Is There A Marketing Authorisation For Tolvaptan In The Uk

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Tolvaptan for treating autosomal dominant polycystic kidney

tolvaptan reduces cell proliferation, cyst formation and fluid excretion. This reduces kidney growth and protects kidney function. Tolvaptan has a marketing authorisation in the UK to slow the progression of cyst development and renal insufficiency of autosomal dominant polycystic

EMPLOYEE v OTSUKA EUROPE AND OTSUKA UK

The Panel noted that Otsuka Europe was the marketing authorisation holder for Jinarc, Samsca and Abilify which were supplied in the UK by Otsuka UK. Otsuka Europe was also the marketing authorisation holder for Abilify Maintena which was supplied in the UK by Otsuka UK and Lundbeck under a co-promotion agreement. It appeared from the

Date of TA Availability of medicine for NHS patients with

within its marketing authorisation, as an option for treating locally advanced, metastatic or locally recurrent non‑small‑cell lung cancer of adenocarcinoma histology that has progressed after first‑line chemotherapy, only if the company provides nintedanib with the discount agreed in the patient access scheme. Sep-15 TA348

Nephro.blog Le blog d'un néphrologue

details and cther undesirable effects. Overdosage: There is no information on overdosage but profuse and prolonged aquaresis is anticipated. Adequate fluid intake must be maintained. Legal category: PO Marketing Authoris*ion numbers: SAMSCA 15 mg SAMSCA 20 mg (EU/1/OY53Y003) Marketing Authorisation Holder: Otsuka Pharmaceutical Europe Ltd

Testimony of Sidney Wolfe MD Public Citizen Health Research Group

According to current FDA data*, there have been 138 REMS programs that have been released after they were begun, presumably because they were no longer needed. These include Byetta (exenatide), Januvia (sitagliptin) and Samsca (tolvaptan). Where is the evidence that these decisions were based on diminished need for the

NCL Joint Formulary Committee (JFC) Meeting - ncl-mon.nhs.uk

line with the Marketing Authorisation for the drug. In November 2012 the JFC had approved the use of ulipristal acetate 5 mg daily for a three month pre-operative treatment course. PEARL III was a multicentre, open-label study of 209 pre-menopausal women with symptomatic uterine fibroids and heavy bleeding.

COMMITTEE FOR MEDICINAL PRODUCTS FOR HUMAN USE SUMMARY OF

International Nonproprietary Name (INN): tolvaptan. On 28 May 2009 the Committee for Medicinal Products for Human Use (CHMP), having considered new information, adopted a positive opinion, ∗∗∗. recommending to grant a marketing authorisation for the medicinal product Samsca, 15 mg and 30 mg tablets intended for the treatment of hyponatraemia.

Evidence for the use of demeclocycline in the treatment of

otic, with a marketing authorisation in the UK for the treatment of chronic HN associated with SIADH secondary to malignant disease, where water restric-tion is ineffective and the patient does not have con-comitant cirrhosis (18). In France, demeclocycline is reimbursed for the treatment of SIADH, particularly

Sunderland DROP list - sunderlandccg.nhs.uk

There is sufficient concern over safety that it is not marketing authorisation DROP list July 2017 9 Chapter 6 Endocrine System Tolvaptan for hyponatraemia

Sunderland DROP list - sunderlandccg.nhs.uk

There is sufficient concern over safety that it is not marketing authorisation DROP list. July 2017. 9 Chapter 6 Endocrine System. Tolvaptan for

CASE AUTH/3151/1/19 ANONYMOUS EMPLOYEES v - pmcpa.org.uk

There was then a further SPC change regarding the addition of acute liver failure to Sections 4.4 and 4.8 which were included in the revised September 2018 prescribing information. In November 2018, the SPC due to a change of marketing authorisation holder and again in December 2018 to include the addition of wallet card blisters.

Latest guidance updates

TA358. Tolvaptan for treating autosomal dominant polycystic kidney disease Tolvaptan (Jinarc) is a selective vaso - pressin V 2 antagonist, which reduces cell proliferation, cyst formation and fluid excretion, reducing kidney growth and protecting kidney function. Tolvaptan has a marketing authorisation in the UK to slow the progression of

PAN MERSEY AREA PRESCRIBING COMMITTEE MEETING

Vedolizumab has recently been granted marketing authorisation for the treatment of adult patients with ulcerative colitis, and active Crohn s disease. A NICE TA is currently underway which will appraise its effectiveness in ulcerative colitis as an alternative to surgical intervention. The committee was asked to consider three proposals; a.

