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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
A16AB02 CEREZYME B Imiglucerase - 400IU 400IU Injectable lyophilised powder for solution 128,412,818 L.L
B05BA01 AMINOPLASMAL B. BRAUN B Amino acids - 10% 10% Injectable solution 1,036,103 L.L
D01AE14 MYCOSTER B Ciclopirox - 1% 1% Cream 284,895 L.L
L01BC59 LONSURF B Trifluridine - 20mg, Tipiracil - 8.19mg Tablet, film coated 75,019,126 L.L
S01GA51 NAPHCON A B Naphazoline HCl - 0.025%, Pheniramine maleate - 0.3% Drops solution 369,557 L.L
C07AG02 DILATREND B Carvedilol - 25mg 25mg Tablet, scored 598,010 L.L
C09DA09 EDARBYCLOR B Azilsartan medoxomil - 40mg, Chlortalidone - 12.5mg Tablet, film coated 1,846,440 L.L
D01AE15 LAMISIL B Terbinafine HCl - 10mg/g 1% Cream 616,824 L.L
G02BA NUVARING B Etonogestrel - 0.12mg/day, Ethinylestradiol - 0.015mg/day Ring 1,052,229 L.L
H02AB04 SOLU MEDROL B Methylprednisolone sodium succinate - 500mg 500mg Injectable powder for solution 718,956 L.L
J02AC03 VFEND B Voriconazole - 200mg 200mg Tablet, film coated 51,904,550 L.L
L01BC59 LONSURF B Trifluridine - 15mg, Tipiracil - 6.14mg Tablet, film coated 58,102,683 L.L
M04AA01 ZYLORIC B Allopurinol - 100mg 100mg Tablet 278,175 L.L
N02CC04 MAXALT B Rizatriptan (benzoate) - 10mg Tablet 439,436 L.L
R03DX10 FASENRA B Benralizumab - 30mg 30mg Injectable solution 214,213,273 L.L
A16AB05 ALDURAZYME B Laronidase - 100U/ml 100U/ml Injectable concentrate for solution 57,138,680 L.L
C09DA09 EDARBYCLOR B Azilsartan medoxomil - 40mg, Chlortalidone - 25mg Tablet, film coated 1,846,440 L.L
G02BA03 MIRENA 20mcg/24h Levonorgestrel B Levonorgestrel - 20mcg/24h 20mcg/24h Implant 10,530,753 L.L
N05AX08 RISPERDAL B Risperidone - 1mg/ml 1mg/ml Solution 1,377,439 L.L
S01GX02 LEVOPHTA B Levocabastine HCl - 0.5mg/ml 0.05% Suspension 682,672 L.L
B05BA10 OLIMEL N9E B Glucose solution - 27.5%, Amino acids solution - 14.2%, Lipid emulsion - 20%, Sodium - 70mmol/2l, Potassium - 60mmol/2l, Magnesium - 8mmol/2l, Calcium - 7mmol/2l, Phosphate - 30mmol/2l, Acetate - 107mmol/2l, Chloride - 90mmol/2l, Azote - 18g/2l Injectable emulsion 5,496,316 L.L
C09DB01 EXFORGE B Amlodipine - 5mg, Valsartan - 160mg Tablet, film coated 1,333,092 L.L
G02CB03 DOSTINEX B Cabergoline - 0.5mg 0.5mg Tablet, scored 415,247 L.L
H02AB04 SOLU MEDROL B Methylprednisolone sodium succinate - 1g 1g Injectable powder for solution 1,444,631 L.L
L04AX04 REVLIMID B Lenalidomide - 5mg 5mg Capsule 105,106,076 L.L
N05AX08 RISPERDAL B Risperidone - 1mg/ml 1mg/ml Solution 1,377,439 L.L
S01GX07 ALLERGODIL B Azelastine HCl - 0.5mg/ml 0.5mg/ml Drops solution 709,549 L.L
B05BA10 PERIOLIMEL N4E B Olive oil + Soja oil - 45.00g, Alanine - 5.50g, Arginine - 3.72g, Aspartic Acid - 1.10g, Glutamic Acid - 1.90g, Glycine - 2.63g, Histidine - 2.26g, Isoleucine - 1.90g, Leucine - 2.63g, Lysine - 2.99g, Methionine - 1.90g, Phenylalanine - 2.63g, Proline - 2.26g, Serine - 1.50g, Threonine - 1.90g, Tryptophan - 0.64g, Tyrosine - 0.10g, Valine - 2.43g, Sodium acetate, 3H2O - 1.73g, Sodium glycerophosphate, H2O - 2.87g, Potassium chloride - 1.79g, Magnesium chloride, 6H2O - 0.67g, Calcium chloride 2H2O - 0.44g, Glucose monohydrate - 123.75g Injectable emulsion 5,288,020 L.L
C07BB03 TENORETIC B Chlortalidone - 25mg, Atenolol - 100mg Tablet, film coated 291,614 L.L
G02CB03 DOSTINEX B Cabergoline - 0.5mg 0.5mg Tablet, scored 1,628,737 L.L
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