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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
N02AJ06 ALGOCOD G Paracetamol - 500mg, Codeine phosphate - 30mg Tablet, effervescent 299,677 L.L
R01BA52 ORADUS P G Pseudoephedrine sulfate - 120mg, Desloratadine - 2.5mg Tablet, extended release 746,153 L.L
D07CC01 BETAFUCIN G Fusidic acid - 20mg/g, Betamethasone valerate - 1mg/1g Cream 210,983 L.L
J07AL02 PREVENAR 20 B Pneumococcal polysaccharide for serotypes 1, 3, 4, 5 , 6A, 7F,8, 9V,10A, 11A, 12F, 14, 15B, 18C, 19A, 19F,22F, 23F, 33F (2.2mcg) Pneumococcal polysaccharide for serotypes 6B (4.4mcg)Conjugated to CRM197 carrier protein (approximately 51mcg) adsorbed on aluminium phosphate (0.125mg aluminium) - Injectable suspension 7,415,107 L.L
N02AJ06 PARACO-DENK 1000/60 G Paracetamol - 1000mg, Codeine phosphate hemihydrate - 60mg Suppository 636,981 L.L
R01BA52 ORADUS P G Pseudoephedrine sulfate - 120mg, Desloratadine - 2.5mg Tablet, extended release 255,970 L.L
L01BA04 PEMETREXED NEAPOLIS G Pemetrexed (disodium) - 500mg Injectable powder L.L
D07CC01 TOPIZONE G Fusidic acid - 20mg/g, Betamethasone (valerate) - 1mg/g Cream 216,359 L.L
J07AL02 VAXNEUVANCE B Pneumococcal polysaccharide for serotypes 1, 3, 4, 5 , 6A, 7F, 9V,14, 18C, 19A, 19F, 22F, 23F,33F (2mcg) Pneumococcal polysaccharide for serotypes 6B (4.4mcg) Conjugated to CRM197 carrier protein and adsorbed on aluminium phosphate adjuvant - Injectable suspension 6,988,413 L.L
N02AJ08 ASTEFOR G Ibuprofen - 400mg, Codeine phosphate hemihydrate - 30mg Tablet, film coated 935,314 L.L
R01BA53 AURIMEL B Phenylephrine HCl - 5mg/5ml, Sodium citrate - 325mg/5ml, Carbinoxamine maleate - 2mg/5ml, Dextromethorphan HBr - 5mg/5ml Syrup 319,963 L.L
D07CC01 ZETA-CORT G Fusidic acid - 20mg/g, Betamethasone (valerate) - 1mg/g Cream 244,579 L.L
N02AJ13 ZALDIAR B Paracetamol - 325mg, Tramadol - 37.5mg Tablet, film coated 404,497 L.L
D07CC01 BETASONE-N G Neomycin (sulfate) - 3.5mg/g, Betamethasone (valerate) - 1mg/g Cream 398,033 L.L
J01CR05 YANOVEN G Piperacillin (sodium) - 2g, Tazobactam (sodium) - 0.25g Injectable powder for solution+diluent 830,623 L.L
J07AP03 TYPHIBEV TYPHOID CONJUGATED VACCINE (MONOVALENT) B Salmonella typhi polysaccharides Vi purified - 25mcg of Vi-PS2/0.5ml Injectable suspension 4,020,777 L.L
N02AJ13 ALGODOL G Paracetamol - 325mg, Tramadol HCl - 37.5mg Capsule 317,403 L.L
D07CC02 GENTACORT-FC G Fluocinolone acetonide - 0.01%, Clotrimazole - 1%, Gentamicin (sulfate) - 0.1% Cream 302,365 L.L
J01CR05 YANOVEN G Piperacillin (sodium) - 2g, Tazobactam (sodium) - 0.25g Injectable powder for solution+diluent 7,236,698 L.L
N02AJ13 MOLCET G Paracetamol - 325mg, Tramadol - 37.5mg Tablet 317,403 L.L
D07XA01 DAKTACORT B Hydrocortisone - 10mg/g, Miconazole nitrate - 20mg/g Cream 208,296 L.L
J01CR05 YANOVEN G Piperacillin (sodium) - 2g, Tazobactam (sodium) - 0.25g Injectable powder for solution 830,623 L.L
J07AX BRONCHO-VAXOM CHILDREN B Lyophilized bacterial lysates of Haemophilus influenzae, Diplococcus pneumoniae, Klebsiella pneumoniae and ozaenae, Staphylococcus aureus, Streptococcus pyogenes and viridans, Neisseria catarrhalis - 3.5mg Capsule 1,988,887 L.L
N02AJ13 TRAMADOL/PARACETAMOL ARROW LAB G Tramadol - 37.5mg, Paracetamol - 325mg Tablet, coated 205,608 L.L
R02A ANGINOVAG G Lidocaine HCl - 100mg/100ml, Hydrocortisone acetate - 60mg/100ml, Tyrothricin - 400mg/100ml, Dequalinium chloride - 100mg/100ml, ?-Glycerrhetinic acid - 60mg/100ml Spray 651,764 L.L
B02BC30-V03AK TISSEEL LYO B Fibrinogen, human (clottable protein) (I) - 91mg/ml, Aprotinin, synthetic (I) - 3000KIU/ml, Thrombin, Human (II) - 500IU/ml, Calcium chloride (II) - 40?mol/ml Injectable powder for solution + solution 53,437,592 L.L
D07XB05 ECOZONE G Dexamethazone sodium phosphate - 0.1%, Econazole nitrate - 1% Cream 364,757 L.L
J01CR05 TAZOCIN B Piperacillin (sodium) - 4g, Tazobactam (sodium) - 0.5g Injectable lyophilised powder for solution 1,306,215 L.L
J07AX BRONCHO-VAXOM ADULTS B Lyophilized bacterial lysates of Haemophilus influenzae, Diplococcus pneumoniae, Klebsiella pneumoniae and ozaenae, Staphylococcus aureus, Streptococcus pyogenes and viridans, Neisseria catarrhalis - 7mg Capsule 2,746,814 L.L
N02AJ14 LENIZAK B Tramadol HCl - 75mg, Dexketoprofen - 25mg Tablet, film coated 494,534 L.L
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