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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 IVIRON G Iron (sucrose) - 100mg/5ml 100mg/5ml Injectable concentrated solution 1,745,203 L.L
B03AC FERINJECT B Iron trivalent (ferric carboxymaltose) - 500mg/10ml 500mg/10ml Injectable solution 10,212,033 L.L
B03AC FERAPPLIC G Iron trivalent (ferric carboxymaltose) - 500mg/10ml 500mg/10ml Injectable dispersion 34,231,559 L.L
B03AB09 FERPLEX B Iron trivalent (ferric proteinsuccinylate) - 800mg 800mg Solution 1,202,739 L.L
B03AB05 ENRICH N G Iron trivalent (hydroxide polymaltose complex) - 50mg/ml 50mg/ml Drops 459,594 L.L
B03AB ENRICH N G Iron trivalent (hydroxide polymaltose complex) - 156.25mg/5ml Syrup 279,519 L.L
B03AA07 PEDIAFER G Ferrous (sulfate) - 15mg/ml 15mg/ml Drops 388,370 L.L
B03AA07 TIMOFEROL G Iron bivalent (as dried ferrous sulfate) - 50mg (172.73mg), Ascorbic acid - 30mg Capsule 652,931 L.L
B03AA02 FERRATE G Ferrous fumarate - 20mg/ml (iron element) 20mg/ml Suspension 533,505 L.L
B03AA02 FEOSTA G Ferrous fumarate - 200mg 200mg Tablet, film coated 682,160 L.L
B03AA02 FEOSTA G Ferrous fumarate - 200mg 200mg Tablet, film coated 9,355,300 L.L
B02BX06 HEMLIBRA BioTech Emicizumab - 60mg/0.4ml 60mg/0.4ml Injectable solution 441,042,377 L.L
B02BX06 HEMLIBRA BioTech Emicizumab - 30mg/ml 30mg/ml Injectable solution 224,585,721 L.L
B02BX06 HEMLIBRA BioTech Emicizumab - 150mg/ml 150mg/ml Injectable solution 716,437,779 L.L
B02BX06 HEMLIBRA BioTech Emicizumab - 105mg/0.7ml 105mg/0.7ml Injectable solution 577,741,643 L.L
B02BX06 HEMLIBRA BioTech Emicizumab - 30mg/ml 30mg/ml Injectable solution L.L
B02BX05 REVOLADE B Eltrombopag Olamine - 25mg 25mg Tablet, film coated 79,847,895 L.L
B02BX05 REVOLADE B Eltrombopag Olamine - 50mg 50mg Tablet, film coated 67,227,846 L.L
B02BX05 REVOLADE B Eltrombopag Olamine - 50mg 50mg Tablet, film coated L.L
B02BX04 NPLATE BioTech Romiplostim - 250mcg 250mcg Injectable powder for solution 67,369,332 L.L
B02BX04 NPLATE BioTech Romiplostim - 250mcg 250mcg Injectable powder for solution L.L
B02BX01 DICYNONE B Etamsylate - 250mg/2ml 250mg Injectable solution 482,439 L.L
B02BX01 DICYNONE B Etamsylate - 500mg 500mg Capsule 1,311,590 L.L
B02BD08 NOVOSEVEN RT BioTech Eptacog alfa (activated) recombinant - 2mg 2mg (100KIU) Injectable powder for solution+diluent 105,957,406 L.L
B02BD08 ARYOSEVEN RT BioTech Eptacog alfa - 1mg 1mg Injectable powder for solution+diluent 16,902,713 L.L
B02BD08 NOVOSEVEN RT BioTech Eptacog alfa (activated) recombinant - 1mg 1mg (50KIU) Injectable powder for solution+diluent 57,890,287 L.L
B02BD08 NOVOSEVEN RT BioTech Eptacog alfa (activated) recombinant - 5mg 5mg (250KIU) Injectable powder for solution+diluent 264,894,762 L.L
B02BD08 RECOFACT VII BioTech Eptacog alfa (activated) recombinant - 1.2mg 1.2mg Injectable powder for solution+diluent 47,533,131 L.L
B02BD08 ARYOSEVEN RT BioTech Eptacog alfa - 1mg 1mg Injectable powder for solution+diluent L.L
B02BD08 NOVOSEVEN RT BioTech Eptacog alfa (activated) recombinant - 1mg 1mg (50KIU) Injectable powder for solution+diluent L.L
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