The CHMP also considered that the survey referred to by the Applicant, showing that papulopustular lesions are readily recognized and rated by dermatologists providing a qualitative as well as quantitative measurement, was relevant; therefore the currently proposed indication was considered clinically applicable and practical.

On 19 July 2007, based on evaluation of the currently available data and the Rapporteurs’ assessment reports, the CHMP considered that the benefit/ risk profile of veralipride-containing medicinal products is negative and therefore adopted an opinion recommending the withdrawal of the Marketing Authorisation for all medicinal products containing veralipride.

Data are currently available on approximately 1,000 preterm newborn from both the literature concerning ibuprofen and clinical trials with Pedea. Causality of adverse events reported in the preterm newborn is difficult to assess since they may be related to the haemodynamic consequences of the patent ductus arteriosus as well as to direct effects of ibuprofen.

Study SCAB2003 was a multicentre, double-blind, double dummy, placebo and lithium-controlled, randomised fixed dose evaluation of the long-term prevention of relapse and recurrence of depression and/ or mania in patients with bipolar I disorder who had recently or were currently experiencing a major depressive episode.

The existence and effect of potential voting rights that are presently (i.e. currently) exercisable or presently convertible should be considered, in addition to the factors described in IAS 27.12 and IAS 28.4 and 5, when assessing whether an enterprise controls (as defined in IAS 27.6) or significantly influences (as defined in IAS 28.3) another enterprise.

The method described in Commission Directive 98/88/EC of 13 November 1998 establishing guidelines for the microscopic identification and estimation of constituents of animal origin for the official control of feedingstuffs(2) is currently the only method validated to control the presence of animal proteins including these proteins treated at 133 °C/3 Bar/20', in feedingstuffs.

As regards the other five hormones (testosterone, progesterone, trenbolone acetate, zeranol and melengestrol acetate), the SCVPH assessment is that, in spite of the individual toxicological and epidemiological data available, which were taken into account, the current state of knowledge does not make it possible to give a quantitative estimate of the risk to consumers.

Study SCAB2006 had a similar design as study SCAB2003, but differed from study SCAB2003 in evaluating a flexible dose of lamotrigine (100 to 400 mg/ day) and including patients with bipolar I disorder who had recently or were currently experiencing a manic episode.

The Applicant further considered the current bridging strategy to be appropriate for the approval of Rapinyl over the 100-800µg dose range for the treatment of BTP in patients as Rapinyl delivers fentanyl within a plasma concentration range already established as safe and effective.

Interaction with other medicinal products and other forms of interaction After an assessment of the documentation provided by the MAH and an evaluation of the current EU- wide clinical practices relating to the use of Lopid, the most suitable harmonised Section 4.5 Interaction with other medicinal products and other forms of interaction (See Annex III). In addition, CHMP/ 1268/ 04

In the absence of the data, the Applicant provided data demonstrating a direct correlation between 33 % responder analysis and PID, and used the current available pain data and the PID values to estimate the responder rates between active and placebo treatment at earlier time points.

As regards, in particular, the use of oestradiol 17ß, with the aim of promoting growth, the SCVPH assessment is that a substantial body of recent evidence suggests that it has to be considered as a complete carcinogen, as it exerts both tumour-initiating and tumour-promoting effects and that the data currently available do not make it possible to give a quantitative estimate of the risk.

In 2004, the Community will assess the situation of the non-LDC which, after consultations with the Community decide that they are not in a position to enter into economic partnership agreements and will examine all alternative possibilities, in order to provide these countries with a new framework for trade which is equivalent to their existing situation and in conformity with WTO rules.

In line with Directive 1999/45/EC, which states in its preamble that the case of alloys has been considered to need further assessment because the characteristics of alloys are such that it may not be possible accurately to determine their properties using currently available conventional methods, the provisions of Article 2 would not apply to pure metal alloys (not contaminated by dangerous substances).

In order to enable investors or market participants to assess at any time the terms of a transaction in shares that they are considering and to verify afterwards the conditions in which it was carried out, common rules should be established for the publication of details of completed transactions in shares and for the disclosure of details of current opportunities to trade in shares.

Based on the evaluation of the currently available data and the (Co-)Rapporteurs’ assessment reports, the CHMP adopted an opinion on 23 March 2006 recommending the variation of the Marketing Authorisations for the addition of the following new indication: “ Prevention of cardiovascular events in patients estimated to have a high risk for a first cardiovascular event (see section 5.1), as an adjunct to correction of other risk factors.”

whereas that decision will be reviewed in the light of additional studies to be supplied by the person responsible for the entry into circulation of avilamycin, concerning the mechanisms of resistance, the development of resistance in certain micro-organisms and in particular Enterococcus faecium, and any cross-resistance to everninomycin, which is currently under development with a view to future approval for use in human medicine or to other substances used in human medicine having the same site of action as avilamycin;

Based on evaluation of the currently available data and the Rapporteurs’ assessment reports, the CHMP concluded that for oral formulations of norfloxacin containing medicinal products the benefit does not outweigh the risk in acute or chronic complicated pyelonephritis, and therefore adopted an opinion on 24 July 2008 recommending the variation of the Marketing Authorisations by removing the therapeutic indication “ acute and chronic complicated pyelonephritis” from the Product Information for the norfloxacin containing medicinal products taken orally.

The educational material should include: • A copy of the SPC • Emphasis that: o Severe haemorrhagic events are more frequent in patients ≥ 75 years of age (including fatal events) or those weighing < 60 kg o Treatment with prasugrel is generally not recommended for patients of ≥ 75 years of age. o If, after a careful individual benefit/ risk evaluation by the prescribing physician, treatment is deemed necessary in the ≥ 75 years age group then following a loading dose of 60 mg, a reduced maintenance dose of 5mg should be prescribed. o Patients weighing < 60 kg should have a reduced maintenance dose of 5mg o The evidence for a 5mg dose is based only on PK/ PD analyses and no clinical data currently exist on the safety of this dose in the at risk sub groups.