CHMP ASSESSMENT REPORT FOR Samsca - Europa

Marketing Authorisation to the European Medicines Agency (EMEA) for Samsca, through the centralised procedure under Article 3(2)(a) of Regulation (EC) No 726/2004. The eligibility to the centralised procedure was agreed upon by the EMEA/CHMP on 19 July 2007. The legal basis for this application refers to:

Chelsea and Westminster Hospital NHS Foundation Trust Trust

Ustekinumab is not recommended within its marketing authorisation for treating active psoriatic arthritis, that is, alone or in combination with methotrexate in adults when the response to previous non-biological disease-modifying antirheumatic drug (DMARD) therapy has been inadequate. Action: Nil - Not recommended 9. IVIG Update

newsletter - pkdcharity.org.uk

sidered for treatment - if Tolvaptan is granted a marketing authorisation to sell the drug in the EU. To enter the trial, participants had to be between 18 and 50, with eGFR2 1 The Otsuka sponsored trial was called TEMPO - Tolvaptan Efficacy and Safety in Management of Autosomal Dominant Polycystic Kidney Disease and its Outcomes. People with ADPKD

City and Hackney Clinical Commissioning Group Homerton

Blinatumomab is recommended within its marketing authorisation as an option for treating Philadelphia-chromosome-negative relapsed or refractory precursor B-cell acute lymphoblastic leukaemia in adults, only if the company provides it with the discount agreed in the patient access scheme.

News and updates from palliativedrugs

Use Marketing Authorisation (PUMA) by the European Commission and is licensed for patients diagnosed with epilepsy from age 3 months to <18 years. A PUMA is a new type of centralised mar-keting authorisation designed to encourage the development of older medicines, no longer cov-ered by a patent, specifi cally for use in children.

Clinical Commissioning Policy - England

Canakinumab has a UK marketing authorisation for the treatment of TRAPS, HIDS/MKD and FMF in adults and children aged 2 years and older. It is available as a solution for subcutaneous injection and is administered every 4 weeks as a single dose. The recommended starting dose of canakinumab is:

Tolvaptan for treating autosomal - njl-admin.nihr.ac.uk

Tolvaptan does not currently have a UK marketing authorisation for the indication detailed in this submission. A submission for marketing authorisation in the European Union (EU)

tolvaptan 15mg, 30mg, 45mg, 60mg and 90mg tablets (Jinarc

monophosphate (cAMP) production. Tolvaptan is a non-peptide specific antagonist of arginine vasopressin at the V2 receptors in the distal portions of the nephron. 1 It is the first disease modifying treatment for ADPKD. The evidence supporting the marketing authorisation is from the pivotal study and its open-label extension study.

pkdcharity.org.uk Issue 14 - Autumn 2014

against approval of Tolvaptan at that time. The FDA required more data and had some safety concerns. In December 2013, Otsuka Pharmaceutical Co Ltd submitted an application to the European Medicines Agency (EMA) for marketing authorisation of Tolvaptan for the treatment of ADPKD in Europe. At the date of this newsletter, the EMA has

NICE Technology Appraisals About Medicines - chelwest.nhs.uk

Tolvaptan is recommended as an option for treating autosomal dominant polycystic kidney disease in adults to slow the progression of cyst development and renal insufficiency only if: they have chronic kidney disease stage 2 or 3 at the start of treatment there is evidence of rapidly progressing disease and

Medicines Optimisation programme Board (MOPB)

Item 6 Tolvaptan for hyponatraemia secondary to SIADH.pdf Rationale for recommendation As stated within the PAC review guidelines do not necessarily reflect current practice within the UK. Following consultation with East of England clinicians it was felt there was a place for Tolvaptan when all other treatments had failed.

POLYYSTI KIDNEY DISEASE (PKD) HARITY - GOV.UK

The PKD harity is the only UK charity solely dedicated to the concerns of people affected by PKD - a range of inherited, incurable renal conditions and a common cause of kidney failure. There are two main forms of PKD: Autosomal Dominant PKD (ADPKD) and Autosomal Recessive PKD (ARPKD). You can read more about ADPKD and ARPKD below.

DERBYSHIRE JOINT AREA PRESCRIBING COMMITTEE (JAPC) Minutes of

marketing authorisation, as an option for treating opioid induced constipation in adults whose constipation has not adequately responded to laxatives. The Trusts had therefore been requested to give their views on whether oral naloxegol could be used as an alternative to subcutaneous methylnaltrexone

City and Hackney Clinical Commissioning Group Homerton

Tolvaptan for treating autosomal dominant polycystic kidney disease TA358 Tolvaptan (Jinarc®) is recommended as a possible treatment for people with autosomal dominant polycystic kidney disease if: they have chronic kidney disease stage 2 or 3 at the start of treatment There is evidence of rapidly progressing disease.

Tolvaptan for treating autosomal dominant polycystic kidney

tolvaptan reduces cell proliferation, cyst formation and fluid excretion. This reduces kidney growth and protects kidney function. Tolvaptan has a marketing authorisation in the UK 'to slow the progression of cyst development and renal insufficiency of autosomal dominant polycystic kidney disease (ADPKD) in