the steps required for the realisation of book entry securities collateral following the occurrence of an enforcement event.

Following a booster dose 10-12 months after primary immunisation, the protective efficacy during the second year was 60.5 % (95%CI:

The safety and immunogenicity of Ambirix administered as a booster dose following a two dose primary course have not been evaluated.

Long-term immunogenicity data following the use of Menitorix as a primary and booster vaccination are not yet available (see section 5.1).

The exposures to individual clients which arise on the trading book shall be calculated by summing the following items (i), (ii) and (iii):

Antibody concentrations were similar to those achieved following a three-dose infant series and a booster dose at less than 2 years of age.

The present Regulation refers to bulls intended for cultural and sporting events registered to the herd-books of the following organisations:

The other study in Peru showed that after a booster dose, the protective effectiveness of Dukoral during the second year of follow-up was 61 %.

The incidence of fever following co-administration of the two vaccines in the primary series was lower than that observed after the booster dose.

Printed books, irrespective of the language in which they are printed and whatever the amount of space given over to illustrations, including the following:

In very rare cases, hyperthermia and lethargy sometimes associated with lameness has been observed one to three weeks following booster vaccination in adult cats.

In a follow-up of the same cohort, the efficacy was confirmed up to 60 months after completion of primary vaccination without administration of a booster dose of pertussis.

This suggests that a second booster dose of pertussis vaccine is warranted in children aged 5-7 years who have previously been vaccinated following this particular schedule.

Percentages of subjects with antibody titres ≥ assay cut-off one month after booster vaccination with Menitorix co-administered with measles-mumps-rubella vaccine (MMR)* were as follows:

Following booster vaccination with tetanus toxoid (recall antigen), the ability to mount an immune response to the tetanus toxoid was preserved in those patients undergoing Raptiva therapy.

Percentages of subjects with antibody titres ≥ assay cut-off one month after booster vaccination with Menitorix administered alone or co-administered with DTPa-HBV-IPV* vaccine were as follows:

Based on data obtained with other boosted PIs and ketoconazole, where ketoconazole AUC showed a 3-fold increase, REYATAZ/ ritonavir is expected to increase ketoconazole or itraconazole concentrations.

Each "Extract", and its copy which shall remain in the T2M booklet, shall include a reference to the initial T2M form referred to in point (a) and shall be clearly marked with one of the following words:

However, antibody responses to booster doses in toddlers following two-dose or three-dose infant series were comparable for all 7 vaccine serotypes and indicated that both infant regimens had elicited adequate priming.

The competent authorities may also permit offsetting of the trading book and of the foreign-exchange positions of undertakings located in third countries, subject to the simultaneous fulfilment of the following conditions:

Additional studies looked at the effectiveness and safety of Prevenar in older infants and children, and at the development of antibodies in infants after the two-dose immunisation schedule followed by a booster injection.

Seroneutralisation rates (MN titre > 20) at 21 days after a booster vaccination with the 7.5 µg dose of the A/ Vietnam and A/ Indonesia vaccines, tested against both the homologous and heterologous strains were as follows:

The following adverse events with an at least possible relationship to ritonavir boosted saquinavir (i. e. adverse reactions) were reported most frequently: nausea, diarrhoea, fatigue, vomiting, flatulence, and abdominal pain.

Over a five year follow-up period, the effectiveness of the Hib components of two hexavalent vaccines, of which one was Infanrix hexa, was 90.4 % for a full primary series and 100 % for a booster dose (irrespective of priming).

Significant increases in antibody (measured by ELISA) were seen for all vaccine serotypes following a three-dose primary series of Prevenar in infants and following booster doses although geometric mean concentrations varied between the 7 serotypes. Prevenar has also been shown to elicit functional

5 months after primary vaccination course followed by annual booster injections In case of increased infection risk or insufficient colostrum intake, an additional initial injection can be given at the age of 4 months followed by the full vaccination programme (primary vaccination course at 5-6 months of age and 4-6 weeks later followed by revaccination).

Results of long term follow-up in Sweden demonstrate that acellular pertussis vaccines are efficacious in infants when administered according to the 3 and 5 months primary vaccination schedule, with a booster dose administered at approximately 12 months.

