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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
C09BB07 RAMIPRIL/AMLODIPINE GENERICON G Ramipril - 2.5mg, Amlodipine - 5mg Capsule, hard 1,358,625 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
A10BD20 EMPAZIMET G Metformin HCl - 1000mg, Empagliflozin - 5mg Tablet, film coated 1,840,168 L.L
C09BB07 RAMIPRIL/AMLODIPINE GENERICON G Ramipril - 5mg, Amlodipine - 5mg Capsule, hard 1,358,625 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
A06AD61 SOFLAX G Lactose - less than 6g/100ml, Galactose - less than 11g/100ml, Lactulose - 67g/100ml Solution 258,018 L.L
A10BD20 FLORIMET 5/1000 G Metformin - 1000mg, Empagliflozin - 5mg Tablet, film coated 1,836,585 L.L
C09BB07 RAMIPRIL/AMLODIPINE GENERICON G Ramipril - 10mg, Amlodipine - 5mg Capsule, hard 1,358,625 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
A10BD21 ENFORZA B Saxagliptin HCl - 5mg, Dapagliflozin - 10mg Tablet, film coated 6,072,824 L.L
C09BB07 RAMIPRIL/AMLODIPINE GENERICON G Ramipril - 10mg, Amlodipine - 10mg Capsule, hard 1,358,625 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
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
C09BX01 TRIPLIXAM B Perindopril arginine - 5mg, Indapamide - 1.25mg, Amlodipine - 5mg Tablet, film coated 968,910 L.L
D07CA01 HYDROMYCINE G Neomycin sulfate - 0.005g/g, Hydrocortisone acetate - 0.01g/g Cream 238,052 L.L
J01CR05 YANOVEN G Piperacillin (sodium) - 2g, Tazobactam (sodium) - 0.25g Injectable powder for solution+diluent 830,623 L.L
N02BA51 ASPIRINE C EFFERVESCENT B Acetylsalicylic acid - 400mg, Vitamin C - 240mg Tablet, effervescent 162,605 L.L
R03AK06 SERETIDE DISKUS 100 B Salmeterol (xinafoate) - 50mcg/inhalation, Fluticasone propionate - 100mcg/inhalation Inhalation powder 2,276,469 L.L
A01AD11 PYRALVEX B Salicylic acid - 0.01g/ml, Rhubarb (Anthraquinone Glycosides) - 0.05g/ml Solution 327,898 L.L
A06AD65 MOVICOL PEDIATRIC PLAIN B Potassium chloride - 23.3mg, Sodium chloride - 175.4mg, Sodium bicarbonate - 89.3mg, Macrogol 3350 - 6.563g Powder for solution 624,887 L.L
C09BX01 TRIPLIXAM B Perindopril arginine - 10mg, Indapamide - 2.5mg, Amlodipine - 5mg Tablet, film coated 1,237,679 L.L
D07CA01 MYCICORT G Neomycin sulfate - 5mg/g, Hydrocortisone acetate - 10mg/g Ointment 485,063 L.L
J01CR05 YANOVEN G Piperacillin (sodium) - 2g, Tazobactam (sodium) - 0.25g Injectable powder for solution+diluent 7,236,698 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
N02BA51 ASPRIVIT G Acetylsalicylic acid - 500mg, Caffeine - 50mg, Vitamin B1 - 2mg Tablet 186,794 L.L
N04BA02 SINEMET B Levodopa - 250mg, Carbidopa - 25mg Tablet, scored 1,283,690 L.L
R03AK06 FLUDALT DUO G Salmeterol (xinafoate) - 50mcg, Fluticasone propionate - 100mcg Capsule, inhalation 1,709,989 L.L
A02AC10 RENNIE B Magnesium carbonate - 80mg, Calcium carbonate - 680mg Tablet, chewable 200,233 L.L
A06AG11 MINILAX G Sodium citrate (dihydrate) - 900mg/10ml, Sodium lauryl sulfate - 150mg/10ml, Glycerol - 1200mg/10ml, Sorbic acid - 10mg/10ml, Sorbitol - 9.96mg/10ml Solution 474,824 L.L
C09BX01 TRIPLIXAM B Perindopril arginine - 10mg, Indapamide - 2.5mg, Amlodipine - 10mg Tablet, film coated 1,315,622 L.L
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