Ursosan

Glavne informacije

  • Zaščiteno ime:
  • Ursosan 250 mg trde kapsule
  • Farmacevtska oblika:
  • kapsula, trda
  • Sestava:
  • ursodeoksiholna kislina 250 mg / 1 kapsula
  • Pot uporabe:
  • Peroralna uporaba
  • Enote v paketu:
  • škatla s 50 kapsulami (5 x 10 kapsul 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:
  • Ursosan 250 mg trde kapsule
    Slovenija
  • Jezik:
  • slovenščina

Terapevtski podatki

  • Terapevtska skupina:
  • ursodeoksiholna 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:
  • 5363-I-615/10
  • Datum dovoljenje:
  • 09-04-2010
  • EAN koda:
  • 3837000081459
  • Zadnja posodobitev:
  • 25-05-2018

Podatki za bolnike

JAZMP-IB/020-01.09.2014

Navodilo za uporabo

URSOSAN 250 mg trde kapsule

ursodeoksiholna kislina

Pred začetkom uporabe 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 ali farmacevtom.

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 ali farmacevtom. Posvetujte

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

Kaj vsebuje navodilo:

Kaj je zdravilo URSOSAN in za kaj ga uporabljamo

Kaj morate vedeti, preden boste vzeli zdravilo URSOSAN

Kako jemati zdravilo URSOSAN

Možni neželeni učinki

Shranjevanje zdravila URSOSAN

Vsebina pakiranja in dodatne informacije

1. Kaj je zdravilo URSOSAN in za kaj ga uporabljamo

Zdravilo URSOSAN je zdravilo za bolezni žolča in jeter. Zdravilna učinkovina, ursodeoksiholna

kislina, je žolčna kislina, ki se v majhnih količinah nahaja v človeškem žolču.

Zdravilo URSOSAN se uporablja za:

raztapljanje holesterolskih žolčnih kamnov. Žolčni kamni na rentgenski sliki ne smejo dajati

nobenih senc in ne smejo biti večji od 15 mm v premeru. Žolčnik pa mora biti kljub žolčnim

kamnom funkcionalen.

zdravljenje vnetja sluznice želodca (gastritisa) zaradi refluksa žolčnih kislin.

simptomatsko zdravljenje primarne biliarne ciroze (primarne biliarne ciroze, pri kateri je

kronično vnetje žolčevodov povezano s cirozo jeter), v kolikor ne gre za dekompenzirano

jetrno cirozo (resno bolezen jeter v fazi, ko preostalo jetrno tkivo ne more nadomestiti

zmanjšane funkcije jeter).

Otroci in mladostniki

Bolezni jeter in žolčevodov v povezavi s cistrično fibrozo pri otrocih starih od 6 do manj kot 18 let.

2. Kaj morate vedeti, preden boste vzeli zdravilo URSOSAN

Ne jemljite zdravila URSOSAN če

ste alergični na žolčne kisline (kot je ursodeoksiholna kislina) ali katero koli sestavino tega

zdravila (navedeno v poglavju 6),

imate akutno vnetje žolčnika ali žolčevodov (biliarnega trakta),

imate zaporo skupnega žolčevoda ali cističnega voda (zaporo biliarnega trakta),

imate pogoste krčem podobne bolečine v zgornjem delu trebuha (žolčne kolike),

imate poapnele žolčne kamne,

imate okvarjeno krčljivost žolčnika.

Posvetujte se z zdravnikom o zgoraj navedenih stanjih. To velja tudi tedaj, če ste imeli kdaj te težave v

preteklosti.

JAZMP-IB/020-01.09.2014

Otroci in mladostniki

Neuspešna kirurška povezava jetrnih žolčevodov s tankim črevesom ali zoženje žolčevodov, ki ne

zagotavlja dobrega pretoka žolča.

Opozorila in previdnostni ukrepi

Pred začetkom jemanja zdravila URSOSAN se posvetujte z zdravnikom ali farmacevtom.

Vaš zdravnik mora prve 3 mesece zdravljenja preverjati vašo jetrno funkcijo vsake 4 tedne.

