Axympa

Glavne informacije

  • Zaščiteno ime:
  • Axympa 360 mg gastrorezistentne tablete
  • Farmacevtska oblika:
  • gastrorezistentna tableta
  • Sestava:
  • mikofenolna kislina 360 mg / 1 tableta
  • Pot uporabe:
  • Peroralna uporaba
  • Enote v paketu:
  • škatla s 120 tabletami (12 x 10 tablet v pretisnem omotu)
  • Tip zastaranja:
  • Rp - Predpisovanje in izdaja zdravila je le na recept
  • Uporabi za:
  • ljudje
  • Vrsta medicine:
  • Alopatska drog

Dokumentov

Lokalizacija

  • Na voljo v:
  • Axympa 360 mg gastrorezistentne tablete
    Slovenija
  • Jezik:
  • slovenščina

Terapevtski podatki

  • Terapevtska skupina:
  • mikofenolna kislina

Drugi podatki

Stanje

  • Source:
  • JAZMP - Javna agencija RS za zdravila in medicinske pripomočke - Slovenia Medicines Agency
  • Status dovoljenje:
  • Zdravilo z dovoljenjem za promet
  • Številka dovoljenja:
  • 10120-299/2015-8
  • Datum dovoljenje:
  • 07-10-2015
  • EAN koda:
  • 3837000150278
  • Zadnja posodobitev:
  • 25-05-2018

Podatki za bolnike

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Stran 1 od 6

NAVODILO ZA UPORABO

Axympa 360 mg gastrorezistentne tablete

mikofenolna kislina

Pred začetkom jemanja zdravila natančno preberite navodilo, ker vsebuje za vas pomembne podatke!

Navodilo shranite. Morda ga boste želeli ponovno prebrati.

Če imate dodatna vprašanja, se posvetujte z zdravnikom, farmacevtom ali medicinsko sestro.

Zdravilo je bilo predpisano vam osebno in ga ne smete dajati drugim. Njim bi lahko celo škodovalo,

čeprav imajo znake bolezni, podobne vašim.

Če opazite kateri koli neželeni učinek, se posvetujte z zdravnikom, farmacevtom ali medicinsko sestro.

Posvetujte se tudi, če opazite katere koli neželene učinke, ki niso navedeni v tem navodilu. Glejte poglavje

Kaj vsebuje navodilo

Kaj je zdravilo Axympa in za kaj ga uporabljamo

Kaj morate vedeti, preden boste vzeli zdravilo Axympa

Kako jemati zdravilo Axympa

Možni neželeni učinki

Shranjevanje zdravila Axympa

Vsebina pakiranja in dodatne informacije

1.

Kaj je zdravilo Axympa in za kaj ga uporabljamo

Zdravilo Axympa vsebuje učinkovino, ki jo imenujemo mikofenolna kislina. Sodi v skupino zdravil, ki jih

imenujemo imunosupresivi.

Zdravilo Axympa se uporablja za zaviranje imunskega sistema pri zavračanju presajene ledvice. Uporablja se ga

skupaj z drugimi zdravili, ki vsebujejo ciklosporin in kortikosteroide.

2.

Kaj morate vedeti, preden boste vzeli zdravilo Axympa

Ne jemljite zdravila Axympa

če ste alergični na mikofenolno kislino, natrijev mikofenolat, mofetil mikofenolat ali katero koli

sestavino tega zdravila (navedeno v poglavju 6).

če dojite (glejte tudi "Nosečnost in dojenje").

če ste ženska v rodni dobi in ne uporabljate zelo učinkovitih kontracepcijskih metod.

Če kaj od navedenega velja za vas, povejte zdravniku in ne vzemite zdravila Axympa.

Opozorila in previdnostni ukrepi

Pred začetkom jemanja zdravila Axympa se posvetujte z zdravnikom, farmacevtom ali medicinsko sestro:

če imate ali ste imeli kdaj prej resne prebavne težave, na primer želodčni ulkus,

če imate redko dedno pomanjkanje encima hipoksantin–gvanin fosforibozil transferaze (HGPRT), kot

sta Lesch-Nyhanov ali Kelley-Seegmillerjev sindrom.

Prav tako morate vedeti, da:

zdravilo Axympa oslabi zaščito kože pred soncem, kar zveča nevarnost za kožnega raka. Izpostavljanje

soncu in ultravijolični (UV) svetlobi morate omejiti, in sicer tako, da čimbolj pokrijete izpostavljene

predele kože in redno uporabljate kremo za sončenje z visokim zaščitnim faktorjem. O zaščiti pred soncem

se posvetujte z zdravnikom.

morate nemudoma obvestiti zdravnika, če opazite kakršne koli znake okužbe (na primer zvišano telesno

temperaturo ali vnetje žrela) ali nepričakovane podplutbe ali krvavitve.

vam bo zdravnik v času uporabe zdravila Axympa morda kontroliral število belih krvnih celic (levkocitov)

in vam povedal, ali lahko nadaljujete zdravljenje z zdravilom Axympa.

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zdravilna učinkovina, mikofenolna kislina, ni enaka drugim zdravilom s podobnimi imeni, kot je na primer

mofetilmikofenolat. Ne smete preiti z enega zdravila na drugega, razen če vam tako naroči zdravnik.

uporaba zdravila Axympa med nosečnostjo lahko škoduje plodu (glejte tudi "Nosečnost in dojenje") in

poveča tveganje za izgubo ploda.

Otroci in mladostniki

Zaradi pomanjkanja podatkov uporaba zdravila Axympa pri otrocih in mladostnikih ni priporočena.

