Meliam 15 mg tablete

Glavna informacija

  • Trgovački naziv:
  • Meliam 15 mg tablete
  • Doziranje:
  • 15 mg
  • Farmaceutski oblik:
  • tableta
  • Sastav:
  • Urbroj: 1 tableta sadržava 15 mg meloksikama
  • Tip recepta:
  • na recept, u ljekarni neponovljivi recept
  • Koristi za:
  • Ljudi
  • Vrsta lijekova:
  • alopatski lijek
  • Proizveden od:
  • mibe GmbH Arzneimittel, Brehna, Njemačka

Dokument

Lokalizacija

  • Na raspolaganju u:
  • Meliam 15 mg tablete
    Hrvatska
  • Jezik:
  • hrvatski

Terapeutski informacija

  • Proizvod sažetak:
  • Pakiranje: 20 tableta u blisteru, u kutiji [HR-H-417661440-01] Urbroj: 381-12-01/38-17-05

Druge informacije

Status

  • Izvor:
  • HALMED Agencija za lijekove i medicinske proizvode - Agency for medicinal products and medical devices of Croatia
  • Broj odobrenja:
  • HR-H-417661440
  • Datum autorizacije:
  • 23-03-2017
  • Zadnje ažuriranje:
  • 04-06-2018

Uputu o lijeku

Uputa o lijeku: Informacije za bolesnika

Meliam 15 mg tablete

meloksikam

Pažljivo pročitajte cijelu uputu prije nego počnete uzimati ovaj lijek jer sadrži Vama važne

podatke.

Sačuvajte ovu uputu. Možda ćete je trebati ponovno pročitati.

Ako imate dodatnih pitanja, obratite se Vašem liječniku ili ljekarniku.

Ovaj je lijek propisan samo Vama. Nemojte ga davati drugima. Može im naškoditi, čak i ako su

njihovi znakovi bolesti jednaki Vašima.

Ako primijetite bilo koju nuspojavu, potrebno je obavijestiti liječnika ili ljekarnika. To uključuje i

svaku moguću nuspojavu koja nije navedena u ovoj uputi. Pogledajte dio 4.

Što se nalazi u ovoj uputi:

1.

Što je Meliam i za što se koristi?

2.

Što morate znati prije nego počnete uzimati Meliam?

3.

Kako uzimati Meliam?

4.

Moguće nuspojave

5.

Kako čuvati Meliam?

6.

Sadržaj pakiranja i druge infromacije

1.

Što je Meliam i za što se koristi?

Meliam

sadrži

djelatnu

tvar

meloksikam.

Meloksikam

pripada

skupini

lijekova

koji

nazivaju

nesteroidni

protuupalni

lijekovi

nesteroidni

antireumatici

(NSAIL).

Lijekovi

skupine

primjenjuju se za ublažavanje upale i bolova u zglobovima i mišićima.

Meliam se koristi kod odraslih bolesnika za:

kratkotrajno liječenje pogoršanja osteoartritisa

dugotrajno liječenje:

- reumatoidnog artritisa

- ankilozantnog spondilitisa (također poznatog kao Bechterewova bolest)

2.

Što morate znati prije nego počnete uzimati Meliam?

Nemojte uzimati Meliam:

ako ste alergični na meloksikam ili neki drugi drugi sastojak ovog lijeka (naveden u dijelu 6.)

tijekom posljednja tri mjeseca trudnoće

djeca i adolesecenati mlađi od 16 godina

ako ste alergični (preosjetljivi) na acetilsalicilnu kiselinu ili druge NSAIL.

u slučaju nekih od sljedećih znakova nakon uzimanja acetilsalicilne kiseline ili drugih NSAIL:

piskanje pri disanju, stezanje u prsnom košu, nedostatak zraka (astma)

začepljenost nosa zbog otečene sluznice nosa (nazalni polipi)

kožni osipi / koprivnjača (urtikarija)

iznenadna otečenost kože ili sluznica, kao što je otečenost područja oko očiju, lica,

usnica, usta ili grla, što može otežati disanje (angioneurotski edem)

nakon prethodne terapije NSAIL-ima i anamnezom:

krvarenja u želucu ili crijevima

rupe (perofracije) u želucu ili crijevima

ako imate čireve (ulkuse) ili krvarenje u želucu ili crijevima

ako imate anamnezu ili nedavne želučane ili peptičke čireve (ulkuse) ili krvarenje (ulceracija ili

krvarenje koje se pojavilo najmanje dva puta)

aktivne upalne bolesti crijeva (Chronova bolest ili ulcerozni kolitis)

ako imate teško oštećenje funkcije jetre

ako imate teško zatajenje bubrega a ne idete na dijalizu

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O D O B R E N O

ako ste imali nedavno krvarenje u mozgu (cerebrovaskularno krvarenje)

ako imate bilo kakvu vrstu poremećaja krvarenja

ako imate teško zatajenje srca

ako imate nepodnošenje nekih šećera jer ovaj lijek sadrži laktozu (vidjeti također „Meliam sadrži

laktozu“).

Ako niste sigurni odnosi li se nešto od prethodno navedenog na Vas, molimo obratite se liječniku.

Upozorenja i mjere opreza

Obratite se svom liječniku ili ljekarniku prije nego uzmete Meliam.

Upozorenja

Lijekovi poput Meliama mogu biti povezani s malo povećanim rizikom od srčanog udara (infarkt

miokarda) ili moždanog udara (apopleksija). Rizik je veći što je veća doza i što se lijek dulje uzima.

Nemojte uzimati više od preporučene doze. Nemojte uzimati Meliam dulje nego što Vam je propisano

(vidjeti dio „Kako uzimati Meliam?“).

Ako imate srčanih problema, imali ste moždani udar ili smatrate da imate povećani rizik za ova stanja,

trebate se posavjetovati oko liječenja sa svojim liječnikom ili ljekarnikom. Primjerice ako:

imate visoki krvni tlak (hipertenziju)

imate visoke razine šećera u krvi (dijabetes melitus)

imate visoke vrijednosti kolesterola u krvi (hiperkolesterolemiju)

ste pušač

Ako dođe do razvoja teške alergijske reakcije, potrebno je odmah prekinuti s primjenom Meliama

odnosno nakon prve pojave osipa na koži, lezija mekog tkiva (mukozne lezije), ili drugog znaka alergije,

te se odmah obratite liječniku.

Odmah prestanite uzimati Meliam čim primijetite krvarenje (koje uzrokuje stolicu boje katrana) ili

ulceraciju u probavnom sustavu (koja izaziva abdominalnu bol).

Meliam nije prikladan ako Vam je potrebno trenutno olakšanje od akutne boli.