The competent authorities may also permit offsetting of the trading book and of the foreign-exchange and commodities positions, respectively, of undertakings located in third countries, subject to the simultaneous fulfilment of the following conditions:`.

However, the CHMP concluded that this is unlikely to lead to a difference in the rate of protection against infection with S. pneumoniae following a booster injection, when Prevenar is used as part of a routine immunisation programme in which most infants are vaccinated.

The billing for the services of a CRS shall be sufficiently detailed to allow the participating carriers and subscribers to see exactly which services have been used and the fees therefor, as a minimum, booking fee bills must include the following information for each segment:

the following indent shall be added to Article 3(1): "- Checks, in relation to bookkeeping, or records of financial movements showing, at the time of the scrutiny, that the documents held by the paying agency as justification for the payment of aid to the beneficiary are accurate.";

The title is replaced by the following: "Commission Regulation (EC) No 296/96 of 16 February 1996 on data to be transmitted by the Member States and the monthly booking of expenditure financed under the Guarantee Section of the European Agricutural Guidance and Guarantee Fund (EAGGF)."

o The following information should also be provided in the appropriate booklet Female patient of childbearing potential • The need to avoid foetal exposure • The need for effective contraception • That if she needs to change or stop using her method of contraception she should inform:

If the budget of the Community body has not been finally adopted at the beginning of the financial year, the following rules shall apply to commitment and payment of expenditure which it has been possible to book to a specific heading in the budget as part of implementation of the last budget duly adopted.

The patient information pack should be provided in both a form of patient information booklet and audio-CD that contain following key elements: • Patient information leaflet • How to prepare for Lucentis treatment • Which are the steps following treatment with Lucentis • Key signs and symptoms of serious adverse events • When to seek urgent attention from the health care provider

Following the initial assessment, the CHMP considered that under the conditions of study, the safety and immunogenicity data provided were adequate to assess the risk-benefit relationship for the use of Menitorix for priming and/ or boosting and could be used to assess the likely protection that will be afforded by the vaccine.

In clinical studies in which some of the vaccinees received Infanrix hexa concomitantly with Prevenar as a booster (4th) dose of both vaccines, fever ≥ 38.0°C was reported following 43.4 % of doses in infants receiving Prevenar and Infanrix hexa at the same time as compared to 30.5 % of doses in infants receiving the hexavalent vaccine alone.

The physician information pack should contain the following: • Summary leaflet of the product features and reconstitution guide, including highlighted changes that have been made for the new formulation of NovoSeven. • Educational slide kit • Dosing reference card • Question & Answer booklet • Patient information pack • Letter to healthcare professionals

It must not be taken by patients who have severe problems with their liver, or who are taking the following medicines: • rifampicin (used to treat tuberculosis); • ritonavir-boosted lopinavir; • St John’ s wort (a herbal preparation used to treat depression); • medicines that are broken down in the same way as Prezista and are harmful at high levels in the blood.

Alternatively, when Prevenar is given as part of a ‘ universal infant immunisation programme’ (when all infants in an area are vaccinated at around the same time), two doses can be given with an interval of at least two months, followed by a booster at 11 to 15 months of age. • Infants aged between seven and 11 months need two doses, with an interval of at least one month between doses.

The Applicant/ MAH is requested to commit to submitting for assessment, to the relevant national competent authorities, the results from the long-term antibody persistence data from the ongoing studies with Menitorix i. e. subjects from booster studies 013 and 022 are being followed up for antibody persistence as follows: o Over 4 years of follow up of subjects from study 013 in studies 027, 028 and 029. o Five years follow-up from 010/ 022 in subsequent studies 023, 024, 025 and 026.

Following the Commission communication "Women and science", and the Resolutions of the Council of 20 May 1999(11) and 26 June 2001(12) and the Resolution of the European Parliament of 3 February 2000(13) on this theme, an action plan is being implemented in order to boost and increase the place and role of women in science and research in Europe, which should ensure the respect of equality of opportunity, irrespective of gender.