Druga zdravila in zdravilo Axympa

Obvestite zdravnika ali farmacevta, če jemljete, ste pred kratkim jemali ali pa boste morda začeli jemati katero

koli drugo zdravilo.

Še posebno morate povedati svojemu zdravniku, če jemljete katero od naslednjih zdravil:

druga imunosupresivna zdravila, kot sta azatioprin ali takrolimus,

zdravila za zniževanje visokih vrednosti holesterola, kot je holestiramin,

aktivno oglje, ki ga uporabljamo za zdravljenje prebavnih težav, kot so driska, razdražen želodec in

vetrovi,

antacide, ki vsebujejo magnezij in aluminij,

zdravila za zdravljenje virusnih okužb, kot sta aciklovir in ganciklovir.

Prav tako morate zdravniku povedati, če nameravate prejeti kakršno koli cepivo.

Zdravilo Axympa skupaj s hrano, pijačo in alkoholom

Zdravilo Axympa je mogoče jemati s hrano ali brez nje. Izberite si jemanje s hrano ali jemanje brez nje in se

potem tega držite vsak dan, s čimer boste zagotovili, da bo telo vsak dan absorbiralo enako količino zdravila.

Starejši bolniki

Starejši bolniki (stari 65 let ali več) lahko jemljejo zdravilo Axympa in jim pri tem ni treba prilagajati

običajnega priporočenega odmerka.

Nosečnost, dojenje in plodnost

Če ste ženska, se morate prepričati, da niste noseči, na primer z negativnim izvidom nosečnostnega testa, preden

začnete jemati zdravilo Axympa. Ker mikofenolna kislina lahko škoduje plodu in poveča tveganje za izgubo

ploda, zdravila Axympa ne smete uporabljati med nosečnostjo, razen če je nujno potrebno.

Če ste ženska, vam mora zdravnik svetovati glede kontracepcije, preden začnete jemati zdravilo Axympa.

Kontracepcijo morate uporabljati preden začnete jemati zdravilo, v času jemanja zdravila in še 6 tednov po

prekinitvi jemanja zdravila. Nemudoma povejte svojemu zdravniku, če v času zdravljenja z zdravilom Axympa

zanosite.

Ni znano, ali zdravilo Axympa prehaja v materino mleko. V času jemanja zdravila in še 6 tednov po prekinitvi

jemanja zdravila Axympa ne dojite.

Posvetujte se z zdravnikom ali farmacevtom, preden vzamete katero koli zdravilo.

Če ste spolno aktiven moški, se med zdravljenjem in še 13 tednov po zadnjem odmerku zdravila Axympa

priporoča uporaba kondomov. Poleg tega se vaši spolni partnerki priporoča uporaba zelo učinkovite

kontracepcije med vašim zdravljenjem in še 13 tednov po zadnjem odmerku zdravila Axympa.

Vpliv na sposobnost upravljanja vozil in strojev

Ni podatkov, ki bi kazali, da zdravilo Axympa vpliva na sposobnost upravljanja vozil in strojev.

Zdravilo Axympa vsebuje natrij

To zdravilo vsebuje 1,21 mmol (27,9 mg) natrija na tableto. To morajo upoštevati bolniki, ki so na dieti z

nadzorovanim vnosom natrija.

3.

Kako jemati zdravilo Axympa

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Pri jemanju tega zdravila natančno upoštevajte napotke v tem navodilu ali navodila zdravnika, farmacevta ali

medicinske sestre. Če ste negotovi, se posvetujte z zdravnikom, farmacevtom ali medicinsko sestro.

Koliko zdravila vzeti

Priporočeni dnevni odmerek zdravila Axympa je 1440 mg (4 tablet po 360 mg). Ta odmerek vzamete v dveh

ločenih odmerkih po 720 mg (2 tablete po 360 mg).

Tablete vzemite zjutraj in zvečer.

Prvi odmerek 720 mg dobite v 72 urah po presaditvi.

Če imate resne težave z ledvicami

Vaš dnevni odmerek ne sem presegati 1440 mg (4 tablet po 360 mg).

Jemanje zdravila Axympa

Tablete pogoltnite cele s kozarcem vode.

Ne lomite in ne drobite tablet.

Ne vzemite tablete, če je zdrobljena ali zlomljena.

Z zdravljenjem je treba nadaljevati, dokler je pri vas potrebno zaviranje imunskega sistema za preprečevanje

zavrnitve presadka.

Če ste vzeli večji odmerek zdravila Axympa, kot bi smeli

Če ste vzeli več zdravila Axympa, kot bi smeli, ali če je kdo drug vzel vaše tablete, takoj obvestite zdravnika

oziroma pojdite v bolnišnico. Morda boste potrebovali zdravniško pomoč. Tablete vzemite s seboj in jih

pokažite zdravniku oziroma bolnišničnemu osebju. Če vam je tablet zmanjkalo, vzemite s seboj prazno škatlico.

Če ste pozabili vzeti zdravilo Axympa

Če ste pozabili vzeti zdravilo Axympa, ga vzemite takoj, ko se na to spomnite, razen če je že skoraj čas za

naslednji odmerek. V tem primeru vzemite samo naslednji odmerek ob običajnem času. Posvetujte se z

zdravnikom. Ne vzemite dvojnega odmerka, če ste pozabili vzeti prejšnji odmerek.

Če ste prenehali jemati zdravilo Axympa

Ne prenehajte jemati zdravila Axympa, razen če vam je tako naročil zdravnik. Prekinitev jemanja zdravila

Axympa lahko zveča verjetnost, da bo vaše telo zavrnilo presajeno ledvico.