Meliam može prikriti simptome infekcije (npr. vrućice). Ako mislite da imate infekciju, trebate se obratiti

Vašem liječniku.

Meliam može otežati začeće. Potrebno je obavijestiti liječnika ako planirate trudnoću ili ako imate

probleme sa začećem.

Mjere opreza

Budući da će biti nužno prilagoditi liječenje, važno je posavjetovati se s liječnikom prije nego uzmete

Meliam u slučaju:

upale jednjaka (ezofagitis) ili upale sluznice želuca (gastritis) u povijeti bolesti ili neke druge bolesti

probavnog sustava (npr. ulcerozni kolitis ili Chronova bolest) u povijeti bolesti

visokog krvnog tlaka (hipertenzija)

starije dobi

bolesti srca, jetre ili bubrega

visokih razina šećera u krvi (dijabetes melitus)

smanjenog volumena krvi (hipovolemija) koji se može pojaviti ako imate ozbiljan gubitak krvi ili

opekline, operaciju ili mali unos tekućine

nepodnošenja nekih šećera dijagnosticiranog od strane Vašeg liječnika jer ovaj lijek sadrži laktozu

visokih vrijednosti kalija u krvi prethodno dijagnosticiranih od strane Vašeg liječnika.

Vaš liječnik će Vas morati pratiti tijekom liječenja.

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Djeca i adolescenti

Lijek Meliam se ne smije primijenjivati u djece i adolescenata ispod 16 godina starosti.

Drugi lijekovi i Meliam

Obavijestite Vašeg liječnika ili ljekarnika ako uzimate, nedavno ste uzeli ili biste mogli uzeti bilo koje

druge lijekove. Meliam može utjecati na druge lijekove i drugi lijekovi mogu utjecati na Meliam.

Osobito recite Vašem liječniku ili ljekarniku ako uzimate/ste uzimali ili primjenjujete nešto od sljedećeg:

druge NSAIL

lijekove koji sprečavaju zgrušavanja krvi

lijekove koji razbijaju krvne ugruške (trombolitici)

lijekove za liječenje srčanih i bubrežnih bolesti

kortikosteroide (npr. koji se koriste protiv upale ili alergijskih reakcija)

ciklosporin

lijek

koji se

uzima

nakon

transplantacije

organa,

teških

kožnih bolesti,

reumatoidnog artritisa ili nefrotskog sindroma

bilo koji diuretik (lijek za izmokravanje). Vaš liječnik može pratiti funkciju Vaših bubrega ako

uzimate diuretike.

lijekove za visoki krvni tlak (npr. beta-blokatori)

litij - lijek koji se primjenjuje kod poremećaja raspoloženja

selektivne inhibitore ponovne pohrane serotonina (SSRI) – koriste se za liječenje depresije

metotreksat - lijek koji se koristi za liječenje tumora ili teških nekontroliranih stanja kože i aktivnog

reumatoidnog artritisa

kolestiramin - lijek koji se koristi za snižavanje vrijednosti kolesterola

ako ste žena koja koristi intrauterini kontracepcijski uložak (obično poznat kao „spirala“) kao

kontracepcijsko sredstvo

Ako ste u dvojbi, upitajte liječnika ili ljekarnika.

Trudnoća, dojenje i plodnost

Ako ste trudni ili dojite, mislite da biste mogli biti trudni ili planirate trudnoću, obratite se Vašem

liječniku ili ljekarniku za savjet prije nego uzmete ovaj lijek.

Plodnost

Meliam može otežati začeće. Potrebno je obavijestiti Vašeg liječnika ako planirate trudnoću ili ako imate

problema sa začećem.

Trudnoća

Ako je utvrđena trudnoća tijekom primjene Meliama, potrebno je obavijestiti liječnika.

Tijekom prvih 6 mjeseci trudnoće, Vaš liječnik može propisati ovaj lijek ako je nužno.

Tijekom zadnja tri mjeseca trudnoće, nemojte uzimati ovaj lijek jer Meliam

može imati ozbiljne

posljedice na Vaše dijete, osobito na srce, pluća i bubrege, čak i uz samo jednu primjenu.

Dojenje

Ne preporučuje se primjena ovog lijeka tijekom dojenja.

Obratite se Vašem liječniku ili ljekarniku za savjet prije uzimanja ovog lijeka.

Upravljanje vozilima i strojevima

Prilikom uzimanja ovog lijeka mogu se javiti poremećaji vida uključujući zamagljen vid, omaglica,

omamljenost, vrtoglavica ili drugi poremećaji središnjeg živčanog sustava. U takvim slučajevima nemojte

voziti ili rukovati strojevima.

Meliam sadrži laktozu.

Ako Vam je liječnik rekao da ne podnosite neke šećere, savjetujte se s liječnikom prije uzimanja ovog

lijeka.

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O D O B R E N O

3.

Kako uzimati Meliam?

Uvijek uzmite ovaj lijek točno onako kako Vam je rekao Vaš liječnik ili ljekarnik. Provjerite s Vašim

liječnikom ili ljekarnikom ako niste sigurni.

Meliam tablete namijenjene su liječenju odraslih i adolesecenata starijih od 16 godina.

Preporučeno doziranje:

Pogoršanje osteoartritisa

7,5 mg (pola tablete od 15 mg) jednom dnevno. Doza se može povećati na 15 mg (1 tableta od 15 mg)

jednom dnevno.

Reumatoidni artritis

15 mg (jedna tableta od 15 mg) jednom dnevno. Doza se može smanjiti na 7,5 mg (pola tablete od 15 mg)

jednom dnevno.

Ankilozantni spondilitis

15 mg (jedna tableta od 15 mg) jednom dnevno. Doza se može smanjiti na 7,5 mg (pola tablete od 15 mg)

jednom dnevno.

Tablete treba progutati s vodom ili drugom tekućinom, tijekom obroka.

Tableta se može razdijeliti na jednake doze.

Nemojte prekoračiti maksimalnu dozvoljenu dnevnu dozu od 15 mg/dan.

Ako se neka od tvrdnji navedenih pod naslovom „Upozorenja i mjere opreza“ odnosi na Vas, Vaš liječnik

može ograničiti dozu na 7,5 mg (pola tablete od 15 mg) jednom dnevno.

Kombinirana primjena različitih dozirnih oblika meloksikama (tablete, otopina za injekciju) ne smije

prekoračiti ukupnu dnevnu dozu od 15 mg. Na tržištu se ne moraju nalaziti svi navedeni farmaceutski

oblici meloksikama.

Meliam se ne smije primjenjivati u djece i adolescenata ispod 16 godina starosti.

Ako smatrate da je učinak Meliama prejak ili preslab, ili ako nakon nekoliko dana uzimanja ne osjećate

nikakvo poboljšanje Vašeg stanja, obratite se Vašem liječniku ili ljekarniku.

