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Lääkealan Turvallisuus- Ja Kehittämiskeskuksen Päätös

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Lääkealan Turvallisuus- Ja Kehittämiskeskuksen Päätös LUONNOS 5.12.2018 Lääkealan turvallisuus- ja kehittämiskeskuksen päätös N:o xxxx lääkeluettelosta Annettu Helsingissä 15. päivänä maaliskuuta 2019 ————— Lääkealan turvallisuus- ja kehittämiskeskus on 10 päivänä huhtikuuta 1987 annetun lääke- lain (395/1987) 83 §:n nojalla päättänyt vahvistaa seuraavan lääkeluettelon: 1 § vallisten valmisteiden ja erityislupavalmis- Luettelon tarkoitus teiden vaikuttavia lääkeaineita. Liitteessä 1 on lueteltu ainoastaan lääkeai- Tämä päätös sisältää luettelon Suomessa neet. Lääkeaineiden suoloja ja estereitä ei ole lääkkeellisessä käytössä olevista aineista ja lueteltu. Lääkeaineet ovat valmisteessa suo- rohdoksista. Lääkeluettelo laaditaan ottaen lamuodossa teknisen käsiteltävyyden vuoksi. huomioon lääkelain 3 §:n ja 5 §:n säännök- Lääkeaine ja sen suolamuoto ovat biologises- set. ti samanarvoisia. Lääkkeellä tarkoitetaan valmistetta tai ai- Liitteen 1 A aineet ovat lääkeaineanalogeja netta, jonka tarkoituksena on sisäisesti tai ja prohormoneja. Kaikki liitteen 1 A aineet ulkoisesti käytettynä parantaa, lievittää tai rinnastetaan aina vaikutuksen perusteella ehkäistä sairautta tai sen oireita ihmisessä tai ainoastaan lääkemääräyksellä toimitettaviin eläimessä. Lääkkeeksi katsotaan myös sisäi- lääkkeisiin. sesti tai ulkoisesti käytettävä aine tai aineiden yhdistelmä, jota voidaan käyttää ihmisen tai 2 § eläimen elintoimintojen palauttamiseksi, Lääkkeitä ovat korjaamiseksi tai muuttamiseksi farmakolo- 1) tämän päätöksen liitteessä 1 luetellut ai- gisen, immunologisen tai metabolisen vaiku- neet, niiden suolat ja esterit; tuksen avulla taikka terveydentilan tai sai- 2) rikoslain 44 luvun 16 §:n 1 momentissa rauden syyn selvittämiseksi. tarkoitetuista dopingaineista annetussa val- Lääkeluettelo ei ole tyhjentävä. Tässä luet- tioneuvoston asetuksessa kulloinkin luetellut telossa mainitsemattomat aineet ja rohdokset, dopingaineet; ja jotka täyttävät lääkelain lääkkeen määritel- 3) tämän päätöksen liitteessä 1 A luetellut män, ovat lääkkeitä. aineet. Lääkeluettelon vahvistamisen lisäksi Lää- kealan turvallisuus- ja kehittämiskeskus päät- 3 § tää lääkelain 6 §:n nojalla tarvittaessa, onko Lääkkeitä ovat seuraavat aineet tai valmis- ainetta tai valmistetta pidettävä lääkkeenä. teet käytettäessä niitä lääkelain 3 §:n Keskus päättää tapauskohtaisesti onko luette- mukaisesti: lossa olevaa ainetta sisältävää valmistetta 1) tämän päätöksen liitteessä 2 luetellut pidettävä lääkkeenä ottaen huomioon tuot- rohdokset ja niistä edelleen valmistetut vai- teen esitystapa, koostumus, farmakologiset kuttavat aineet, joita ovat kasvirohdostuotteet ominaisuudet, käyttötavat, levityksen laajuus, (mm. uutteet, tinktuurat, puristemehut) ja kuluttajatieto ja käytöstä aiheutuva vaara. vastaavat eläinperäiset vaikuttavat aineet sekä näistä valmistetut lääkevalmisteet; Lääkeluettelon liitteissä mainittu aine voi 2) erinäiset tavanomaisista lääkkeistä olo- kuulua myös muun kuin lääkelainsäädännön muodoltaan, koostumukseltaan, valmistusta- alaan, mikäli siitä on erikseen säädetty. valtaan tai vaikutusmekanismiltaan poikkea- vat