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4542. Xeplion - paliperidone

to be fulfilled post-authorisation on 15 December 2010. Xeplion ASSESSMENT REPORT EMA/60983/2011 Page 5/118 2. Scientific discussion 2.1. Introduction This is a complete, Article 8(3) application for XEPLION (paliperidone) for a known active substance (paliperidone) through the centralised procedure. The product is intended for prescription only. Paliperidone (9-hydroxy-risperidone) is the major metabolite of risperidone, which is approved for treatment of schizophrenia since 1994. Paliperidone shares (...) ) and by spectroscopic methods such as UV, IR, 1 H-NMR, 13 C-NMR as well as by mass spectral analysis. The IR, NMR and MS spectrum assignations were consistent with the declared chemical structure. In addition the morphology of the substance was studied. Data generated by scanning electron microscopy (SEM) analysis during the screening studies indicated that the drug substance morphology remains identical even when applying a broad range of variables/conditions and using different isolation/drying techniques

2011 European Medicines Agency - EPARs

4543. Tobi Podhaler - tobramycin

pharmacopoeia monographs. Inhaler development Tobramycin inhalation powder is delivered with a hand-held, manually operated, breath-activated, single-dose dry-powder inhaler that uses no stored power sources or electronics. The product bears a CE mark as a Class I Medical Device under 93/42/EEC the Medical Device Directive and applicable amendments. It was subjected to controlled extraction studies. No substances from those tests were identified as a safety risk which would need to be monitored during (...) concentration Activated Sludge, Respiration Inhibition Test OECD 209 EC50 >1000 mg/L Conclusion phase IIa Based on the risk quotients in the phase II tier A assessment, no adverse effects from tobramycin are expected for the aquatic environment.Page 18/62 Based on the orphan status for tobramycin inhalation powder, the Fpen can be refined using prevalence of cystic fibrosis (worst-case, 1 in 8000 inhabitants) and the prescribed dose regime of 28 days cycles on treatment followed by 28 days off treatment

2011 European Medicines Agency - EPARs

4544. Vyndaqel - tafamidis

/85 List of abbreviations ADL activities of daily living AE adverse event ALP alkaline phosphatase ALT alanine aminotransaminase ANCOVA analysis of covariance ANOVA analysis of variance AST aspartate aminotransaminase ATTR transthyretin amyloidosis ATTR-CM transthyretin amyloid cardiomyopathy ATTR-PN transthyretin amyloid polyneuropathy AV atrioventricular BUN blood urea nitrogen Ca calcium ECG electrocardiogram eCRF electronic case report form EU European Union FAP familial amyloid polyneuropathy

2011 European Medicines Agency - EPARs

4545. Libertek - roflumilast

: Committee for Medicinal Products for Human Use. COPD: Chronic Obstructive Pulmonary Disease. eCTD: electronic Common Technical Document. EEA: European Economic Area. FEV1: Forced Expiratory Volume in one second. GMP: Good Manufacturing Practice. MA: Marketing Authorisation. MAA: Marketing Authorisation Application. EMA/836394/2010 3/12 Medicinal product no longer authorised1. Background information on the procedure 1.1. Submission of the dossier The applicant Nycomed GmbH submitted on 30 September 2010 (...) of roflumilast is unlikely to represent a risk to the environment following its prescribed usage in patients, and no further actions have to be taken. 2.4. Clinical aspects Since this application is an informed consent of the Daxas marketing authorisation, the clinical data in support of the Libertek application are identical to the up-to-date clinical data of the Daxas dossier, which have been assessed and approved (including all post-marketing procedures). 2.5. Pharmacovigilance Detailed description

