Orphacol

Glavna informacija

  • Trgovački naziv:
  • Orphacol
  • Koristi za:
  • Ljudi
  • Vrsta lijekova:
  • alopatski lijek

Dokument

Lokalizacija

  • Na raspolaganju u:
  • Orphacol
    Europska Unija
  • Jezik:
  • hrvatski

Terapeutski informacija

  • Terapijska grupa:
  • Kiseli pripravci
  • Područje terapije:
  • Bolesti probavnog sustava
  • Terapijske indikacije:
  • Orphacol je indiciran za liječenje urođene pogreške u primarne žučne kiseline sinteza 3β-hidroksi-Δ5-C27-steroidni oxidoreductase manjak ili nedostatak Δ4-3-oxosteroid-5β-reduktaze u dojenčadi, djece i adolescenata u dobi od jednog mjeseca do 18 godina i odrasle osobe.

Druge informacije

Status

  • Izvor:
  • EMA - European Medicines Agency
  • Status autorizacije:
  • odobren
  • Broj odobrenja:
  • EMEA/H/C/001250
  • Datum autorizacije:
  • 12-09-2013
  • EMEA koda:
  • EMEA/H/C/001250
  • Zadnje ažuriranje:
  • 02-03-2018

Izvješće o ocjeni javnog

Agencija Europske unije

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Telefaks

+44 (0)20 7418 8416

E-pošta

Web stranica

© European Medicines Agency, 2013. Umnažanje je dopušteno samo uz citiranje izvora.

EMA/572393/2013

EMEA/H/C/001250

EPAR, sažetak za javnost

Orphacol

kolna kiselina

Ovo je sažetak Europskoga javnog izvješća o ocjeni dokumentacije lijeka (EPAR) za Orphacol.

Objašnjava kako je Agencija ocijenila lijek da bi preporučila njegovo odobrenje u EU te uvjete za

njegovu primjenu. Svrha sažetka nije davati praktične savjete o načinu korištenja lijeka Orphacol.

Praktične informacije o korištenju lijeka Orphacol bolesnici trebaju pročitati u uputi o lijeku ili se

obratiti svom liječniku ili ljekarniku.

Što je Orphacol i za što se koristi?

Orphacol je lijek koji sadrži kolnu kiselinu, tvar koja se nalazi u žuči i koja se koristi za probavljanje

masnoća.

Koristi se za liječenje odraslih i djece u dobi od mjesec dana koja imaju genetički poremećaj koji ih

sprječava da proizvode žuč. Orphacol se koristi kod bolesnika koji nemaju dovoljno dva specifična

jetrena enzima (3β-hidroksi-Δ

-steroid oksidoreduktaze ili Δ

-3-oksosteroid-5β-reduktaza). To čini

njihovu jetru nesposobnom za produkciju dovoljne količine žuči zvanih primarne žučne kiseline poput

kolne kiseline. Kad ove primarne žučne kiseline manjkaju, tijelo proizvodi nenormalne žučne kiseline

koje mogu oštetiti jetru i uzrokovati po život opasno zatajenje jetre.

Budući da je broj bolesnika s urođenim pogreškama u sintezi primarnih žučnih kiselina, dotična se

bolest smatra „rijetkom” te se Orphacol od 18. prosinca 2002. označava kao lijek za liječenje rijetkih i

teških bolesti.

Kako se Orphacol koristi?

Lijek se može dobiti samo na recept i liječenje Orphacolom treba započeti i nadzirati liječnik

specijaliziran za bolesti jetre.

Orphacol je dostupan u obliku kapsula i treba ga uzimati svaki dan u približno isto vrijeme, uz obrok.

Dnevna doza je između 5 i 15 mg po kg tjelesne težine prilagođena za svakog bolesnika u skladu sa

Orphacol

EMA/572393/2013

Stranica 2/3

stanjem njegove žučne kiseline s minimalnom dnevnom dozom od 50 mg i maksimalnom dozom od

500 mg. Za malu djecu koja ne mogu gutati kapsule, sadržaj se može promiješati s dječjom hranom ili

sokom. Liječenje treba prekinuti ako se jetrena funkcija ne poboljša unutar tri mjeseca.

Kako djeluje Orphacol?