valmisteet tai aineet. Tällaisia ovat muun Liitteissä 1 ja 2 on lueteltu Suomessa lääk- muassa radioaktiiviset lääkevalmisteet, aller- keellisessä käytössä olevat aineet ja rohdok- geenivalmisteet, rokotteet, lääkkeelliset kaa- set. Liitteen 1 aineet ovat pääosin myyntilu- sut, pitkälle kehitetyssä terapiassa käytettävät Lääkeluettelo Luonnos 5.12.2018 lääkkeet sekä ihmisverestä tai -veriplasmasta Tällä päätöksellä kumotaan lääkeluettelosta peräisin olevat lääkkeet; ja 16. päivänä maaliskuuta 2016 annettu Lää- 3) vitamiini- ja kivennäisainevalmisteet. kealan turvallisuus- ja kehittämiskeskuksen päätös (201/2016). 4 § Lääkeluettelon luonnoksesta on toimitettu ilmoitus työ- ja elinkeinoministeriöön. Ilmoi- Tämä päätös tulee voimaan 1. päivänä huh- tus on tehty Euroopan parlamentin ja neuvos- tikuuta 2019. ton direktiivin 98/34/EY mukaisesti, sellai- sena kuin se on muutettuna direktiivillä 98/48/EY. Helsingissä 15. päivänä maaliskuuta 2019 Ylijohtaja Eija Pelkonen Yliproviisori Kristiina Pellas 2 Lääkeluettelo Luonnos 5.12.2018 LIITE 1 Suomenkielinen nimi Latinankielinen nimi Ruotsinkielinen nimi Englanninkielinen nimi Finskt namn Latinskt namn Svenskt namn Engelskt namn (N)-Hydroksietyyli-prometatsiini (N)-Hydroxy- (N)-Hydroxietyl-prometazin (N)-Hydroxyethyl- aethylprometazinum promethazine 2,4-Diklooribentsyyli-alkoholi 2,4-Dichlorbenzyl- 2,4-Diklorbensylalkohol 2,4-Dichlorobenzyl alco- alcoholum hol 2-Isopropoksifenyyli-N- 2-Isopropoxyphenyl-N- 2-Isopropoxifenyl-N-metylkarbamat 2-Isopropoxyphenyl-N- metyylikarbamaatti methylcarbamas methylcarbamate 4-Dimetyyliaminofenoli 4-Dimethyl- ami- 4-Dimetylaminofenol 4-Dimethylaminophenol nophenolum 6,7-diF-1-MeTIQ 6,7-diF-1-MeTIQ 6,7-diF-1-MeTIQ 6,7-diF-1-MeTIQ Abakaviiri Abacavirum Abakavir Abacavir Abareliksi Abarelixum Abarelix Abarelix Abatasepti Abataceptum Abatacept Abatacept Abirateroni Abirateronum Abirateron Abiraterone Absiksimabi Abciximabum Absiximab Abciximab Adalimumabi Adalimumabum Adalimumab Adalimumab Adapaleeni Adapalenum Adapalen Adapalene Adefoviiridipivoksiili Adefovirum dipivoxilum Adefovirdipivoxil Adefovir dipivoxil Ademetioniini Ademetioninum Ademetionin Ademetionine Adenosiini Adenosinum Adenocin Adenosine Adinatsolaamimesilaatti Adinazolami mesilas Adinazolammesilat Adinazolam mesilate Adipiodoni Adipiodonum Adipiodon Adipiodone Adrafiniili Adrafinilum Adrafinil Adrafinil Adrenaliini Adrenalinum Adrenalin Adrenaline Adrenaliinitartraatti Adrenalini tartras Adrenalintartrat Adrenaline tartrate Adrenaloni Adrenalonum Adrenalon Adrenalone Afamelanotidi Afamelanotidum Afamelanotid Afamelanotide Afatinibi Afatinibum Afatinib Afatinib Aflibersepti Afliberceptum Aflibercept Aflibercept Afobatsoli Afobazolum Afobazol Afobazole Afoksolaneeri Afoxolanerum Afoxolaner Afoxolaner Agalsidaasi Agalsidasum Agalsidas Agalsidase Aglepristoni Aglepristonum Aglepriston Aglepristone 3 Lääkeluettelo Luonnos 5.12.2018 Agomelatiini Agomelatinum Agomelatin Agomelatine Aimaliini Ajmalinum Ajmalin Ajmaline Akamprosaatti Acamprosatum Acamprosat Acamprosate Akarboosi Acarbosum Akarbos Acarbose Aklarubisiini Aclarubicinum Aklarubicin Aclarubicin Aklidinium Aclidinium Aclidinium Aclidinium Akrivastiini Acrivastinum Acrivastin Acrivastine Aksikabtageenisiloleuseeli Axicabtagenum