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Danish

note for guidance on clinical investigation of medicinal products in the

Dutch

of medicinal products in the treatment of epileptic disorders points to consider on clinical investigation

Last Update: 2011-10-23
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Danish

note for guidance on clinical investigation of medicinal products in the treatment of depression.

Dutch

note for guidance on clinical investigation of medicinal products in the treatment of depression.

Last Update: 2011-10-23
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Danish

note for guidance on clinical investigation of medicinal products in the treatment of diabetes mellitus.

Dutch

note for guidance on clinical investigation of medicinal products in the treatment of diabetes mellitus.

Last Update: 2011-10-23
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Danish

concept paper on the development of a cpmp note for guidance on the clinical investigation of medicinal products in the treatment of asthma

Dutch

investigation of medicinal products in the treatment of asthma concept paper on the development of a cpmp points to consider on biostatistical/methodological issues arising

Last Update: 2011-10-23
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Danish

concept paper on the development of a cpmp note for guidance on clinical investigation of medicinal products in the treatment of diabetes mellitus

Dutch

investigation of medicinal products in the treatment of diabetes mellitus points to consider on clinical investigation

Last Update: 2011-10-23
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Danish

this is an annex to the note for guidance on gene therapy product quality aspects in the production of vectors and genetically modified somatic cells.

Dutch

this is an annex to the note for guidance on gene therapy product quality aspects in the production of vectors and genetically modified somatic cells.

Last Update: 2011-10-23
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Danish

concept paper on the development of an addendum on acute cardiac failure to the cpmp note for guidance on clinical investigation of medicinal products in the treatment of acute cardiac failure

Dutch

concept paper on the development of an addendum on acute cardiac failure to the cpmp note for guidance on clinical investigation of medicinal products in the treatment of acute cardiac failure

Last Update: 2011-10-23
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Danish

concept paper on the development of an appendix to the cpmp note for guidance on the clinical investigation of medicinal products in the treatment of schizophrenia, on methodology of clinical trials concerning the development of depot preparations of approved medicinal products in schizophrenia

Dutch

concept paper on the development of an appendix to the cpmp note for guidance on the clinical investigation of medicinal products in the treatment of schizophrenia, on methodology of clinical trials concerning the development of depot preparations of approved medicinal products in schizophrenia

Last Update: 2011-10-23
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Danish

titel på dokumentet note for guidance on the use of bovine serum in the manufacture of human biological medicinal products points to consider on quality aspects of medicinal products containing active substances produced by stable transgene expression in higher plants revision of note for guidance on minimising the risks of tse transmission via medicinal products points to consider on the development of live attenuated influenza vaccines

Dutch

titel document note for guidance on the use of bovine serum in the manufacture of human biological medicinal products points to consider on quality aspects of medicinal products containing active substances produced by stable transgene expression in higher plants revision of note for guidance on minimising the risks of tse transmission via medicinal products points to consider on the development of live attenuated influenza vaccines

Last Update: 2011-10-23
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Danish

choice of delta points to consider on the requirements for clinical documentation for metered dose inhalers addenda for neuropathic pains to be considered clinical investigation of hypnotic medicinal products clinical investigation of medical products in the treatment of generalised anxiety disorder, panic disorder and obsessive- compulsive disorderrevision note for guidance on anthiarrhythmics note for guidance on clinical investigation of steroid contraceptives in women clinical investigation of corticosteroids intended for use on the skin.

Dutch

choice of delta points to consider on the requirements for clinical documentation for metered dose inhalers addenda for neuropathic pains to be considered clinical investigation of hypnotic medicinal products clinical investigation of medical products in the treatment of generalised anxiety disorder, panic disorder and obsessive-compulsive disorderrevision note for guidance on anthiarrhythmics note for guidance on clinical investigation of steroid contraceptives in woman clinical investigation of corticosteroids intended for use on the skin.

Last Update: 2011-10-23
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Danish

adjustment for baseline covariates points to consider on the clinical investigation of medicinal products in the treatment of asthma note for guidance on the clinical investigation of medicinal products for the treatment of urinary incontinence in women note for guidance on the evaluation of medicinal products for treatment of migraine appendix to the cpmp note for guidance on the clinical investigation of medicinal products in the treatment of schizophrenia, on methodology of clinical trials concerning the development of depot preparations of approved medicinal products in schizophrenia note for guidance on the evaluation of medicinal products indicated for thrombolysis in acute myocardial infarction addendum on acute cardiac failure to the cpmp note for guidance on clinical investigation of medicinal products in the treatment of acute cardiac failure note for guidance on the evaluation of medicinal products for the treatment of dyslipoproteinaemia points to consider on clinical investigation of slow- acting anti- rheumatic medicinal products in rheumatoid arthritis points to consider on irritable bowel syndrome points to consider document on the evaluation of new anti- fungal agents for invasive fungal infections points to consider on biostatistical/ methodological issues arising from cpmp discussion on licensing applications:

Dutch

adjustment for multiplicity and related topics points to consider on biostatistical/methodological issues arising from cpmp discussion on licensing applications: adjustment for baseline covariates points to consider on clinical investigation of medicinal products in the treatment of asthma note for guidance on the clinical investigation of medicinal products for the treatment of urinary incontinence in women note for guidance on the evaluation of medicinal products for treatment of migraine appendix to the cpmp note for guidance on the clinical investigation of medicinal products in the treatment of schizophrenia, on methodology of clinical trials concerning the development of depot preparations of approved medicinal products in schizophrenia note for guidance on the evaluation of medicinal products indicated for thrombolysis in acute myocardial infarction addendum on acute cardiac failure to the cpmp note for guidance on clinical investigation of medicinal products in the treatment of acute cardiac failure note for guidance on the evaluation of medicinal products for treatment of dyslipoproteinaemia points to consider on clinical investigation of slow-acting anti-rheumatic medicinal products in rheumatoid arthritis points to consider on irritable bowel syndrome points to consider document on the evaluation of new anti-fungal agents for invasive fungal infections points to consider on biostatistical/methodological issues arising from cpmp discussion on licensing applications:

Last Update: 2011-10-23
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