Maintenance phase: overview of efficacy results MabThera vs. observation (28 months median observation time)

In particular, give an overview of the main reasons for the transaction, including its economic and strategic rationale.

The clinical overview is intended to provide a critical analysis of the clinical data included in the clinical summary and Module 5.

a general overview of the financing arrangements in the Member State and of the main schemes to implement the financing requirement,

An overview of such specific requests shall be sent to the Commission on a quarterly basis within one month after the end of each quarter.

The following table provides an overview of the services that will be available in the recording equipment and are defined in this document.

An overview of the principles of how the method works, such as DNA molecular biology based (e.g. for real-time PCR) information must be provided.

4 The table below gives an overview of the ADRs where the incidence is at least 0.5 % higher in the parathyroid hormone group compared to placebo.

send to the Commission a report giving an overview of the situation as regards exceedance of the target values as laid down in section II of Annex I.

An overview of the possible environmental and competitive effects of the proposed measures on other airports, operators and other interested parties.

to provide an overview, the sections 4 for each of the shipments covered by the authorization must be attached to the final acknowledgement of receipt.

While trying to give a fair overview of the various justifications for vertical restraints, these Guidelines do not claim to be complete or exhaustive.

Where the complainant is an undertaking, identify the corporate group to which it belongs and provide a concise overview of the nature and scope of its business activities.

an interim overview of the significant water management issues identified in the river basin, at least two years before the beginning of the period to which the plan refers;

That opinion provides a comprehensive overview of the possible risks for animal and public health as the consequence of the presence of different undesirable substances in animal feed.

Appendix B is an informative Annex providing an overview of the landfill options available within the Directive and examples of possible subcategorisation of landfills' non-hazardous waste.

Member States shall ensure the establishment of programmes for the monitoring of water status in order to establish a coherent and comprehensive overview of water status within each river basin district:

It is necessary, for the protection of investors, to guarantee the internal overview of every management company in particular by means of a two-man management and by adequate internal control mechanisms.

in paragraph 2, the fifth subparagraph shall be replaced by the following: "An overview of such requests shall be sent to the Commission on a quarterly basis, within one month after the end of each quarter.

For the indication in Severe Aggression in Children/ Adolescents with Conduct Disorder, the CHMP assessed the safety profile in children/ adolescents, requesting further clarifications, especially with regards to the Contradictions and discrepancies between the actual Safety Overview (April 2008) and the previous Safety Overview (January 2008) in children/ adolescents with Disruptive Behaviour Disorder (DBD).

Give an overview of the different "Seveso-like" measures (external emergency plans, land-use planning, information to the public, etc.) that might apply to a certain extent to ports and/or marshalling yards.

A cumulative overview of all events reported during the period, stratified according to type of reporter (patient or health care professional), seriousness, expectedness, and whether spontaneous or solicited.

The data field of the "positive response transfer data overview" message shall provide the following data in the following order under the SID 76 Hex, the TREP 01 Hex and appropriate sub message splitting and counting:

The competent authorities shall require institutions to set up systems to monitor and control the interest-rate risk on all of their business, and those systems shall be subject to overview by the competent authorities.

ANNEXES Annex 1 EMEA structure Annex 2 EMEA establishment plan 2004-2006 Annex 3 Revenue and expenditure overview 2004-2006 Annex 4 Management Board and scientific committee meeting dates in 2006 Annex 5 EMEA contact points

The information to be given under A1 and A2 should provide an overview of the number of all permitted discharges (directly into surface water or indirectly via sewer) for the industrial sectors/processes mentioned in Appendix 2.

Give an overview of the strategy and means for inspection, including rough estimate of the total man-hours of the inspectorate, fulfilling the requirements laid down by the directive, tasks of the inspectors and their minimum qualifications.

It is mandatory for the IDE to request the overview data transfer (TRTP 01) during a download session as this only will ensure that the VU certificates are recorded within the downloaded file (and allow for verification of digital signature).

The monitoring network shall be designed so as to provide a coherent and comprehensive overview of groundwater chemical status within each river basin and to detect the presence of long-term anthropogenically induced upward trends in pollutants.

Member States shall provide the Commission with an overview report, which includes the national totals of all reported emissions for each of the source categories with the main Annex I activity and the corresponding NOSE-P code as specified in Annex A3.

The monitoring network shall be designed so as to provide a coherent and comprehensive overview of ecological and chemical status within each river basin and shall permit classification of water bodies into five classes consistent with the normative definitions in section 1.2.

an overview of the balance-of-payments situation and prospects, including a consideration of the internal and external factors having a bearing on the balance-of-payment situation and the domestic policy measures taken in order to restore equilibrium on a sound and lasting basis;

support for the eEurope steering group to provide a strategic overview of implementation of the eEurope 2005 action plan, to offer a forum to exchange experiences and to permit early participation of candidate countries and, where appropriate, to invite other stakeholders to express their views;

All events reported by patients that have been entered into the database by data-lock point A cumulative overview of all events reported during the period, stratified according to type of reporter (patient or health care professional), seriousness, expectedness, and whether spontaneous or solicited.

The Commission shall publish annually, and for the first time by 31 December 2003, a report on actual fuel quality in the different Member States and geographical coverage of fuels with a maximum sulphur content of 10 mg/kg, aiming to provide an overview of the fuels quality data in the different Member States.";

The Applicant provided an overview of the current knowledge of cancer breakthrough pain (BTP), describing the currently available treatment, and the published data and available safety and efficacy data for other fentanyl products, concluding that fentanyl is an ideal analgesic for treatment of breakthrough pain.

To allow the Commission to establish the Community alcohol balance provided for in Article 3(2) of Regulation (EC) No 670/2003 and to have an overview of the development of trade, the Member States should regularly send to the Commission, in a standard format, data on the quantities of alcohol produced, imported, exported and disposed of, and on the stocks held at the end of the marketing year and estimated production.

publish annually a list of the zones and agglomerations submitted pursuant to paragraph 1(a) and, by 30 November each year, a report on the ozone situation during the current summer and the preceding calendar year, aiming to provide overviews, in a comparable format, of each Member State's situation, taking into account the different meteorological conditions and transboundary pollution, and an overview of all the exceedances of the long-term objective in the Member States;

The non-clinical and/or clinical overviews must explain the relevance of any data submitted which concern a product different from the product intended for marketing.

At the end of each of the three preparatory phases, the Contracting Parties shall report to the Central Group on progress made towards completing the timetable, whilst providing detailed overviews.

• The importance of measuring creatinine clearance • Brief overview of methods of measuring creatinine clearance • That rises in serum transaminases occur in patients treated with Exjade o The need for liver function tests prior to prescription, then at monthly intervals or more often if clinically indicated o Not to prescribe to patients with pre-existing severe hepatic disease o The need to interrupt treatment if persistent or progressive increase in liver enzymes were noted. • The need for annual auditory and ophthalmic testing • The need for a guidance table highlighting pre-treatment measurements of serum creatinine, creatinine clearance, proteinuria, hepatic enzymes, ferritin, such as:

every claim in the summary of product characteristics not known from or inferred from the properties of the medicinal product and/or its therapeutic group should be discussed in the non clinical/clinical overviews/summaries and substantiated by published literature and/or additional studies.