XEFO 8MG POWDER AND SOLVENT FOR SOLUTION FOR INJECTION

Main information

  • Trade name:
  • XEFO 8MG POWDER AND SOLVENT FOR SOLUTION FOR INJECTION
  • Active ingredient:
  • LORNOXICAM
  • Available from:
  • Nycomed UK Limited
  • Dosage:
  • 8 Milligram
  • Pharmaceutical form:
  • Pdr+Solv for soln for Inf
  • Medicine type:
  • Human

Localization

  • Available in:
  • Ireland
  • Language:
  • English

Therapeutic information

Status

  • Source:
  • IMB
  • Authorization date:
  • 2010-02-26

Documents

9-12-2015

Orphan designation: Imatinib mesilate, for the: Treatment of myelodysplastic / myeloproliferative diseases

On 23 December 2005, orphan designation (EU/3/05/340) was granted by the European Commission Novartis Europharm Limited, United Kingdom, for imatinib mesilate for the treatment of myelodysplastic / myeloproliferative diseases. Please note that this product was withdrawn from the Community Register of designated orphan medicinal products in April 2012 on request of the sponsor.

Europe - EMA - European Medicines Agency

4-7-2015

Scientific Opinion on the safety of UV-treated bread as a novel food EFSA Panel on Dietetic Products, Nutrition and Allergies

EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA) Following a request from the European Commission, the EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA Panel) was asked to carry out the additional assessment for UV-treated bread as a novel food (NF) in the context of Regulation (EC) No 258/97, taking into account the comments and objections of a scientific nature raised by Member States. The NF is bread to which a treatment with UV radiation is applied after baking in o...

Europe - EFSA - European Food Safety Authority EFSA Journal

4-7-2015

Scientific Opinion on the substantiation of a health claim related to Symbiosal® and lowering of blood pressure and reduced risk of hypertension pursuant to Article 14 of Regulation (EC) No 1924/2006

EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA) Following an application from Han-Asiabiotech GmbH, submitted for authorisation of a health claim pursuant to Article 14 of Regulation (EC) No 1924/2006 via the Competent Authority of Germany, the EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA) was asked to deliver an opinion on the scientific substantiation of a health claim related to Symbiosal® and lowering of blood pressure and reduced risk of hypertension....

Europe - EFSA - European Food Safety Authority EFSA Journal

4-7-2015

Scientific and technical assistance on the evaluation of the temperature to be applied to pre-packed fishery products at retail level

European Food Safety Authority Relevant hazards associated with pre-packed fresh fishery products were identified through a literature search. The main temperature-dependent hazards identified are histamine formation, Listeria monocytogenes, Clostridium botulinum, and Yersinia enterocolitica. To assess bacterial growth and histamine production during storage and transport at retail level and to evaluate different storage scenarios, published predictive microbiology growth models were used assuming ...

Europe - EFSA - European Food Safety Authority EFSA Journal

4-7-2015

Updating risk management recommendations to limit exposure of non-target Lepidoptera of conservation concern in protected habitats to Bt-maize pollen

EFSA Panel on Genetically Modified Organisms (GMO) Using mathematical modelling, the EFSA GMO Panel has previously quantified the risk to non-target (NT) Lepidoptera of conservation concern, potentially occurring within protected habitats, associated with the ingestion of Bt-maize pollen deposited on their host plants. To reduce the estimated larval mortality to a negligible level, an isolation distance of 20 and 30 m was recommended between protected habitats and the nearest fields of m...

Europe - EFSA - European Food Safety Authority EFSA Journal

4-7-2015

Scientific Opinion on the re-evaluation of oxidised polyethylene wax (E 914) as a food additive

EFSA Panel on Food Additives and Nutrient Sources added to food (ANS) The EFSA ANS Panel delivered a scientific opinion re-evaluating the safety of oxidised polyethylene wax (OPEW) (E 914) as a food additive. E 914 is authorised at quantum satis only for the surface treatment of some fruits. The Scientific Committee on Food (SCF) evaluated the use of OPEW as a food additive but could not allocate an ADI and as an additive in food contact materials. The EFSA Panel on Food Contact Mat...

Europe - EFSA - European Food Safety Authority EFSA Journal

2-7-2015

The safe and reliable use of adrenaline pens are being enhanced

The safe and reliable use of adrenaline pens are being enhanced The Committee for Human Medicinal Products in the European Medicines Agency recommends measures to enhance safe and reliable use of adrenaline autoinjectors (adrenaline pens). The instructions for use will be supplemented and the users of pens will be provided with further educational material. It is essential that the persons needing adrenaline pen keep the familiar pen along and are able to use it in reliable manner in case of emergen...

Finland - Fimea News

2-7-2015

Safe Use of Pesticides in and Around Your Home

Have insects or rodents invaded your home? Is your lawn or garden being destroyed by pests? If you choose to use a pesticide to deal with a pest problem, make sure to follow Health Canada's advice on how to use, store and dispose of pesticides safely.

Canada - Health Canada

1-7-2015

New missions for ANSES relating to plant protection products, fertilisers and growing media

(Soon in English) Depuis 2010, dans les domaines de la santé humaine, animale et végétale, l’Anses exerce ses missions d’évaluation des risques, de référence et de recherche en se fondant sur deux principes essentiels : rigueur et indépendance de son expertise scientifique ; transparence et ouverture, dans le respect du rôle de chacun. Language English

France - Agence Nationale du Médicament Vétérinaire

1-7-2015

Reasoned opinion on the modification of the existing MRLs for ametoctradin in sage and basil

European Food Safety Authority In accordance with Article 6 of Regulation (EC) No 396/2005, Belgium, hereafter referred to as the evaluating Member State (EMS), compiled an application to modify the existing maximum residue levels (MRLs) for the active substance ametoctradin in sage and basil. In order to accommodate for the intended uses of ametoctradin, Belgium proposed to raise the existing MRLs from the limit of quantification (LOQ) 0.01* mg/kg to 60 mg/kg. Belgium drafted an evaluation report in a...