Kolna kiselina je glavna primarna žučna kiselina koju proizvodi jetra. Kolna kiselina u Orphacolu

zamjenjuje kolnu kiselinu koja nedostaje bolesniku. To pomaže smanjivanju produkcije nenormalnih

žučnih kiselina i pridonosi normalnoj aktivnosti žuči u probavnom sustavu olakšavajući tako simptome

stanja.

Koje su koristi lijeka Orphacol dokazane u ispitivanjima?

S obzirom na to da je kolna kiselina dobro poznata tvar te je njezina upotreba u nedostacima ovih

enzima dobro utvrđena, predlagatelj je prezentirao podatke iz znanstvene literature. Predlagatelj je

predao podatke za 49 bolesnika s urođenim greškama u sintezi primarne žučne kiseline, dobivene iz

znanstvene literature (38 bolesnika s manjkom 3β-hidroksi-Δ

-steroidne oksidoreduktaze i 11

bolesnika s manjkom Δ

-3-oksosteroid-5β-reduktaze). Usporedio je ishode 28 bolesnika koji su primali

kolnu kiselinu s drugima koji su primali različite žučne kiseline ili nisu bili liječeni žučnom kiselinom.

U znanstvenoj literaturi dokazano je da liječenje kolnom kiselinom smanjuje količinu nenormalnih

žučnih kiselina u bolesnika kako bi se povratile normalne funkcije jetre i pomoglo odgoditi ili spriječiti

potrebu za transplantacijom jetre.

Koji su rizici povezani s lijekom Orphacol?

Nuspojave uočene s Orphacolom bili su proljev, pruritus (svrbež), porast u razinama transaminaza

(jetreni enzima) i mogućih žučnih kamenaca, iako se njihova učestalost ne može pouzdano procijeniti

iz dostupnih ograničenih podataka.

Orphacol se ne smije koristiti kod osoba koje bi mogle biti preosjetljive (alergične) na kolnu kiselinu ili

na bilo koji od sastojaka. Ne smiju ga uzimati bolesnici koji već uzimaju fenobarbital, lijek za liječenje

epilepsije.

Zašto je Orphacol odobren?

Povjerenstvo za humane lijekove (CHMP) napomenulo je da je upotreba kolne kiseline za liječenje

urođenih grešaka u sintezi primarne žučne kiseline dobro utvrđena u medicinskoj praksi i

dokumentirana u znanstvenoj literaturi, iako je broj dokumentiranih slučajeva bio nizak zbog rijetkosti

bolesti. Povjerenstvo je odlučilo da su na temelju dokaza iz znanstvene literature koristi lijeka Orphacol

veće od njegovih rizika i preporučilo izdavanje odobrenja za stavljanje lijeka Orphacol u promet.

Orphacol je odobren pod „iznimnim okolnostima”. Razlog za navedeno je nemogućnost dobivanja

potpunih informacija o Orphacolu zbog male učestalosti bolesti. Svake godine Europska agencija za

lijekove procjenjuje sve nove dostupne informacije te se ovaj sažetak po potrebi obnavlja.

Koje se još informacije očekuju o lijeku Orphacol?

S obzirom da je Orphacol odobren pod iznimnim okolnostima, tvrtka koja trži Orphacol uspostavit će

bazu podataka bolesnika liječenih Orphacolom kako bi nadzirala sigurnost i djelotvornost terapije te će

predati rezultate CHMP-u u redovitim, određenim intervalima.

Orphacol

EMA/572393/2013

Stranica 3/3

Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita

primjena lijeka Orphacol?

Razvijen je plan upravljanja rizikom kako bi se osiguralo da se Orphacol koristi što je sigurnije moguće.

Na temelju ovog plana sigurnosne informacije uključene su u Sažetak opisa svojstava lijeka i Uputu o

lijeku za Orphacol uključujući i odgovarajuće mjere opreza kojih se trebaju pridržavati zdravstveni

djelatnici i bolesnici.

Tvrtka koja proizvodi Orphacol također će snabdjeti liječnike u svim državama članicama koji će

koristiti Orphacol s paketom koji sadrži literaturu o proizvodu i informacije u vezi ispravne dijagnoze

ovih bolesti, rizika od nuspojava i kako ispravno koristiti lijek.

