The Marketing Authorisation Holder provided the following information: • An updated Environmental Risk Assessment • The complete information submitted to the Reference Member State and the CMD(v) in respect to environmental risk assessment.

First there are the risks which are directly related to the contracts concluded and/or negotiated by the agent on behalf of the principal, such as financing of stocks.

To be taken into account in pregnant or breast-feeding women, children and high-risk groups such as patients with liver disease, or epilepsy.

Results in this population are less convincing and further differentiation of risk may be needed before this patient group can be included in the wording of the indication.

Whilst there is no controlled epidemiological data on the risk with Angiotensin II Receptor Antagonists (AIIRAs), similar risks may exist for this class of drugs.

There is no evidence for benefit in terms of confirmed disability progression in the majority of patients receiving “ immediate” treatment.

That sum of the exposures to an individual client or group of connected clients shall be limited in accordance with Article 4 of Directive 92/121/EEC subject to the transitional provisions of Article 6 of the same Directive.

Of the patients in the fondaparinux group, 5.8 % experienced an event by Day 9 compared to 5.7 % for enoxaparin-treated patients (hazard ratio 1.01, 95 % CI, 0.90, 1.13, one-sided non-inferiority p value = 0.003).

This shall be calculated by selecting those components of the total trading exposure to the client or group of clients in question which attract the highest specific-risk requirements in Annex I and/or requirements in Annex II, the sum of which equals the amount of the excess referred to in 1;

With regard to OTC derivatives, additional risk-spreading rules should apply to exposures to a single counterparty or group of counterparties.

Atorvastatin is rapidly absorbed after oral administration; maximum plasma concentrations (Cmax) occur within 1 to 2 hours. Extent of absorption increases in proportion to atorvastatin dose. After oral administration, atorvastatin film-coated tablets are 95 % to 99 % bioavailable compared to the oral solution.

Additional information on special population Congenital or acquired immunodeficiency has been identified as a risk factor for neurotropic disease (See sections 4.3 and 4.4).

Multiple event analysis showed a 36 % risk reduction in developing SREs in the Zometa group compared with placebo.

ischaemia (RI) within 9 days of randomisation. Of the patients in the fondaparinux group, 5.8 % experienced an event by Day 9 compared to 5.7 % for enoxaparin-treated patients (hazard ratio 1.01, du

Whereas the risks and advantages of the substances newly classified, by Directive 96/54/EC, as carcinogenic, mutagenic and toxic to reproduction of category 1 or 2 have been taken into account;

'risk characterization' is the estimation of the incidence and severity of the adverse effects likely to occur in a human population or environmental sphere due to actual or predicted exposure to a substance, and may include 'risk estimation', i.e. the quantification of that likelihood.

This trial gave evidence of no increased risk of intussusception in the Rotarix group when compared with the placebo group as shown in the table below.

Multiple event analysis showed 30.7 % risk reduction in developing SREs in the Zometa group compared with placebo.

Where risks to the safety and health of workers cannot be prevented or sufficiently limited by collective or technical means of protection, they must be provided with personal protective equipment.

Whilst there is no controlled epidemiological data on the risk with AIIRAs, similar risks may exist for this class of drugs.

Whilst there is no controlled epidemiological data on the risk with Angiotensin II Receptor Inhibitors (AIIRAs), similar risks may exist for this class of drugs.

the assets shall be properly diversified in such a way as to avoid excessive reliance on any particular asset, issuer or group of undertakings and accumulations of risk in the portfolio as a whole.

The Marketing Authorisation Holder should provide complete information submitted to the Reference Member State and the CMD(v) in respect to environmental risk assessment; 2.

In the case of activities involving exposure to several groups of biological agents, the risk shall be assessed on the basis of the danger presented by all hazardous biological agents present.

That percentage, to be proposed by the Working Group on Plant Health and set by the Committee, shall be determined by plant, plant product or other object in accordance with the plant-health risk.

Institutions referred to in Article 5 (2) shall monitor and control their exposures to individual clients and groups of connected clients as defined in Directive 92/121/EEC, subject to the following modifications.

