Glatiramer – Scientific Conclusions and Basis for Modification of Registration Approval Terms – PSUSA-00001529-202011
In view of the available evidence of severe liver damage from clinical trials and spontaneous reports, including in some cases a close temporal relationship, positive withdrawal, and/or re-challenge, PRAC believes that a causal relationship between [...]
Information letter No. 01I-1468/21 of 09.11.2021 on introduction of new safety info into the instruction for use of the drug Baeta® (INN – Exenatide)
New data on the efficacy and safety of the drug were obtained, therefore significant changes were made to the Instructions for Medical Use (SMPC), including the sections Pharmacodynamics, Pharmacokinetics, Indications for use, Use during pregnancy [...]
Information letter from 09.11.2021 № 01I-1463/21 On the results of state quality control of the drug “Amiodarone”
Federal Service for Surveillance in Healthcare reports information about the detection of the drug "AMIODARON, concentrate for preparation of solution for intravenous injection 50 mg/ml 3 ml, ampoules (10), packs of cartons, series 080519 manufactured [...]
Ministry of Health extends increased prices for lomustine and azathioprine
From November 17, 2021, the Ministry of Health extended the prices of the anticancer drug lomustine and the immunosuppressant azathioprine increased by the Government Decree № 1771 from 31.10.2020. This follows from the State Register [...]
Audit with LLC “Zavod Medsintez”, 29.06.2021
On 29.06.2021 ANO NSC of Pharmacovigilance together with "Zavod Medsintez" LLC conducted an audit*, the scope of which was critical processes of pharmacovigilance. Medsintez pharma plant specializes in the production of pharmaceutical products and devices [...]
A total of 4 billion doses of COVID-19 vaccines have been used worldwide
More than 4 billion doses of coronavirus vaccines have been used cumulatively worldwide since immunization programs began, MedicalXpress reports. The rate of vaccination has slowed a bit recently: the last, fourth billion doses were used [...]
New data on the safety of octreotide
2 August 2021 EMA/PRAC/380226/2021 Corr2 Pharmacovigilance Risk Assessment Committee (PRAC) PRACTICAL recommendations on signals Adopted at the July 5-8, 2021 PRAC meeting This document provides an overview of the recommendations adopted by the Office of [...]
Change of the Instructions for Medical Use for Octreotide
It is worth paying attention to the following information: "4.4. Special warnings and precautions for use Function of the pancreas: Exocrine pancreatic insufficiency was observed in some patients treated with octreotide due to gastroenteropancreatic neuroendocrine [...]