CPMP oor Spaans
CPMP
Vertalings in die woordeboek Engels - Spaans
plan de gestión del programa del país
Geskatte vertalings
Vertoon algoritmies gegenereerde vertalings
voorbeelde
Advanced filtering
Voorbeelde moet herlaai word.
Because of the May budget submission deadline, the CPMP and support budget have been completed several months before the country programme is finalized.
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This paper assumes that compliance with the joint CPMP/CVMP note for guidance eliminates, as far as possible, the risk of introducing TSE infectivity into an IVMP during the process of manufacture through the use of materials of biological origin which are used in routine production (e.g. serum and blood products, tissue or tissue extracts).
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the CPMP considered that the lack of predictability of potential drug interactions and the difficulties
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The MAH should submit to the CPMP, the Reference Member State and the Concerned Member States, a PSUR including a report on their isotretinoin Pregnancy Prevention Programme and an integrated assessment of pregnancy exposures and outcomes
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11 In the context of the mutual recognition procedure, the CPMP is responsible for issuing opinions concerning the granting, withdrawal, variation or suspension of a marketing authorisation (Articles 8 to 15 of Directive 75/319).
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The Working Party, upon request, also gives advice on safety aspects raised by the CPMP
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The first alleges that the referral to the CPMP pursuant to Article 30 HUM was unlawful and that there was a misuse of powers.
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The CPMP, having considered the points of disagreement and the responses provided by the Marketing Authorisation Holder, was of the opinion that the objections raised by Germany and Italy should not prevent the granting of a Marketing Authorisation for the new indication persistent severe primary hyperhidrosis of the axillae, which interferes with the activities of daily living and is resistant to topical treatment subject to certain essential conditions for the safe and effective use of the medicinal product
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At this meeting, the CPMP considered that, in view of the benefit and risk re-assessment, it was not appropriate to withdraw combined oral contraceptives containing gestodene or desogestrel.
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Cooperation with the other working parties continued, particularly with the Joint CPMP/CVMP quality working party on modified release oral and transdermal dosage form, with the joint group on kinetics and with the BWP on clinical investigation of new vaccines and gene therapy
los fundamentos jurídicos de los nuevos instrumentos de financiación establecen claramente el papel del Parlamento en la definición de los objetivos de los programas geográficos o temáticos que se derivarán de esos instrumentosEMEA0.3 EMEA0.3
Iceland and Norway completed their first year as members of the CPMP and CVMP
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62 On 17 September 1998, the CPMP initiated the procedure under Article 13 of Directive 75/319 in respect of the substances referred to in the Austrian request.
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On the basis of the CPMP Note for Guidance and new national guidelines, he relied on the developments in the evaluation criteria in order to assert that there was now a general consensus' that the treatment of obesity requires a significant and long-term loss of weight (over more than one year).
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expertise.In order to keep that balance, applicants were reminded to suggest three to four alternative CPMP members coming from three to four different members States. It should also be noted
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44 As regards the benefit/risk balance, the CPMP considered that [o]n the basis of the available evidence on [amfepramone's] efficacy, it is no longer possible to consider that amfepramone has therapeutic efficacy in the treatment of obesity or (as a consequence) that its benefit/risk balance is positive.'
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Whenever new country programme plans are proposed, or existing programme plans are adjusted in the course of a mid-term review (MTR), a country programme management plan (CPMP) must be formulated to ensure that the management structure supports the country programme
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Benefit/Risk considerations Based on the documentation submitted by the MAH and the scientific discussion within the Committee, the CPMP considered that the benefit/risk ratio of Calcitugg is favourable for use relating to prevention and treatment of calcium deficiency, for use as Calcium supplement as an adjunct to specific therapy in the prevention and treatment of osteoporosis and Phosphate binder in hyperphosphataemia
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8 Second Council Directive 75/319/EEC of 20 May 1975 on the approximation of provisions laid down by law, regulation or administrative action relating to medicinal products (OJ 1975 L 147, p. 13), as amended by Directive 93/39 (‘Directive 75/319’), contains a Chapter III entitled ‘Committee for Proprietary Medicinal Products’ (‘the CPMP’) and consisting of Articles 8 to 15c.
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12 By letter of 31 August 1998, likewise addressed to the chairman of the CPMP, the Austrian Ministry of Labour, Health and Social Affairs pointed out that, in addition to phentermine and amfepramone, clobenzorex, fenbutrazate, fenproporex, mazindol, mefenorex, norpseudoephedrine, phenmetrazine, phendimetrazine and propylhexedrine belonged to the same group of amphetamine-related anorectics.
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In assembling the dossier for application for marketing authorisation, applicants shall also take into account the scientific guidelines relating to the quality, safety and efficacy of medicinal products for human use as adopted by the Committee for Proprietary Medicinal Products (CPMP) and published by the European Medicine Evaluation Agency (EMEA) and the other pharmaceutical Community guidelines published by the Commission in the different volumes of The rules governing medicinal products in the European Community.
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The CPMP expected the applicant to adduce appropriate evidence of the efficacy of norpseudoephedrine whereas it should itself have proved the inefficacy of that substance.
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The MAH should submit to the CPMP, the Reference Member State and the Concerned Member States, a pregnancy review including a report on their Pregnancy Prevention Programme and an integrated assessment of pregnancy exposures and outcomes, # monthly for the first # years after the adoption of the European Commission Decision and annually thereafter
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32 The Commission submits that, when it adopts measures to protect public health with regard to medicinal products, the scientific process of assessing risk is not undertaken by it but by scientific experts, namely the members of the CPMP.
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80 Second, Hänseler submits that the procedure before the CPMP and the Commission in this instance was marked by a serious breach of the procedural rules laid down in Articles 13 and 14 of Directive 75/319, since the CPMP and the Commission did not comply at all with the time-limits prescribed by those provisions.
Después de # semanas de tratamiento, los niveles séricos medios de #-hidroxivitamina D fueron significativamente superiores (# %) en el grupo de FOSAVANCE (# mg/# UI) (# nmol/l [ # ng/ml ]) que en el grupo de alendronato sólo (# nmol/l [ # ng/ml ]EurLex-2 EurLex-2
9 On 17 May 1995 the Federal Republic of Germany made a referral to the CPMP in accordance with Article 12 of Directive 75/319, as amended by Directive 93/39, expressing its fears as regards anorectics, which include medicinal products containing phentermine, liable to cause serious pulmonary artery hypertension.
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203 sinne gevind in 6 ms. Hulle kom uit baie bronne en word nie nagegaan nie.