The European Parliament and the Council shall adopt specific measures against pollution of water by individual pollutants or groups of pollutants presenting a significant risk to or via the aquatic environment, including such risks to waters used for the abstraction of drinking water.

Risk assessment in accordance with Article 4 shall take account of the potential adverse effects which may occur in the following human populations exposed or liable to be exposed to substances with the following properties.

'risk characterization' is the estimation of the incidence and severity of the adverse effects likely to occur in a human population or environmental compartment due to actual or predicted exposure to a substance, and may include 'risk estimation', i.e, the quantification of that likelihood;

Thus, beyond 3 months of treatment, the benefit observed in the clopidogrel + ASA group was not further increased, whereas the risk of haemorrhage persisted (see section 4.4).

Due to the relatively high risk of infection, the group of infants born to Hepatitis B positive mothers represents the population, which would be most vulnerable to a possible insufficient immunogenicity of the vaccine.

For the combined endpoint, complicated and symptomatic ulcers, the incidence was significantly lower in the celecoxib group compared to the NSAID group, relative risk 0.66, 95 % CI 0.45-0.97 but not between celecoxib and diclofenac.

The risk reduction was 51 % in bisphosphonate-naïve patients and 42 % in patients allowed to take concomitant osteoporosis therapy.

There was also a significant risk reduction for doubling of the serum creatinine and for end-stage renal failure in the patient group treated with losartan.

Whilst there is no controlled epidemiological data on the risk with angiotensin II receptor antagonists, similar risks may exist for this class of drugs.

These patients might be at risk of disease by uncommon serogroups (particularly Y, W135 and X), although meningococcal disease due to any serogroup may occur.

This specific group had a higher risk (19 %; N = 10/ 53) of developing elevations in ALT and/ or AST > 3 x ULN indicating that appropriate care should be exercised when initiating sitaxentan in this patient population.

Neurologic events During the treatment period, four patients (2 %) treated with R-CHOP, all with cardiovascular risk factors, experienced thromboembolic cerebrovascular accidents during the first treatment cycle.

Both groups may be at increased risk of Neuroleptic Malignant Syndrome as well as having an increased sensitivity to antipsychotic medicinal products; these patients were excluded from clinical trials.

Limited data have demonstrated that Prevenar induces an acceptable immune response in infants with sickle cell disease with a safety profile similar to that observed in non-high-risk groups.

List I contains the individual substances which belong to the families and groups of substances enumerated below, with the exception of those which are considered inappropriate to list I on the basis of a low risk of toxicity, persistance and bioaccumulation.

Risk assessment in accordance with Article 4 shall take account of the potential adverse effects which may occur in the following human populations liable to exposure to substances with the following properties.

Because LeukoScan has not been studied in patients aged 21 years or younger, doctors should carefully weigh the benefits and the risks of its use before administering it to a patient in this age group.

In the RESIST trials, the risk of rash was similar between APTIVUS/ ritonavir and comparator arms (16.3 % vs. 12.5 %, respectively; see section 4.4).

Under Directive 2000/60/EC specific measures must be adopted at Community level against pollution of water by individual pollutants or groups of pollutants presenting a significant risk to or via the aquatic environment, including such risks to waters used for the abstraction of drinking water.

Medicines known as “ statins” and “ fibrates” used to treat elevated cholesterol and triglycerides have been associated with an increased risk of muscle breakdown (rhabdomyolysis).

"group of connected clients" shall mean: - two or more natural or legal persons who, unless it is shown otherwise, constitute a single risk because one of them, directly or indirectly, has control over the other or others or

As with other medicines in the same group as Dynastat, the risk of heart and blood vessel problems may increase with higher doses and longer durations of Dynastat treatment.

• higher-risk myelodysplastic syndromes (MDS) a group of illnesses of the bone marrow resulting in the production of too few blood cells. • chronic myelomonocytic leukaemia (CMML). • acute myeloid leukaemia (AML).

These trials were carried out in different risk groups and age categories, i. e. children born to Hepatitis B positive mothers, infants, healthy young adults and healthy subjects between 16-35 years of age.