Примери за използване на Proposed harmonised на Английски и техните преводи на Български
{-}
-
Medicine
-
Colloquial
-
Official
-
Ecclesiastic
-
Ecclesiastic
-
Computer
Overall, the undesirable effects listed in the CSP agreed during the PSUR work-sharing procedure number GR/H/PSUR/0001/001 have been included in section 4.8 of the proposed harmonised SmPC using the MedDRA Preferred Terms(PTs),
The proposed withdrawal time of 0 days was well supported by a residue study where pigs were treated using the proposed harmonised dosing regimen 10 mg/kg bw/day for 7 days,
gives an opinion on the proposed harmonised classification of substances as carcinogenic,
gives an opinion on the proposed harmonised classification of substances as carcinogenic,
the CHMP acknowledged that it could represent an alternative treatment option and considered the proposed harmonised wording acceptable.
the long-term management of severe chronic pain in children from 2 years of age who are receiving opioid therapy is indicated in section 4.1 of the proposed harmonised SmPC, and also present in the majority of SmPCs.
If the proposed harmonised classification and labelling submitted under the first subparagraph is not included
section 4.4 of the proposed harmonised SPC.
The information on castor oil is given under section 2 and section 6 of the proposed harmonised SmPC text
based on the recommended posology for cattle(100 000 IU colistin per kg body weight daily for 3-5 consecutive days) and the proposed harmonised posology for pigs
A critical evaluation of the MAH's proposed harmonised SmPC is discussed below.
Most statements were either already covered by the proposed harmonised text, or lacked supportive evidence.
The Commission has not proposed harmonised definitions, but is happy to offer its opinion on any questions that arise.
funding from markets in order to meet any proposed harmonised minimum requirements;
EFSA also proposed harmonised epidemiological indicators for food-borne hazards that are covered by existing meat inspection procedures as well as the highlighted biological hazards.
The MAH also proposed harmonised Product Information texts for section 4.3 Contraindications reflecting the hypersensitivity to formulation constituents
justifying the proposed harmonised Product Information.
The MAH has used the MRP SmPC text as the proposed harmonised SmPC text as the overdose wording across the Member State SmPCs is essentially identical to the current MRP SmPC text.
Section 4.7- Effects on ability to drive and use machines The majority of markets currently have the proposed harmonised wording, which is in line with the SmPC guideline dated September 2009.
If the Commission finds that the proposed harmonised classification and labelling is appropriate,