Примери за използване на Existing product information на Английски и техните преводи на Български
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Medicine
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Colloquial
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Official
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Ecclesiastic
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Ecclesiastic
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Computer
The main areas of disharmony in the existing product information relate to.
The existing product information shall be amended(insertion, replacement or deletion of the text as appropriate) to reflect the agreed wording as provided below.
The main areas of disharmony in the existing product information relate to.
The existing product information shall be amended(insertion, replacement or deletion of the text as appropriate) to reflect the agreed wording as provided below.
For all chlormadinone containing combined hormonal contraceptives listed in Annex I, the existing product information shall be amended(insertion, replacement or deletion of the text as appropriate) to reflect the agreed wording as provided below.
The existing product information shall be amended(insertion, replacement or deletion of the text as appropriate) to reflect the agreed wording as provided below.
For all topical retinoids containing adapalene, alitretinoin, isotretinoin,tretinoin and tazarotene, the existing product information shall be amended(insertion, replacement or deletion of the text, as appropriate) to reflect the agreed wording as provided below.
The existing product information shall be amended(insertion, replacement or deletion of the text as appropriate) to reflect the agreed wording as provided below.
For products containing the angiotensin II receptor blockers azilsartan, eprosartan, irbesartan, losartan,olmesartan and telmisartan, the existing product information shall be amended(insertion, replacement or deletion of the text as appropriate) to reflect the agreed wording as provided below.
The existing product information shall be amended(insertion, replacement or deletion of the text as appropriate) to reflect the agreed wording as provided below.
For products containing the angiotensin-converting enzyme inhibitors(ACE-inhibitors) benazepril, captopril, cilazapril, delapril, enalapril, fosinopril, imidapril, lisinopril, moexipril, perindopril, quinapril, ramipril, spirapril,trandolapril and zofenopril, the existing product information shall be amended(insertion, replacement or deletion of the text as appropriate) to reflect the agreed wording as provided below.
The main areas of disharmony in the existing product information relate to target species, indications, posology and withdrawal periods.
The existing product information shall be amended(insertion, replacement or deletion of the text as appropriate) to reflect the agreed wording as provided below.
However, current experience has raised concerns that the existing product information, in particular relating to dosing and the way the medicine is handled in the body(pharmacokinetics), might need updating.
The existing product information shall be amended(insertion, replacement or deletion of the text as appropriate) to reflect the agreed wording as provided below.
Package Leaflet[For all products in Annex I, the existing product information shall be amended(insertion, replacement or deletion of the text, as appropriate) to reflect the agreed wording as provided below].
The existing product information shall be amended(insertion, replacement or deletion of the text as appropriate) to reflect the newly agreed wording as provided below.
For all desogestrel-containing products listed in Annex I, the existing product information shall be amended(insertion, replacement or deletion of the text as appropriate) to reflect the agreed wording as provided below.
The existing product information shall be amended(insertion, replacement or deletion of the text, as appropriate) to reflect the agreed wording as provided below Summary of product characteristics.
SUMMARY OF PRODUCT CHARACTERISTICS(SmPC)[For all products in Annex I, the existing product information shall be amended(insertion, replacement or deletion of the text, as appropriate) to reflect the agreed wording as provided below].
The existing product information including the indications, dosage recommendations and pharmacokinetic and pharmacodynamic information for vancomycin-containing products in the EU need to be revised in accordance with the latest available information, .
For all products in Annex I, the existing product information shall be amended(insertion, replacement or deletion of the text, as appropriate) to reflect the agreed wording as provided below.
For products containing aliskiren, the existing product information shall be amended(insertion, replacement or deletion of the text as appropriate) to reflect the agreed wording as provided below.
For all products listed in Annex I, the existing product information shall be amended(insertion, replacement or deletion of the text as appropriate) to reflect the agreed wording as provided below.
For all products in Annex I, the existing product information shall be amended(insertion, replacement or deletion of the text, as appropriate) to reflect the agreed wording as provided below} Summary of product characteristics.
The CHMP requested that specifically for the specialpopulations of hepatic and renal impaired patients the warnings related to paracetamol use are all in line with the warnings existing in the mono-component's product information, for completeness of the safety information. .
The existing preclinical and clinical data and the product information including the indications, dosage recommendations and pharmacokinetic and pharmacodynamic information for polymyxin-based products in the EU are not up to date or based on robust data, as highlighted by recent reports of suboptimal efficacy and the emergence of colistin resistance.
Advertising would not exist in this new system outside of general product information available to a person who thinks they might need it.
In addition to the places indicated in Article 7(1) of Regulation(EC) No 842/2006, the labels may also be placed on, or adjacent to existing nameplates or product information labels, or adjacent to servicing access locations.
Warnings already exist in the zaleplon product information however based on the available information the PRAC considered it prudent within this procedure to strengthen the wording in SmPC and PL to ensure clear information is available for patients and healthcare professionals given the potentially serious consequences of next day psychomotor impairment.