Če imate dodatna vprašanja o uporabi zdravila, se posvetujte z zdravnikom, s farmacevtom ali medicinsko

sestro.

4.

Možni neželeni učinki

Kot vsa zdravila ima lahko tudi to zdravilo neželene učinke, ki pa se ne pojavijo pri vseh bolnikih.

Pri starejših bolnikih lahko zaradi slabše imunske odpornosti pride do povečanega števila neželenih učinkov.

Imunosupresivi, med katerimi je tudi zdravilo Axympa, oslabijo obrambne mehanizme telesa, da bi preprečili

zavrnitev presajenega organa. Tako se telo ne more ubraniti pred okužbami, kot bi se sicer. Iz tega razloga pri

jemanju zdravila Axympa pogosteje pride do okužb možganov, kože, ust, želodca in črevesja, pljuč in sečil.

Zdravnik vam bo redno pregledoval kri, da bo lahko spremljal spremembe števila krvnih celic ali koncentracij

nekaterih snovi v krvi, kot so sladkor, maščobe in holesterol.

Nekateri učinki so lahko resni:

znaki okužbe, med drugim zvišana telesna temperatura, mrazenje, potenje, utrujenost, dremavost ali

pomanjkanje energije. Če jemljete zdravilo Axympa, je verjetnost okužbe večja kot sicer. Take okužbe

lahko prizadenejo različne dele telesa, vendar najpogosteje prizadenejo ledvica, sečni mehur, zgornje in/ali

spodnje dihalne poti.

bruhanje krvi, črno ali krvavo blato, želodčna ali črevesna razjeda.

otekanje bezgavk, pojav nove kožne tvorbe, povečanje že obstoječe ali sprememba obstoječega kožnega

znamenja. Čeprav se pri bolnikih, ki jemljejo imunosupresivna zdravila, lahko razvije rak na koži ali

bezgavkah, je do tega prišlo le pri zelo majhnem številu bolnikov, ki so jemali zdravilo Axympa.

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Če po jemanju zdravila Axympa opazite kar koli od navedenega, takoj obvestite svojega zdravnika.

Drugi neželeni učinki so lahko:

Zelo pogosti (pojavijo se lahko pri več kot 1 od 10 bolnikov)

driska

zmanjšano število belih krvnih celic (levkocitov).

Pogosti (pojavijo se lahko pri največ 1 od 10 bolnikov)

zmanjšano število rdečih krvnih celic, ki lahko povzroči utrujenost, zadihanost in bledico (slabokrvnost)

nepričakovana krvavitev ali podplutba (možni znaki nizke koncentracije trombocitov)

glavobol

kašelj

bolečine v trebuhu ali želodcu, vnetje želodčne sluznice, napenjanje v trebuhu, zaprtost, prebavne težave z

bolečinami v zgornjem delu trebuha, vetrovi (flatulenca), odvajanje redkega blata, občutek slabosti

(navzea), slabost z bruhanjem

utrujenost, zvišana telesna temperatura

nenormalni izvidi testov delovanja jeter ali ledvic

okužbe dihal.

Občasni (pojavijo se lahko pri največ kot 1 od 100 bolnikov)

hitro ali nepravilno bitje srca, zastajanje tekočine v pljučih

vrečasta tvorba (cista), ki vsebuje tekočino (limfo)

tresenje, težave s spanjem

srbenje, rdečina in oteklina oči, zamegljen vid

piskanje v pljučih

spahovanje, slab zadah, zapora črevesja, razjede na ustnicah, zgaga, spremenjena barva jezika, suha usta,

vnetje dlesni, vnetje trebušne slinavke, ki povzroča hude bolečine v zgornjem delu trebuha, zapora žlez

slinavk, vnetje trebušne mrene

okužba kosti, krvi in kože

kri v urinu, okvara ledvic, boleče in oteženo odvajanje urina

izguba las, kožne podplutbe

vnetje sklepov, bolečine v hrbtenici, mišični krči

izguba apetita, zvišane koncentracije maščob, sladkorja in holesterola v krvi ali znižana koncentracija

fosfatov v krvi

znaki gripe (kot so utrujenost, mrazenje, bolečine v grlu in žrelu, bolečine v sklepih ali mišicah), otekanje

gležnjev in stopal, občutek žeje ali slabotnosti

nenavadne sanje, prepričanje v stvari, ki ne obstajajo (iluzije)

nezmožnost doseganja ali zadrževanja erekcije.

Pogostnost neznana (pogostnosti iz razpoložljivih podatkov ni mogoče oceniti)

izpuščaj

težave s pljuči, kot so:

kratka sapa, kašelj, ki je lahko posledica bronhiektazije (bolezni, pri kateri so dihalne poti neobičajno

razširjene) in druge manj pogoste bakterijske okužbe, ki lahko povzročijo resne težave s pljuči

(tuberkuloza in atipična mikobakterijska okužba). Posvetujte se z zdravnikom, če se pri vas pojavi

trdovraten kašelj ali zasoplost.

Drugi neželeni učinki opisani pri zdravilih, ki so podobna zdravilu Axympa

Za skupino zdravil, v katero sodi zdravilo Axympa, so poročali še o dodatnih neželenih učinkih: vnetje kolona

(debelega črevesa), vnetje želodčne sluznice, ki ga povzroča citomegalovirus, nastanek luknje v črevesni steni,

ki povzroča hude bolečine v trebuhu in lahko tudi krvavitev, razjede v želodcu ali dvanajstniku, nizke

koncentracije določenih vrst levkocitov ali vseh krvnih celic, resne okužbe, kot so vnetje srca in srčnih zaklopk,

vnetje možganske ovojnice in hrbtenjače ter druge manj pogoste bakterijske okužbe, ki običajno povzročajo

resne pljučne bolezni (tuberkuloza in atipična okužba z mikobakterijo).