ciloleuce- Axikabtagenciloleucel Axicabtagene ciloleucel lum Aksitinibi Axitinibum Axitinib Axitinib Alaproklaatti Alaproclatum Alaproklat Alaproclate Alatrofloksasiini Alatrofloxacinum Alatrofloxacin Alatrofloxacin Albendatsoli Albendazolum Albendazol Albendazole Albiglutidi Albiglutidum Albiglutid Albiglutide Albumiini, ihmisen Albuminum humanum Albumin Albumin, human Albumiinitannaatti Albumini tannas Albumintannat Albumin tannate Aldesleukiini Aldesleukinum Aldesleukin Aldesleukin Aldesulfoninatrium Aldesulfonum natricum Aldesulfonnatrium Aldesulfone sodium Aldosteroni Aldosteronum Aldosteron Aldosterone Alektinibi Alectinibum Alektinib Alectinib Alemtutsumabi Alemtuzumabum Alemtuzumab Alemtuzumab Alendronihappo Acidum alendronicum Alendronsyra Alendronic acid Alfakalsidoli Alfacalcidolum Alfakalcidol Alfacalcidol Alfaksaloni Alfaxalonum Alfaxalon Alfaxalone; alphaxalone Alfentaniili Alfentanilum Alfentanil Alfentanil Alfutsosiini Alfuzosinum Alfuzosin Alfuzosin Algeldraatti Algeldratum Algeldrat Algeldrate Algiinihappo Acidum alginicum Alginsyra Alginic acid Alglukosidaasialfa Alglucosidase alfa Alglukosidas alfa Alglucosidase alfa Alimematsiini Alimemazinum Alimemazin Alimemazine Aliskireenifumaraatti Aliskireni fumaras Aliskirenfumarat Aliskiren fumarate Alitretinoiini Alitretinoinum Alitretinoin Alitretinoin Alklofenaakki Alclofenacum Alklofenak Alclofenac Alklometasonidipropionaatti Alclometasoni dipropionas Alklometason-dipropionat Alclometasone dipro- pionate Alkuroniumkloridi Alcuronii chloridum Alkuroniumklorid Alcuronium chloride Allobarbitaali Allobarbitalum Allobarbital Allobarbital Allopurinoli Allopurinolum Allopurinol Allopurinol Allyyliestrenoli Allylestrenolum Allylestrenol Allylestrenol 4 Lääkeluettelo Luonnos 5.12.2018 Almitriini Almitrinum Almitrin Almitrine Almotriptaani Almotriptanium Almotriptan Almotriptan Alogliptiini Alogliptinum Alogliptin Alogliptin Aloksipriini Aloxiprinum Aloxiprin Aloxiprin Alpratsolaami Alprazolamum Alprazolam Alprazolam Alprenololi Alprenololum Alprenolol Alprenolol Alprostadiili Alprostadilum Alprostadil Alprostadil Alteplaasi Alteplasum Alteplas Alteplase Altrenogesti Altrenogestum Altrenogest Altrenogest Altretamiini Altretaminum Altretamin Altretamine Aluminiumasetotartraatti Aluminii acetotartras Aluminiumacetotartrat Aluminium acetotartrate Aluminiumklofibraatti Aluminii clofibras Aluminiumklofibrat Aluminium clofibrate Alveriini Alverinum Alverin Alverine Amantadiini Amantadinum Amantadin Amantadine Ambatsoni Ambazonum Ambazon Ambazone Ambenonium Ambenonium Ambenonium Ambenonium Ambenoniumkloridi Ambenonii chloridum Ambenoniumklorid Ambenonium chloride Ambrisentaani Ambrisentanum Ambrisentan Ambrisentan Ambroksoli Ambroxolum Ambroxol Ambroxol Ambroksolihydrokloridi Ambroxoli hydrochloridum Ambroxolhydroklorid Ambroxol hydrochloride Ambutoniumbromidi Ambutonii bromidum Ambutoniumbromid Ambutonium bromide Ametsiniummetilsulfaatti Amezinii metilsulfas Ameziniummetilsulfat Amezinium metilsulfate Amfepramoni Amfepramonum Amfepramon Amfepramone Amfetamiini Amphetaminum Amfetamin Amphetamine; amfetami- ne Amfetaminilum Amfetaminil Amfetaminil Amfetaminiili Amfoterisiini Amphotericinum Amfotericin Amphotericin Amifampridiini Amifampridinum
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