Europe - EFSA - European Food Safety Authority EFSA Journal

1-7-2015

Scientific opinion on the safety of the extension of use of steviol glycosides (E 960) as a food additive

EFSA Panel on Food Additives and Nutrient Sources added to food (ANS) Following a request from the European Commission, EFSA carried out an exposure assessment of steviol glycosides (E 960) arising from their use as a food additive, taking into account the proposed extension of uses. In 2010, the EFSA Panel on Food Additives and Nutrient Sources added to Food (ANS) adopted a scientific opinion on the safety of steviol glycosides (E 960) and established an Acceptable Daily Intake (ADI) o...

Europe - EFSA - European Food Safety Authority EFSA Journal

1-7-2015

Scientific Opinion on the re-evaluation of sorbic acid (E 200), potassium sorbate (E 202) and calcium sorbate (E 203) as food additives

EFSA Panel on Food Additives and Nutrient Sources added to food (ANS) The EFSA Panel on Food Additives and Nutrient Sources added to Food (ANS) was asked to deliver a scientific opinion re-evaluating sorbic acid (E 200), potassium sorbate (E 202) and calcium sorbate (E 203) when used as food additives. Sorbic acid is absorbed and mainly excreted as expired carbon dioxide. The Panel noted that there was no evidence of genotoxic activity for sorbic acid or potassium sorbate. Sub-acu...

Europe - EFSA - European Food Safety Authority EFSA Journal

1-7-2015

Scientific Opinion on re-evaluation of copper complexes of chlorophylls (E 141(i)) and chlorophyllins (E 141(ii)) as food additives

EFSA Panel on Food Additives and Nutrient Sources added to food (ANS) Copper complexes of chlorophylls (Cu-chlorophylls) (E 141(i)) and copper complexes of chlorophyllins (Cu-chlorophyllins) (E 141(ii)) are prepared from sources that could not be regarded as edible plant material or food (grass, lucerne, nettle) for humans. Considering their manufacturing process, these compounds cannot be regarded as natural compounds. The Panel noted that very few studies have been conducted using Cu-...

Europe - EFSA - European Food Safety Authority EFSA Journal

30-6-2015

Fimea meets 2014 performance targets with ease

Fimea meets 2014 performance targets with ease According to the Ministry of Social Affairs and Health’s statement on Fimea’s final accounts, Fimea has engaged in efficient cooperation, been active and carried out assignments to an extremely high standard. Fimea met its 2014 performance targets with ease and scored 4+ on a scale of 1–5. The year 2014 was Fimea’s best to date. Fimea’s service provision meets pharmaceutical safety standards, and staff’s job satisfaction is above the public ...

Finland - Fimea News

2-7-2015

BICARUVAS (Antacid) Powder, For Solution [PROSANA DISTRIBUCIONES, S.A. DE C.V.]

Updated Date: Jul 2, 2015 EST

US - DailyMed

2-7-2015

OXYCODONE HYDROCHLORIDE Solution [Morton Grove Pharmaceuticals, Inc.]

Updated Date: Jul 2, 2015 EST

US - DailyMed

2-7-2015

IBANDRONATE SODIUM Injection, Solution [Sagent Pharmaceuticals]

Updated Date: Jul 2, 2015 EST

US - DailyMed

2-7-2015

IBANDRONATE SODIUM Injection, Solution [Heritage Pharmaceuticals Inc.]

Updated Date: Jul 2, 2015 EST

US - DailyMed

1-7-2015

News and press releases: Regulatory information – Mandatory use of common repository for human centralised procedures as of today

Companies now to submit their applications to the European Medicines Agency only

Europe - EMA - European Medicines Agency

1-7-2015

News and press releases: Regulatory information - Electronic application becomes mandatory today

EMA application forms should be used for all human and veterinary centralised procedure applications as of 1 July 2015

Europe - EMA - European Medicines Agency

1-7-2015

News and press releases: Staying safe when buying medicines online

EU-wide logo to protect patients from falsified medicines

Europe - EMA - European Medicines Agency

1-7-2015

SKIN TAG SOLUTION (Thuja Occidentalis) Liquid [VITACOST.COM, INC.]

Updated Date: Jul 1, 2015 EST

US - DailyMed

1-7-2015

HYDROGEN PEROXIDE Solution [Better Living Brands LLC]

Updated Date: Jul 1, 2015 EST

US - DailyMed

1-7-2015

SODIUM FLUORIDE Solution [Target Corp.]

Updated Date: Jul 1, 2015 EST

US - DailyMed

1-7-2015

TETANUS AND DIPHTHERIA TOXOIDS ADSORBED Injection [Grifols]

Updated Date: Jul 1, 2015 EST

US - DailyMed

1-7-2015

ACETAMINOPHEN AND CODEINE PHOSPHATE Tablet [Direct RX]

Updated Date: Jul 1, 2015 EST

US - DailyMed

1-7-2015

MEROPENEM Injection, Powder, For Solution [Hospira, Inc.]

Updated Date: Jul 1, 2015 EST

US - DailyMed

1-7-2015

ASPIRIN AND DIPYRIDAMOLE Capsule [Teva Pharmaceuticals USA Inc]

Updated Date: Jul 1, 2015 EST

US - DailyMed

30-6-2015

News and press releases: Facilitating the development of advanced therapies

Joint workshop with International Society for Cellular Therapy to take place on 25 September 2015 in Seville, Spain

Europe - EMA - European Medicines Agency

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