Poročanje o neželenih učinkih

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Če opazite kateri koli neželeni učinek, se posvetujte z zdravnikom, farmacevtom ali medicinsko sestro.

Posvetujte se tudi, če opazite neželene učinke, ki niso navedeni v tem navodilu. O neželenih učinkih lahko

poročate tudi neposredno na

Univerzitetni klinični center Ljubljana, Interna klinika

Center za zastrupitve

Zaloška cesta 2

SI-1000 Ljubljana

Faks: + 386 (0)1 434 76 46

e-pošta: farmakovigilanca@kclj.si

S tem, ko poročate o neželenih učinkih, lahko prispevate k zagotovitvi več informacij o varnosti tega zdravila.

5.

Shranjevanje zdravila Axympa

Zdravilo shranjujte nedosegljivo otrokom!

Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli. Rok uporabnosti

zdravila se izteče na zadnji dan navedenega meseca.

Za shranjevanje zdravila ni posebnih temperaturnih omejitev.

Shranjujte v originalni ovojnini za zagotovitev zaščite pred svetlobo.

Ne uporabljajte tega zdravila, če opazite opis vidnih znakov kvarjenja.

Zdravila ne smete odvreči v odpadne vode ali med gospodinjske odpadke. O načinu odstranjevanja zdravila, ki

ga ne uporabljate več, se posvetujte s farmacevtom. Taki ukrepi pomagajo varovati okolje.

6.

Vsebina pakiranja in dodatne informacije

Kaj vsebuje zdravilo Axympa

Zdravilna učinkovina je mikofenolna kislina (v obliki natrijevega mikofenolata).

Ena tableta vsebuje 360 mg mikofenolne kisline.

Druge sestavine zdravila so:

Jedro tablete: mikrokristalna celuloza (E460), premreženi natrijev karmelozat (E468), povidon

K30 (E1201),

smukec (E553b), brezvodni koloidni silicijev dioksid (E551), magnezijev stearat (E470b).

Obloga tablete:

metakrilna kislina – etilakrilat kopolimer (1:1), smukec (E553b), titanov dioksid (E171), trietil citrat (E1505),

brezvodni koloidni silicijev dioksid (E551), natrijev hidrogenkarbonat (E500), rumeni železov oksid (E172),

rdeči železov oksid (E172), natrijev lavrilsulfat (E487).

Natis tablete:

šelak, delno zaestren (E904), črni železov oksid (E172), propilenglikol (E1520).

Izgled zdravila Axympa in vsebina pakiranja

Zdravilo Axympa 360 mg gastrorezistentne tablete so okrogle, bikonveksne, gastrorezistentne tablete breskove

barve z zaobljenim robom, z natisnjenim M2 s črnim črnilom na eni strani in prazne na drugi strani.

Zdravilo Axympa 360 mg gastrorezistentne tablete so na voljo v pretisnih omotih, pakiranih po 50, 100, 120 in

250 tablet.

Na trgu morda ni vseh navedenih pakiranj.

Imetnik dovoljenja za promet z zdravilom

Teva Pharma B.V.

Swensweg 5

2031 GA Haarlem

Nizozemska

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Izdelovalec

Accord Healthcare Limited

Sage House, 319, Pinner Road

North Harrow

Middlesex HA1 4HF

Velika Britanija

Pharmadox healthcare Ltd.

KW20A Kordin Industrial Park, Paola PLA 3000

Malta

Način/režim predpisovanja in izdaje zdravila:

Rp – Predpisovanje in izdaja zdravila je le na recept.

Zdravilo je v državah članicah EGP pridobilo dovoljenje za promet z naslednjimi imeni:

Država

Predlagano ime

Axympa 360 mg comprimidos gastrorresistentes EFG

Axympa 360 mg magensaftresistente Tabletten

Axympa 360 mg gastro-resistant tablets

Axympa 360 mg enterosolventní tablety

Axympa

Axympa 360 mg gyomornedv ellenálló tabletta

Axympa 360 mg Gastro-resistant Tablets

Axympa 360 mg skrandyje neirios tabletės

Axympa 360 mg zarnās šķīstošās tabletes

Axympa 360 mg Gastro-resistant Tablets

Axympa

Axympa

Axympa 360 mg comprimate gastro-rezistente

Axympa 360 mg gastrorezistentne tablete

Axympa 360 mg gastrorezistentné tablety

Navodilo je bilo nazadnje revidirano dne 09.09.2015.

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

Published on: Fri, 16 Nov 2018 The applicant BASF Agro B.V. submitted a request to the competent national authority in Germany to evaluate the confirmatory data that were identified for picolinafen 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 validated analytical method for enforcement of the residue in dry/high starch‐, high water content‐, high acid content‐ and high oil content commodities ...

Europe - EFSA - European Food Safety Authority Publications

15-11-2018

Safety evaluation of the food enzyme maltogenic amylase from a genetically modified Bacillus subtilis (strain NZYM‐OC)

Safety evaluation of the food enzyme maltogenic amylase from a genetically modified Bacillus subtilis (strain NZYM‐OC)

Published on: Wed, 14 Nov 2018 The food enzyme maltogenic amylase (glucan 1,4‐a‐maltohydrolase; EC 3.2.1.133) is produced with a genetically modified Bacillus subtilis strain NZYM‐OC by Novozymes A/S. The genetic modifications do not give rise to safety concerns. The food enzyme is free from viable cells of the production microorganism and recombinant DNA. This maltogenic amylase is intended to be used in baking processes. Based on the maximum use levels recommended, dietary exposure to the food enzyme–...

