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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
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
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
L01FX14 POLIVY BioHuman Polatuzumab vedotin - 140mg 140mg Injectable powder for concentrate for solution 1,146,496,418 L.L
C05BB02 AETHOXYSKLEROL B Polidocanol (Lauromacrogol 400) - 0.5% 0.5% Injectable solution 1,441,943 L.L
C05BB02 AETHOXYSKLEROL B Polidocanol (Lauromacrogol 400) - 1% 1% Injectable solution 1,732,213 L.L
C05BB02 AETHOXYSKLEROL B Polidocanol (Lauromacrogol 400) - 3% 3% Injectable solution 2,576,146 L.L
J07BF03 POLIOMYELITIS VACCINE INACTIVATED B Poliomyelitis virus type 1 inactivated - 40D.U, Poliomyelitis virus type 2 inactivated - 8D.U, Poliomyelitis virus type 3 inactivated - 32D.U Injectable suspension 1,206,771 L.L
J07CA06 PENTAXIM B Poliomyelitis virus type 3 inactivated(Prefilled syringe) - 32D.U., Poliomyelitis virus type 2 inactivated(Prefilled syringe) - 8D.U., Poliomyelitis virus type 1 inactivated(Prefilled syringe) - 40D.U., Bordetella pertussis antigen (Prefilled syringe) - toxoid 25mcg+filamentous haemaglutinin 25mcg, Tetanus toxoid (Prefilled syringe) - ?40IU, Diphtheria toxoid (Prefilled syringe) - ?30IU, H. Influenza type b polysaccharide(Vial) - 10mcg Injectable dry powder+suspension 2,558,676 L.L
J07CA06 INFANRIX IPV + HIB B Poliomyelitis virus type 3 inactivated(Prefilled syringe) - 32D.U., Poliomyelitis virus type 2 inactivated(Prefilled syringe) - 8D.U., Poliomyelitis virus type 1 inactivated(Prefilled syringe) - 40D.U., Bordetella pertussis antigen(Prefilled syringe) - toxoid 25mcg+filamentous haemaglutinin 25mcg+pertactin 8mcg, Tetanus toxoid (Prefilled syringe) - ?40IU, Diphtheria toxoid (Prefilled syringe) - ?30IU, H. Influenza type b polysaccharide(Vial) - 10mcg Injectable dry powder+suspension 3,014,239 L.L
J07AL02 PREVENAR 13 B Polysaccharide for serotypes 1, 3, 4, 5 , 6A, 7F, 9V,14, 18C, 19A, 19F, 23F (2.2mcg)Polysaccharide for serotypes 6B (4.4mcg)Conjugated to CRM197 carrier protein and adsorbed on aluminium phosphate (0.125mg aluminium) - Injectable suspension 6,352,343 L.L
J07AL02 SYNFLORIX B Polysaccharide from each of 10 capsular types of pneumococcus (conjugated to carrier proteins) adsorbed onto aluminium phosphate - 1mcg/0.5ml, Polysaccharide of serotypes 41,2, 18C1,3 and 19F1,4 - 3mcg/0.5ml, 1 adsorbed onto aluminium phosphate - 0.5mg Al3+, 2 conjugated to protein D (derived from NTHi) carrier protein - ~ 13mcg, 3 conjugated to tetanos toxoid carrier protein - ~ 8mcg, 4 conjugated to diphteria toxoid carrier protein - ~ 5mcg Injectable suspension 4,675,228 L.L
J07AH08 NIMENRIX B Polysaccharide of Neisseria meningitidis (serogroups A, C, Y and W-135) conjugated - 5mcg/0.5ml, Tetanus toxoid carrier protein - 44mcg/0.5ml Injectable lyophilised powder for solution+diluent 4,483,059 L.L
J07AL01 PNEUMOVAX 23 B Polysaccharides from each of 23 capsular types of Streptococcus pneumoniae - 25mcgx23serotypes/0.5ml Injectable solution 2,378,601 L.L
L04AX06 IMNOVID B Pomalidomide - 2mg 2mg Capsule, hard 407,188,707 L.L
L04AX06 IMNOVID B Pomalidomide - 4mg 4mg Capsule, hard L.L
L04AX06 IMNOVID B Pomalidomide - 4mg 4mg Capsule, hard 417,741,356 L.L
L01EA05 ICLUSIG B Ponatinib - 15mg 15mg Tablet, film coated 103,555,839 L.L
L01EA05 ICLUSIG B Ponatinib - 45mg 45mg Tablet, film coated 207,092,651 L.L
J02AC04 NOXAFIL B Posaconazole - 100mg 100mg Tablet, gastroresistant 62,027,714 L.L
A06AD65 MOVICOL B Potassium chloride - 0.0466g, Sodium chloride - 0.3507g, Sodium bicarbonate - 0.1785g, Macrogol 3350 - 13.125g Powder for solution 853,340 L.L
B05XA01 CHLORURE DE POTASSIUM PROAMP G Potassium chloride - 0.0746g/ml 0.0746g/ml Injectable concentrated solution 1,252,461 L.L
B05BB02 HI-SODIUM INJECTION WITH POTASSIUM G Potassium chloride - 0.149g/100ml, Sodium dihydrogenophosphate - 0.137g/100ml, Sodium lactate (anhydre) - 0.223g/100ml, Sodium chloride - 0.175g/100ml, Dextrose monohydrate - 5g/100ml Injectable solution 165,727 L.L
B05BB02 LO-SODIUM WITH POTASSIUM INJECTION G Potassium chloride - 0.149g/100ml, Sodium dihydrogenophosphate - 0.137g/100ml, Sodium lactate - 0.223g/100ml, Sodium chloride - 0.0585g/100ml, Dextrose monohydrate - 5g/100ml Injectable solution 165,727 L.L
A06AD65 FORTRANS POUDRE POUR SOLUTION BUVABLE B Potassium chloride - 0.750g, Sodium chloride - 1460g, Sodium bicarbonate - 1680g, Sodium sulfate anhydrous - 5700g, Macrogol 4000 - 64.000g Powder for solution 927,251 L.L
A12BA01 EURO-K G Potassium chloride - 1.5g 1.5g Tablet, sustained release 894,999 L.L
B05XA01 CHLORURE DE POTASSIUM RENAUDIN G Potassium chloride - 10g/100ml 10g/100ml Injectable solution 360,150 L.L
B05XA01 POTASSIUM CHLORIDE G Potassium chloride - 10g/100ml 10g/100ml Injectable solution 3,023,493 L.L
B05XA01 POTASSIUM CHLORIDE G Potassium chloride - 11.2g/100ml 11.2g/100ml Injectable solution 789,487 L.L
B05XA01 POTASSIUM CHLORIDE G Potassium chloride - 15g/100ml 15g/100ml Injectable solution 5,688,441 L.L
B05ZA CONCENTRATE SOLUTION FOR HEMODIALYSIS TYPE E G Potassium chloride - 2.611g/l, Magnesium chloride, 6H2O - 5.32g/l, Calcium chloride, 2H2O - 7.00g/l, Sodium acetate, 3H2O - 190.505g/l, Sodium chloride - 205.49g/l Injectable solution L.L
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