Ako uzmete više Meliama nego što ste trebali

Ako ste uzeli previše tableta ili sumnjate na predoziranje, odmah se obratite Vašem liječniku ili otiđite u

najbližu bolnicu.

Simptomi akutnog predoziranja NSAIL lijekovima obično su ograničeni na:

nedostatak energije (letargija)

omamljenost

mučninu i povraćanje

bol u području trbuha (epigastrična bol)

Ovi simptomi se obično ublažavaju kada prestanete uzimati Meliam. Možete imati krvarenje u želucu ili

crijevima (gastrointestinalno krvarenje).

Teško trovanje može imati za posljedicu ozbiljnu reakciju na lijek (vidjeti dio 4.):

visoki krvni tlak (hipertenzija)

akutno zatajenje bubrega (renalno zatajenje)

disfunkcija jetre (hepatička disfunkcija)

smanjenje/zaravnjenje ili zastoj disanja (respiratorna depresija)

gubitak svijesti (koma)

napadaji (konvulzije)

kolaps cirkulacije krvi (kardiovaskularni kolaps)

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O D O B R E N O

zastoj srca (srčani arest)

trenutne alergijske reakcije (reakcije preosjetljivosti), uključujući:

nesvjesticu

nedostatak zraka

reakcije na koži

Ako ste zaboravili uzeti Meliam

Nemojte uzeti dvostruku dozu kako biste nadoknadili zaboravljenu dozu. Samo uzmite sljedeću dozu u

uobičajeno vrijeme.

Ako imate bilo kakvih pitanja u vezi s primjenom ovog lijeka, obratite se Vašem liječniku ili ljekarniku.

4.

Moguće nuspojave

Kao i svi lijekovi, ovaj lijek može uzrokovati nuspojave iako se one neće pojaviti kod svakoga.

Odmah

prestanite

uzimati

Meliam

i

obratite

se

liječniku

ili

otiĎite

u

najbližu

bolnicu

ako

primijetite:

Bilo koju alergijsku reakciju (reakciju preosjetljivosti) koja se može pojaviti u obliku:

- kožnih reakcija kao što je svrbež (pruritus), stvaranje mjehura ili ljuštenje kože koje mogu

predstavljati kožne osipe potencijalno opasne po život (Stevens-Johnsonov sindrom, toksična

epidermalna nekroliza), lezije mekog tkiva (mukozne lezije) ili erythema multiforme

(multiformni eritem) (vidjeti dio 2.). Erythema multiforme (multiformni eritem) je ozbiljna

alergijska kožna reakcija koja uzrokuje mrlje, crvene fleke ili ljubičasta područja ili mjehure na

koži. Također može zahvatiti usta, oči i druge vlažne površine tijela.

- otečenosti kože ili sluznica, kao što je otečenost oko očiju, lica i usnica, usta ili grla što može

otežavati disanje, te oticanje gležnjeva ili nogu (edem donjih udova)

- nedostatka zraka ili napada astme

- upale jetre (hepatitis). To može uzrokovati simptome kao štu su:

žuta obojenost kože ili očnih jabučica (žutica)

bol u trbuhu

gubitak apetita

Bilo koju nuspojavu u probavnom sustavu, osobito:

krvarenje (koje uzrokuje stolicu boje katrana)

ulceraciju (čir) u probavnom sustavu (koji uzrokuje bol u trbuhu)

Krvarenje u probavnom sustavu (gastrointestinalno krvarenje), nastanak čireva ili nastanak puknuća u

probavnom sustavu (perforacija) koji mogu ponekad biti teški, s mogućnošću smrtnog ishoda, osobito u

starijih osoba.

Ako ste prethodno već imali bilo kakve simptome probavnog sustava zbog dugotrajne primjene NSAIL,

potražite odmah liječnički savjet, osobito ako ste starije dobi. Vaš liječnik će možda nadzirati Vaš

napredak dok ste na liječenju.

Ako imate smetnje vida, nemojte voziti ili upravljati strojevima.

Općenite nuspojave NSAIL

Primjena nekih NSAIL može biti povezana s malo povećanim rizikom od začepljenja arterija (arterijski

trombotski događaji), npr. srčani udar (infarkt miokarda) ili moždani udar (apopleksija), osobito kod

primjene visokih doza te kod dugotrajnog liječenja.

Zadržavanje tekućine (edem), visoki krvni tlak (hipertenzija) i zatajenje srca su prijavljeni u vezi s

liječenjem NSAIL.

Najčešće primjećene nuspojave zahvaćaju probavni sustav (gastrointestinalni događaji):

čirevi (ulkusi) želuca i gornjeg dijela tankog crijeva (gastrointestinalni/gastroduodenalni ulkusi)

puknuće u stijenci crijeva (perforacija) ili krvarenje u probavnom sustavu (ponekad sa smrtnim

ishodom, osobito u starijih osoba)

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Sljedeće nuspojave su prijavljene nakon primjene NSAIL:

mučnina i povraćanje

proljev

nadutost

konstipacija (zatvor)

probavne tegobe /smetnje (dispepsija)

bol u trbuhu

stolica boje katrana zbog krvarenja u probavnom sustavu (melena)

povraćanje krvi (hematemeza)

upala sa stvaranjem ranica u ustima (ulcerativni stomatitis)

pogoršanje upale probavnog sustava (npr. egzacerbacija kolitisa ili Chronove bolesti)

Manje često je primijećena upala želuca (gastritis).

Nuspojave meloksikama – djelatne tvari Meliama

Vrlo često: mogu se javiti u više od 1 na 10 osoba

probavne tegobe /smetnje (dispepsija)

mučnina, povraćanje

bol u trbuhu

zatvor (konstipacija)

nadutost

rijetka stolica (proljev)

Često: mogu se javiti u manje od 1 na 10 osoba

glavobolja

Manje često: mogu se javiti u manje od 1 na 100 osoba

osjećaj omaglice ili vrtnje (vrtoglavica)

izrazita pospanost (omamljenost)

anemija (smanjenje koncentracije crvenog krvnog pigmenta hemoglobina)

povišenje krvnog tlaka (hipertenzija)

napadaji vrućine (prolazno crvenilo lica i vrata)

zadržavanje natrija i vode

povećane razine kalija (hiperkalemija)

To može dovesti do simptoma kao što su:

promjene u otkucajima srca (aritmije)

palpitacije (osjećaj lupanja srca)

slabost mišića

podrigivanje (eruktacija)

upala želuca (gastritis)

krvarenje u probavnom sustavu

upala usta (stomatitis)

trenutne alergijske reakcije (reakcije preosjetljivosti)

svrbež (pruritus)

osip na koži

otečenost izazvana zadržavanjem tekućine (edem), uključujući otečene gležnjeve/noge