Europe - EFSA - European Food Safety Authority Publications

15-11-2018

Safety evaluation of the food enzyme maltogenic amylase from a genetically modified Bacillus subtilis (strain NZYM‐SO)

Safety evaluation of the food enzyme maltogenic amylase from a genetically modified Bacillus subtilis (strain NZYM‐SO)

Published on: Wed, 14 Nov 2018 The food enzyme maltogenic amylase (glucan 1,4‐α‐maltohydrolase; EC 3.2.1.133) is produced with a genetically modified Bacillus subtilis strain NZYM‐SO by Novozymes A/S. The genetic modifications do not give rise to safety concerns. The food enzyme is free from viable cells of the production microorganism and recombinant DNA. This maltogenic amylase is intended to be used in baking processes. Based on the maximum use levels, dietary exposure to the food enzyme–total organi...

Europe - EFSA - European Food Safety Authority Publications

15-11-2018

Safety evaluation of the food enzyme acetolactate decarboxylase from a genetically modified Bacillus licheniformis (strain NZYM‐JB)

Safety evaluation of the food enzyme acetolactate decarboxylase from a genetically modified Bacillus licheniformis (strain NZYM‐JB)

Published on: Wed, 14 Nov 2018 The food enzyme acetolactate decarboxylase (α‐acetolactate decarboxylase; EC 4.1.1.5) is produced with a genetically modified Bacillus licheniformis strain NZYM‐JB by Novozymes A/S. The genetic modifications do not give rise to safety concerns. The food enzyme is free from viable cells of the production organism and recombinant DNA. This acetolactate decarboxylase is intended to be used in distilled alcohol production and brewing processes. Residual amounts of total organi...

Europe - EFSA - European Food Safety Authority Publications

9-11-2018

Safety assessment of the active substance polyacrylic acid, sodium salt, cross‐linked, for use in active food contact materials

Safety assessment of the active substance polyacrylic acid, sodium salt, cross‐linked, for use in active food contact materials

Published on: Thu, 08 Nov 2018 00:00:00 +0100 The EFSA Panel on Food Contact Materials, Enzymes and Processing Aids (CEP) assessed the safety of polyacrylic acid, sodium salt, cross‐linked, FCM substance No 1015, which is intended to be used as a liquid absorber in the packaging of fresh or frozen foods such as meat, poultry and seafood as well as fresh fruits and vegetables. Specific migration tests were not performed due to the high absorption of liquids by the substance. The Panel noted that if polya...

Europe - EFSA - European Food Safety Authority Publications

9-11-2018

Safety assessment of the substance Ln 1,4‐benzene dicarboxylic acid (with Ln = La, Eu, Gd, Tb) for use in food contact materials

Safety assessment of the substance Ln 1,4‐benzene dicarboxylic acid (with Ln = La, Eu, Gd, Tb) for use in food contact materials

Published on: Wed, 07 Nov 2018 00:00:00 +0100 The EFSA Panel on Food Contact Materials, Enzymes and Processing Aids (CEP Panel) assessed the safety of the additive Ln 1,4‐benzene dicarboxylic acid (with Ln = La, Eu, Gd, Tb) for use in food contact materials. It is a family of mixtures combining the four lanthanides lanthanum (La), europium (Eu), gadolinium (Gd) and/or terbium (Tb) in different proportions as their 1,4‐benzene dicarboxylate complexes, used as a taggant in plastics for authentication and ...

Europe - EFSA - European Food Safety Authority Publications

1-11-2018

Safety evaluation of the food enzyme endo‐1,4‐β‐xylanase from a genetically modified Bacillus subtilis (strain LMG S‐24584)

Safety evaluation of the food enzyme endo‐1,4‐β‐xylanase from a genetically modified Bacillus subtilis (strain LMG S‐24584)

Published on: Wed, 31 Oct 2018 00:00:00 +0100 The food enzyme endo‐1,4‐β‐xylanase (EC 3.2.1.8) is produced with the genetically modified Bacillus subtilis strain LMG S‐24584 by Puratos N. V. The genetic modifications do not give rise to safety concerns. The Panel noted that, although the production strain was not detected in the food enzyme, recombinant DNA was present in all batches of the food enzyme tested. The food enzyme is intended to be used in baking processes. Based on the maximum use levels re...

Europe - EFSA - European Food Safety Authority Publications

1-11-2018

Safety evaluation of the food enzyme glucan 1,4‐α‐glucosidase from a genetically modified Aspergillus niger (strain NZYM‐BW)

Safety evaluation of the food enzyme glucan 1,4‐α‐glucosidase from a genetically modified Aspergillus niger (strain NZYM‐BW)

Published on: Wed, 31 Oct 2018 00:00:00 +0100 The food enzyme glucan 1,4‐α‐glucosidase (EC 3.2.1.3) is produced with the genetically modified Aspergillus niger strain NZYM‐BW by Novozymes A/S. The genetic modifications do not give rise to safety concerns. The food enzyme is free from viable cells of the production organism and recombinant DNA. The glucan 1,4‐α‐glucosidase food enzyme is intended to be used in distilled alcohol production and starch processing for the production of glucose syrups. Residu...

