PubMed Journals Articles About "Human Medicines European Public Assessment Report EPAR Tadalafil" RSS

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Showing "Human medicines European public assessment report EPAR Tadalafil" PubMed Articles 1–25 of 44,000+

Falsified tadalafil tablets distributed in Japan via the internet.

The adverse health effects of falsified medicines for erectile dysfunction have been reported in Japan. We purchased tadalafil (Cialis) tablets online and assessed their authenticity and quality. Of the 45 samples we tested, nine were genuine, 23 were falsified, nine were unregistered/unlicensed samples, and the authenticity of four samples could not be ascertained. Observation of packaging and tablet size, weight, and color revealed differences between some genuine and falsified samples. All genuine sample...

The European Medicines Agency facilitates access to medicines in low- and middle-income countries.

: As part of its contribution to promoting global health, the European Medicines Agency can assess medicines for use outside the European Union (EU) and issue scientific opinions in collaboration with the World Health Organization and non-EU national regulatory authorities. Ten positive scientific opinions have been adopted by the Committee for Medicinal Products for Human Use of the European Medicines Agency medicines (EU-M4all, or article 58). We have investigated for the first time their impact.: We incl...

The Effect of Tadalafil on Reepithelialization and Scarring of Partial Thickness Porcine Burns.

Burn conversion from second to third degree is common leading to delayed healing and scarring. We hypothesized that tadalafil, a phosphodiesterase 5 inhibitor (PDE5I) that results in vasodilation, would reduce burn conversion leading to faster reepithelialization and less scarring of partial thickness porcine burns. We conducted a prospective, randomized, controlled, animal experiment using six female pigs (25-30 kg). We created 20 standardized partial thickness burns on each of the animals with an aluminum...

Modern slavery and public health: a rapid evidence assessment and an emergent public health approach.

Modern slavery is a human rights violation and a global public health concern. To date, criminal justice approaches have dominated attempts to address it. Modern slavery has severe consequences for people's mental and physical health, and there is a pressing need to identify and implement effective preventative measures. As such, a public health approach to modern slavery requires elucidation. The objectives of this study were to explore the case for public health involvement in addressing modern slavery an...

A successful treatment of tadalafil in incontinentia pigmenti with pulmonary hypertension.

We describe a female infant with incontinentia pigmenti complicated by severe pulmonary arterial hypertension that was markedly improved by tadalafil administration. The infant was referred to our institution because of neonatal seizures and generalized skin rash at the age of 1 day. She was diagnosed with incontinentia pigmenti on skin biopsy findings. In addition to incontinentia pigmenti, she had pulmonary arterial hypertension without structural heart disease. The pulmonary hypertension rapidly worsened...

A randomized controlled study of the efficacy of tadalafil monotherapy versus combination of tadalafil and mirabegron for the treatment of persistent overactive bladder symptoms in men presenting with lower urinary tract symptoms (CONTACT Study).

To evaluate efficacy and safety of combination of tadalafil + mirabegron for overactive bladder/benign prostatic hyperplasia (OAB/BPH).

What does non-eligibility for myoma surgery mean in the context of sequential prescription of ulipristal acetate?

Ulipristal Acetate (UPA) is the only selective progesterone receptor modulator currently approved for medical management of myomas. Following several cases of liver toxicity during UPA treatment, new recommendations of PRAC (Pharmacovigilance Risk Assessment Committee) and EMA (European Medicines Agency) have been proposed, including a pre-therapeutic assessment of liver function and a close monitoring during treatment. Repeated courses of UPA have also been restricted to women who are defined as "non-eligi...

New regulatory strategies to manage medicines shortages in Europe.

Medicine shortages have been spreading in European countries. In many cases, the unavailability of medicinal products has a substantial impact on the capability of National healthcare systems in ensuring the continuity of care. Shortages originate from multifactorial causes. In particular, they can be due to supply-related factors (e.g., manufacturing issues, regulatory issues, logistics, distribution) and demand-related ones (e.g., fluctuating drug demand, parallel market, tendering, price and reimbursemen...

Policy developments of health technology assessment in the European Union.

The purpose of the note below is to familiarize readers with the current status and future initiatives of cooperation in the field of health technology assessment (HTA) in the European Union (EU). The European Commission is trying to create a framework for efficient collaboration between member states of EU in the field of HTA and is gradually working on strengthening it. The following initiatives, projects and programs have already been implemented: - Project on Coordination and Development of Health Care ...

A Quantitative Public Health Risk Assessment Tool for Planning for At-Risk Populations.

The Drexel University Center for Public Health Readiness and Communication developed a quantitative public health risk assessment tool that has been used in Pennsylvania and across the United States. The tool assesses hazard impacts on health care and public health metrics and incorporates the planning needs of at-risk populations. The flexible platform using Microsoft Excel allows planners to customize hazard assessment and use jurisdiction-specific data. Findings from the risk assessment can guide plannin...

Which Drug to Discontinue 3 Months After Combination Therapy of Tadalafil plus Tamsulosin for Men with Lower Urinary Tract Symptom and Erectile Dysfunction? Results of a Prospective Observational Trial.

Safety and efficacy of tamsulosin and tadalafil for men with benign prostatic enlargement (BPE) and/or erectile dysfunction (ED) are defined. However, there are only a few pilot studies on combination therapy with these drugs for men with lower urinary tract symptom (LUTS)/BPE and ED. Moreover, preliminary reports are limited to 12 wk, without any information about subsequent therapies.

Human Rabies - Utah, 2018.

