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Showing 3181–3190 of 57858 articles for “Art. 14 and 15”
The labelling and, where applicable, the package leaflet of the medicinal products referred to in article L. 5121-13 must bear the following information only: 1° Homeopathic medicinal product in clear…
…y medicinal product or product is compulsory, unless the information referred to in article R. 5121-149 appears directly on the outer packaging or the immediate packaging. It must be written in French…
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…
…information: 1° The name of the medicinal product or product, the strength, the pharmaceutical form and, where appropriate, a reference to the recipient ("infants", "children" or "adults") and, where…
…information: 1° The name of the medicinal product or product, the strength, the pharmaceutical form and, where appropriate, the name of the recipient ("infants", "children" or "adults") and, where the…
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…
…ere appropriate, its code name or international non-proprietary name; 2° The name or corporate name and address of the company manufacturing the medicinal product; 3° The batch number; 4° The route an…
…l 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 u…
…here appropriate, its code name or international 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…
…kage leaflet is drawn up in accordance with the summary of product characteristics. It includes a standard text, expressly inviting patients to report any suspected adverse reaction to their doctor, p…
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