Europe - EFSA - European Food Safety Authority Publications

1-11-2018

Safety of the food enzyme glucoamylase from a genetically modified Aspergillus niger (strain NZYM‐BF)

Safety of the food enzyme glucoamylase from a genetically modified Aspergillus niger (strain NZYM‐BF)

Published on: Wed, 31 Oct 2018 00:00:00 +0100 The food enzyme glucoamylase (glucan 1,4‐α‐glucosidase; EC 3.2.1.3) is produced with the genetically modified strain of Aspergillus niger by Novozymes A/S. The genetic modifications do not give rise to safety concerns. The food enzyme is free from viable cells of the production organism and recombinant DNA. This glucoamylase is intended to be used in brewing processes and in starch processing for glucose syrups production. Residual amounts of total organic s...

Europe - EFSA - European Food Safety Authority Publications

1-11-2018

Safety evaluation of the food enzyme α‐amylase from a genetically modified Aspergillus niger (strain NZYM‐MC)

Safety evaluation of the food enzyme α‐amylase from a genetically modified Aspergillus niger (strain NZYM‐MC)

Published on: Wed, 31 Oct 2018 00:00:00 +0100 The food enzyme alpha‐amylase (4‐α‐d‐glucan glucanohydrolase; EC 3.2.1.1) is produced with the genetically modified strain of Aspergillus niger by Novozymes A/S. The genetic modifications do not give rise to safety concerns. The food enzyme is free from viable cells of the production organism and recombinant DNA. This α‐amylase is intended to be used in starch processing for glucose syrups production, beverage alcohol (distilling) processes and baking proces...

Europe - EFSA - European Food Safety Authority Publications

31-10-2018

Safety and efficacy of a super critical carbon dioxide extract of Humulus lupulus L. flos when used as a feed flavouring for all animal species

Safety and efficacy of a super critical carbon dioxide extract of Humulus lupulus L. flos when used as a feed flavouring for all animal species

Published on: Tue, 30 Oct 2018 00:00:00 +0100 Following a request from the European Commission, the EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) was asked to deliver a scientific opinion on the safety and efficacy of a super critical carbon dioxide extract of Humulus lupulus L. flos (hop strobiles) when used as a sensory feed additive for all animal species. The additive is specified to containing 40% beta acids and less than 0.2% alpha acids. Known substances of conce...

Europe - EFSA - European Food Safety Authority Publications

26-10-2018

Safety and efficacy of l‐threonine produced by fermentation using Escherichia coli CGMCC 7.232 for all animal species

Safety and efficacy of l‐threonine produced by fermentation using Escherichia coli CGMCC 7.232 for all animal species

Published on: Thu, 25 Oct 2018 00:00:00 +0200 The product subject of this assessment is l‐threonine produced by fermentation with a genetically modified strain of Escherichia coli (CGMCC 7.232). It is intended to be used in feed and water for drinking for all animal species and categories. The production strain and its recombinant DNA were not detected in the additive. The product l‐threonine, manufactured by fermentation with E. coli CGMCC 7.232, does not raise any safety concern with regard to the gen...

Europe - EFSA - European Food Safety Authority Publications

15-10-2018

Toy Land Company recalls Boom Boom ChemsSlime andPutty

Toy Land Company recalls Boom Boom ChemsSlime andPutty

Health Canada has determined that the slime and putty products do not meet the Canadian toy safety requirements related to boric acid content.

Health Canada

15-10-2018

Dollar Novelty (Karapelle Inc) recalls Barrel-O-Slime Toy

Dollar Novelty (Karapelle Inc) recalls Barrel-O-Slime Toy

Health Canada's sampling and evaluation program has determined the Barrel-O-Slime toy does not meet the Canadian toy safety requirements related to boric acid content.

Health Canada

11-10-2018

Re‐evaluation of oxidised soya bean oil interacted with mono‐ and diglycerides of fatty acids (E 479b) as a food additive

Re‐evaluation of oxidised soya bean oil interacted with mono‐ and diglycerides of fatty acids (E 479b) as a food additive

Published on: Wed, 10 Oct 2018 00:00:00 +0200 The EFSA Panel on Food Additives and Flavourings (FAF) provides a scientific opinion re‐evaluating the safety of thermally oxidised soya bean oil interacted with mono‐ and diglycerides of fatty acids (TOSOM) (E 479b) when used as a food additive. The Scientific Committee on Food (SCF) and the Joint FAO/WHO Expert Committee on Food Additives (JECFA) derived an acceptable daily intake (ADI) of 25 and 30 mg/kg body weight (bw) per day, respectively. There was n...

Europe - EFSA - European Food Safety Authority Publications

22-9-2018

Risk assessment of new sequencing information on genetically modified carnation FLO‐40689‐6

Risk assessment of new sequencing information on genetically modified carnation FLO‐40689‐6

Published on: Fri, 21 Sep 2018 00:00:00 +0200 The GMO Panel has previously assessed genetically modified (GM) carnation FLO‐40689‐6 and concluded that there is no scientific reason to consider that the import, distribution and retailing in the EU of carnation FLO‐40689‐6 cut flowers for ornamental use will cause any adverse effects on human health or the environment. On 27 October 2017, the European Commission requested EFSA to analyse new nucleic acid sequencing data and updated bioinformatics data for...

Europe - EFSA - European Food Safety Authority Publications

22-9-2018

Risk assessment of new sequencing information for genetically modified soybean BPS‐CV127‐9

Risk assessment of new sequencing information for genetically modified soybean BPS‐CV127‐9

Published on: Fri, 21 Sep 2018 00:00:00 +0200 The GMO Panel has previously assessed genetically modified (GM) soybean BPS‐CV127‐9. This soybean was found to be as safe and nutritious as its conventional counterpart and commercial soybean varieties with respect to potential effects on human and animal health and the environment in the context of its intended uses. On 16 February 2018, European Commission requested EFSA to analyse new nucleic acid sequencing data and updated bioinformatics data for GM soy...