On November 3, 2018, the Utah Department of Health (UDOH) was notified of a suspected human rabies case in a man aged 55 years. The patient's symptoms had begun 18 days earlier, and he was hospitalized for 15 days before rabies was suspected. As his symptoms worsened, he received supportive care, but he died on November 4. On November 7, a diagnosis of rabies was confirmed by CDC. This was the first documented rabies death in a Utah resident since 1944. This report summarizes the patient's clinical course a...

Trends in licence approvals for ophthalmic medicines in the United Kingdom.

The grant of marketing authorisation (MA) for new medicines requires comprehensive assessment by regulatory authorities. This study sought to identify ophthalmic medicines granted United Kingdom MA and consider trends in licence approvals.

A Letter to the Editor Concerning the Meta-Analysis by Zhou et al: Meta-Analysis of the Long-Term Efficacy and Tolerance of Tadalafil Daily Compared With Tadalafil On-Demand in Treating Men With Erectile Dysfunction.

Brucellosis: A rapid risk assessment by a regional outbreak team and its coordinated response with the Directorate-General for Food and Veterinary, North region of Portugal, 2019.

We report a Brucella outbreak with seven cases in the Northern Region of Portugal in 2018-2019, associated with the consumption of fresh cheese. This outbreak has implications for risk assessment in Portuguese migrants related to this area, and it is an example of cooperation between public institutions, in a One Health based approach.

Public engagement in health technology assessment in Brazil: the case of the Trastuzumab public consultation.

Public engagement in health technology assessment (HTA) is increasing worldwide. There are several forms of public engagement and it is not always possible to determine which stakeholders participate in the HTA process and how they contribute. Our objective was to investigate which types of social representatives contributed to the public consultation on the incorporation of Trastuzumab for early-stage breast cancer treatment within the public health system in Brazil, held in 2012 by the National Committee ...

Publicly accessible evidence of health-related quality of life benefits associated with cancer drugs approved by the European Medicines Agency between 2009 and 2015.

Health-related quality of life (HRQoL) is one of the most important patient-relevant study end-points for the direct measurement of the benefit of cancer drugs. Therefore, our aim is to detect cancer indications with no published information on HRQoL at the time of European Medicines Agency (EMA) approval and monitor any reported HRQoL evidence updates after at least three years of follow-up.

Workshop Report: FDA Workshop on Improving Cardiotoxicity Assessment With Human-Relevant Platforms.

Given that cardiovascular safety concerns remain the leading cause of drug attrition at the preclinical drug development stage, the National Center for Toxicological Research of the US Food and Drug Administration hosted a workshop to discuss current gaps and challenges in translating preclinical cardiovascular safety data to humans. This white paper summarizes the topics presented by speakers from academia, industry, and government intended to address the theme of improving cardiotoxicity assessment in dru...

19 Annual Meeting of the Safety Pharmacology Society: regulatory and safety perspectives for advanced therapy medicinal products (cellular and gene therapy products).

: This report summarizes and discusses talks delivered at an educational course offered during the 2019 Annual Meeting of the Safety Pharmacology Society on advanced therapy medicinal products (ATMPs) and cell gene therapeutic products (CGTPs).: ATMPs and CGTPs comprise gene and cell therapy medicinal products, tissue-engineered products, or the incorporation of one of these products into a medical device. Cited examples of ATMPs are autologous CD34 cells encoding for the β-globin gene, CAR (chimeric antig...

The implementation of health technology assessment principles in public decisions concerning orphan drugs.

Over the last few years, the share of public spending for orphan drugs (ODs) has increased in several western countries, raising concern on the exemptions granted to this sector with respect to the implementation of health technology assessment (HTA) principles. The aim of this paper is to shed light on both the HTA criteria adopted and the international agreements implemented in the OD regulation, given the new challenges imposed on western countries by a growing number of therapies for rare diseases.

Improvement of peripheral vascular impairment by a phosphodiesterase type 5 inhibitor tadalafil prevents oxaliplatin-induced peripheral neuropathy in mice.

Oxaliplatin, a platinum-based chemotherapeutic drug, frequently induces peripheral neuropathy. Accumulating evidences suggest a possible relationship between peripheral vascular impairment and peripheral neuropathy. In this study, we investigated the effects of vasodilators on cumulative peripheral neuropathy induced by repeated injections of oxaliplatin (10 mg/kg) once a week for 8 weeks in mice. Single injections of vasodilators, including a phosphodiesterase type 5 inhibitor tadalafil acutely alleviated...

Pharmaceutical cost analysis of dental diseases: An Indian scenario.

Medicines are an integral part of the health system and the accessibility hugely depends on affordability and availability of medicines. Oral health is an integral component of overall well-being but is ironically often one of the most neglected areas of healthcare. There is paucity of data on the pharmaceutical cost components of dental disease, so this study aims to address this lacuna on the pricing of medicines. This research study can be considered a partial economic evaluation that focuses on an estim...

Kidney graft survival of >25 years: A single center report including associated graft biopsy results.

We appreciate the valuable comments to our report. Epitope matching or total eplet mismatch could indeed be an attractive explanation for the favorable outcome of the subjects in our report, at least for those without rejection. This relatively novel view of immunological assessment could be very important although its true value remains to be determined.

Hospital pharmacists call for European action to combat medicines shortages.

Smart spectrophotometric assessment of tamsulosin hydrochloride and tadalafil in their new pharmaceutical formulation for treatment of benign prostatic hyperplasia and erectile dysfunction.

A novel combination of tamsulosin hydrochloride and tadalafil is recently available for treatment of benign prostatic hyperplasia and erectile dysfunction. For the first time, four simple, accurate, smart and robust spectrophotometric methods have been suggested for their simultaneous quantification. The methods, namely; first derivative, ratio difference, derivative ratio and mean centering of ratio spectra, successfully resolved the spectral overlap of their challenging binary mixture. Calibration curves ...

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