(edem donjih udova)

iznenadna otečenost kože ili sluznica kao što je otečenost oko očiju, lica, usnica, usta

ili grla što može otežati disanje (angioneurotski edem)

trenutni poremećaj testova jetrene funkcije (npr. povišeni jetreni enzimi poput

transaminaza ili povećanje žučnog pigmenta bilirubina). Ovo može otkriti Vaš liječnik

putem nalaza krvi.

poremećaj laboratorijskih nalaza koji pokazuju bubrežnu funkciju (npr. povišen

kreatinin ili ureja)

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O D O B R E N O

Rijetko: mogu se javiti u manje od 1 na 1000 osoba

poremećaji raspoloženja

noćne more

abnormalna krvna slika, uključujući:

abnormalna diferencijalna krvna slika

smanjen broj bijelih krvnih stanica (leukocitopenija)

smanjen broj krvnih pločica (trombocitopenija)

Ove nuspojave mogu dovesti do povećanog rizika od infekcija i simptoma kao što su nastanak

modrica i krvarenje iz nosa.

zvonjenje u ušima (tinitus)

osjećaj lupanja srca (palpitacije)

čirevi (ulkusi) želuca ili gornjeg dijela tankog crijeva (gastrointestinalni/gastroduodenalni

ulkusi)

upala jednjaka (ezofagitis)

nastup astmatičnih napada (opaženo kod ljudi koji su alergični na acetilsalicilnu

kiselinu ili druge NSAIL)

teški oblici mjehura na koži ili ljuštenje kože (Stevens-Johnsonov sindrom i toksična

epidermalna nekroliza)

koprivnjača (urtikarija)

poremećaji vida uključujući:

zamagljen vid

konjunktivitis (upala očne jabučice ili očnih kapaka)

upala debelog crijeva (kolitis)

Vrlo rijetko: mogu se javiti u manje od 1 na 10 000 osoba

reakcije stvaranja mjehura na koži (bulozne reakcije) i erythema multiforme (multiformni

eritem). Erythema multiforme je ozbiljna alergijska kožna reakcija koja uzrokuje mrlje,

crvene fleke ili ljubičasta područja ili mjehure na koži. Također može zahvatiti usta, oči i

druge vlažne površine tijela.

upala jetre (hepatitis). To može uzrokovati simptome kao što su:

žuta obojenost kože ili očnih jabučica (žutica)

bol u trbuhu

gubitak apetita

akutno zatajenje bubrega, osobito u bolesnika s faktorima rizika kao što je srčana bolest, šećerna

bolest ili bubrežna bolest

puknuće u stijenci crijeva (peroforacija)

Nepoznato: učestalost se ne može procijeniti iz dostupnih podataka

smetenost

dezorijentiranost

nedostatak zraka i kožne reakcije (anafilaktične/anafilaktoidne reakcije), osipi uzrokovani

izlaganjem sunčevom svjetlu (reakcije fotoosjetljivosti)

zatajenje srca je prijavljeno u vezi s liječenjem NSAIL lijekovima

potpuni gubitak specifične vrste bijelih krvnih stanica (agranulocitoza), osobito u

bolesnika koji uzimaju Meliam zajedno s drugim lijekovima koji imaju potencijalni

inhibitorni, depresivni ili destruktivni učinak na komponentu koštane srži (mijelotoksični

lijekovi). To može uzrokovati:

iznenadnu vrućicu

upalu grla

infekcije

Nuspojave uzrokovane NSAIL, ali nisu još primijećene nakon uzimanja meloksikama

Promjene u strukturi bubrega koje rezultiraju akutnim zatajenjem bubrega:

vrlo rijetki slučajevi upale bubrega (intersticijski nefritis)

smrt nekih stanica unutar bubrega (akutna tubularna ili papilarna nekroza)

H A L M E D

23 - 03 - 2017

O D O B R E N O

proteini u urinu (nefrotski sindrom s proteinurijom)

Prijavljivanje nuspojava

Ako primijetite bilo koju nuspojavu, potrebno je obavijestiti Vašeg liječnika ili ljekarnika. To uključuje i

svaku moguću nuspojavu koja nije navedena u ovoj uputi. Nuspojave možete prijaviti izravno putem

nacionalnog sustava za prijavu nuspojava: navedenog u Dodatku V.

Prijavljivanjem nuspojava možete pridonijeti u procjeni sigurnosti ovog lijeka.

5.

Kako čuvati Meliam?

Ovaj lijek čuvajte izvan pogleda i dohvata djece.

Lijek ne zahtijeva posebne uvjete čuvanja.

Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na pakiranju. Rok valjanosti

odnosi se na zadnji dan navedenog mjeseca.

Nikada nemojte nikakve lijekove bacati u otpadne vode ili kućni otpad. Pitajte Vašeg ljekarnika kako

baciti lijekove koje više ne koristite. Ove će mjere pomoći u očuvanju okoliša.

6.

Sadržaj pakiranja i druge informacije

Što Meliam sadrži?

Djelatna tvar je meloksikam. Jedna tableta sadrži 15 mg meloksikama.

Drugi sastojci (pomoćne tvari) su: laktoza hidrat; celuloza, mikrokristalična; silicijev dioksid,

koloidni, bezvodni; magnezijev stearat; natrijev citrat; krospovidon.

Kako Meliam izgleda i sadržaj pakiranja?

Meliam 15 mg tablete su svijetlo žute, okrugle, bikonveksne tablete kosih rubova, sa slovom B i brojkom

19 utisnutima sa svake strane ureza na jednoj strani tablete, promjera 9 mm . Tableta se može razdijeliti

na jednake doze.

Pakirane su po 20 (2x10) tableta u blisteru, u kutiji.

Nositelj odobrenja za stavljanje lijeka u promet i proizvoĎač

Nositelja odobrenja:

Farmal d.d. Ludbreg, Branitelja domovinskog rata 8, 42230 Ludbreg

ProizvoĎač:

mibe GmbH Arzneimittel, Münchener Strasse 15, 06796 Brehna, Njemačka

Način i mjesto izdavanja lijeka

Lijek se izdaje na recept, u ljekarni.

Ova uputa je zadnji puta revidirana u ožujku 2017.

H A L M E D

23 - 03 - 2017

O D O B R E N O

16-11-2018

Setting of an import tolerance for pyraclostrobin in rice

Setting of an import tolerance for pyraclostrobin in rice

Published on: Thu, 15 Nov 2018 In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant BASF SE submitted a request to the competent national authority in Germany to set an import tolerance for the active substance pyraclostrobin in rice. The data submitted in support of the request were found to be sufficient to derive a maximum residue level (MRL) proposal for rice. Based on the risk assessment results, EFSA concluded that the short‐term intake of residues resulting from the use of p...

