In mid-February, an order was published on the website of the State Register of Medicines (GRLS) to resume the use of the drug Nurofen for children. The use of the drug was suspended on August 7, 2019. We are talking about the drug ibuprofen in the dosage form of rectal suppositories, 60 mg. The marketing authorization holder is Reckitt Benckiser

The US Food and Drug Administration (FDA) has approved the first drug to combat severe frostbite. The drug Aurlumyn (iloprost) showed its effectiveness in clinical trials involving 47 people. Aurlumyn (iloprost) is a vasodilator drug where active ingredient is iloprost – the synthetic analogue of prostacyclin PGI2. Iloprost improves blood flow to tissues, inhibits platelet aggregation and reduces high blood

With the entry into force of the EAEU Medicines Registration Rules, applicants have the opportunity to follow more flexible regulatory procedures and, for example, add a new dosage form within the framework of an existing registration. In this article, we will look at how you can avoid new registration if you plan to introduce a new dosage form of an

In July, the State Register of Medicinal Products (GRLS) published two information letters from the Ministry of Health of the Russian Federation with recommendations for changes to the instructions for medical use (IMP), summary of product characteristics (SmPC) and package leaflets (PL). We are talking about preparations containing warfarin and acenocoumarol as active ingredients, as well as topiramate. Warfarin (5

The court ordered drug manufacturer Servier to pay 424 million euros for the sale of the drug Mediator (benfluorex), the use of which can cause serious side effects for patients. Mediator (benfluorex) was first registered in France by Servier in 1976. The drug is a selective serotonin reuptake inhibitor that can suppress appetite. The drug was prescribed mainly to patients

Often in the specification of a regulatory document (ND) on quality you can find such a quality indicator as “Related substances”. What is this indicator? Why is it important and how is it standardized? Related substances (e.g., precursor substances, certain degradation products) are variants of the molecular structure formed during manufacturing and/or storage that do not have properties comparable to

The well-known antibiotic amoxicillin has been found to have new undesirable effects. An information letter was published on the Roszdravnadzor website about this. Back in November 2022, it became known about a possible relationship between amoxicillin administration and the development of aseptic meningitis, Kounis syndrome (allergic acute coronary syndrome), crystalluria (including acute renal failure), drug-induced enterocolitis syndrome (DIES) and linear

According to Novo Nordisk’s official website, the company is primarily engaged in the development and production of drugs for the treatment of type 1 and type 2 diabetes, obesity, dysplasia and hemophilia. In August, 2023 it became known that the Danish company plans purchase of the Canadian company Inversago Pharma for $1.07 billion. Inversago Pharma is dedicated to developing treatments

We are talking about the entry into force of amendments 9 and 10 of the edition of Decision 78 “On the Rules for Registration and Examination of Medicines for Medical Use.” All participants in the pharmaceutical industry were eagerly awaiting the entry into force of Decision No. 60 (Edition 9), according to which clause 30 of the Registration Rules was