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MBROTIR L (Potassium iodide) has granted the Marketing Authorization

MBROTIR L (Potassium iodide) has granted the Marketing Authorization

Press Release Details

Oct 07,2022

LEKLI Announces that the National Agency for Medicines and Medical Devices, has granted the Marketing Authorization for Potassium Iodide (MBROTIR L) used in cases of nuclear accidents or nuclear reactor accidents to prevent the uptake of radioactive iodine by the thyroid

 

TIRANË-- Oct 07, 2022—LEKLI sh.p.k. announced that the National Agency for Medicines and Medical Devices has validated the Marketing Authorization Application (MAA) for Potassium Iodide (MBROTIR L). The submission was supported by previously disclosed positive results of two years of work to achieve this vital formula for our current living situation.

“Today marks a significant milestone in our efforts to bring new medicine to the people in Albania, Kosovo, and all around the world who are living the current reality of the difficult situation created by the war in Ukraine combined with the fear and insecurity regarding nuclear power plants all over the world.,” said K. Lekli, Pharm.D., Executive Vice President and CMO at LEKLI. “We are looking forward to working with the National Agency for Medicines and Medical Devices on other important applications.”

About nuclear accidents or nuclear reactor accidents

In the event of accidents in nuclear facilities, particularly nuclear power plants, radioactive iodine may be released and affect the health of the population exposed to the cloud and then to the deposition. When inhaled or ingested, radioiodine tends to concentrate in the thyroid gland, giving rise to high concentrations in this organ. High concentrations of radioiodine in the thyroid gland increases the risk of thyroid cancer development in the exposed people.

When taken in due time at the appropriate dosage, potassium iodide tablets prevent the accumulation of radioactive iodine in the thyroid gland by saturating it with non-radioactive iodine. This protection action is recommended by several international organizations and has been adopted by several countries worldwide.

The ICRP, IAEA, and WHO have taken positions on intervention action level and target population in order to reinforce the prevention measures by targeting the more sensitive groups. These recommendations are based primarily on the results of thyroid cancer research on exposed children.

The recommendations adopted for iodine prophylaxis, in particular those regarding the administration timing, the iodine quantity to be given, and the possible side effects occurring as a result of this measure were made based on the scientific information available to the medical community concerning the effects of stable iodine on the health status of people receiving the treatment. Since then, many teams around the world have continued their research (basic research and clinical research), especially those dealing with the iodine transfer mechanisms through the cells within the thyroid gland, and those regarding the side effects observed after the administration of stable iodine, in response to the information provided by the physicians who noted the adverse health effects observed in people receiving stable iodine.

*) EUROPEAN COMMISSION RADIATION PROTECTION NO 165 Medical effectiveness of iodine prophylaxis in a nuclear reactor emergency and overview of European practices Final Report of Contract TREN/08/NUCL/SI2.520028

ABOUT LEKLI SH.P.K

LEKLI sh.p.k is a pharmaceutical company focused on market research and manufacture of medical products for human use.Our experience in pharmaceuticals began in 1986 and resulted in the establishment of LEKLI sh.p.k in 1991 by Dr. Luan Lekli. During these years, LEKLI sh.p.k managed to grow from a well- established Pharma company to a company with cross border presence.

In the following years, we specialized in the field of rare diseases, leading the market and making sure that every single patient is able to live a better life. In 2015, LEKLI sh.p.k established a production facility, manufacturing generic drugs, Phytotherapeutics and orphan drugs. To cover all the needs of the Albanian market, we produce prescription, non-prescription, extemporaneous and stock pharmaceutical preparations.

Our experience spans more than 25 years in the Balkan market, during which we have established our presence through our operations in Albania and in Kosovo. Today we have a strong brand equity and awareness. Together with our highly motivated, experienced and empowered management team we lead the market in special indications areas.

LEKLI disclaims any obligation to update the information contained in this press release as new information becomes available.

LEKLI sh.p.k :

Kristian Lekli, +355 69 720 3644

Besmira Basholli, +355 69 357 1311

David Lekli, +355 69 833 4620

Shpend Hasani, +383 44 197 654 (Kosove)

Email: This email address is being protected from spambots. You need JavaScript enabled to view it.

1
LEKLI sh.p.k  Headquaters
Blv. Bajram Curri, Nd.172,
H.8, 1010 Tiranë, Albania
+355 42 374517
+355 68 900 5483
[email protected]
5
LEKLI sh.p.k Kosove
Rr: Xhemail Mustafa,
23, Prishtine, Kosove 
+383 44 197 654
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Production Facility
Autostrada Tiranë-Durrës,
Rr. Egnatia, Mbrapa Megatek,
Tiranë, Albania
+355 68 900 5486
3
LEKLI sh.p.k Tiranë
Rr. Reshit Petrela,
Pall.14, H.21, 1010,
Tiranë, Albania
+355 68 900 5488
4
LEKLI sh.p.k Durrës
Rr. Aleksandër Goga,
2001 Durrës, Albania
+355 68 900 5489
5
LEKLI sh.p.k Kosove
Rr: Xhemail Mustafa,
23, Prishtine, Kosove 
+383 44 197 654
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