg 1mg Tablet, film coated 18,729,193 L.L
G04CB01 STERIBO G Finasteride - 1mg 1mg Tablet, film coated 2,636,619 L.L
N05BA25 SEDOXIL G Mexazolam - 1mg 1mg Tablet 1,705,336 L.L
S02AA15 SEPTOCIPRO OTICO B Ciprofloxacine (HCl) - 1mg/0.5ml 1mg/0.5ml Solution 473,033 L.L
V03AE02 SEVELAMER CARBONATE ARROW G Sevelamer - 2.4g 2.4g Powder for suspension 12,969,932 L.L
R03BB04 SPIRIVA RESPIMAT B Tiotropium bromide - 2.5mcg/dose 2.5mcg/dose Inhalation solution 3,000,800 L.L
B05BA02 SMOFLIPID G Soya oil - 6%, Olive oil - 5%, Fish oil - 3%, Medium chain triglycerides - 6% 20% Injectable emulsion 1,424,473 L.L
B05XA03 SODIUM CHLORIDE G Sodium chloride - 20% 20% Injectable solution 5,675,800 L.L
B05XA03 SODIUM CHLORIDE G Sodium chloride - 20% 20% Injectable solution 784,890 L.L
J01DD08 SUPRAX B Cefixime (trihydrate) - 200mg 200mg Capsule 1,067,011 L.L
J01DD08 SUPRAX B Cefixime (trihydrate) - 200mg 200mg Capsule 1,067,011 L.L
A03AA04 SPASMINE (Mebeverine HCl 200mg SR) G Mebeverine HCl - 200mg 200mg Capsule, slow release 712,876 L.L
R07AA SURFACTANTE B RICHET G Pulmonary surfactant, bovine - 200mg/8ml 200mg/8ml Suspension 26,568,472 L.L
R07AA01 SURVANTA B Colfosceril palmitate - 200mg/8ml 200mg/8ml Suspension 36,957,499 L.L
B05BC01 SERUFLEX MANNITOL 20% INJECTION, USP G Mannitol - 20g/100ml 20g/100ml Injectable solution 402,213 L.L
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