2011 European Medicines Agency - EPARs

4546. Daliresp - roflumilast

: Committee for Medicinal Products for Human Use. COPD: Chronic Obstructive Pulmonary Disease. eCTD: electronic Common Technical Document. EEA: European Economic Area. FEV1: Forced Expiratory Volume in one second. GMP: Good Manufacturing Practice. MA: Marketing Authorisation. MAA: Marketing Authorisation Application. EMA/43726/2011 3/12 Medicinal product no longer authorised1. Background information on the procedure 1.1. Submission of the dossier The applicant Nycomed GmbH submitted on 30 September 2010 (...) of roflumilast is unlikely to represent a risk to the environment following its prescribed usage in patients, and no further actions have to be taken. 2.4. Clinical aspects Since this application is an informed consent of the Daxas marketing authorisation, the clinical data in support of the Daliresp application are identical to the up-to-date clinical data of the Daxas dossier, which have been assessed and approved (including all post-marketing procedures). 2.5. Pharmacovigilance Detailed description

2011 European Medicines Agency - EPARs

4547. Aflunov

with structural studies of NA in complex with specific monoclonal antibodies, by electron microscopy, X-ray crystallography amino acid sequencing and gene sequencing. The concentrations of potentially contaminant substances (formaldehyde, barium sulphate, sodium citrate, and CTAB) are controlled during the process or in the MPH. Limits are applied. Polysorbate 80 is also used as an excipient of MF59C.1 adjuvant and is not considered as a residual of production but is nevertheless tested on the MPH

2011 European Medicines Agency - EPARs

4548. Ivermectin Lotion 0.5% (Sklice)

Evaluation and Mitigation Strategies There are no recommendations for a specific postmarketing risk management plan. Routine risk minimization measures such as professional labeling, prescription status, and spontaneous adverse event reporting, comprise an adequate risk management plan for this drug at this time. 1.4 Recommendations for Postmarket Requirements and Commitments A theoretical concern about medication errors that might result in the ingestion of the ivermectin product (particularly in young (...) with SAS transport files in electronic form. The applicant has complied with each of the above requests in the NDA submission. 2.6 Other Relevant Background Information See Section 7.2.6 for discussion of ivermectin use under IND and literature review of use of oral ivermectin. Reference ID: 3067484Clinical Review {Insert Reviewer Name} {Insert Application Type and Number} {Insert Product Trade and Generic Name} 18 3 Ethics and Good Clinical Practices 3.1 Submission Quality and Integrity Department

2011 FDA - Drug Approval Package

4549. Fentanyl sublingual spray

None Never marketed due to safety issues regarding the device component Fentora ® 21-947 September 25, 2006 • Increased • Off label use in opioid naïve patients Reference ID: 3059426Clinical Review {Insert Reviewer Name} {Insert Application Type and Number} {Insert Product Trade and Generic Name} 12 (fentanyl buccal tablet) warnings regarding mis-prescribing to opioid naïve patients and improper dosing • RiskMAP was part of original approval • Improper dosing stemming from fact that this product (...) is not bioequivalent to Actiq and therefore doses are not interchangeable Onsolis ® (fentanyl bioerodible mucoadhesive system) 22-266 July 16, 2009 • Increased warnings regarding mis-prescribing to opioid naïve patients and improper dosing • REMS was part of original approval • Off label use in opioid naïve patients • Improper dosing stemming from fact that this product is not bioequivalent to Actiq and therefore doses are not interchangeable Abstral ® (fentanyl sublingual tablet) 22-510 January 7, 2010

2011 FDA - Drug Approval Package

4550. Diagnosis and Treatment of Peripheral Artery Diseases

into account when exercising their clinical judgement. The guidelines do not, however, override the individual responsibility of health professionals to make appropriate decisions in the circumstances of the individual patients, in consultation with that patient, and, where appropriate and necessary the patient’s guardian or carer. It is also the health professional’s responsibility to verify the rules and regulations applicable to drugs and devices at the time of prescription. & The European Society (...) the creation of edu- cational tools and implementation programmes for the recommendations. To implement the guidelines, condensed pocket guidelines versions, summary slides, booklets with essential messages, and electronic version for digital applications (smart- phones, etc.), are produced. These versions are abridged and, thus, if needed, one should always refer to the full text version which is freely available on the ESC website. The National Societies of the ESC are encouraged to endorse, translate