Europe - EFSA - European Food Safety Authority Publications

16-11-2018

Evaluation of confirmatory data following the Article 12 MRL review for pyraclostrobin

Evaluation of confirmatory data following the Article 12 MRL review for pyraclostrobin

Published on: Thu, 15 Nov 2018 The applicant BASF SE submitted a request to the competent national authority in Germany to evaluate the confirmatory data that were identified for pyraclostrobin in the framework of the MRL review under Article 12 of Regulation (EC) No 396/2005 as not available. To address the data gaps, residues trials supporting the existing use of pyraclostrobin on table grapes authorised in southern EU Member States and an analytical method for analysing residues of pyraclostrobin in ...

Europe - EFSA - European Food Safety Authority Publications

7-11-2018

Kadesh Incorporation Issues Voluntary Nationwide Recall of Puriton Eye Relief Drops Due to Non-Sterile Production Conditions

Kadesh Incorporation Issues Voluntary Nationwide Recall of Puriton Eye Relief Drops Due to Non-Sterile Production Conditions

Kadesh, Inc. of Garden Grove, CA is voluntarily recalling all lots of Puriton Eye Relief Drops, 0.5 oz. (15ml) bottle, UPC 7 36972 1679 0, to the consumer level. During a recent FDA inspection, investigators observed that ophthalmic drugs, which are required to be sterile, are manufactured without necessary production controls and conditions to assure sterility.

FDA - U.S. Food and Drug Administration

20-10-2018

Scientific Opinion of Flavouring Group Evaluation 411 (FGE.411): 2‐(4‐methylphenoxy)‐N‐(1H‐pyrazol‐3‐yl)‐N‐(thiophen‐2‐ylmethyl)acetamide from chemical group 30 (miscellaneous substances)

Scientific Opinion of Flavouring Group Evaluation 411 (FGE.411): 2‐(4‐methylphenoxy)‐N‐(1H‐pyrazol‐3‐yl)‐N‐(thiophen‐2‐ylmethyl)acetamide from chemical group 30 (miscellaneous substances)

Published on: Fri, 19 Oct 2018 00:00:00 +0200 EFSA was requested to deliver a scientific opinion on the implications for human health of the flavouring substance 2‐(4‐methylphenoxy)‐N‐(1H‐pyrazol‐3‐yl)‐N‐(thiophen‐2‐ylmethyl)acetamide [FL‐no: 16.133], in the Flavouring Group Evaluation 411 (FGE.411), according to Regulation (EC) No 1331/2008 of the European Parliament and of the Council. The substance has not been reported to occur in natural source materials of botanical or animal origin. It is intende...

Europe - EFSA - European Food Safety Authority Publications

17-10-2018

Faribault Foods, Inc. Announces Voluntary Recall of a Limited Quantity of S&W Brand White Beans Due to the Presence of Undeclared (Sulfites)

Faribault Foods, Inc. Announces Voluntary Recall of a Limited Quantity of S&W Brand White Beans Due to the Presence of Undeclared (Sulfites)

Faribault Foods, Inc. of Faribault, MN is recalling its 15 ounce S&W White Beans because it contains undeclared sulfites. People who have an allergy or severe sensitivity to sulfites run the risk of serious or life-threatening allergic reaction if they consume this product.

FDA - U.S. Food and Drug Administration

17-10-2018

Enforcement Report for the Week of October 17, 2018

Enforcement Report for the Week of October 17, 2018

Recently Updated Records for the Week of October 17, 2018 Last Modified Date: Monday, October 15, 2018

FDA - U.S. Food and Drug Administration

16-10-2018

October 15, 2018: Leader of Fraudulent Prescription Conspiracy Sentenced to Six Years in Prison

October 15, 2018: Leader of Fraudulent Prescription Conspiracy Sentenced to Six Years in Prison

October 15, 2018: Leader of Fraudulent Prescription Conspiracy Sentenced to Six Years in Prison

FDA - U.S. Food and Drug Administration

16-10-2018

October 15, 2018: Four Men and Seven Companies Indicted for Billion-Dollar Telemedicine Fraud Conspiracy, Telemedicine Company and CEO Plead Guilty in Two Fraud Schemes

October 15, 2018: Four Men and Seven Companies Indicted for Billion-Dollar Telemedicine Fraud Conspiracy, Telemedicine Company and CEO Plead Guilty in Two Fraud Schemes

October 15, 2018: Four Men and Seven Companies Indicted for Billion-Dollar Telemedicine Fraud Conspiracy, Telemedicine Company and CEO Plead Guilty in Two Fraud Schemes

FDA - U.S. Food and Drug Administration

16-10-2018

Pest categorisation of Cronartium harknessii, Cronartium kurilense and Cronartium sahoanum

Pest categorisation of Cronartium harknessii, Cronartium kurilense and Cronartium sahoanum

Published on: Mon, 15 Oct 2018 00:00:00 +0200 Following a request from the European Commission, the EFSA Panel on Plant Health performed a pest categorisation of Cronartium harknessii, Cronartium kurilense and Cronartium sahoanum, which are well‐defined and distinguishable tree fungal pathogens of the family Cronartiaceae. In 2018, these species were moved from the genus Endocronartium to the genus Cronartium. These pathogens are not known to be present in the EU and are regulated in Council Directive 2...

Europe - EFSA - European Food Safety Authority Publications

16-10-2018

Modification of the existing maximum residue levels for mepiquat in cotton seeds and animal commodities

Modification of the existing maximum residue levels for mepiquat in cotton seeds and animal commodities

Published on: Mon, 15 Oct 2018 00:00:00 +0200 In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant, BASF SE, submitted an application to the competent national authority in Greece to modify the existing maximum residue level (MRL) for the active substance mepiquat in cotton seeds. The data submitted in support of the application were found to be sufficient to derive a MRL proposal for cotton seeds and the previously derived MRL proposals for animal commodities were found to be stil...

Europe - EFSA - European Food Safety Authority Publications

16-10-2018

Assessment of low pathogenic avian influenza virus transmission via raw poultry meat and raw table eggs

Assessment of low pathogenic avian influenza virus transmission via raw poultry meat and raw table eggs

Published on: Mon, 15 Oct 2018 00:00:00 +0200 A rapid qualitative assessment has been done by performing a theoretical analysis on the transmission of low pathogenic avian influenza (LPAI) via fresh meat from poultry reared or kept in captivity for the production of meat (raw poultry meat) or raw table eggs. A predetermined transmission pathway followed a number of steps from a commercial or non‐commercial poultry establishment within the EU exposed to LPAI virus (LPAIV) to the onward virus transmission...