Druge informacije o lijeku Orphacol

Europska komisija izdaje odobrenje za stavljanje u promet koje za lijek Orphacol vrijedi na prostoru

Europske unije od 12. rujna 2013.

Cjelovito Europsko javno izvješće o ocjeni dokumentacije o lijeku (EPAR) može se naći na internetskim

stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European Public Assessment

Reports. Više informacija o liječenju lijekom Orphacol pročitajte u uputi o lijeku (također dio EPAR-a) ili

se obratite svom liječniku ili ljekarniku.

Sažetak mišljenja Povjerenstva za lijekove za rijetke i teške bolesti o lijeku Orphacol možete naći na

internetskim stranicama Agencije:

ema.europa.eu/Find medicine/Human medicines/Rare disease

designation.

Sažetak je posljednji put obnovljen 09.2013.

Uputu o lijeku

B. UPUTA O LIJEKU

UPUTA O LIJEKU: INFORMACIJA ZA KORISNIKA

Orphacol 50 mg tvrde kapsule

Orphacol 250 mg tvrde kapsule

kolatna kiselina

Ovaj je lijek pod dodatnim praćenjem. Time se omogućuje brzo otkrivanje novih sigurnosnih

informacija. Prijavom svih sumnji na nuspojavu i Vi možete pomoći. Za postupak prijavljivanja nuspojava,

pogledajte dio 4.

Pažljivo pročitajte cijelu ovu 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 svom liječniku ili ljekarniku.

Ovaj je lijek propisan Vama. Nemojte ga davati drugima. Može im štetiti, čak i ako imaju simptome

jednake 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:

Što je Orphacol i za što se koristi

Prije nego počnete uzimati Orphacol

Kako uzimati Orphacol

Moguće nuspojave

Kako čuvati Orphacol

Sadržaj pakiranja i druge informacije

1.

Što je Orphacol i za što se koristi

Orphacol sadrži kolatnu kiselinu, žučnu kiselinu koju normalno stvara jetra. Određena medicinska stanja

uzrokovana su poremećajima u stvaranju žučne kiseline. Orphacol se koristi za liječenje dojenčadi u dobi od

jednog mjeseca starosti do 2 godine, djece, adolescenata i odraslih osoba s ovim medicinskim stanjima.

Kolna kiselina sadržana u lijeku Orphacol zamjenjuje žučne kiseline koje nedostaju zbog poremećaja u

stvaranju žučne kiseline.

2.

Prije nego počnete uzimati Orphacol

Nemojte uzimati Orphacol

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

ako uzimate fenobarbital, lijek za liječenje epilepsije.

Upozorenja i mjere opreza

Liječnik će propisati laboratorijske pretrage krvi, mokraće i jetre prilikom početka liječenja te redovito

tijekom liječenja. Obavite ove redovite preglede kod liječnika najmanje jednom godišnje.

Drugi lijekovi i Orphacol

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

druge lijekove.

Određeni lijekovi koji se koriste za snižavanje razina kolesterola, takozvani sekvestranti žučne kiseline

(kolestiramin, kolestipol, kolesevelam), i lijekovi protiv žgaravice koji sadrže aluminij, mogu umanjiti

djelovanje lijeka Orphacol. Ako uzimate ove lijekove, Orphacol uzmite najmanje 5 sati prije ili najmanje 5

sati nakon uzimanja ovih lijekova. Ciklosporin (lijek koji se koristi za supresiju imunološkog sustava) može

također promijeniti djelovanje lijeka Orphacol. Molimo obavijestite svojeg liječnika ako uzimate ove

lijekove.

Trudnoća i dojenje

Molimo savjetujte se sa svojim liječnikom ako planirate zatrudniti. Napravite test na trudnoću čim

posumnjate na trudnoću. Izuzetno je važno da nastavite uzimati Orphacol tijekom trudnoće.

Ako zatrudnite tijekom liječenja lijekom Orphacol, Vaš će liječnik odlučiti koje je liječenje i doza najbolja za

Vas. Kao mjera opreza potrebno je pažljivo pratiti Vas i Vaše nerođeno dijete tijekom trudnoće.

Orphacol se može koristiti tijekom dojenja. Obavijestite svojeg liječnika ako planirate dojiti ili ako dojite

prije uzimanja lijeka Orphacol.

Obratite se svom liječniku ili ljekarniku za savjet prije nego uzmete bilo koji lijek.

