Примери за използване на Each active substance на Английски и техните преводи на Български
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For each active substance there is a brief description of its action.
Notifications shall be submitted for each active substance separately, as follows.
We select each active substance and excipient according to strict quality criteria.
The Member States transmit statistics on each active substance to Eurostat.
For each active substance for which it has been designated rapporteur, the Member State shall.
The medicine has been shown to reduce blood pressure more than each active substance alone.
For each active substance that needs to be evaluated, an EU country is appointed‘rapporteur'.
The adverse events seen with the adjunctive therapy have been observed with each active substance alone.
Dividing these by the maximum daily dose for each active substance gives the limit in parts per million(see Table 1).
Patients already taking vildagliptin andmetformin should switch to Icandra containing the same amounts of each active substance.
The information provided shall be sufficient to precisely identify each active substance and define it in terms of its specification and nature.
Patients already taking vildagliptin andmetformin should switch to Eucreas containing the same amounts of each active substance.
The name and amount of each active substance expressed as provided for in Article 6 of Directive 67/548/EEC and in particular paragraph(2)(d) of that Article.
It is clear from those requirements that the information submitted must be sufficient to identify precisely each active substance and to define it in terms of its specification and nature.
(b) for each active substance in the plant protection product, a dossier satisfying, in the light of current scientific and technical knowledge, the requirements set out in Annex II.
The information provided must be sufficient to identify with precision each active substance, to define it in terms of its specification and to characterize it as to its nature.
EMLA is a fixed combination product consisting of an oil/water emulsion and eutectic mixture of lidocaine and prilocaine in equal quantities(by weight)with 2.5% of each active substance included.
In respect of medicinal products to be administered by drops, by the mass orunits of biological activity of each active substance contained in the number of drops corresponding to 1 ml or 1 g of the preparation.
For each active substance, safener and synergist contained in the plant protection product, a complete and a summary dossier for each point of the data requirements of the active substance, safener and synergist;
Applicants also need to submit a draft summary of biocidal product characteristics and either a dossier ora letter of access on each active substance contained in the biocidal product.
For each active substance, safener and synergist and adjuvant, rapporteur Member States shall prepare a list of the test and study reports necessary for first approval, amendment of approval conditions or renewal of the approval and make it available to the Member States and the Commission.
It is clear from those requirements that the information submitted must be sufficient to identify precisely each active substance and to define it in terms of its specification and nature.
In order to give"quantitative particulars" of the active substances of the medicinal products, it is necessary, depending on the pharmaceutical form concerned, to specify the mass, or the number of units of biological activity, either per dosage-unit orper unit of mass or volume, of each active substance.
In respect of medicinal products to be administered by drops, by the mass orunits of biological activity of each active substance contained in the number of drops corresponding to 1 ml or 1 g of the preparation.
In respect of syrups, emulsions, granular preparations and other pharmaceutical forms to be administered in measured quantities, by the mass orunits of biological activity of each active substance per measured quantity.
Calls on the Commission to improve transparency by establishing a webpage displaying the timeline andstages of the approval of each active substance, indicating the RMS, EFSA and ECHA decisions, PAFF Committee decisions, the duration of the licence and other relevant details;
A clinical interaction study performed in healthy subjects showed that co-administration of repeat-dose anagrelide 1 mg once daily andacetylsalicylic acid 75 mg once daily may enhance the anti-platelet aggregation effects of each active substance compared with administration of acetylsalicylic acid alone.
Alternatively, he may provide a collated document containing information equivalent to that in the representative SmPCs for each active substance that could be used as an IMP in the clinical trial.
When fluticasone furoate, umeclidinium and vilanterol were administered in combination by the inhaled route from a single inhaler in healthy subjects,the pharmacokinetics of each component were similar to those observed when each active substance was administered either as fluticasone furoate/vilanterol combination or as an umeclidinium/vilanterol combination or umeclidinium monotherapy.
Any producer wishing to secure the inclusion of an active substance referred to in Annex I to this Regulation, or any variants thereof such as salts, esters or amines,in Annex I to the Directive shall so notify, for each active substance separately, the rapporteur Member State designated in Annex I to this Regulation within six months after the date of entry into force of this Regulation.