2011 European Society of Cardiology

4551. Acute Coronary Syndromes (ACS) in patients presenting without persistent ST-segment elevation

to drugs and devices at the time of prescription. & The European Society of Cardiology 2011. All rights reserved. For permissions please email: journals.permissions@oup.com European Heart Journal (2011) 32, 2999–3054 doi:10.1093/eurheartj/ehr236 Downloaded from https://academic.oup.com/eurheartj/article-abstract/32/23/2999/477824 by guest on 02 April 2019The disclosure forms of the authors and reviewers are available on the ESC website www.escardio.org/guidelines (...) ://academic.oup.com/eurheartj/article-abstract/32/23/2999/477824 by guest on 02 April 2019recommendations. To implement the guidelines, condensed pocket guidelines versions, summary slides, booklets with essential mess- ages, and an electronic version for digital applications (smartphones, etc.) are produced. These versions are abridged and, thus, if needed, one should always refer to the full text version, which is freely avail- able on the ESC website. The National Societies of the ESC are encouraged to endorse

2011 European Society of Cardiology

4552. Guidelines for the management of dyslipidaemias

and regulations applicable to drugs and devices at the time of prescription. &2011 The European Society of Cardiology and the European Atherosclerosis Association. All rights reserved. For permissions please email: journals.permissions@oup.com. European Heart Journal (2011) 32, 1769–1818 doi:10.1093/eurheartj/ehr158The disclosure forms of the authors and reviewers are available on the ESC website www.escardio.org/guidelines (...) and implementation programmes for the rec- ommendations. To implement the guidelines, condensed pocket guidelines versions, summary slides, booklets with essential mess- ages, and electronic version for digital applications (smartphones, etc.) are produced. These versions are abridged and, thus, if needed, one should always refer to the full text version which is freely available on the ESC website. The National Societies of the ESC are encouraged to endorse, translate, and implement the ESC Guidelines

2011 European Society of Cardiology

4553. Cardiovascular Diseases during Pregnancy

appropriate decisions in the circumstances of the individual patients, in consultation with that patient, and where appropriate and necessary the patient’s guardian or carer. It is also the health professional’s responsibility to verify the rules and regulations applicable to drugs and devices at the time of prescription. & The European Society of Cardiology 2011. All rights reserved. For permissions please email: journals.permissions@oxfordjournals.org. European Heart Journal (2011) 32, 3147–3197 doi (...) , booklets with essential messages, and an electronic version for digital applications (smart- phones, etc.) are produced. These versions are abridged and, thus, if needed, one should always refer to the full text version which is freely available on the ESC website. The National Societies of the ESC are encouraged to endorse, translate, and implement the ESC Guidelines. Implementation Table 1 Classes of recommendation Classes of recommendations De?nition Suggested wording to use Class I Evidence

2011 European Society of Cardiology

4555. Management of Sickle Cell Disease in Pregnancy

RCOG Green-top Guideline No. 61 © Royal College of Obstetricians and Gynaecologists 4.4 What is the importance of antibiotic prophylaxis and immunisation? Penicillin prophylaxis or the equivalent should be prescribed. Vaccination status should be determined and updated before pregnancy. Patients with SCD are hyposplenic and are at risk of infection, in particular from encapsulated bacteria such as Neisseria meningitides, Streptococcus pneumonia and Haemophilus influenzae. There is clear evidence (...) /obstetrician during pregnancy. 4.5 What vitamin supplements should be given? Folic acid (5 mg) should be given once daily both preconceptually and throughout pregnancy. Folic acid is recommended in all pregnant women to prevent neural tube defects. 39 Folic acid at a dosage of at least 1 mg daily is recommended for women with SCD outside pregnancy in view of their haemolytic anaemia, which puts them at increased risk of folate deficiency. 40 Folic acid 5 mg daily should be prescribed during pregnancy

