scholarly journals Monitoring of Foreign Drug Safety Information

2019 ◽  
Vol 7 (4) ◽  
pp. 221-226
Author(s):  
Editorial Article
Keyword(s):  
Nalidixic Acid ◽  
Drug Safety ◽  
Safety Profile ◽  
Safety Information ◽  
Expert Evaluation ◽  
Medicinal Products ◽  
Pipemidic Acid ◽  
Direct Acting Antiviral ◽  
Direct Acting ◽  
Drug Safety Information

Analysis of administrative decisions of foreign regulatory authorities on the recoil of medicines and/or the need for changes in the instructions for their medical use due to changes in the safety profile, conducted by experts of the Scientific Centre for Expert Evaluation of Medicinal Products revealed 23 administrative decisions. These decisions contained information on the following medicines registered in Russia: аmitriptyline, duloxetine, quetiapine, lamotrigine, topiramate, phenytoin, articaine, epinephrine, bupivacaine, oxybutynin, dexlansoprazole, pantoprazole, esomeprazole, famotidine, ketoconazole, minocycline, quinolone and fluoroquinolone (cinoxacin, ciprofloxacin, flumequine, levofloxacin, lomefloxacin, moxifloxacin, nalidixic acid, norfloxacin, ofloxacin, pefloxacin, pipemidic acid, prulifloxacin and rufloxacin), antiretrovirals (abacavir, abacavir, dolutegravir, lamivudine, zidovudine, atazanavir, cobicistat, emtricitabine, tenofovir, darunavir, didanosine, rilpivirine, efavirenz, enfuvirtide, etravirine, fosamprenavir, indinavir, lopinavir, ritonavir, maraviroc, raltegravir, rilpivirine, nevirapine, saquinavir, tipranavir), direct-acting antiviral drugs (daclatasvir, dasabuvir, elbasvir, grazoprevir, glecaprevir, pibrentasvir, sofosbuvir, ombitasvir, ritonavir). 

scholarly journals Monitoring Drug Safety Information - Recommendations of Foreign Regulatory Authorities

2020 ◽  
Vol 8 (1) ◽  
pp. 52-54
Author(s):  
Artiсle Editorial
Keyword(s):  
Safety Information ◽  
Insulin Degludec ◽  
Ethyl Esters ◽  
Expert Evaluation ◽  
Omega 3 ◽  
Medicinal Products ◽  
Recombinant Human Insulin ◽  
Regulatory Authorities ◽  
Monitoring Drug ◽  
Drug Safety Information

Analysis of administrative decisions of foreign regulatory authorities on the recoil of medicines and/or the need for changes in the instructions for their medical use due to changes in the safety profi le, conducted by experts of the Scientifi c Centre for Expert Evaluation of Medicinal Products revealed 16 administrative decisions. These decisions contained information on the following medicines registered in Russia: norepinephrine, xylometazoline, mometason, liraglutide recombinant, exenatide, insulin recombinant human, insulin degludec, teriparatide, progesterone, gestodene, desogestrel, dienogest, drospirenone, norgestrel, lynestrenol, levonorgestrel, medroxyprogesterone, mestranol, nomegestrol, norethisterone, norgestimate, chlormadinone, cyproterone, estradiol, ethinylestradiol, etonogestrel, ethinylestradiol, fi nasteride, abiraterone, thiamazole, omega-3-acid ethyl esters, pitavastatin. 

scholarly journals Drug Safety Monitoring Information

2020 ◽  
Vol 8 (2) ◽  
pp. 104-106
Author(s):  
Article Editorial
Keyword(s):  
Drug Safety ◽  
Safety Profile ◽  
Safety Monitoring ◽  
Expert Evaluation ◽  
Medicinal Products ◽  
Regulatory Authorities ◽  
Drug Safety Monitoring ◽  
Prescribing Information ◽  
Monitoring Information

Experts of the Department for Evaluation of Medicinal Products’ Safety of the Scientific Centre for Expert Evaluation of Medicinal Products analysed administrative decisions of foreign regulatory authorities on the recall of medicines and/or the need to amend the prescribing information due to changes in their safety profile. The analysis helped to identify 11 administrative decisions that contain information on the following medicines registered in Russia: ranitidine, nizatidine, famotidine, pantoprazole, ondansetron, domperidone. 

scholarly journals Drug Safety Monitoring Information

2021 ◽  
Vol 9 (2) ◽  
pp. 103-105
Author(s):  
E. V. Shubnikova ◽  
E. O. Zhuravleva ◽  
N. Yu. Velts ◽  
P. M. Giulakhmedova ◽  
A. A. Druzhinina
Keyword(s):  
Drug Safety ◽  
Safety Profile ◽  
Safety Monitoring ◽  
Expert Evaluation ◽  
Medicinal Products ◽  
Regulatory Authorities ◽  
Drug Safety Monitoring ◽  
Monitoring Information

Analysis of administrative decisions of foreign regulatory authorities on the recall of medicines and/or the need for changes in the instructions for their medical use due to changes in the safety profile, conducted by experts of the Scientific Centre for Expert Evaluation of Medicinal Products revealed 19 administrative decisions. These decisions contained information on the following medicines registered in Russia: amikacin, tobramycin, gentamicin, neomycin, ciprofloxacin, delafloxacin, levofloxacin, lomefloxacin, moxifloxacin, norfloxacin, ofloxacin, pefloxacin, prulifloxacin, rufloxacin, сeftriaxone, ceftaroline, rifapentine, tigecycline, bacitracin, ertapenem, daptomycin, erythromycin, fosfomycin, ampicillin+sulbactam, chloroquine, hydroxychloroquine.

Keeping Up With Drug Safety Information

2006 ◽  
Author(s):  
Michelle Meadows
Keyword(s):  
Drug Safety ◽  
Safety Information ◽  
Drug Safety Information

New FDA guidance on drug safety information communication

2007 ◽  
Vol &NA; (1142) ◽  
pp. 2
Author(s):  
&NA;
Keyword(s):  
Drug Safety ◽  
Safety Information ◽  
Information Communication ◽  
Fda Guidance ◽  
Drug Safety Information

Drug safety information on the Internet inadequate

2003 ◽  
Vol &NA; (952) ◽  
pp. 3
Author(s):  
&NA;
Keyword(s):  
Drug Safety ◽  
Safety Information ◽  
The Internet ◽  
Drug Safety Information

scholarly journals What is the quality of drug safety information for patients: A n analysis of REMS educational materials

2018 ◽  
Vol 27 (9) ◽  
pp. 969-978 ◽  
Author(s):  
Hilda W. Chan ◽  
Andrea M. Russell ◽  
Meredith Y. Smith
Keyword(s):  
Drug Safety ◽  
Safety Information ◽  
Educational Materials ◽  
Drug Safety Information
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