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Showing 11891–11900 of 38939 articles for “Art. al. 4”
…de sécurité du médicament et des produits de santé has the prerogatives set out in Article R. 5121-34. II.- As soon as a first request for authorisation for compassionate access for a medicinal produc…
…corporate name and address of the company manufacturing the medicinal product; 3° The batch number; 4° The route and, if applicable, the method of administration of the medicinal product; 5° The compo…
The marketing authorisation holder must comply with the good package leaflet practices established by decision of the Director General of the Agence nationale de sécurité du médicament et des produits…
…he holder of the marketing authorisation for the medicinal product or product; 3° The batch number; 4° The expiry date.
Any measures taken by the holder of the exploitation rights to disseminate any information relating to the compassionate access authorisation from which it benefits to the healthcare professionals con…
…packaging on which it is impossible to include all the information provided for in Article R. 5121-146-2 may bear only the information provided for in a, c, d and h of 1° of Article R. 5121-146-2, in…
…2° The method of administration and, if necessary, the route of administration; 3° The expiry date; 4° The batch number; 5° Content by weight, volume or units.
The Director General of the Agence nationale de sécurité du médicament et des produits de santé shall refuse authorisation for compassionate access if the conditions laid down in I, II and V of Articl…
…licable, its code name or international non-proprietary name, its pharmaceutical form and strength; 4° Where applicable, the classification of the medicinal product in the categories listed in the sec…
The information provided for in Articles R. 5121-138 and R. 5121-139 is written in French. They may also be written in other languages, provided that the same information appears in all the languages…
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