2011 Royal College of Obstetricians and Gynaecologists

4556. Antepartum Haemorrhage

of the evidence This guideline was developed in accordance with standard methodology for producing RCOG Green-top Guidelines. 20–22 Cochrane reviews on interventions for suspected placenta praevia 23 and for treating placental abruption have highlighted the lack of evidence to guide practice. 24 3.1 Search strategy The Cochrane Library (including the Cochrane Database of Systematic Reviews, DARE and EMBASE), TRIP , Medline and PubMed (electronic databases) were searched for relevant randomised controlled (...) Guidelines are unlike protocols or guidelines issued by employers, as they are not intended to be prescriptive directions defining a single course of management. Departure from the local prescriptive protocols or guidelines should be fully documented in the patient’s case notes at the time the relevant decision is taken. The guideline review process will commence in 2015 unless evidence requires earlier review. This guideline was produced on behalf of the Guidelines Committee of the Royal College

2011 Royal College of Obstetricians and Gynaecologists

4557. The Care of Women Requesting Induced Abortion

from the relevant laws and regulations and therefore free for general use. Product liability: Drugs and their doses are mentioned in this text. While every effort has been made to ensure the accuracy of the information contained within this publication, neither the authors nor the publishers can accept liability for errors or omissions. The final responsibility for delivery of the correct dose remains with the physician prescribing and administering the drug. In every individual case the respective (...) practice recommendations to be based on evidence wherever possible. In developing the earlier versions of this guideline, searches were carried out for each topic of interest. The electronic database MEDLINE (Ovid version including foreign language publications) was searched for the period January 1966 to September 2003. The searches were performed using relevant medical subject headings (MeSH) terms and text words. In addition, the electronic database EMBASE was searched between 1974 and September

2011 Royal College of Obstetricians and Gynaecologists

4558. Management of Suspected Ovarian Masses in Premenopausal Women

methodology for developing RCOG Green-top Guidelines. 14–16 The Cochrane Library (including the Cochrane Database of Systematic Reviews, DARE and EMBASE), TRIP , Medline and PubMed (electronic databases) were searched for relevant papers. The search was restricted to articles published between 1966 and May 2011 and performed by the British Society for Gynaecological Endoscopy (BSGE) using RCOG methodology. The databases were searched using the relevant medical subject heading terms including all (...) subheadings and this was combined with a keyword search. The medical subject heading search included ‘adnexa’, ‘ovary’ and ‘management’. The search was limited to humans and papers in the English language. Relevant guidelines were also searched using the same criteria in the National Guidelines Clearinghouse, the National electronic Library for Health, the Organising Medical Networked Information (OMNI) and the Canadian Medical Association (CMA) Infobase. 4. Preoperative assessment of women with ovarian

2011 Royal College of Obstetricians and Gynaecologists

4560. Models of community care for the elderly involving collaboration between specialized geriatric services and primary care practitioners

. Summary table of relevant services/models 2. References of studies/reports summarized 3. References of potentially relevant reviews 4. References of potentially relevant reports which were unavailable electronically 5. References of excluded articles APPENDIX A: Grey literature searches NOTES ON METHODOLOGY - Assessed herein are the full-text reports retrieved from electronic database searches only (n=217). Screening and interpreting this literature required an extensive time commitment and conceptual (...) ) RefID273 ; Fitzgerald(2004) RefID356 Wright et US Low-income elderly patients with chronic conditions and functional impairment at high established by a multidisciplinary team and reflects the patients assessment, prescribed services, and target objectives. PCP collaboration: The case manager works closely with the PCP. PCPs attend the interdisciplinary team meetings in which patients ISPs are formulated (those unable to attend the meeting, usually discuss the case with the case manager before

2011 OHRI Knowledge to Action

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