Upravljanje vozilima i strojevima

Ne očekuje se utjecaj lijeka Orphacol na sposobnost upravljanja vozilima i strojevima.

Orphacol sadrži laktoze

Orphacol sadrži određeni šećer (laktozu hidrat). Ako Vam je Vaš liječnik rekao da ne podnosite određene

šećere, obratite se svom liječniku prije uzimanja lijeka Orphacol.

3.

Kako uzimati Orphacol

Uvijek uzmite ovaj lijek točno onako kako Vam je rekao Vaš liječnik. Provjerite sa svojim liječnikom, ako

niste sigurni.

Uobičajena početna doza iznosi 5 do 15 mg po kilogramu tjelesne težine svaki dan u dojenčadi, djece,

adolescenata i odraslih osoba.

Prije početka liječenja Vaš liječnik mora procijeniti Vaše laboratorijske nalaze kako bi utvrdio ispravnu

dozu za Vas. Vaš liječnik može zatim dodatno prilagođavati dozu ovisno o odgovoru Vašeg tijela.

Orphacol kapsule uzimaju se kroz usta uz obrok, i to svaki dan otprilike u isto vrijeme, odnosno ujutro i/ili

uvečer. Redovito uzimanje lijeka Orphacol uz obrok pomaže Vam da zapamtite uzeti ovaj lijek te može

pomoći Vašem tijelu da ga lakše podnese. Kapsule se moraju progutati cijele s vodom. Ne žvačite kapsule.

Ako je Vaš liječnik propisao dozu koja zahtjeva da uzimate više od jedne kapsule dnevno, Vi i Vaš liječnik

možete odlučiti o načinu uzimanja lijeka tijekom dana. Primjerice, možete uzeti jednu kapsulu ujutro i jednu

kapsulu uvečer. Na ovaj način morat ćete uzeti manji broj kapsula odjednom.

Primjena u djece

Za dojenčad i djecu koja ne mogu progutati kapsule, kapsule se mogu otvoriti, a sadržaj se može dodati u

pripravak za dojenčad ili u sok od jabuke/naranče ili jabuke/marelice, koji su prilagođeni maloj djeci.

Ako uzmete više lijeka Orphacol nego što ste trebali

Ako uzmete više lijeka Orphacol nego što trebate, obratite se svom liječniku što je prije moguće. Liječnik će

procijeniti rezultate Vaših laboratorijskih pretraga i savjetovat će Vam kada da nastavite liječenje Vašom

normalnom dozom.

Ako zaboravite uzeti Orphacol

Uzmite svoju sljedeću dozu u uobičajeno vrijeme. Nemojte uzeti dvostruku dozu kako biste nadoknadili

zaboravljenu dozu.

Ako prestanete uzimati Orphacol

Postoji rizik od trajnog oštećenja jetre ako prestanete uzimati Orphacol. Orphacol ne smijete nikada prestati

uzimati, osim ako Vam to ne savjetuje liječnik.

U slučaju bilo kakvih pitanja u vezi s primjenom ovog lijeka, obratite se svom liječniku.

4.

Moguće nuspojave

Kao i svi lijekovi, Orphacol može uzrokovati nuspojave iako se one neće javiti kod svakoga.

Kod nekoliko bolesnika pojavili su se svrbež i/ili proljev, no nije poznato koliko je izgledno da će se ove

nuspojave pojaviti (učestalost se ne može procijeniti na temelju dostupnih podataka). Ako svrbež i/ili

proljev traju dulje od tri dana, molimo obratite se svom liječniku.

Žučni kamenci prijavljeni su nakon dugotrajne terapije lijekom Orphacol.

Prijavljivanje nuspojava

Ako primijetite bilo koju nuspojavu, potrebno je obavijestiti liječnika. Ovo 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 Orphacol

Ovaj lijek čuvajte izvan dohvata i pogleda djece.

Orphacol se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na kutiji i blisteru iza „Rok

valjanosti“. Rok valjanosti odnosi se na zadnji dan navedenog mjeseca.

Čuvati na temperaturi ispod 30°C.

Lijekovi se ne smiju uklanjati putem otpadnih voda ili kućnog otpada. Pitajte svog ljekarnika kako ukloniti

lijekove koje više ne trebate. Ove mjere pomoći će u zaštiti okoliša.