Europe - EFSA - European Food Safety Authority Publications

16-10-2018

Pest categorisation of Melampsora farlowii

Pest categorisation of Melampsora farlowii

Published on: Mon, 15 Oct 2018 00:00:00 +0200 Following a request from the European Commission, the EFSA Panel on Plant Health performed a pest categorisation of Melampsora farlowii, a well‐defined and distinguishable fungus of the family Melampsoraceae. M. farlowii is the causal agent of a leaf and twig rust of hemlocks (Tsuga spp.) in eastern North America. The pathogen is regulated in Council Directive 2000/29/EC (Annex IAI) as a harmful organism whose introduction into the EU is banned. M. farlowii ...

Europe - EFSA - European Food Safety Authority Publications

16-10-2018

Evaluation of confirmatory data following the Article 12 MRL review for teflubenzuron

Evaluation of confirmatory data following the Article 12 MRL review for teflubenzuron

Published on: Mon, 15 Oct 2018 00:00:00 +0200 The applicant BASF Agro BV submitted a request to the competent national authority in United Kingdom to evaluate the confirmatory data that were identified for teflubenzuron in the framework of the maximum residue level (MRL) review under Article 12 of Regulation (EC) No 396/2005 as not available. To address the data gaps, a new metabolism study on leafy crops, a study investigating the nature of residues under standard hydrolytic conditions and a validated ...

Europe - EFSA - European Food Safety Authority Publications

3-10-2018

Sportminister Bruno Bruins brengt verrassingsbezoek aan Talent TeamNL in Buenos Aires

Sportminister Bruno Bruins brengt verrassingsbezoek aan Talent TeamNL in Buenos Aires

Van 6 tot 18 oktober wordt in Buenos Aires, Argentinië, de derde editie van de Jeugd Olympische Spelen gehouden. Toptalenten uit 206 landen tussen de 15 en 18 jaar oud doen hieraan mee. Talent TeamNL bestaat uit 41 sporters die uitkomen in  19 disciplines. Minister voor Sport Bruno Bruins bracht vandaag een verrassingsbezoek aan de Nederlandse ploeg. Hij bezocht het Olympisch Dorp waar de talenten onder leiding van Chef de Mission Mark Huizinga zich voorbereiden op de Spelen die zaterdag beginnen. 

Netherlands - Ministerie van Volksgezondheid, Welzijn en Sport

28-9-2018

EpiPen and EpiPen Jr auto-injectors may stick in their carrier tube

EpiPen and EpiPen Jr auto-injectors may stick in their carrier tube

Pfizer Canada has advised Health Canada that, in a very small number of cases, some EpiPen (0.3 mg) and EpiPen Jr (0.15 mg) auto-injector devices may not slide out of their carrier tube easily, or at all. This could delay or prevent emergency treatment, possibly leading to patient disability or death.

Health Canada

28-9-2018

Avian influenza overview May – August 2018

Avian influenza overview May – August 2018

Published on: Thu, 27 Sep 2018 00:00:00 +0200 Between 16 May and 15 August 2018, three highly pathogenic avian influenza (HPAI) A(H5N8) outbreaks in poultry establishments and three HPAI A(H5N6) outbreaks in wild birds were reported in Europe. Three low pathogenic avian influenza (LPAI) outbreaks were reported in three Member States. Few HPAI and LPAI bird cases have been detected in this period of the year, in accordance with the seasonal expected pattern of LPAI and HPAI. There is no evidence to date ...

Europe - EFSA - European Food Safety Authority Publications

26-9-2018

Technical Report on the notification of syrup from Sorghum bicolor (L.) Moench as a traditional food from a third country pursuant to Article 14 of Regulation (EU) 2015/2283

Technical Report on the notification of syrup from Sorghum bicolor (L.) Moench as a traditional food from a third country pursuant to Article 14 of Regulation (EU) 2015/2283

Published on: Tue, 25 Sep 2018 00:00:00 +0200 Abstract Following a notification from Sorghum Zrt., submitted to the European Commission under Article 14 of Regulation (EU) 2015/2283 to place on the market syrup from Sorghum bicolor (L.) Moench as a traditional food from a third country (TF), and in line with Article 15(2) of that Regulation, EFSA was asked by the European Commission whether there are duly reasoned safety objections to the placing on the market of the TF within the European Union. The ap...

Europe - EFSA - European Food Safety Authority Publications

29-8-2018

Risk to human and animal health related to the presence of 4,15‐diacetoxyscirpenol in food and feed

Risk to human and animal health related to the presence of 4,15‐diacetoxyscirpenol in food and feed

Published on: Thu, 16 Aug 2018 00:00:00 +0200 4,15‐Diacetoxyscirpenol (DAS) is a mycotoxin primarily produced by Fusarium fungi and occurring predominantly in cereal grains. As requested by the European Commission, the EFSA Panel on Contaminants in the Food Chain (CONTAM) assessed the risk of DAS to human and animal health related to its presence in food and feed. Very limited information was available on toxicity and on toxicokinetics in experimental and farm animals. Due to the limitations in the avai...

Europe - EFSA - European Food Safety Authority Publications

16-8-2018

August 15, 2018: Florida Man Pleads Guilty to Scheme to Market Dietary Supplements

August 15, 2018: Florida Man Pleads Guilty to Scheme to Market Dietary Supplements

August 15, 2018: Florida Man Pleads Guilty to Scheme to Market Dietary Supplements

FDA - U.S. Food and Drug Administration

15-8-2018

Enforcement Report for the Week of August 15, 2018

Enforcement Report for the Week of August 15, 2018

Recently Updated Records for the Week of August 15, 2018 Last Modified Date: Monday, August 13, 2018

FDA - U.S. Food and Drug Administration

14-8-2018

Minister-president Rutte bij herdenking capitulatie Japan

Minister-president Rutte bij herdenking capitulatie Japan

Minister-president Rutte neemt woensdagmiddag 15 augustus 2018 deel aan de herdenking van de capitulatie van Japan op 15 augustus 1945. De herdenking vindt plaats bij het Indisch Monument in Den Haag.

Netherlands - Ministerie van Volksgezondheid, Welzijn en Sport

10-8-2018

Westminster Pharmaceuticals, LLC. Issues Voluntary Nationwide Recall of Levothyroxine and Liothyronine (Thyroid Tablets, USP) Due to Risk of Adulteration

Westminster Pharmaceuticals, LLC. Issues Voluntary Nationwide Recall of Levothyroxine and Liothyronine (Thyroid Tablets, USP) Due to Risk of Adulteration

Westminster Pharmaceuticals, LLC is voluntarily recalling all lots, within expiry, of Levothyroxine and Liothyronine (Thyroid Tablets, USP) 15 mg, 30 mg, 60 mg, 90 mg, & 120 mg to the wholesale level. These products are being recalled as a precaution because they were manufactured using active pharmaceutical ingredients that were sourced prior to the FDA’s Import Alert of Sichuan Friendly Pharmaceutical Co., Ltd., which as a result of a 2017 inspection were found to have deficiencies with Current Good Ma...

