Você procurou por: sanohex (Inglês - Maltês)

sanohex
spanja

what is sanohex?
x’ inhu sanohex?

why was sanohex reviewed?
għaliex ġie rivedut sanohex?

sanohex is a ‘ generic medicine’.
sanohex huwa ‘ mediċina ġenerika ’.

sanohex is a medicine in a pressurised inhaler that contains salbutamol as active substance.
sanohex hija mediċina f’ inalatur taħt pressjoni li fiha salbutamol bħala sustanza attiva.

overall summary of the scientific evaluation of sanohex and associated names (see annex i)
sommarju Ġenerali tal- evalwazzjoni xjentifika ta ’ sanohex u ismijiet assoĊjati (ara l- anness i)

- the chmp considered that sanohex and the reference product possess the same systemic safety profile, as
- is- chmp ikkunsidra li salbumalin u l- prodott ta ’ referenza għandhom l- istess profil ta ’ sigurtà

questions and answers on the referral for sanohex salbutamol, metered dose aerosol inhaler, 100 μ g/ dose
mistoqsija u tweġiba dwar ir- referenza għal sanohex salbutamol, inalatur ajrosol b’ doża mkejla, 100 μg/ doża

the grounds for the referral were concerns regarding that there was not enough data showing that sanohex is equivalent to the reference medicine.
ir- raġunijiet għar- referenza kienu tħassib dwar il- fatt li ma kienx hemm biżżejjed dejta li turi li sanohex huwa ekwivalenti għall- mediċina ta ’ referenza.

sanohex is used to treat the breathing difficulties caused by asthma and chronic obstructive pulmonary disease (copd).
sanohex jintuża biex jittratta d- diffikultajiet fit- teħid tan- nifs ikkawżati mill- ażżma u minn mard pulmonari ostruttiv kroniku (copd).

sanohex is a metered dose aerosol inhaler containing a suspension formulation of salbutamol sulphate 100 µg/ spray, with hfa 134a as propellant.
sanohex huwa inalatur aerosol ta ’ doża mkejla li fih formulazzjoni ta ’ sospensjoni ta ’ salbutamol sulfat 100 µg/ sprej, b’ hfa 134a bħala propellent.

the european medicines agency (emea) has completed a referral procedure following a disagreement among member states of the european union regarding the authorisation of the medicine sanohex.
l- aġenzija ewropea dwar il- mediċini (emea) temmet proċedura ta ’ referenza wara nuqqas ta ’ qbil fost l- istati membri tal- unjoni ewropea fir- rigward tal- awtorizzazzjoni tal- mediċina sanohex.

this means that sanohex is similar to a ‘ reference medicine’ already authorised in the european union (eu) called sultanol inhaler.
dan ifisser li sanohex huwa simili għal ‘ mediċina ta ’ referenza ’ li hija diġà awtorizzata fl- unjoni ewropea (ue) imsejħa sultanol inalatur.

the pharmacokinetic bioequivalence data also confirmed that sanohex and the reference product possess the same systemic safety profile since bioequivalence in systemic levels (auc and cmax) have been shown, when used with or without a spacer.
id- dejta ta ’ bijoekwivalenza farmakokinetika kkonfermat ukoll li salbumalin u l- prodott ta ’ referenza għandhom l- istess profil ta ’ sigurtà sistemika minħabba li ntweriet il- bijoekwivalenza f’ livelli sistemiċi (auc u cmax), meta użati bi jew mingħajr spejser.

the chmp has recommended the granting of the marketing authorisations for which the valid summary of product characteristics, labelling and package leaflet are the final versions achieved during the coordination group procedure are set out in annex iii for sanohex and associated names (see annex i).
is- chmp irrakkomanda l- għoti ta ’ awtorizzazzjonijiet għat- tqegħid fis- suq li s- sommarju tal - karatteristiċi tal- prodott, tikketta u fuljett ta ’ tagħrif għalihom validi huma l- verżjonijiet finali miksubin waqt il- proċedura tal- grupp ta ’ koordinament kif stabbiliti fl- anness iii għal sanohex u ismijiet assoċjati (ara l- anness i).