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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
L01XX02 ERWINASE BioTech Erwinia L-asparaginase - 10,000IU 10,000IU Injectable lyophilised powder for solution 444,434,845 L.L
H05BX01 CINACALCET ARROW BioTech Cinacalcet - 90mg 90mg Tablet, coated, scored 22,062,995 L.L
L01XX02 SPECTRILA BioTech Asparaginase, recombinant - 10,000IU 10,000IU Injectable powder for concentrate for solution 21,370,813 L.L
H05BX01 CINACALCET ARROW BioTech Cinacalcet - 60mg 60mg Tablet, coated, scored 16,494,074 L.L
G03DA04 BIOGEST BioTech Progesterone, bio-identical - 100mg/2ml 100mg/2ml Injectable solution 2,328,879 L.L
L01XX44 ZALTRAP BioTech Aflibercept - 100mg/4ml 100mg/4ml Injectable concentrate for solution 35,658,713 L.L
L01XX44 ZALTRAP BioTech Aflibercept - 100mg/4ml 100mg/4ml Injectable concentrate for solution 35,658,713 L.L
L01XX44 ZALTRAP BioTech Aflibercept - 200mg/8ml 200mg/8ml Injectable concentrate for solution 63,807,499 L.L
M05BX04 PROLIA BioTech Denosumab - 60mg/ml 60mg/ml Injectable solution 21,603,638 L.L
V03AB37 PRAXBIND BioTech Idarucizumab - 50mg/ml 50mg/ml Injectable solution 287,986,627 L.L
L01XX44 ZALTRAP BioTech Aflibercept - 200mg/8ml 200mg/8ml Injectable concentrate for solution 63,807,499 L.L
M05BX04 XGEVA BioTech Denosumab - 120mg 120mg Injectable solution 33,545,669 L.L
M05BX06 EVENITY BioTech Romosozumab - 105mg/1.17ml 105mg/1.17ml Injectable solution 56,729,091 L.L
L01XY02 PHESGO BioTech Pertuzumab - 600mg, Trastuzumab - 600mg Injectable solution 326,054,156 L.L
L01XY02 PHESGO BioTech Pertuzumab - 1200mg, Trastuzumab - 600mg Injectable solution 591,417,874 L.L
G03GA09 ELONVA BioTech Corifollitropin alfa - 150mcg/0.5ml 150mcg/0.5ml Injectable solution 44,141,610 L.L
B01AD02 ACTILYSE BioTech Alteplase - 50mg 50mg Injectable dry powder for solution+diluent 97,130,035 L.L
B01AD11 METALYSE BioTech Tenecteplase - 10,000IU 10,000IU Injectable powder for solution+diluent 74,851,424 L.L
A06AD04 EPSOM SALT G Magnesium sulfate - 40g 40g Granules 89,590 L.L
A10BD20 FLORIMET 5/1000 G Metformin - 1000mg, Empagliflozin - 12.5mg Tablet, film coated 1,836,585 L.L
B01AF01 RIXALTA 15 G Rivaroxaban - 15mg 15mg Tablet, film coated 1,164,664 L.L
B05BC01 MANNITOL G Mannitol - 10g/100ml 10g/100ml Injectable solution 494,147 L.L
C01EX CARDIOVITEX G Coenzyme Q10 - 300mg, Magnesium oxide - 100mg Tablet 2,822,069 L.L
C10AA05 LORVAST G Atorvastatin (calcium) - 10mg 10mg Tablet, film coated 1,114,045 L.L
J01CR02 AMOCLAN FORTE G Amoxicillin (trihydrate) - 250mg/5ml, Clavulanic Acid (potassium) - 62.5mg/5ml 312mg/5ml Powder for suspension 288,926 L.L
J01FA10 AZICIN 500 BENTA G Azithromycin - 500mg 500mg Tablet, film coated 573,373 L.L
L01EB01 APO-GEFITINIB G Gefitinib - 250mg 250mg Tablet 87,345,820 L.L
L02BG04 LETROZOLE ARROW LAB G Letrozole - 2.5mg 2.5mg Tablet, coated 2,000,981 L.L
N03AX14 LEVIPRAM IV G Levetiracetam - 500mg/100ml 500mg/100ml Injectable solution 1,869,733 L.L
R01AA07 DECOZAL G Xylometazoline HCl - 0.05% 0.05% Metered dose spray 108,851 L.L
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