Je was op zoek naar: compagel (Engels - Maltees)

compagel gel for horses
compagel gel għaż - żwiemel

compagel gel for horses is a generic product.
il- Ġel għaż- Żwiemel compagel huwa prodott ġeneriku.

compagel gel for horses contains heparin sodium, levomenthol and hydroxyethyl salicylates.
il- Ġel għaż- Żwiemel compagel fih heparin sodium, levomenthol u hydroxyethyl salicylates.

opinion following an article 33 (4) referral for compagel gel for horses
opinjoni wara riferiment skont l- artikolu 33 (4) gĦall- Ġel gĦaŻ- Żwiemel compagel

compagel gel for horses proved to be essentially similar to the reference product, tensolvet 50000.
Ġie ppruvat li l- compagel gel għaż- żwiemel kien essenzjalment simili għall- prodott ta ’ referenza, tensolvet 50000.

the objections raised by france and sweden should not prevent the granting of a marketing authorisation for compagel gel for horses.
l- objezzjonijiet imqajma minn franza u l- iżvezja m’ għandhomx jipprevjenu l - għoti ta ’ l- awtorizzazzjoni għat- tqegħid fis- suq għal compagel gel għaż- żwiemel.

all concerned member states in the mutual recognition procedure agreed that compagel gel for horses is essentially similar to tensolvet 50000.
l- istati membri kollha konċernati fil- proċedura għall- għarfien reċiproku qablu li compagel gel għaż- żwiemel huwa essenzjalment simili għal tensolvet 50000.

having considered the referral notification and responses of the applicant, the cvmp concluded that all concerned member states in the mutual recognition procedure agreed that compagel gel for horses is essentially similar to tensolvet 50000.
wara li qies in- notifika tar- riferiment u t- tweġibiet tal- applikant, is- cvmp ikkonkluda li l- istati membri kollha kkonċernati fil- proċedura ta ’ għarfien reċiproku qablu li l- Ġel għaż- Żwiemel compagel huwa essenzjalment simili għal tensolvet 50000.

in response to the questions, the applicant submitted the dossier and argued on the basis of a comparison of the compositions that there are no differences between compagel gel for horses and the reference product that could justify different conclusions on the safety and efficacy.
bi tweġiba għall- mistoqsijiet, l- applikant issottometta d- dokumentazzjoni u argumenta abbażi tat - tqabbil tal- kompożizzjonijiet li ma hemmx differenzi bejn il- Ġel għaż- Żwiemel compagel u l- prodott ta ’ referenza li jistgħu jiġġustifikaw konklużjonijiet differenti fuq is- sigurtà u l- effikaċja.

the marketing authorisation holder was requested to provide a copy of the dossier and, in view of the concerns raised by france and sweden, to indicate and to substantiate where necessary any differences between compagel gel for horses and the reference product that could justify different conclusions on the safety or efficacy for the two products.
id- detentur tal- awtorizzazzjoni għat- tqegħid fis- suq intalab jipprovdi kopja tad- dokumentazzjoni u, fid- dawl tat- tħassib imqajjem minn franza u l- iżvezja, biex jindika u jissostanzja fejn meħtieġ xi differenzi li jista ’ jkun hemm bejn il- Ġel għaż- Żwiemel compagel u l- prodott ta ’ referenza li jistgħu jiġġustifikaw konklużjonijiet differenti dwar is- sigurtà u l- effikaċja taż- żewġ prodotti.

germany, reference member state in the decentralised procedure, notified the emea on 21 december 2008 that the co-ordination group for mutual recognition and decentralised procedures - veterinary (cmd(v)) failed to reach an agreement for compagel gel for horses.
il- Ġermanja, stat membru ta ’ referenza fil- proċedura ta ’ deċentralizzazzjoni, fil- 21 ta ’ diċembru 2007, għarraf lill- emea li l- grupp ta ’ koordinazzjoni għall- għarfien reċiproku u l- proċeduri deċentralizzati - veterinarji (is- cmd( v)) naqas milli jilħaq ftehim fuq compagel gel għaż- żwiemel.