What is the reason for the suspension of Analgin-Quinine in Bulgaria?

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At the beginning of the Covid-19 pandemic, it was rumored that Analgin-Quinine had positive results in the treatment of coronavirus patients. This drug was sold in Bulgaria but is no longer available on the pharmacy network. Currently a Bulgarian company produces and exports it to Russia.

There have been numerous claims and speculations as to why Analgin-Quinine is no longer available on the Bulgarian market. They included the name of GERB deputy Desislava Atanasova.

Therefore, she has addressed an official question in her capacity as MP to the Minister of Health Kiril Ananiev. In it Atanasova asks when the authorization for use of the medication in Bulgaria has been revoked, as well as with the act of which state body the change was made. In addition, Atanasova asked what was the reason for the change of the marketing authorization.

The deputy received a response from Ananiev, who posted on her profile on the social network Facebook. It states that Analgin-Quinine had a valid registration in Bulgaria until 2000. The reason is that with the adopted amendment to the Human Medicines and Pharmacies Act 1995, all medicines registered prior to the entry into force of the statutory document, including Analgin-Quinine, retain their registration for a period of 5 years.

Within this period, the manufacturing company did not submit an application and a current dossier for re-registration of the medicinal product, which led to its withdrawal. Thereafter, no changes were made to the authorization for use of Analgin-Quinine because it does not have valid ones because of the expired registration.

In addition, the Ministry of Health states that currently we have authorized medicines Analgin Chin 250 mg and Analgin Chin 500 mg. They have the international name Metamizole sodium. They were authorized in 2011 under a national procedure.

Analgin Chin contains both the active substance Metamizole sodium and other types of excipients – quinine hydrochloride, povidone, cellulose, colloidal anhydrous talc.

The health ministry also states what condition Analgin Chin is used for. It affects: headache, toothache, neuralgia, myalgia, trauma, burns, postoperative pain, cancer pain, renal and biliary colic. It is also used as an antipyretic agent in the complex therapy of various conditions accompanied by fever.

Analgin-Quinine also contains: metamizole sodium, quinine hydrochloride, MCC, sodium carboxymethyl starch (primogel), colidone (povidone), talcum powder, magnesium stearate.

Desislava Atanasova states in her Facebook profile that she was found guilty of suspending Analgin-Quinina and therefore decided to publish the response of the health department. She urges her friends to share the documents on the social network to stop speculation on the subject.

Translation: Diana Todorova

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