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Excipients with Known Action


Announcement: List of Excipients with Known effect available in the medicines authorized for use in Lebanon

Date March 5th, 2024

The Lebanese National Pharmacovigilance Program (LNPVP) at the Ministry of Public Health (MoPH) has undertaken a comprehensive review of the available medicines authorized for use in the Lebanese market, with the collaboration and support of drug distributors and Marketing Authorization Holders (MAH) who actively contributed to the project.

The Role of Excipients in Medicines

According to the European Medicines Agency (EMA), excipients, constituents in medicines excluding the active substance, play crucial roles in drug formulation. These roles range from aiding in manufacturing processes to enhancing stability, bioavailability, and patient acceptability.

Understanding Excipients with Known Effect in Drug Formulation

Excipients contribute to product identification, overall safety attributes, effectiveness, and the delivery of the drug in use. Additionally, they play a key role in maintaining the integrity of drug products during storage. Although excipients are generally considered 'inert’, it is important to note that some may have a recognized action or effect in specific circumstances. Excipients with known effects may pose challenges in sensitive patients (those with allergies or specific intolerance syndromes), necessitating particular precautions during use. Therefore, to ensure the highest level of safety, it is advisable to consider these excipients when prescribing, dispensing, or providing advice on any medication.

The objective of the project

The main objective of the project was to establish a thorough compilation of excipients with known effects present in medications authorized for use in the Lebanese market in 2024. This compilation specifically focused on drugs for which input was received from both drug distributors and Marketing Authorization Holders (MAHs). As such the list is not exhaustive, and Healthcare professionals should give special care to controlling the excipients when prescribing or dispensing any medication.The received list underwent rigorous cleaning, validation, and compilation processes to serve as a valuable reference for identifying excipients with known effects that might be subject to inquiry.

List of Excipients with Known effect available in the medicines authorized for use in Lebanon
 
Excipients with a Known Effect List to be filled by the drug distributors
 
On behalf of the Lebanese National Pharmacovigilance Program (LNPVP) at the Ministry of Public Health (MoPH), we kindly request to provide information regarding your products in the context of a project on “Excipients with a Known Effect or Action”. 

The information related to pharmaceutical excipients with known effects is important in pharmacy practice. In general, excipients are considered to be ‘inert’. Whilst it is desirable that excipients should have little or no pharmacological action of their own, some do indeed have a recognized action or effect in certain circumstances. Excipients with a known effect have the particularity of being poorly tolerated in sensitive patients (allergic or presenting a particular intolerance syndrome) and require certain precautions for use. Consequently, in order to guarantee the best level of safety, it is useful to take these excipients into account when prescribing, dispensing or even advising of any medication.

The project aims to provide a list of drugs marketed in Lebanon with their corresponding excipients that have a known action or effect in certain circumstances.
 
You are therefore kindly requested to identify, from the provided list (Excipients with a Known Effect List to be filled by the drug distributors), the excipients with a known effect that are present in your corresponding drug products.

To this end, you are kindly invited to apply the following instructions:

The below link for the excel sheet (Excipients with a Known Effect List to be filled by the drug distributors) is a list of the products marketed in Lebanon with their relevant information. It is extracted from the latest Drugs Public Price List from the MoPH’s official website. (extracted on 7th March, 2023) Excipient List to be filled by drug distributors in Lebanon
 
For each of your products:
  1. In the “Agent” column (Column C), apply the filter to choose your company name; this will display only your products in the “Brand name” column (Column D).
  2. In the “Excipients” column (Column K), choose for each of your products the identified excipients from the dropdown list provided. To access the dropdown list, select the cell (under the ‘Excipient” column) corresponding to each product; a downwards arrow will appear at the lower-right corner of the cell. Select it and choose from the provided list of excipients.
  3. If your product contains more than one excipient, include each in a separate column (Columns M and O). Add as much columns as needed. If your product doesn’t contain any of the listed excipients, select the “None” option from the excipients’ dropdown list.
  4. Fill the “Route of Administration” column (Column J) appropriately using the drop down list. (Capitalize only the first letter)
  5. Fill the “Comment” column (Column Q) with any information present on the label and /or package leaflet regarding the identified excipients. If nothing is mentioned keep the cell blank.
  6. Please refer to raw number 4 as an example.
  7. Send us the filled excel sheet at the following email addresses: excipients.moph@gmail.com or excipients@moph.gov.lb
  8. Ensure that your file is named as follow: (name of the distributor-excipientlist2023),Example: Mersaco-excipientlist2023
 
You are kindly expected to reply back within 2 months after receiving this email (by May 31st, 2023), the latest.
 
Thank you for your time and cooperation.

Reminder,

Reference to previous communication related to the submission of Excipients with a known Action list, we would like to kindly remind all drug distributers and local manufacturers to complete this list by May 31st, 2023.

