Clinical guidelines describing the aggressive management of CTID includes specific recommendations on patient communication and awareness, recognition of early warning signs, use of anti-diarrhoeals and antibiotics, changes in fluid intake and diet, and need for hospitalization.

The clinical picture, diagnotic procedures and stepwise management of allergic rhinitis are then described.

Guidelines and procedures for clinical examination and sampling on pigs in suspected holdings

provides guidelines and minimum requirements on diagnostic procedures, sampling methods and criteria for the evaluation of the results of clinical and post-mortem examinations and laboratory tests for a proper diagnosis of classical swine fever(1);

Member States shall ensure that appropriate clinical examinations, sampling and laboratory investigations are carried out in suspected holdings to confirm or exclude classical swine fever, in accordance with the guidelines and procedures laid down in subparagraphs 2 to 7.

If, after the examination carried out in a suspected holding, clinical signs or lesions suggestive of classical swine fever are not detected, but further laboratory tests are deemed necessary by the competent authority to rule out classical swine fever, the sampling procedures laid down in subparagraph 5 shall be used for guidance purposes.

The programme must include two annual clinical health inspections according to the guidelines given in Part I.

A. GUIDELINES AND PROCEDURES FOR CLINICAL EXAMINATION OF AND SAMPLING ON PIGS IN SUSPECTED HOLDINGS

The type and amount of additional data (i.e. toxicological and other non-clinical and appropriate clinical data) shall be determined on a case by case basis in accordance with relevant scientific guidelines.

(a) provides guidelines and minimum requirements on diagnostic procedures, sampling methods and criteria for the evaluation of the results of clinical and post-mortem examinations and laboratory tests for a correct diagnosis of ASF;

Member States shall ensure that appropriate clinical examinations, sampling and laboratory investigations are carried out in suspected holdings to confirm or exclude ASF, in accordance with the guidelines and procedures laid down in points 2 to 6.

When submitted in accordance with the relevant Guideline published by the Agency, case report forms and individual patient data listings shall be provided and presented in the same order as the clinical study reports and indexed by study.

If, after the examination carried out in a suspected holding, clinical signs or lesions suggestive of ASF are not detected, but further laboratory tests are deemed necessary by the competent authority to rule out ASF, the sampling procedures laid down in point 5 shall be used for guidance purposes.

Nevertheless the CHMP acknowledged that current clinical guidelines (e. g. the Global Initiative for Asthma (GINA) guidelines) describe circumstances which could lead to the initiation of maintenance therapy with the combination.

Guidelines were developed in clinical trials for dose modification.

Guidelines for checks on pigs showing clinical signs of swine vesicular disease

- The endometrial safety data is not in accordance with the European guideline on clinical

Patients should be managed according to local clinical guidelines for management of hyperlipidaemia.

GUIDELINES AND PROCEDURES FOR CLINICAL EXAMINATION OF AND SAMPLING ON PIGS IN SUSPECTED HOLDINGS

During maintenance treatment, corticosteroids may be tapered in accordance with clinical practice guidelines.

The safety and efficacy of these dose interval adjustment guidelines have not been clinically evaluated.

During clinical trials, these changes were usually reversible when monitoring and discontinuation guidelines were followed.

The applicant felt that this was more adapted towards the Guideline EMEA/ CVMP/ 816/ 00 and obtained greater clinical significance.

The CVMP concluded that according to “ current” GCP requirements this pivotal study design has many deficiencies.

The principles of good clinical practice and detailed guidelines in line with those principles shall be adopted and, if necessary, revised to take account of technical and scientific progress in accordance with the procedure referred to in Article 21(2). These detailed guidelines shall be published by the Commission.

In addition, these guidelines shall lay down adapted provisions relating to labelling for investigational medicinal products intended for clinical trials with the following characteristics:

As a result, the size of the clinical database for the assessment of the vaccine’ s safety was not sufficient to fulfil the requirements of the EMEA’ s guidelines on prepandemic vaccines.

