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Lääkealan Turvallisuus- Ja Kehittämiskeskuksen Päätös Lääkealan turvallisuus- ja kehittämiskeskuksen päätös N:o xxxx lääkeluettelosta Annettu Helsingissä xx päivänä maaliskuuta 2016 ————— Lääkealan turvallisuus- ja kehittämiskeskus on 10 päivänä huhtikuuta 1987 annetun lääke- lain (395/1987) 83 §:n nojalla päättänyt vahvistaa seuraavan lääkeluettelon: 1 § Lääkeaineet ovat valmisteessa suolamuodossa Luettelon tarkoitus teknisen käsiteltävyyden vuoksi. Lääkeaine ja sen suolamuoto ovat biologisesti samanarvoisia. Tämä päätös sisältää luettelon Suomessa lääk- Liitteen 1 A aineet ovat lääkeaineanalogeja ja keellisessä käytössä olevista aineista ja rohdoksis- prohormoneja. Kaikki liitteen 1 A aineet rinnaste- ta. Lääkeluettelo laaditaan ottaen huomioon lää- taan aina vaikutuksen perusteella ainoastaan lää- kelain 3 ja 5 §:n säännökset. kemääräyksellä toimitettaviin lääkkeisiin. Lääkkeellä tarkoitetaan valmistetta tai ainetta, jonka tarkoituksena on sisäisesti tai ulkoisesti 2 § käytettynä parantaa, lievittää tai ehkäistä sairautta Lääkkeitä ovat tai sen oireita ihmisessä tai eläimessä. Lääkkeeksi 1) tämän päätöksen liitteessä 1 luetellut aineet, katsotaan myös sisäisesti tai ulkoisesti käytettävä niiden suolat ja esterit; aine tai aineiden yhdistelmä, jota voidaan käyttää 2) rikoslain 44 luvun 16 §:n 1 momentissa tar- ihmisen tai eläimen elintoimintojen palauttami- koitetuista dopingaineista annetussa valtioneuvos- seksi, korjaamiseksi tai muuttamiseksi farmako- ton asetuksessa kulloinkin luetellut dopingaineet; logisen, immunologisen tai metabolisen vaikutuk- ja sen avulla taikka terveydentilan tai sairauden 3) tämän päätöksen liitteessä 1 A luetellut ai- syyn selvittämiseksi. neet. Lääkeluettelo ei ole tyhjentävä. Tässä luette- lossa mainitsemattomat aineet ja rohdokset, jotka 3 § täyttävät lääkelain lääkkeen määritelmän, ovat Lääkkeitä ovat seuraavat aineet tai valmisteet lääkkeitä. käytettäessä niitä lääkelain 3 §:n Lääkeluettelon vahvistamisen lisäksi Lääkealan mukaisesti: turvallisuus- ja kehittämiskeskus päättää lääkelain 1) tämän päätöksen liitteessä 2 luetellut rohdok- 6 §:n nojalla tarvittaessa, onko ainetta tai valmis- set ja niistä edelleen valmistetut vaikuttavat ai- tetta pidettävä lääkkeenä. Keskus päättää tapaus- neet, joita ovat kasvirohdostuotteet (mm. uutteet, kohtaisesti onko luettelossa olevaa ainetta sisältä- tinktuurat, puristemehut) ja vastaavat eläinperäi- vää valmistetta pidettävä lääkkeenä ottaen huo- set vaikuttavat aineet sekä näistä valmistetut lää- mioon tuotteen esitystapa, koostumus, farmako- kevalmisteet; logiset ominaisuudet, käyttötavat, levityksen 2) erinäiset tavanomaisista lääkkeistä olomuo- laajuus, kuluttajatieto ja käytöstä aiheutuva vaara. doltaan, koostumukseltaan, valmistustavaltaan tai vaikutusmekanismiltaan poikkeavat valmisteet tai Lääkeluettelon liitteissä mainittu aine voi kuu- aineet. Tällaisia ovat muun muassa radioaktiiviset lua myös muun kuin lääkelainsäädännön alaan, lääkevalmisteet, allergeenivalmisteet, rokotteet, mikäli siitä on erikseen säädetty. lääkkeelliset kaasut, pitkälle