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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
N03AG01 DEPAKINE B Sodium Valproate - 500mg 500mg Tablet, enteric coated 479,752 L.L
R05CB01 FLUIMUCIL B N-acetylcysteine - 600mg 600mg Tablet, effervescent 567,102 L.L
G03BA03 TESTOVIRON DEPOT B Testosterone Enantate - 250mg/ml 250mg/ml Injectable solution 456,906 L.L
J05AB01 ZOVIRAX B Aciclovir - 200mg/5ml 200mg/5ml Suspension 487,815 L.L
L01CD02 TAXOTERE B Docetaxel (trihydrated) - 80mg/4ml 80mg/4ml Injectable concentrated solution+diluent 24,150,868 L.L
S01XA20 TEARS NATURALE B Duasorb - 0.4% 0.4% Drops solution 189,482 L.L
A10BB12 AMARYL B Glimepiride - 3mg 3mg Tablet 392,402 L.L
B05XB02 DIPEPTIVEN B L-alanine-L-Glutamine - 20g/100ml 20g/100ml Injectable concentrated solution 2,940,456 L.L
C09DB02 SEVIKAR B Olmesartan medoxomil - 40mg, Amlodipine - 10mg Tablet, film coated 1,245,742 L.L
G03BB01 PROVIRON B Mesterolone - 25mg 25mg Tablet 391,058 L.L
H02AB09 SOLU CORTEF ACT-O-VIAL B Hydrocortisone (sodium succinate) - 250mg 250mg Injectable lyophilised powder for solution+diluent 421,967 L.L
J01DD15 OMNICEF B Cefdinir - 250mg/5ml 250mg/5ml Powder for suspension 3,670,034 L.L
L01CD02 TAXOTERE B Docetaxel (trihydrated) - 80mg/4ml 80mg/4ml Injectable concentrated solution+diluent 24,150,868 L.L
M05BA04 FOSAMAX 70MG ONCE WEEKLY B Alendronate - 70mg 70mg Tablet 1,988,887 L.L
N03AG01 DEPAKINE B Sodium Valproate - 200mg 200mg Tablet, enteric coated 240,548 L.L
R05CB01 EXOMUC B N-acetylcysteine - 200mg 200mg Granules for solution 588,603 L.L
C09DB02 VOCADO B Olmesartan medoxomil - 40mg, Amlodipine besylate - 10mg Tablet, film coated 1,186,613 L.L
G03CA03 OESTRODOSE B Estradiol (17 bêta estradiol anhydre) - 0.06% 0.06% Gel 642,357 L.L
H02AB09 HYDROCORTISONE ROUSSEL B Hydrocortisone - 10mg 10mg Tablet, scored 260,705 L.L
J01DD52 ZAVICEFTA B Ceftazidime - 2g, Avibactam - 0.5g Injectable powder for concentrate for solution 101,659,975 L.L
N03AG01 DEPAKINE B Sodium Valproate - 400mg 400mg Injectable lyophilised powder for solution+diluent 450,187 L.L
C09DB04 TWYNSTA B Telmisartan - 80mg, Amlodipine - 10mg Tablet 991,756 L.L
D02AF REPARIL GEL-N B Diethylamine salicylate - 5g/100g, Ascine - 1g/100g Gel 481,096 L.L
H02AB13 DEFAL B Deflazacort - 6mg 6mg Tablet 415,247 L.L
L01XG01 VELCADE B Bortezomib - 3.5mg 3.5mg Injectable lyophilised powder for solution 23,616,000 L.L
N03AG01 DEPAKINE CHRONO L.P. B Valproic acid - 145mg, Sodium Valproate - 333mg 500mg Tablet, coated, scored, prolonged release 362,837 L.L
R05CB01 FLUIMUCIL MUCOLYTIC B N-acetylcysteine - 2% 2% Syrup 595,322 L.L
S02AA15 SEPTOCIPRO OTICO B Ciprofloxacine (HCl) - 1mg/0.5ml 1mg/0.5ml Solution 473,033 L.L
D02AX BIAFINE B Trolamine - 0.67g/100g 0.67g/100g Emulsion 524,099 L.L
G03CA03 ESTROFEM B Estradiol (hemihydrate) - 2mg 2mg Tablet, film coated 399,121 L.L
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