FDA - U.S. Food and Drug Administration

31-7-2018

ADM Animal Nutrition Recalls Mintrate® 36-15 Breed Right Cattle Tub - A specific lot of product may contain elevated levels of non-protein nitrogen, could harm cattle

ADM Animal Nutrition Recalls Mintrate® 36-15 Breed Right Cattle Tub - A specific lot of product may contain elevated levels of non-protein nitrogen, could harm cattle

ADM Animal Nutrition, a division of Archer Daniels Midland Company (NYSE: ADM), is recalling 200-pound tubs of Mintrate® 36-15 Breed Right Tub cattle feed, product number 54549AAA6H, because the product may contain elevated levels of non-protein nitrogen, which could be harmful to cattle. Excessive levels of non-protein nitrogen can be toxic to cattle and can cause muscle tremors (especially of face and ears), abdominal pain, bloat, frothy salivation, excessive urination, teeth grinding, incoordination, ...

FDA - U.S. Food and Drug Administration

18-7-2018

Blokhuis: jaarlijkse subsidie voor 113Zelfmoordpreventie omhoog naar 5,4 miljoen

Blokhuis: jaarlijkse subsidie voor 113Zelfmoordpreventie omhoog naar 5,4 miljoen

Staatssecretaris Paul Blokhuis (VWS) wil het aantal zelfmoorden en zelfmoordpogingen terugdringen. Om dat te bereiken geeft hij structureel 2 miljoen per jaar extra instellingssubsidie aan 113Zelfmoordpreventie. Het jaarlijkse budget van de organisatie gaat daarmee fors omhoog, van 3,4 miljoen naar 5,4 miljoen euro. Daarnaast zijn er extra middelen voor andere lopende activiteiten zoals de lokale aanpakken suïcidepreventie en onderzoek. In totaal is daar 15 miljoen mee gemoeid.

Netherlands - Ministerie van Volksgezondheid, Welzijn en Sport

17-7-2018

July 17, 2018: Former President of Cumberland Distribution, Inc. Sentenced to 15 Years in Federal Prison for $50 Million Drug Diversion Scheme

July 17, 2018: Former President of Cumberland Distribution, Inc. Sentenced to 15 Years in Federal Prison for $50 Million Drug Diversion Scheme

July 17, 2018: Former President of Cumberland Distribution, Inc. Sentenced to 15 Years in Federal Prison for $50 Million Drug Diversion Scheme

FDA - U.S. Food and Drug Administration

29-6-2018

Wish Bone Salad Dressing Issues Allergy Alert On Undeclared Milk and Egg in 15 oz. Wish-Bone House Italian Salad Dressing

Wish Bone Salad Dressing Issues Allergy Alert On Undeclared Milk and Egg in 15 oz. Wish-Bone House Italian Salad Dressing

Pinnacle Foods Inc. is voluntarily recalling a limited quantity of Wish Bone House Italian Salad Dressing 15 oz. with the health and safety of our consumers as our top priority. The recall was initiated after learning from a retail customer that a limited number of bottles were mislabeled. The product contains milk and egg, known allergens not declared on the bottle. People who have an allergy or severe sensitivity to milk or egg may run the risk of a serious or life-threatening allergic reaction if t...

FDA - U.S. Food and Drug Administration

8-11-2018

There's only 1 week until the 2018 Patient Engagement Advisory Committee meeting. Join the @US_FDA on Nov 15 to discuss patient-generated health data from sources like social media, activity trackers, and patient-driven registries.pic.twitter.com/WkDNnXqm

There's only 1 week until the 2018 Patient Engagement Advisory Committee meeting. Join the @US_FDA on Nov 15 to discuss patient-generated health data from sources like social media, activity trackers, and patient-driven registries.pic.twitter.com/WkDNnXqm

There's only 1 week until the 2018 Patient Engagement Advisory Committee meeting. Join the @US_FDA on Nov 15 to discuss patient-generated health data from sources like social media, activity trackers, and patient-driven registries. pic.twitter.com/WkDNnXqmbw

FDA - U.S. Food and Drug Administration

31-10-2018

Imraldi (Samsung Bioepis NL B.V.)

Imraldi (Samsung Bioepis NL B.V.)

Imraldi (Active substance: adalimumab) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)7344 of Wed, 31 Oct 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4279/T/15

Europe -DG Health and Food Safety

22-10-2018

EU/3/16/1640 (Celgene Europe B.V.)

EU/3/16/1640 (Celgene Europe B.V.)

EU/3/16/1640 (Active substance: 2-methyl-1-[(4-[6-(trifluoromethyl)pyridin-2-yl]-6-{[2-(trifluoromethyl)pyridin-4-yl]amino}-1,3,5-triazin-2-yl)amino]propan-2-ol methanesulfonate) - Transfer of orphan designation - Commission Decision (2018)6989 of Mon, 22 Oct 2018 European Medicines Agency (EMA) procedure number: EMA/OD/253/15/T/01

Europe -DG Health and Food Safety

22-10-2018

EU/3/15/1495 (Ultragenyx Netherlands B.V.)

EU/3/15/1495 (Ultragenyx Netherlands B.V.)

EU/3/15/1495 (Active substance: Triheptanoin) - Transfer of orphan designation - Commission Decision (2018)6992 of Mon, 22 Oct 2018 European Medicines Agency (EMA) procedure number: EMA/OD/007/15/T/02

Europe -DG Health and Food Safety

22-10-2018

EU/3/15/1532 (Sirius Regulatory Consulting EU Limited)

EU/3/15/1532 (Sirius Regulatory Consulting EU Limited)

EU/3/15/1532 (Active substance: Insulin human) - Transfer of orphan designation - Commission Decision (2018)6985 of Mon, 22 Oct 2018

Europe -DG Health and Food Safety

17-10-2018

Interact with experts from CDER, CBER & CDRH to learn what’s important when conducting clinical trials & preparing submissions for FDA review.