As per the previously shared instruction, the list must be filled out with utmost accuracy. It is essential to carefully select the appropriate excipient(s) and indicate the salt with its corresponding dose in the excipient dose section. Additionally, it is important to include any relevant package leaflet information in the comment section. We stress the importance of adhering to these instructions to ensure the safety and efficacy of medication use.

In case there are there are no excipients with known action in your corresponding products, please verify this by an email to excipients.moph@gmail.com.

We appreciate your cooperation in this matter.

Quality Assurance of Pharmaceutical Products Department
Lebanese National Pharmacovigilance Program
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ATC Name B/G Ingredients Dosage Form Price
B03AC FERINJECT B Iron trivalent (ferric carboxymaltose) - 500mg/10ml 500mg/10ml Injectable solution 10,212,033 L.L
B05DB DIANEAL PD4 CYCLER 3.86% GLUCOSE B Sodium lactate - 4.48g/l, Magnesium chloride - 0.051g/l, Calcium chloride - 0.184g/l, Sodium chloride - 5.38g/l, Anhydrous glucose - 38.6g/l Injectable solution 1,150,329 L.L
C05CX TANAKAN B Ginkgo biloba - 40mg 40mg Tablet, film coated 600,698 L.L
C09CA08 OLMETEC B Olmesartan medoxomil - 20mg 20mg Tablet, film coated 888,280 L.L
L01AX03 TEMODAL B Temozolomide - 100mg 100mg Capsule 7,731,224 L.L
L04AA44 RINVOQ B Upadacitinib - 15mg 15mg Tablet, prolonged release 45,469,094 L.L
N05AD01 HALDOL B Haloperidol - 5mg 5mg Tablet 231,141 L.L
S01AE03 CILOXAN B Ciprofloxacine (HCl) - 3mg/ml 3mg/ml Drops solution 348,055 L.L
B05XA PEDITRACE B Sodium selenite 5H2O (anhydrous) - 6.66mcg/ml, Sodium fluoride - 126mcg/ml, Potassium iodide - 1.31mcg/ml, Zinc chloride - 521mcg/ml, Copper chloride - 53.7mcg/ml, Manganese chloride 4H2O - 3.6mcg/ml Injectable concentrated solution 4,749,139 L.L
C05CX TANAKAN B Ginkgo biloba - 40mg 40mg Tablet, film coated 1,662,333 L.L
C09CA08 VOTUM B Olmesartan medoxomil - 20mg 20mg Tablet, film coated 954,128 L.L
J01MA17 KINODROX B Prulifloxacin - 600mg 600mg Tablet, film coated 1,407,835 L.L
B03AD MALTOFER FOL B Folic acid - 0.35mg, Iron trivalent (hydroxide polymaltose) - 100mg Tablet, chewable 854,684 L.L
C09CA08 VOTUM B Olmesartan medoxomil - 20mg 20mg Tablet, film coated 954,128 L.L
J01MA23 BAXDELA B Delafloxacin - 450mg 450mg Tablet 93,777,847 L.L
N05AD01 HALDOL DECANOAS B Haloperidol (Decanoate) - 50mg/ml 50mg/ml Injectable solution 444,812 L.L
R03AL03 ANORO ELLIPTA B Vilanterol - 25mcg, Umeclidinium bromide - 62.5mcg Inhalation powder 5,367,774 L.L
L01XX41 HALAVEN B Eribulin mesylate - 0.88mg/2ml 0.88mg/2ml Injectable solution L.L
J01MA23 BAXDELA B Delafloxacin - 300mg 300mg Injectable concentrate for solution 78,349,010 L.L
R03AL04 ULTIBRO BREEZHALER B Indacaterol - 110mcg, Glycopyronium - 50mcg Capsule, inhalation 4,031,528 L.L
L01ED03 ALECENSA B Alectinib - 150mg 150mg Capsule, hard L.L
C05CX REPARIL B Aescine - 20mg 20mg Tablet, sugar coated 510,660 L.L
C09CA08 OLMETEC B Olmesartan medoxomil - 40mg 40mg Tablet, film coated 920,532 L.L
C10AA07 CRESTOR B Rosuvastatin (calcium) - 5mg 5mg Tablet 589,947 L.L
G04CA04 SILOSIN B Silodosine - 4mg 4mg Capsule 1,251,693 L.L
L01AX03 TEMODAL B Temozolomide - 20mg 20mg Capsule 1,612,611 L.L
R03AL06 SPIOLTO RESPIMAT B Olodaterol HCl - 2.5mcg/puff, Tiotropium bromide monohydrate - 2.5mcg/puff Inhalation solution 5,087,788 L.L
B03AD03 GYNO-TARDYFERON B Folic acid - 0.35mg, Ferrous (sulfate) - 80mg Tablet, sugar coated, slow release 682,672 L.L
C09CA08 VOTUM B Olmesartan medoxomil - 40mg 40mg Tablet, film coated 1,032,071 L.L
N02BE01 TYLENOL B Paracetamol - 350mg 350mg Suppository 239,204 L.L
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