Article R5121-74-4
I.-The compassionate access authorisation may be renewed. Renewal is the subject of a request from the holder of this authorisation addressed to the Director General of the Agence nationale de sécurit…
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Showing 11881–11890 of 38939 articles for “Art. al. 4”
I.-The compassionate access authorisation may be renewed. Renewal is the subject of a request from the holder of this authorisation addressed to the Director General of the Agence nationale de sécurit…
…knowledge of which is necessary for the safe and effective use of the medicinal product or product;4° The instructions necessary for proper use, in particular : a) Dosage ; b) The method and, if nece…
The Director General of the Agence nationale de sécurité du médicament et des produits de santé may suspend or withdraw a compassionate access authorisation if the conditions laid down in I, II and V…
…non-proprietary name; 2° The name or business name and address of the company; 3° The batch number; 4° The route and, where appropriate, the method of administration of the medicinal product; 5° The e…
…products containing radionuclides, in addition to the information provided for in article R. 5121-140, the labelling of the protective shielding provides all the explanations relating to the codes us…
I.-When a medicinal product, which is the subject of a compassionate access authorisation, obtains a marketing authorisation, the Director General of the Agence nationale de sécurité du médicament et…
I.-The granting of a compassionate access authorisation is subject to the establishment by the Agence nationale de sécurité du médicament et des produits de santé of a therapeutic use and patient moni…
Classification as a hospital prescription-only medicinal product may only take place if the restrictions placed on the prescription of the medicinal product are justified by the need to carry out the…
I. - On the basis of the information referred to in article R. 5121-76-3 and the scientific knowledge available, as well as, where applicable, the information transmitted in application of article R.…
In order to be able to continuously assess the benefit/risk balance of the medicinal product, the Director General of the Agence nationale de sécurité du médicament et des produits de santé may at any…
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