Nato mora preverjati jetrno funkcijo vsake 3 mesece.

Če imate drisko, nemudoma obvestite zdravnika. Morda bo potrebno odmerek zmanjšati ali zdravljenje

z zdravilom URSOSAN prekiniti.

Druga zdravila in zdravilo URSOSAN

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

katero koli drugo zdravilo.

Zdravilo URSOSAN lahko povzroči spremenjeno delovanje teh zdravil.

Pri jemanju zdravila URSOSAN se lahko

zmanjšajo učinki

naslednjih zdravil:

holestiramina, holestipola (za zniževanje krvnih lipidov – maščob in maščobam podobnih

snovi) ali antacidov (zdravila, ki vežejo želodčno kislino) in ki vsebujejo aluminijev hidroksid,

smektit (aluminijev oksid). Če morate nujno vzeti zdravilo, ki vsebuje katero od teh učinkovin,

ga vzemite dve uri prej ali dve uri potem, ko ste vzeli zdravilo URSOSAN.

ciprofloksacin, dapson (antibiotike), nitrendipin (ki se uporablja za zdravljenje visokega

krvnega tlaka) in druga zdravila, ki se presnavljajo na podoben način. Morda vam bo moral vaš

zdravnik spremeniti odmerek teh zdravil.

Pri jemanju zdravila URSOSAN je možno

povečanje učinkov

naslednjih zdravil:

ciklosporina (zmanjšuje aktivnost imunskega sistema). Če se zdravite s ciklosporinom, mora

vaš zdravnik preveriti vsebnost ciklosporina v krvi. Če je potrebno, vam bo vaš zdravnik

prilagodil odmerek.

Če jemljete zdravilo URSOSAN za raztapljanje žolčnih kamnov, obvestite zdravnika v primeru, da

jemljete kakršnokoli zdravilo, ki vsebuje estrogenske hormone ali učinkovine, ki znižujejo holesterol v

krvi, kot je klofibrat. Ta zdravila lahko spodbujajo nastajanje žolčnih kamnov, kar je nasprotni učinek

zdravljenju z zdravilom URSOSAN.

V primeru, da jemljete ali ste pred kratkim jemali katerokoli zdravilo, tudi če ste ga dobili brez recepta,

vam bo vaš zdravnik morda vseeno predpisal zdravilo URSOSAN. Vaš zdravnik bo določil, kaj je

ustrezno za vas.

Zdravilo URSOSAN skupaj s hrano in pijačo

Za zdravilno učinkovino ursodeoksiholno kislino ni dovolj podatkov o vplivu hrane. Zaradi dejstva, da

ni na voljo kliničnih podatkov, ni podatka o možnem priporočilu jemanja zdravila z ali brez hrane.

Nosečnost in dojenje

Če ste noseči ali dojite, menite, da bi lahko bili noseči ali načrtujete zanositev, se posvetujte z

zdravnikom ali farmacevtom, preden vzamete to zdravilo.

Zdravila URSOSAN ne smete jemati med nosečnostjo, razen če vaš zdravnik meni, da je nujno

potrebno. Če ste ženska v rodnem obdobju se posvetujte z zdravnikom tudi če niste noseči. Ženske v

rodnem obdobju se lahko zdravijo z zdravilom URSOSAN le, če uporabljajo varno in učinkovito

zaščito pred zanositvijo. Priporočena je uporaba nehormonskih ali nizkoestrogenskih peroralnih

kontracepcijskih sredstev. Če jemljete zdravilo URSOSAN za raztapljanje žolčnih kamnov, morate

uporabljati samo nehormonska kontracepcijska sredstva saj lahko peroralna hormonska kontracepcijska

sredstva spodbudijo nastajanje žolčnih kamnov. Vaš zdravnik bo pred pričetkom zdravljenja z

zdravilom URSOSAN preveril, če ste morda noseči.

Ne jemljite zdravila URSOSAN, če dojite. Ni znano ali zdravilna učinkovina v zdravilu URSOSAN

prehaja v materino mleko. Če je potrebno zdravljenje z zdravilom URSOSAN, prenehajte dojiti otroka.

