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2005 m. kovo 29 d.chmp/187488/2004
29 march 2005 chmp/187488/2004

2005 m. birzelio 23 d.chmp nusprend, jog:
on 23 june 2005, the chmp concluded that:

2005 m. lapkricio 7 d.chmp/408150/2005
7 november 2005 chmp/408150/2005

rlt pateik savo atsakym 2006 m. rugsjo 29 d.chmp klausim sras.
the mah submitted its response to the chmp list of questions on 29 september 2006.

2005 m. vasario 17 d.chmp registravimo liudijimo turtojui pateik klausim sras.
the chmp issued a list of questions (loq) to the mah on 17 february 2005.

siame dokumente ir prieduose pateikta informacija atspindi tik 2006 m. kovo 23 d.chmp nuomon.
the information given in this document and annexes reflect only the chmp opinion dated 23 march 2006.

siame dokumente ir prieduose pateikta informacija atspindi tik 2005 m. balandzio 21 d.chmp nuomon.
the information given in this document and annexes reflect only the chmp opinion dated 21 april 2005.

2004 m. lapkricio 18 d.chmp papras pateikti issami informacij apie si preparat saugum sirdies ir kraujagysli sistemai.
on 18 november 2004, the chmp requested comprehensive cardiovascular safety information for these products.

2005 m. geguzs 26 d.chmp pritar btinybei susaukti ekspert grups ad hoc susitikim dl rekombinacins hepatito b vakcinos trumpalaiks ir ilgalaiks apsaugos nuo hepatito b.
on 26 may 2005, the chmp agreed on the need to convene an ad hoc expert group meeting on hepatitis short and long-term protection afforded by recombinant hepatitis b vaccines.

2007 m. birzelio 21 d.chmp, siekdamas pabrzti ir palengvinti konkreci preparato charakteristik santraukos dalini pakeitim gyvendinim, prim pakartotinai apsvarstyt nuomon su is dalies pakeistais ii ir iii priedais.si nuomon buvo dar kart apsvarstyta 2007 m. spalio mnes.
on 21 june 2007 the chmp, in order to focus and facilitate the translations of the specific amendments in the summary of product characteristics, adopted a revised opinion with amended annex ii and annex iii, which was further reconsidered in october 2007.

apsvarsts rlt pateiktus ir pranesj vertintus atsakymus, 2006 m. lapkricio 16 d.chmp patvirtino prasym pateikti papildom informacij, kuriame rlt buvo prasoma pateikti issamesn informacij apie klinikin naudingum ir pareiksti savo pastabas dl silom spc 4. 1 skyriaus ir 4. 2 skyriaus dozavimo dalies formuluoci.
having considered the response provided by the mah and assessed by the rapporteurs, on 16 november 2006, the chmp adopted a request of supplementary information, in which the mah was asked to further expand on the issue of clinical utility and to comment on a proposed wordings regarding the indication in 4.1 and the posology in 4.2 of the spc.

2007 m. birzelio 21 d.chmp nusprend, kad remiantis epidemiologini tyrim duomenimis galima daryti isvad, kad, lyginant su kitais nsaid, vartojant vaistus, kuri sudtyje yra piroksikamo, kyla didesnis rimto virskinimo sistemos apnuodijimo pavojus, taip pat, lyginant su kitais nsaid, kuri sudtyje nra oksikamo, padidja sunki odos reakcij (scar) pavojus.
the chmp concluded on 21 june 2007 that epidemiological studies suggest that systemic formulations of piroxicam are associated with a higher risk of serious gastrointestinal toxicity, relative to other nsaids, and a higher risk of serious skin reactions (scar) than other non-oxicam nsaids.