6.

Sadržaj pakiranja i druge informacije

Što Orphacol sadrži

Djelatna tvar je kolna kiselina.

Orphacol 50 mg: svaka tvrda kapsula sadrži 50 mg kolatne kiseline.

Orphacol 250 mg: svaka tvrda kapsula sadrži 250 mg kolatne kiseline.

Drugi sastoji su:

Sadržaj kapsule: laktoza hidrat, koloidni bezvodni silicijev dioksid, magnezijev stearat

Ovojnica kapsule:

Orphacol 50 mg: želatina, titanijev dioksid (E171), tamno plava (E132);

Orphacol 250 mg: želatina, titanijev dioksid (E171), tamno plava (E132), žuti željezov oksid (E172).

Kako Orphacol izgleda i sadržaj pakiranja

Orphacol su tvrde kapsule (kapsule) duguljastog oblika. Kapsule koje sadrže 50 mg kolatne kiseline su

plavo-bijele boje, a kapsule koje sadrže 250 mg kolatne kiseline su zeleno-bijele boje. Lijek je sadržan u

blisterima s po 10 kapsula u svakom.

Dostupna su pakiranja po 30, 60 i 120 kapsula.

Na tržištu se ne moraju nalaziti sve veličine pakiranja.

Nositelj odobrenja za stavljanje u promet gotovog lijeka i proizvođač

Nositelj odobrenja za stavljanje lijeka u promet

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Uputa je zadnji puta revidirana u

Ovaj lijek je odobren u „iznimnim okolnostima”.

To znači da s obzirom na malu učestalost bolesti i zbog etičkih razloga nije bilo moguće doći do potpunih

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Europska agencija za lijekove će svake godine procjenjivati nove informacije o ovom lijeku te će se ova

uputa obnavljati prema potrebi.

Drugi izvori informacija

Detaljnije informacije o ovom lijeku dostupne su na web stranici Europske agencije za lijekove:

http://www.ema.europa.eu

. Tamo se također nalaze poveznice na druge web stranice o rijetkim bolestima i

liječenjima istih.

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

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

18-5-2018

EU/3/14/1328 (Roche Registration GmbH)

EU/3/14/1328 (Roche Registration GmbH)

EU/3/14/1328 (Active substance: 4-{[(2R,3S,4R,5S)-4-(4-chloro-2-fluoro-phenyl)-3-(3-chloro-2-fluoro-phenyl)-4-cyano-5-(2,2-dimethyl-propyl)-pyrrolidine-2-carbonyl]-amino}-3-methoxy-benzoic acid) - Transfer of orphan designation - Commission Decision (2018)3149 of Fri, 18 May 2018 European Medicines Agency (EMA) procedure number: EMA/OD/100/14/T/01

Europe -DG Health and Food Safety

18-5-2018

EU/3/13/1220 (IQVIA RDS Ireland Limited)

EU/3/13/1220 (IQVIA RDS Ireland Limited)

EU/3/13/1220 (Active substance: Poly[2-[(4-{[1-carboxy-2-(hexadecylcarbamoyl)ethyl]sulfanyl}-2,3-bis({2-[((2S)-2-(2-{[(2R)-2-carbamoyl-(2-{[(2S)-1-ethoxy-3-(3-hydroxy-4oxo-1,4-dihydropyridin-1-yl)-1-oxopropan-2-yl]carbamoyl}ethyl]sulfanyl}-3-{[(2S)-1-ethoxy-3-(3-hydroxy-4-oxo-1,4-dihydropyridin-1-yl)-1-oxopropan-2-yl]carbamoyl}propanamido)-3-(3-hydroxy-4-oxo-1,4-dihydropyridin-1-yl)propanoyl Ethyl ester) )-methoxy]acetyl}oxy)butyl)sulfanyl]-3-(hexadecylcarbamoyl)propanoic acid]-poly(ethylene glycol)-este...

Europe -DG Health and Food Safety

15-5-2018

Orphacol (Laboratoires CTRS)

Orphacol (Laboratoires CTRS)

Orphacol (Active substance: Cholic acid) - Centralised - Yearly update - Commission Decision (2018)3061 of Tue, 15 May 2018

Europe -DG Health and Food Safety