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Thursday 23 May 2019
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Topic: european commission

July 11, 2018
The drug will be now available for dose optimisation in UC patients with a body weight of less than 80kg, who do not respond to induction therapy.

The European Commission (EC) has approved a label change for Simponi (golumumab) allowing early dose optimisation in patients with ulcerative colitis (UC).
 
The drug will be now available for dose optimisation in UC patients with a body weight of less than 80kg, who do not respond to induction therapy.
 

June 20, 2018
Manufacturer Amgen has received approval from the European Commission (EC) to include overall survival (OS) data on the labels of the drug BLINCYTO (blinatumomab), it has announced.

Manufacturer Amgen has received approval from the European Commission (EC) to include overall survival (OS) data on the labels of the drug BLINCYTO (blinatumomab), it has announced.
 
The EC granted the company a full marketing authorisation for the drug based on the overall survival date from the Phase 3 TOWER study in adult patients with Philadelphia chromosome-negative (PH-) relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL).
 

April 9, 2018
<p>Italian research-focussed group granted marketing authorisation for treatment for ultra-rare disorder</p>

International research-focussed healthcare group Chiesi, has announced that the European Commission has granted the marketing authorisation for Lamzede® (velmanase alfa).

 

This is the first enzyme replacement therapy for the treatment of non-neurological manifestations in patients with mild to moderate alpha-mannosidosis (AM) - an ultra-rare, progressive, and debilitating disease. Patients present with a broad range of symptoms and their long-term prognosis is generally poor, with reduced life expectancy.1

 

April 27, 2015
The European Commission has licenced Avastin in combination with standard chemotherapy for the treatment of women with advanced cervical cancer. Until now, the treatment has been available ahead of licence to eligible patients in England via individual requests to the Cancer Drugs Fund (CDF).

The European Commission has licenced Avastin in combination with standard chemotherapy for the treatment of women with advanced cervical cancer. Until now, the treatment has been available ahead of licence to eligible patients in England via individual requests to the Cancer Drugs Fund (CDF).

January 9, 2015
At the start of the new European Commission’s first full year of operation, the European Association of Hospital Pharmacists (EAHP) has issued a call to EU policy makers to make 2015 a year of action in meeting the antimicrobial resistance challenge.

At the start of the new European Commission’s first full year of operation, the European Association of Hospital Pharmacists (EAHP) has issued a call to EU policy makers to make 2015 a year of action in meeting the antimicrobial resistance challenge.

Publishing a new policy statement of its 34 national member associations, EAHP President Dr Roberto Frontini said:

August 28, 2014
Bristol-Myers Squibb has announced that the European Commission has approved Daklinza for use in combination with other medicinal products across genotypes 1, 2, 3 and 4 for the treatment of chronic hepatitis C virus infection in adults.

Bristol-Myers Squibb has announced that the European Commission has approved Daklinza (daclatasvir), a potent, pan-genotypic NS5A replication complex inhibitor (in vitro), for use in combination with other medicinal products across genotypes 1, 2, 3 and 4 for the treatment of chronic hepatitis C virus (HCV) infection in adults.

July 8, 2014
mHealth applications linked to the use of medicines must have levels of regulatory oversight, ideally involving pharmacist expertise, in order to ensure their safety.

mHealth applications linked to the use of medicines must have levels of regulatory oversight, ideally involving pharmacist expertise, in order to ensure their safety.

This is the stance taken by the European Commission (EC), which has been backed by the European Association of Hospital Pharmacists (EAHP).

August 5, 2009
Treatment increases chances of successful stem cell transplant for lymphoma and multiple myeloma patients

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August 4, 2009
Drug firms could take advantage of a loophole in the law to advertise their products to the public if new European Commission (EC) proposals are accepted

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February 13, 2009
Sandoz has received final approval for its third biosimilar, filgrastim, paving the way for this important oncology medicine to be made available to patients across the European Union

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February 5, 2009
European Commission orders Sanofi-Aventis to sell off its drug stocks in eastern Europe

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January 23, 2009
New biologic Stelara receives approval in Europe for treatment of moderate to severe plaque psoriasis

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December 10, 2008
Advertising arms race fears over prescription drugs promotion aimed at consumers

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December 1, 2008
Lawyer warns that EU Commission faces uphill battle in its bid to curb protectionist practices

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October 10, 2008
Ceplene granted marketing approval for Acute Myeloid Leukaemia

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June 6, 2008
The European Commission is consulting on measures to tackle the rise in fake medicines. Although the measures may be costly, they are certainly welcome

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May 27, 2008
The European Commission has approved Extavia (interferon beta-1b) for the treatment of MS

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March 20, 2008
The European Commission instigates a public consultation on the growing counterfeit medicines market

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February 6, 2008
The European Commission has approved Galvus (vildagliptin), an oral treatment, for type 2 diabetes patients

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February 5, 2008
The European Commission approves oral chemotherapy drug Xeloda

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January 23, 2008
The European Commission has approved a new treatment for metastatic breast cancer, the manufacturer has announced.

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January 22, 2008
The European Commission has approved Januvia (sitagliptin) for two additional uses for patients with type 2 diabetes, the drug's manufacturer Merck has announced.

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December 3, 2007
EC approves Torisel (temsirolimus) for the first-line treatment of patients with advanced renal cell carcinoma

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