Register for FDA #CDERSBIA Clinical Investigator Training Course – November 13-15 in Silver Spring, MD.  https:

Interact with experts from CDER, CBER & CDRH to learn what’s important when conducting clinical trials & preparing submissions for FDA review. Register for FDA #CDERSBIA Clinical Investigator Training Course – November 13-15 in Silver Spring, MD. https:

Interact with experts from CDER, CBER & CDRH to learn what’s important when conducting clinical trials & preparing submissions for FDA review. Register for FDA #CDERSBIA Clinical Investigator Training Course – November 13-15 in Silver Spring, MD. https://go.usa.gov/xPqku  pic.twitter.com/EYNZANlgr9

FDA - U.S. Food and Drug Administration

15-10-2018

Riximyo (Sandoz GmbH)

Riximyo (Sandoz GmbH)

Riximyo (Active substance: rituximab) - Centralised - Yearly update - Commission Decision (2018)6811 of Mon, 15 Oct 2018

Europe -DG Health and Food Safety

1-10-2018

EU/3/16/1762 (Pharma Gateway AB)

EU/3/16/1762 (Pharma Gateway AB)

EU/3/16/1762 (Active substance: Synthetic 15-amino-acid macrocyclic peptide acylated with a polyethyleneglycol palmitoylated linker) - Transfer of orphan designation - Commission Decision (2018)6399 of Mon, 01 Oct 2018 European Medicines Agency (EMA) procedure number: EMA/OD/107/16/T/01

Europe -DG Health and Food Safety

25-9-2018

Conducting clinical trials & preparing a submission for #FDA review?

Register for #CDERSBIA’s Clinical Investigator Training Course: November 13-15 to learn about FDA regulations, scientific principles for conducting clinical trials, & more!  https://go.

Conducting clinical trials & preparing a submission for #FDA review? Register for #CDERSBIA’s Clinical Investigator Training Course: November 13-15 to learn about FDA regulations, scientific principles for conducting clinical trials, & more! https://go.

Conducting clinical trials & preparing a submission for #FDA review? Register for #CDERSBIA’s Clinical Investigator Training Course: November 13-15 to learn about FDA regulations, scientific principles for conducting clinical trials, & more! https://go.usa.gov/xPqku . pic.twitter.com/Ktqq9Slx0y

FDA - U.S. Food and Drug Administration

24-9-2018

Tomorrow, September 25th at 9:15 AM, join the #FDA for a session at #MedTechCon about our #DigitalHealth Software Precertification #FDAPrecert Pilot Program...

Tomorrow, September 25th at 9:15 AM, join the #FDA for a session at #MedTechCon about our #DigitalHealth Software Precertification #FDAPrecert Pilot Program...

Tomorrow, September 25th at 9:15 AM, join the #FDA for a session at #MedTechCon about our #DigitalHealth Software Precertification #FDAPrecert Pilot Program...

FDA - U.S. Food and Drug Administration

18-8-2018

EU/3/16/1645 (Salzman Group Ltd)

EU/3/16/1645 (Salzman Group Ltd)

EU/3/16/1645 (Active substance: Cannabidiol) - Transfer of orphan designation - Commission Decision (2018)4806 of Sat, 18 Aug 2018 European Medicines Agency (EMA) procedure number: EMA/OD/248/15/T/01

Europe -DG Health and Food Safety

15-8-2018

EU/3/18/1994 (Quality Regulatory Clinical Ireland Limited)

EU/3/18/1994 (Quality Regulatory Clinical Ireland Limited)

EU/3/18/1994 (Active substance: Ivosidenib) - Transfer of orphan designation - Commission Decision (2018)5555 of Wed, 15 Aug 2018 European Medicines Agency (EMA) procedure number: EMA/OD/172/17/T/01

Europe -DG Health and Food Safety

15-8-2018

Orbactiv (Rempex London Ltd)

Orbactiv (Rempex London Ltd)

Orbactiv (Active substance: oritavancin) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)5556 of Wed, 15 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/3785/T/20

Europe -DG Health and Food Safety

15-8-2018

Komboglyze (AstraZeneca AB)

Komboglyze (AstraZeneca AB)

Komboglyze (Active substance: saxagliptin / metformin) - Centralised - 2-Monthly update - Commission Decision (2018)5559 of Wed, 15 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2059/WS/1289

Europe -DG Health and Food Safety

15-8-2018

Ivabradine Zentiva (Zentiva, k.s.)

Ivabradine Zentiva (Zentiva, k.s.)

Ivabradine Zentiva (Active substance: ivabradine) - Centralised - Yearly update - Commission Decision (2018)5558 of Wed, 15 Aug 2018

Europe -DG Health and Food Safety

27-7-2018

EU/3/15/1473 (Celgene Europe B.V.)

EU/3/15/1473 (Celgene Europe B.V.)

EU/3/15/1473 (Active substance: Lenalidomide) - Transfer of orphan designation - Commission Decision (2018)5042 of Fri, 27 Jul 2018 European Medicines Agency (EMA) procedure number: EMA/OD/284/14/T/01

Europe -DG Health and Food Safety

27-7-2018

EU/3/16/1635 (Leadiant GmbH)

EU/3/16/1635 (Leadiant GmbH)

EU/3/16/1635 (Active substance: N-acetyl-D-mannosamine monohydrate) - Transfer of orphan designation - Commission Decision (2018)5053 of Fri, 27 Jul 2018 European Medicines Agency (EMA) procedure number: EMA/OD/228/15/T/01

Europe -DG Health and Food Safety

10-7-2018

Corbilta (Orion Corporation)

Corbilta (Orion Corporation)

Corbilta (Active substance: levodopa / carbidopa / entacapone) - Centralised - Renewal - Commission Decision (2018)4468 of Tue, 10 Jul 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2785/R/15

Europe -DG Health and Food Safety

27-6-2018

EU/3/15/1606 (Bayer AG)

EU/3/15/1606 (Bayer AG)

EU/3/15/1606 (Active substance: (S)-N-(5-((R)-2-(2,5-difluorophenyl)pyrrolidin-1-yl)pyrazolo[1,5-a]pyrimidin-3-yl)-3-hydroxypyrrolidine-1-carboxamide hydrogen sulfate) - Transfer of orphan designation - Commission Decision (2018)4094 of Wed, 27 Jun 2018 European Medicines Agency (EMA) procedure number: EMA/OD/184/15/T/02

Europe -DG Health and Food Safety

27-6-2018

EU/3/15/1460 (Eisai GmbH)

EU/3/15/1460 (Eisai GmbH)

EU/3/15/1460 (Active substance: Lenvatinib) - Transfer of orphan designation - Commission Decision (2018)4080 of Wed, 27 Jun 2018 European Medicines Agency (EMA) procedure number: EMA/OD/287/14/T/01

Europe -DG Health and Food Safety

27-6-2018

EU/3/15/1590 (Merck Europe B.V.)

EU/3/15/1590 (Merck Europe B.V.)

EU/3/15/1590 (Active substance: Recombinant human monoclonal IgG1 antibody against programmed death ligand-1) - Transfer of orphan designation - Commission Decision (2018)4088 of Wed, 27 Jun 2018 European Medicines Agency (EMA) procedure number: EMA/OD/150/15/T/02

Europe -DG Health and Food Safety