You searched for: data lock point (Engelska - Maltesiska)

first data-lock point is 14 days later.
l-ewwel punt ta’ waqfien tad-dejta huwa 14-il ġurnata wara.

- first data-lock point is 14 days later.
- l- ewwel data- lock point hu 14- il jum wara.

the data lock points
wara d-data lock

the data lock point (dlp) for the next psur would be 31 august 2016.
id- data lock point (dlp) għall-psur li jmiss tkun 31 ta’ awwissu 2016.

all events reported by patients that have been entered into the database by data-lock point
l-avvenimenti kollha rrappurtati minn pazjenti li ddaħħlu f’dejtabażi skont il-punt ta’ waqfien tad-dejta

all events reported by patients that have been entered into the database by data-lock point 6.
6.

all non-medically confirmed events are those that have been entered into the database by the data-lock point.
il-każijiet mhux ikkonfermati b’mod mediku kollha huma dawk li jkunu ġew mdaħħla fid-dejtabejż mid-data-lock point.

the mah will continue to submit yearly psurs (data lock point 21 september) unless otherwise specified by the chmp.
id- detentur ta ’ l- awtorizzazzjoni għat- tqegħid fis- suq se jkompli jissottometti psurs ta ’ kull sena (data lock point 21 ta ’ settembru) sakemm mhux speċifikat mod ieħor mis- chmp.

when it has been agreed by the chmp that the s-psur is no longer necessary, a full psur covering the period since the data lock point of the last routine psur will be submitted within a time frame to be agreed with the rapporteur.
meta jiġi miftiehem mis-chmp li r-rapport ta’ aġġornament dwar is-sigurtà simplifikat m’għadux aktar meħtieġ, rapport ta’ aġġornament dwar is-sigurtà sħiħ li jkopri l-perijodu mid-data lock point sal-aħħar rapport ta’ aġġornament dwar is-sigurtà ta’ rutina għandu jiġi sottomess f’perijodu ta’ żmien inkwadrat li jrid jiġi miftiehem mir-rapporter.

cumulatively, since the granting of the marketing authorisation up to the data lock- point (dlp) of the current psur, a total of 527 reported post-marketing cases of hypersensitivity reactions of which more than 50 % were serious including life threatening allergic reactions (264 serious, 263 non-serious).
b’kollox, minn meta ingħatat l-awtorizzazzjoni għat-tqegħid fis-suq sal-punt meta waqfet tinġabar id-dejta (dlp – data lock-point) tal-psur attwali, kienu rrappurtati total ta’ 527 każ ta’ reazzjonijiet ta’ sensittività eċċessiva wara t-tqegħid fis-suq li minnhom aktar minn 50% kienu serji inkluż reazzjonijiet allerġiċi ta’ periklu għall-ħajja (264 serji, 263 mhux serji).