Booklet for male partners of women with childbearing potential The information for male partners of women with childbearing potential should include the following information: • That Volibris may cause serious birth defects in unborn babies conceived before, during, or within a month after stopping treatment. • The need to ensure that women of child bearing potential are using reliable contraception. • That Volibris cannot be taken if a woman is or might become pregnant.

orthopaedic bootmaker ('orthopédiste-cordonnier'),These courses are of a total duration of 14 years, including at least five years' training followed within a structured training framework, partly received in the workplace and partly provided by the vocational training establishment, and culminating in an examination which must be passed in order to be able to practise any activity considered as skilled, either independently or as an employee with a comparable level of responsibility.

o All booklets should contain the following information That Thalidomide Celgene is teratogenic That Thalidomide Celgene may cause thromboembolism, cardiovascular events and neuropathy Description of the patient card and its use in the individual Member State National or other applicable specific arrangements for a prescription for thalidomide to be dispensed That Thalidomide Celgene must not be given to any other person That the patient should not donate blood during therapy and for one week following discontinuation of thalidomide That the patient should tell their doctor about any adverse events That any unused capsules should be returned to the pharmacist at the end of the treatment

the exposures due to the unsettled transactions, free deliveries and over-the-counter (OTC) derivative instruments referred to in paragraphs 1, 2, 3 and 5 of Annex II, the exposures due to repurchase agreements and securities lending which are based on securities included in the trading book as defined in (a) referred to in paragraph 4 of Annex II, those exposures due to reverse repurchase agreements and securities-borrowing transactions described in the same paragraph, provided the competent authorities so approve, which meet either the conditions (i), (ii), (iii) and (v) or conditions (iv) and (v) as follows:

the exposures due to the unsettled transactions, free deliveries and over-the-counter (OTC) derivative instruments referred to in paragraphs 1, 2, 3 and 5 of Annex II, the exposures due to repurchase agreements and securities and commodities lending which are based on securities or commodities included in the trading book as defined in (a) referred to in paragraph 4 of Annex II, those exposures due to reverse repurchase agreements and securities-borrowing and commodities-borrowing transactions described in the same paragraph, provided the competent authorities so approve, which meet either conditions (i), (ii), (iii) and (v) or conditions (iv) and (v) as follows:

The MAH shall agree the details of a controlled distribution system with the National Competent Authorities and must implement such programme nationally to ensure that: o Prior to launch, all doctors and pharmacists who intend to prescribe or dispense Thalidomide Celgene receive a Dear Healthcare Professional letter as described below. o Prior to prescribing all healthcare professionals who intend to prescribe (and in agreement with the National Competent Authority, dispense) Thalidomide Celgene are provided with an Educational Healthcare Professional’ s Kit containing the following: o Healthcare professional booklet o Patient booklets o Patient cards o Summary of Product Characteristics, Package Leaflet and Labelling

Educational healthcare professional’ s kit The Educational healthcare professional’ s kit shall contain the following elements: • Healthcare professional booklet o History of thalidomide, background on Thalidomide Celgene and its licensed indication o Posology o Maximum duration of prescription 4 weeks for women with childbearing potential 12 weeks for men and women without childbearing potential o Teratogenicity and the need to avoid foetal exposure o Obligations of healthcare professionals who intend to prescribe or dispense Thalidomide Celgene including The need to provide comprehensive advice and counselling to patients That patients should be capable of complying with the requirements for the safe use of thalidomide Need to provide patients with the appropriate patient educational material Report any pregnancy, neuropathy or other adverse events to Celgene and the local health authority using the forms provided in the “ Educational Healthcare Professional’ s Kit” (if applicable to a Member State)

Educational healthcare professional’ s kit The educational healthcare professional’ s kit shall contain the following elements: • Healthcare professional booklet o History of thalidomide, background on Thalidomide Celgene and its licensed indication o Posology o Maximum duration of prescription 4 weeks for women with childbearing potential 12 weeks for men and women without childbearing potential o Teratogenicity and the need to avoid foetal exposure o Obligations of healthcare professionals who intend to prescribe or dispense Thalidomide Celgene including The need to provide comprehensive advice and counselling to patients That patients should be capable of complying with the requirements for the safe use of thalidomide Need to provide patients with the appropriate patient educational material Report any pregnancy, neuropathy or other adverse events to Celgene and the local health authority (if applicable to a Member State) using the forms provided in the “ Educational Healthcare Professional’ s Kit” o Safety advice relevant to all patients Description and management of thromboembolic and cardiovascular events, and peripheral neuropathy Disposal of unwanted medicine Not to donate blood during treatment and for one week after treatment ends