kehitetyssä terapias- sa käytettävät lääkkeet sekä ihmisverestä tai - Liitteissä 1 ja 2 on lueteltu Suomessa lääkkeel- veriplasmasta peräisin olevat lääkkeet; ja lisessä käytössä olevat aineet ja rohdokset. Liit- 3) vitamiini- ja kivennäisainevalmisteet. teen 1 aineet ovat pääosin myyntiluvallisten val- misteiden ja erityislupavalmisteiden vaikuttavia lääkeaineita. Liitteessä 1 on lueteltu ainoastaan lääkeaineet. Lääkeaineiden suoloja ja estereitä ei ole lueteltu. vallisuus- ja kehittämiskeskuksen päätös (207/2015). 4 § Lääkeluettelon luonnoksesta on toimitettu ilmoi- Tämä päätös tulee voimaan 1. päivänä huhti- tus työ- ja elinkeinoministeriöön. Ilmoitus on kuuta 2016. tehty Euroopan parlamentin ja neuvoston direk- tiivin 98/34/EY mukaisesti, sellaisena kuin se on muutettuna direktiivillä 98/48/EY. Tällä päätöksellä kumotaan lääkeluettelosta 26. päivänä helmikuuta 2015 annettu Lääkealan tur- Helsingissä xx päivänä maaliskuuta 2016 Ylijohtaja Sinikka Rajaniemi Yliproviisori Kristiina Pellas LÄÄKELUETTELON AINEET, LIITE 1. ÄMNENA I LÄKEMEDELSFOÖRTECKNINGEN, BILAGA 1. Suomenkielinen nimi, Latinankielinen nimi, Ruotsinkielinen nimi, Englanninkielinen nimi, Finskt namn Latinskt namn Svenskt namn Engelskt namn (N)-Hydroksietyyli- (N)-Hydroxy- (N)-Hydroxietyl-prometazin (N)-Hydroxyethyl- prometatsiini aethylprometazinum promethazine 2,4-Diklooribentsyyli-alkoholi 2,4-Dichlorbenzyl- 2,4-Diklorbensylalkohol 2,4-Dichlorobenzyl alcoholum alcohol 2-Isopropoksifenyyli-N- 2-Isopropoxyphenyl-N- 2-Isopropoxifenyl-N- 2-Isopropoxyphenyl-N- metyylikarbamaatti methylcarbamas metylkarbamat methylcarbamate 4-Dimetyyliaminofenoli 4-Dimethyl- 4-Dimetylaminofenol 4-Dimethylaminophenol aminophenolum 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 Afobazol Afoksolaneeri Afoxolanerum Afoxolaner Afoxolaner Agalsidaasi Agalsidasum Agalsidas Agalsidase Aglepristoni Aglepristonum Aglepriston Aglepristone 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 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 25.11.2015 1 LÄÄKELUETTELON AINEET, LIITE 1. ÄMNENA I LÄKEMEDELSFOÖRTECKNINGEN, BILAGA 1. Alemtutsumabi Alemtuzumabum Alemtuzumab Alemtuzumab Alendronihappo Acidum alendronicum Alendronsyra Alendronic acid Alfakalsidoli Alfacalcidolum Alfakalcidol Alfacalcidol Alfaksaloni Alfaxalonum Alfaxalon Alfaxalone; alphaxalone Alfentaniili Alfentanilum Alfentanil Alfentanil Alfutsosiini Alfuzosini 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 Alkuroniumkloridi Alcuronii chloridum Alkuroniumklorid Alcuronium chloride Allobarbitaali Allobarbitalum Allobarbital Allobarbital Allopurinoli Allopurinolum Allopurinol Allopurinol Allyyliestrenoli Allylestrenolum Allylöstrenol Allylestrenol 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; Amfoterisiini Amphotericinum Amfotericin Amphotericin Amifampridiini Amifampridinum Amifampridin Amifampridine Amifostiini Amifostinum Amifostin Amifostine Amikasiini Amikacinum Amikacin Amikacin Amiloridi Amiloridum Amilorid Amiloride Aminoakridiini Aminoacridinum Aminoakridin Aminoacridine Aminoetikkahappo
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