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prospective planning of pharmacovigilance notice to applicants – guideline on the summary of product characteristics (ec december 1999 – revised version)
prospective planning of pharmacovigilance notice to applicants – guideline on the summary of product characteristics (ec december 1999 – revised version)

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forslaget understøttes af en konsekvensanalyse, hvis nøgledokumenter kan findes på [once the iar is published, insert link to the summary sheet and to the positive opinion of the regulatory scrutiny board].
der vorschlag wird von einer folgenabschätzung begleitet; die wichtigsten unterlagen dazu finden sich hier: [once the iar is published, insert link to the summary sheet and to the positive opinion of the regulatory scrutiny board].

det gælder ikke mindst agenturets note for guidance on the pharmacodynamic section of the summary of product characteristics (spc) for anti‑bacterial medicinal products, der for nylig blev godkendt af cpmp26.
das gilt insbesondere für die vor kurzem vom ausschuß für arznei­spezialitäten (cpmc)25 gebilligte "note for guidance on the pharmacodynamic section of the summary of product characteristics (spc) for anti-bacterial medicinal products" ("leitfaden zum pharmakodynamischen teil der zusammenfassung der produkteigenschaften (spc) für anti­bakterielle medizinische erzeugnisse").

note for guidance on clinical investigation of medical products in the treatment of obsessive- compulsive disorder 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 note for guidance on clinical investigation of steroid contraceptives in women revision of note for guidance on evaluation of new anti- bacterial medicinal products (cpmp/ ewp/ 558/ 95) and note for guidance on the pharmacodynamic section of the summary of product characteristics for antibacterial medicinal products
note for guidance on clinical investigation of medical products in the treatment of obsessive-compulsive disorder 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 note for guidance on clinical investigation of steroid contraceptives in women revision of note for guidance on evaluation of new anti-bacterial medicinal products (cpmp/ewp/558/95) and note for guidance on the pharmacodynamic section of the summary of product characteristics for antibacterial medicinal products