JAZMP-IB/020-01.09.2014

Vpliv na sposobnost upravljanja vozil in strojev

Ni znano, da bi zdravilo URSOSAN vplivalo na sposobnost za upravljanje vozil in strojev.

3. Kako jemati zdravilo URSOSAN

Pri jemanju tega zdravila natančno upoštevajte navodila zdravnika. Če ste negotovi, se posvetujte z

zdravnikom ali farmacevtom.

Za raztapljanje holesterolskih žolčnih kamnov

Odmerjanje

Približno 10 mg na kg telesne mase dnevno, zvečer pred spanjem, kar ustreza:

do 60 kg

2 kapsuli

61 do 80 kg

3 kapsule

81 do 100 kg

4 kapsule

nad 100 kg

5 kapsul

Trajanje zdravljenja

Za raztapljanje žolčnih kamnov je običajno potrebno 6 do 24 mesecev.

Če se žolčni kamni po 1 letu ne zmanjšajo, se zdravljenje prekine.

Vaš zdravnik bo preverjal uspešnost zdravljenja z ultrazvočno ali rentgensko preiskavo vsakih 6

mesecev. Pri kontrolnih pregledih bo preveril, če je prišlo, v primerjavi s prejšnjo kontrolo, do

poapnenja žolčnih kamnov. V tem primeru bo vaš zdravnik zdravljenje prekinil.

Za zdravljenje gastritisa zaradi žolčnega refluksa

Odmerjanje

Priporočeni dnevni odmerek je 1 kapsula (250 mg) zdravila URSOSAN, zvečer pred spanjem.

Trajanje zdravljenja

Zdravljenje traja običajno 10 do 14 dni.

Vaš zdravnik bo glede na vaše zdravstveno stanje določil, kako dolgo boste jemali zdravilo.

Za simptomatsko zdravljenje primarne biliarne ciroze

Odmerjanje

Prve 3 mesece zdravljenja jemljite zdravilo URSOSAN zjutraj, opoldne in zvečer. Ko se vrednosti

jetrnih testov izboljšajo, lahko vzamete celoten dnevni odmerek zvečer.

Dnevni odmerek je odvisen od telesne mase in znaša od 3 do 7 kapsul (14

2 mg ursodeoksiholne

kisline na kg telesne mase).

Telesna masa

(kg)

Dnevni

odmerek

(mg/kg telesne

mase)

URSOSAN

trde kapsule

prve 3 mesece

po 3 mesecih

jemanja

zjutraj

opoldne

zvečer

zvečer

(1 x dnevno)

47 – 62

12 – 16

63 – 78

13 – 16

79 – 93

13 - 16

94 – 109

14 – 16

nad 110

Trajanje zdravljenja

Uporaba zdravila URSOSAN pri primarni biliarni cirozi ni časovno omejena.

JAZMP-IB/020-01.09.2014

Opozorilo

Pri bolnikih s primarno biliarno cirozo lahko v redkih primerih na začetku zdravljenja pride do

poslabšanja simptomov, npr. do hujšega srbenja. Vaš zdravnik vam bo odmerek zmanjšal na 1 kapsulo

zdravila URSOSAN na dan. Vaš zdravnik bo nato dnevni odmerek postopoma zvečal (vsak teden za

eno kapsulo), dokler ne boste dosegli odmerka, predvidenega v shemi odmerjanja.

Uporaba pri otrocih in mladostnikih

Otroci s cistično fibrozo stari od 6 do manj kot 18 let:

20 mg/kg/dan v 2-3 deljenih odmerkih, z

nadaljnjim povečanjem do 30 mg/kg/dan, če je potrebno.

Obvestite svojega zdravnika ali farmacevta, če menite da je učinek zdravila URSOSAN premočan ali

prešibek.

Kako jemati zdravilo URSOSAN

Kapsule pogoltnite cele z nekaj tekočine. Ne smete jih žvečiti.

Zdravilo jemljite redno.

