NWPF

News ArchivesRead News

EMEA Adopts Positive Opinion On Neupro (Parkinson’s Disease) And Rotarix (Infant Gastro-Entiritis Prevention) And Others, E

Thursday December 22, 2005

17 Dec 2005(Medical News Today) - The Committee for Medicinal Products for Human Use (CHMP) adopted positive opinions on initial marketing authorisation applications for:

-- Neupro (rotigotine), Schwarz Pharma Ltd. Neupro is indicated for the treatment of idiopathic Parkinson’s disease. EMEA review began on 18 October 2004 with an active review time of 202 days.

-- Rotarix (human rotavirus, live attenuated), GlaxoSmithKline Biologicals S.A. Rotarix is indicated for active immunisation of infants from the age of 6 weeks for prevention of gastro-enteritis due to rotavirus infection. EMEA review began on 20 December 2004 with an active review time of 175 days.

The CHMP adopted a negative opinion for Zelnorm, Novartis Europharm Limited. The indication proposed was: the repeated symptomatic short-term treatment of Irritable Bowel Syndrome in women whose predominant bowel habit is constipation. EMEA review began on 18 October 2004 with an active review time of 204 days. A question and answer document has been published and can be found on EMEA website http://www.emea.eu.int

Extensions of indications and other recommendations

The Committee adopted positive opinions on the extension of indication of medicinal products that are already authorised in the European Union.

-- Invanz (ertapenem), Merck Sharp & Dohme, to extend its indication to add diabetic foot infections of the skin and soft tissue. Invanz was first authorised in the European Union on 18 April 2002 and is currently indicated for the treatment of bacterial infections.

-- Tamiflu (oseltamivir), Roche Registration Ltd, to include children between 1 and 12 years of age in the indication prevention of influenza. Tamiflu was first authorised in the European Union on 20 June 2002 and is currently indicated for the treatment of influenza in adults and children from one year of age and for prevention of influenza in adults and adolescents of 13 years and older.

Summaries of opinions for all these products are available and can be found on EMEA website http://www.emea.eu.int

Safety updates

A review by the European Medicines Agency (EMEA) of new safety data for Tamiflu has concluded that there is no new safety signal relating to psychiatric disorders while taking Tamiflu and therefore no change to the product safety information of Tamiflu is needed.

A separate press release has been issued and can be found here. Rare cases of macular oedema (swelling of the back of the eye) have been reported with rosiglitazone- (Avandia/ Avandamet, from SmithKline Beecham) and pioglitazone- (Actos/Glustin, from Takeda Europe) containing medicinal products.

Following discussions of these post-marketing findings, the CHMP concluded that a further review should be performed to establish whether there is a possible association between macular oedema and the use of rosiglitazone and pioglitazone.

Referral procedures started

The Committee started a referral procedure for atorvastatin-containing medicinal products (Sortis and other associated names) in relation to an application submitted by Parke-Davis GmbH to extend the indication to the prevention of cardiovascular events in patients with multiple risk factors.

The procedure was initiated by Spain under Article 6(12) of Commission Regulation EC No 1084/2003 because of differences between Member States with regard to the extent of the patient population likely to benefit from atorvastatin therapy in this clinical setting.

The Committee started a referral procedure for mifepristone-containing medicinal products (Mifegyne). France triggered this referral following safety and efficacy concerns with regards to the use of the approved dose of 600 mg mifepristone in the indication of "medical termination of developing intra-uterine pregnancy in sequential use with prostaglandin analogue" as compared to the use of a 200 mg mifepristone dose. The procedure was initiated under Article 31 of Directive 2001/83/EC as amended.

Recent News

Sep 12 - Australian Researchers Develop New Diagnostic Tool to Spot Early Signs of Parkinson’s
Sep 11 - GeneFo Webinar to Focus on Using Humor to Manage Parkinson’s Disease
Sep 6 - Parkinson’s and the ‘D’ word
Sep 6 - Compounds in Asthma Drugs Might Be Used as Parkinson’s Treatment
Sep 5 - AstraZeneca Joins Takeda, Berg to Advance Development of Parkinson’s Disease Therapies
Sep 1 - Stem Cell Transplant Trial in Parkinson’s Patients Planned After Test in Japan Succeeds in Monkeys
Sep 1 - Titan to Start Phase 1/2 Study of Subdermal Implant to Deliver Requip to Parkinson’s Patients
Aug 30 - FDA Refuses Acorda’s Inbrija New Drug Application Due to Manufacturing Questions
Aug 23 - Support Groups: Are They for You?
Aug 22 - Internet Visits with Parkinson’s Specialist Can Be as Effective as In-person Visits, Trial Finds
Aug 21 - Cavion’s New CMO to Lead Cav3 Platform Development for Neurological Diseases
Aug 15 - Singing Helps Early-stage Parkinson’s Patients Retain Speech, Respiratory Control, Studies Show
Aug 14 - 16 Tips to Increase Your Mobility Confidence While Living With Parkinson’s Disease
Aug 10 - Boxers are fighting back against Parkinson’s
Aug 9 - Parkinson’s Experiment to Be Aboard Next Flight to International Space Station
Aug 9 - Parkinson’s Disease and Sleeping with the Enemy
Aug 7 - The Importance of Oral Health in Parkinson’s Disease
Aug 7 - Researchers Gain Better Insight Into Alpha-Synuclein’s Role in Parkinson’s Disease
Jul 31 - New Digital Cognitive Assessment Tool Receives Positive FDA Review
Jul 20 - Parkinson’s DREAM Challenge Uses Mobile Sensor Data to Monitor Health Based on Movement