Europe - EFSA - European Food Safety Authority Publications

10-9-2018

Kangaroo Manufacturing Inc. recalls Kangaroo's Super Cool Slime

Kangaroo Manufacturing Inc. recalls Kangaroo's Super Cool Slime

Health Canada's sampling and evaluation program has determined the Super Cool Slime products donot meet the Canadian toy safety requirements related to boric acid content.

Health Canada

14-8-2018

Genius Premium Craft Boxes recalls Do-It-Yourself Slime Kits

Genius Premium Craft Boxes recalls Do-It-Yourself Slime Kits

Health Canada’s sampling and evaluation program has determined the Do-It-Yourself Slime Kits do not meet the Canadian toy safety requirements related to boric acid content.

Health Canada

10-8-2018

FDA approves first-of-its kind targeted RNA-based therapy to treat a rare disease

FDA approves first-of-its kind targeted RNA-based therapy to treat a rare disease

FDA approves new drug for treatment of polyneuropathy caused by hereditary transthyretin-mediated amyloidosis (hATTR). This is the first FDA-approved treatment for this rare, debilitating and often fatal genetic disease and the first FDA approval of a new class of drugs called small interfering ribonucleic acid (siRNA) treatment.

FDA - U.S. Food and Drug Administration

3-8-2018

Scientific guideline:  Cholic acid capsules 50 mg and 250 mg product-specific bioequivalence guidance, adopted

Scientific guideline: Cholic acid capsules 50 mg and 250 mg product-specific bioequivalence guidance, adopted

Cholic acid capsules 50 mg and 250 mg product-specific bioequivalence guidance

Europe - EFSA - European Food Safety Authority EFSA Journal

18-7-2018

Sodium glucose co-transporter 2 inhibitors

Sodium glucose co-transporter 2 inhibitors

Safety advisory - diabetic ketoacidosis and surgical procedures

Therapeutic Goods Administration - Australia

5-11-2018

EU/3/18/2070 (Accelsiors CRO and Consultancy Services Ltd)

EU/3/18/2070 (Accelsiors CRO and Consultancy Services Ltd)

EU/3/18/2070 (Active substance: (6aR,10aR)-3-(1,1-dimethylheptyl)-delta8-tetrahydro-cannabinol-9-carboxylic acid) - Orphan designation - Commission Decision (2018)7271 of Mon, 05 Nov 2018 European Medicines Agency (EMA) procedure number: EMA/OD/114/18

Europe -DG Health and Food Safety

30-10-2018

EU/3/18/2076 (Orphan Europe S.A.R.L.)

EU/3/18/2076 (Orphan Europe S.A.R.L.)

EU/3/18/2076 (Active substance: Glycine, L-alanine, L-arginine, L-aspartic acid, L-cysteine, L-cystine, L-glutamic acid, L-histidine, L-lysine monohydrate, L-methionine, L-phenylalanine, L-proline, L-serine, L-threonine, L-tryptophan, L-tyrosine, taurine) - Orphan designation - Commission Decision (2018)7277 of Tue, 30 Oct 2018 European Medicines Agency (EMA) procedure number: EMA/OD/100/18

Europe -DG Health and Food Safety

29-10-2018

Clopidogrel/Acetylsalicylic acid Zentiva (Sanofi-Aventis groupe)

Clopidogrel/Acetylsalicylic acid Zentiva (Sanofi-Aventis groupe)

Clopidogrel/Acetylsalicylic acid Zentiva (Active substance: clopidogrel / acetylsalicylic acid) - Centralised - 2-Monthly update - Commission Decision (2018)7249 of Mon, 29 Oct 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/1144/WS1433/0051

Europe -DG Health and Food Safety

29-10-2018

DuoPlavin (Sanofi Clir SNC)

DuoPlavin (Sanofi Clir SNC)

DuoPlavin (Active substance: clopidogrel / acetylsalicylic acid) - Centralised - 2-Monthly update - Commission Decision (2018)7255 of Mon, 29 Oct 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/1143/WS/1433/0050

Europe -DG Health and Food Safety

2-10-2018

Zoledronic acid Actavis (Actavis Group PTC ehf.)

Zoledronic acid Actavis (Actavis Group PTC ehf.)

Zoledronic acid Actavis (Active substance: zoledronic acid) - Centralised - Yearly update - Commission Decision (2018)6488 of Tue, 02 Oct 2018

Europe -DG Health and Food Safety

2-10-2018

EU/3/16/1786 (Voisin Consulting S.A.R.L.)

EU/3/16/1786 (Voisin Consulting S.A.R.L.)

EU/3/16/1786 (Active substance: Recombinant adeno-associated viral vector serotype 2 carrying the gene for the human aromatic L-amino acid decarboxylase protein) - Transfer of orphan designation - Commission Decision (2018)6427 of Tue, 02 Oct 2018 European Medicines Agency (EMA) procedure number: EMA/OD/183/16/T/02

Europe -DG Health and Food Safety

2-10-2018

Zoledronic acid Mylan (Mylan S.A.S.)

Zoledronic acid Mylan (Mylan S.A.S.)

Zoledronic acid Mylan (Active substance: zoledronic acid) - Centralised - Yearly update - Commission Decision (2018)6486 of Tue, 02 Oct 2018

Europe -DG Health and Food Safety

2-10-2018

Zoledronic acid Teva (Teva B.V.)

