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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
C09DA07 MICARDIS PLUS B Telmisartan - 80mg, Hydrochlorothiazide - 12.5mg Tablet 1,101,951 L.L
H02AB01 DIPROFOS B Betamethasone (dipropionate) - 5mg/ml, Betamethasone (sodium phosphate) - 2mg/ml Injectable suspension 446,156 L.L
L04AA42 MAYZENT B Siponimod - 0.25mg 0.25mg Tablet, film coated 124,258,444 L.L
N04BA02 SINEMET B Levodopa - 100mg, Carbidopa - 25mg Tablet 2,742,335 L.L
C07AB12 NEBILET B Nebivolol HCl - 5mg 5mg Tablet, scored 694,767 L.L
D01AC12 LOMEXIN B Fenticonazole nitrate - 2g/100g 2% Cream 758,029 L.L
H02AB02 DECADRON B Dexamethasone - 0.5mg/5ml 0.5mg/5ml Elixir 449,227 L.L
L04AA42 MAYZENT B Siponimod - 2mg 2mg Tablet, film coated 124,258,444 L.L
C09DA08 VOTUM PLUS B Olmesartan medoxomil - 40mg, Hydrochlorothiazide - 25mg Tablet, film coated 933,971 L.L
D01AC14 DERMOFIX B Sertaconazole nitrate - 20mg/g 2% Cream 382,995 L.L
J01XX08 ZYVOX IV B Linezolide - 600mg/300ml 600mg/300ml Injectable solution 4,414,523 L.L
L01BA04 ALIMTA B Pemetrexed (disodium) - 100mg 100mg Injectable concentrated powder for solution 16,854,009 L.L
L04AA44 RINVOQ B Upadacitinib - 15mg 15mg Tablet, prolonged release 45,469,094 L.L
R03AK06 SERETIDE DISKUS 500 B Salmeterol (xinafoate) - 50mcg/inhalation, Fluticasone propionate - 500mcg/inhalation Inhalation powder 3,199,689 L.L
R06AX27 AERIUS B Desloratadine - 0.5mg/ml 0.5mg/ml Solution 403,153 L.L
B05AA06 GELASPAN B Gelatine, succinylated - 4% 4% Injectable solution 9,107,572 L.L
D01AE14 MYCOSTER B Ciclopirox - 8g/100g 8% Film forming solution 756,583 L.L
A10BA02 GLUCOPHAGE XR B Metformin HCl - 500mg 500mg Tablet, prolonged release 484,421 L.L
A16AB02 CEREZYME B Imiglucerase - 400IU 400IU Injectable lyophilised powder for solution 128,412,818 L.L
B05AA07 VOLUVEN B Starch poly(O-2-Hydroxyethyl) - 6% 6% Injectable solution 987,724 L.L
C09DA08 VOTUM PLUS B Olmesartan medoxomil - 40mg, Hydrochlorothiazide - 12.5mg Tablet, film coated 933,971 L.L
D01AE14 MYCOSTER B Ciclopirox - 8g/100g 8% Film forming solution 756,583 L.L
B05BA01 AMINOVEN 10% B Glacial Acetic Acid 99% - 5.297g/l, L-Proline - 15.0g/l, L-Alanine - 15.0g/l, Glycine - 14.0g/l, L-Histidine - 3.00g/l, L-Arginine - 12.0g/l, L-Valine - 6.20g/l, L-Tryptophan - 2.00g/l, L-Threonine - 4.40g/l, L-Phenylalanine - 5.10g/l, L-Methionine - 4.30g/l, L-Lysine (monoacetate) - 6.60g/l, L-Leucine - 7.40g/l, L-Isoleucine - 5.00g/l Injectable solution 951,440 L.L
D01AE14 MYCOSTER B Ciclopirox - 1% 1% Cream 325,210 L.L
J01DD07 CEFIZOX B Ceftizoxime (sodium) - 1g 1g Injectable powder for solution 788,836 L.L
N04BB01 PK-MERZ B Amantadine (sulfate) - 100mg 100mg Tablet, film coated 1,382,814 L.L
A16AB05 ALDURAZYME B Laronidase - 100U/ml 100U/ml Injectable concentrate for solution 57,138,680 L.L
B05BA01 AMINOVEN INFANT B L-Leucine - 13g/l, L-Isoleucine - 8g/l, L-Lysine Acetate - 12g/l, L-Methionine - 3.12g/l, L-Phenylalanine - 3.75g/l, L-Threonine - 4.40g/l, L-Tryptophan - 2.01g/l, L-Valine - 9g/l, Arginine - 7.5g/l, L-Histidine - 4.76g/l, Glycine - 4.15g/l, L-Taurine - 0.40g/l, L-Serine - 7.67g/l, L-Alanine - 9.3g/l, L-Proline - 9.71g/l, N-Acetyl-L-Tyrosine - 5.176g/l, N-Acetyl-L-Cysteine - 0.70g/l, L-Malic Acid - 2.62g/l 10% Injectable solution 880,217 L.L
C09DA08 VOTUM PLUS B Olmesartan medoxomil - 20mg, Hydrochlorothiazide - 25mg Tablet, film coated 900,374 L.L
D01AE15 LAMISIL B Terbinafine HCl - 10mg/g 1% Cream 616,824 L.L
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