Posology Clinical treatment guidelines should be considered as regards the need for prophylactic treatment against postoperative nausea and vomiting (PONV).

8 The frequency and nature of subsequent examinations should be based on established guidelines and be adapted to the individual woman on the basis of clinical impression.

The safety and efficacy of the dose interval adjustment guidelines provided in section 4.2 are based on pharmacokinetic modelling and have not been clinically evaluated.

whereas, if clinical studies may be accepted, it is taken as given that such studies comply with the Helsinki Declaration and OECD Guidelines for Good Clinical Practice;

The CVMP/ 627/ 01 and GCP guideline stated that the response to therapy must be based on clinical and microbiological criteria wherever possible.

encouraging the development of evidence-based guidelines for good clinical practice and improved public health strategies by accelerating the translation of existing research results into applications.

(1) The safety and efficacy of the dose interval adjustment has not been clinically evaluated and the recommendation is based on pharmacokinetic modelling data (see sections 4.4 and 5.2).

According to the guideline on clinical investigation of medicinal products for hormone replacement therapy of oestrogen deficiency symptoms in postmenopausal women (EMEA/ CHMP/ 021/ 97 Rev.

According to the guideline of the SPC, negative interactions should be mentioned in the SPC only if they are of clinical interest to the prescriber.

provides guidelines and minimum requirements on diagnostic procedures, sampling methods and criteria for the evaluation of the results of clinical and post-mortem examinations and laboratory tests for a correct diagnosis of ASF(1);

In clinical practice, these benign findings do not warrant further evaluation in women with no vaginal bleeding, in accordance with guidelines for postmenopausal women (see section 4.4).

The Agency will also continue to support implementation of the clinical trials directive and will further develop relevant procedures and guidelines, and support the operation and further development of the clinical trials database.

The detailed guidelines on the documentation relating to the clinical trial, which shall constitute the master file on the trial, archiving, qualifications of inspectors and inspection procedures to verify compliance of the clinical trial in question with this Directive shall be adopted and revised in accordance with the procedure referred to in Article 21(2).

These recommendations are also in line with current treatment guidelines, with clinical practice in most European countries and with the recommendations of previously approved European original and generic ciprofloxacin products.

Based on the limited clinical experience in children from reports and studies covering 83 patients, dosing guidelines for adult subjects are considered valid for neonatal and paediatric patient population (see section 5.1).

The safety and efficacy of the dose interval adjustment guidelines provided in section 4.2 are based on single dose pharmacokinetic data and modelling and have not been clinically evaluated.

The review of available guidelines and clinical efficacy data showed that moxifloxacin can be used for treatment of PID in the sense of a monotherapy only after results of microbiological testing are available.

However, the CHMP considered that there were concerns regarding the long-term antibody persistence, the adequacy of the safety data set in the light of the CHMP Guideline on Clinical Evaluation of New Vaccines, and the indication of Menitorix for both priming and boosting.

Finally, regarding the demonstration of bioequivalence, the discussions pertained to the deviations to the guideline “ Note for guidance on modified release oral and trans-dermal dosage forms: section II: pharmacokinetic and clinical evaluation- (CPMP/ EWP/ 280/ 96)”.

Therefore, the CHMP considered that the size of the safety database was already satisfactory before provision of the additional clinical study data and that the new information submitted brings the total to well above the minimum suggested in the CHMP guideline.

The Applicant/ MAH considers that the extent of the total safety database is entirely consistent with the recommendations of the CHMP Guideline on Clinical Evaluation of New Vaccines and is sufficiently large to identify uncommon events.

However, in clinical practice, these benign findings do not warrant further evaluation in women with no vaginal bleeding (in accordance with guidelines for postmenopausal women), as the risks of diagnostic uterine procedures in asymptomatic women outweigh any benefits.

Does the BPWP consider necessary the development of a specific Note for Guidance on the Clinical Investigation of Human Plasma derived Hepatitis-B Immunoglobulins to outline requirements particularly with regard to the design of the clinical studies and the required safety data for the claimed indications?