Zoledronic acid Teva (Teva B.V.)

Zoledronic acid Teva (Active substance: zoledronic acid) - Centralised - Yearly update - Commission Decision (2018)6466 of Tue, 02 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

24-9-2018

Zoledronic acid Hospira (Pfizer Europe MA EEIG)

Zoledronic acid Hospira (Pfizer Europe MA EEIG)

Zoledronic acid Hospira (Active substance: zoledronic acid) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)6243 of Mon, 24 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2365/T/33

Europe -DG Health and Food Safety

28-8-2018

EU/3/18/2056 (Nogra Pharma Limited)

EU/3/18/2056 (Nogra Pharma Limited)

EU/3/18/2056 (Active substance: (S)-(-)-3-(4-aminophenyl)-2-methoxypropanoic acid) - Orphan designation - Commission Decision (2018)5728 of Tue, 28 Aug 2018 European Medicines Agency (EMA) procedure number: EMA/OD/075/18

Europe -DG Health and Food Safety

6-8-2018

Zoledronic acid Accord (Accord Healthcare Limited)

Zoledronic acid Accord (Accord Healthcare Limited)

Zoledronic acid Accord (Active substance: zoledronic acid) - Centralised - Yearly update - Commission Decision (2018)5386 of Mon, 06 Aug 2018

Europe -DG Health and Food Safety

1-8-2018

Ucedane (Lucane Pharma)

Ucedane (Lucane Pharma)

Ucedane (Active substance: carglumic acid) - Centralised - Yearly update - Commission Decision (2018)5230 of Wed, 01 Aug 2018

Europe -DG Health and Food Safety

27-7-2018

EU/3/17/1932 (Millendo Therapeutics SAS)

EU/3/17/1932 (Millendo Therapeutics SAS)

EU/3/17/1932 (Active substance: Synthetic cyclic 8 amino acid analogue of human unacylated ghrelin) - Transfer of orphan designation - Commission Decision (2018)5049 of Fri, 27 Jul 2018 European Medicines Agency (EMA) procedure number: EMA/OD/066/17/T/01

Europe -DG Health and Food Safety

11-7-2018

Vantavo (Merck Sharp and Dohme B.V.)

Vantavo (Merck Sharp and Dohme B.V.)

Vantavo (Active substance: alendronic acid / colecalciferol) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)4511 of Wed, 11 Jul 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/1180/T/30

Europe -DG Health and Food Safety

3-7-2018

Granupas (Eurocept International B.V.)

Granupas (Eurocept International B.V.)

Granupas (Active substance: Para-aminosalicylic acid) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018) 4256 of Tue, 03 Jul 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2709/T/25

Europe -DG Health and Food Safety

27-6-2018

EU/3/11/849 (Merck Sharp and Dohme B.V.)

EU/3/11/849 (Merck Sharp and Dohme B.V.)

EU/3/11/849 (Active substance: (S)-{8-fluoro-2-2[4-(3-methoxyphenyl)-1-piperazinyl]-3-[2-methoxy-5-(trifluoromethyl)-phenyl]-3,4-dihydro-4-quinazolinyl} acetic acid) - Transfer of orphan designation - Commission Decision (2018)4102 of Wed, 27 Jun 2018 European Medicines Agency (EMA) procedure number: EMA/OD/090/10/T/02

Europe -DG Health and Food Safety

19-6-2018

Dany's BienenWohl (Dany Bienenwohl GmbH)

Dany's BienenWohl (Dany Bienenwohl GmbH)

Dany's BienenWohl (Active substance: oxalic acid dihydrate) - Centralised - Authorisation - Commission Decision (2018)3892 of Tue, 19 Jun 2018 European Medicines Agency (EMA) procedure number: EMEA/V/C/4667

Europe -DG Health and Food Safety

4-6-2018

Chenodeoxycholic acid Leadiant (Leadiant GmbH)

Chenodeoxycholic acid Leadiant (Leadiant GmbH)

Chenodeoxycholic acid Leadiant (Active substance: chenodeoxycholic acid) - Centralised - Yearly update - Commission Decision (2018)3627 of Mon, 04 Jun 2018

Europe -DG Health and Food Safety

1-6-2018

Valproate

Valproate

Valproate (Active substance: medicinal products containing substances related to valproate (sodium valproate, valproic acid, valproate semisodium, valpromide, valproate magnesium)) - Community Referrals - Art 31 - Commission Decision (2018)3623 of Fri, 01 Jun 2018 European Medicines Agency (EMA) procedure number: EMEA/H/A-31/1454

Europe -DG Health and Food Safety

29-5-2018

EU/3/14/1400 (Orphan Europe S.A.R.L.)

EU/3/14/1400 (Orphan Europe S.A.R.L.)

EU/3/14/1400 (Active substance: (1S,4R,5R,7S)-3,4-dibenzyl-2-oxo-6,8-dioxa-3-azabyciclo[3.2.1]octane-7-carboxylic acid-L-lysine) - Transfer of orphan designation - Commission Decision (2018)3402 of Tue, 29 May 2018 European Medicines Agency (EMA) procedure number: EMA/OD/185/14/T/01

Europe -DG Health and Food Safety

29-5-2018

EU/3/10/826 (Eurocept International B.V.)

EU/3/10/826 (Eurocept International B.V.)

EU/3/10/826 (Active substance: Para-aminosalicylic acid) - Transfer of orphan designation - Commission Decision (2018)3396 of Tue, 29 May 2018 European Medicines Agency (EMA) procedure number: EMA/OD/072/10/T/02

Europe -DG Health and Food Safety