Če ste vzeli večji odmerek zdravila URSOSAN, kot bi smeli

Preveliki odmerki lahko povzročijo drisko. V primeru driske morate poskrbeti za nadomeščanje

tekočine in soli. Pri zaužitju večjega števila kapsul naenkrat se posvetujte z zdravnikom.

Če ste pozabili vzeti zdravilo URSOSAN

Ne vzemite dvojnega odmerka, če ste pozabili vzeti prejšnji odmerek, pač pa nadaljujte zdravljenje s

predpisanim odmerkom.

Če ste prenehali jemati zdravilo URSOSAN

Preden se odločite za prekinitev zdravljenja z zdravilom URSOSAN, se posvetujete s svojim

zdravnikom.

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

4. Možni neželeni učinki

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

Pogosti neželeni učinki

(pojavijo se lahko pri največ 1 od 10 bolnikov)

Kašasto blato ali driska.

Zelo redki neželeni učinki

(pojavijo se lahko pri največ 1 od 10.000 bolnikov)

Pri zdravljenju primarne biliarne ciroze: hude bolečine v zgornjem desnem delu trebuha, hudo

poslabšanje (dekompenzacija) jetrne ciroze, ki se po prenehanju zdravljenja delno povrne v prejšnje

stanje.

Poapnevanje žolčnih kamnov.

Koprivnica (urtikarija).

Če katerikoli neželeni učinek postane resen ali če opazite katerikoli neželeni učinek, ki ni omenjen v

tem navodilu, obvestite svojega zdravnika ali farmacevta.

Poročanje o neželenih učinkih

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

Fax: + 386 (0)1 434 76 46

JAZMP-IB/020-01.09.2014

e-mail: farmakovigilanca@kclj.si

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

zdravila.

5. Shranjevanje zdravila URSOSAN

Zdravilo shranjujte nedosegljivo otrokom!

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

oznake Upor. do. Rok uporabnosti zdravila se izteče na zadnji dan navedenega meseca.

Shranjujte pri temperaturi do 25 °C.

Shranjujte v originalni ovojnini za zagotovitev zaščite pred vlago.

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 URSOSAN

Zdravilna učinkovina je ursodeoksiholna kislina.

Ena trda kapsula zdravila URSOSAN vsebuje 250 mg ursodeoksiholne kisline.

Pomožne snovi:

Vsebina kapsule: koruzni škrob, predgelirani koruzni škrob, koloidni brezvodni silicijev dioksid,

magnezijev stearat.

Ovojnica kapsule: titanov dioksid in želatina.

Izgled zdravila URSOSAN in vsebina pakiranja

Zdravilo URSOSAN so bele trde želatinaste kapsule, ki vsebujejo bele granule.

Zdravilo je na voljo v:

škatli s 50 trdimi kapsulami (5 x 10 kapsul v pretisnem omotu),

škatli s 100 trdimi kapsulami (10 x 10 kapsul v pretisnem omotu).

Na trgu morda ni vseh navedenih pakiranj.

Način in režim izdaje zdravila URSOSAN

Predpisovanje in izdaja zdravila je le na recept.

Imetnik dovoljenja za promet z zdravilom in izdelovalec

PRO.MED.CS Praha a.s.

Telčska 1., 140 00 Praga 4

Češka republika

Navodilo je bilo nazadnje revidirano dne 01.09.2014

17-11-2018

Safety evaluation of the food enzyme endo‐1,4‐β‐xylanase from a genetically modified Aspergillus oryzae (strain NZYM‐FA)

Safety evaluation of the food enzyme endo‐1,4‐β‐xylanase from a genetically modified Aspergillus oryzae (strain NZYM‐FA)

Published on: Fri, 16 Nov 2018 The food enzyme is an endo‐1,4‐β‐xylanase (EC 3.2.1.8) produced with a genetically modified strain of Aspergillus oryzae 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 xylanase is intended to be used in baking and cereal‐based processes. Based on the proposed maximum use levels, dietary exposure to the food enzyme–total organic solids (TOS) was e...

Europe - EFSA - European Food Safety Authority Publications

17-11-2018

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

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