Belkyra

Glavna informacija

  • Trgovački naziv:
  • Belkyra 10 mg/ml otopina za injekciju
  • Doziranje:
  • 10 mg/ml
  • Farmaceutski oblik:
  • otopina za injekciju
  • Sastav:
  • Urbroj: 1 ml otopine za injekciju sadrži 10 mg deoksikolatne kiseline
  • Tip recepta:
  • na recept, u ljekarni ograničeni recept
  • Koristi za:
  • Ljudi
  • Vrsta lijekova:
  • alopatski lijek
  • Proizveden od:
  • Almac Pharma Services Limited, Craigavon, County Armagh, Ujedinjeno Kraljevstvo

Dokument

Lokalizacija

  • Na raspolaganju u:
  • Belkyra 10 mg/ml otopina za injekciju
    Hrvatska
  • Jezik:
  • hrvatski

Terapeutski informacija

  • Proizvod sažetak:
  • Pakiranje: 4 bočice s 2 ml otopine, u kutiji [HR-H-830108151-01] Urbroj: 381-12-01/70-17-09

Druge informacije

Status

  • Izvor:
  • HALMED Agencija za lijekove i medicinske proizvode - Agency for medicinal products and medical devices of Croatia
  • Broj odobrenja:
  • HR-H-830108151
  • Datum autorizacije:
  • 27-06-2017
  • Zadnje ažuriranje:
  • 04-06-2018

Uputu o lijeku

Uputa o lijeku: Informacije za korisnika

BELKYRA 10 mg/ml otopina za injekciju

deoksikolatna kiselina

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

važne podatke.

Sačuvajte ovu uputu. Možda ćete je trebati ponovno pročitati.

Ako imate dodatnih pitanja, obratite se liječniku, ljekarniku ili medicinskoj sestri.

Ako primijetite bilo koju nuspojavu, potrebno je obavijestiti liječnika, ljekarnika ili medicinsku

sestru. To uključuje i svaku moguću nuspojavu koja nije navedena u ovoj uputi. Pogledajte dio

Što se nalazi u ovoj uputi

Što je BELKYRA i za što se koristi

Što morate znati prije nego počnete primjenjivati BELKYRU

Kako primjenjivati BELKYRU

Moguće nuspojave

Kako čuvati BELKYRU

Sadržaj pakiranja i druge informacije

1.

Što je BELKYRA i za što se koristi

Belkyra sadrži djelatnu tvar deoksikolatnu kiselinu. Deoksikolatna kiselina prirodno se stvara u tijelu i

pomaže u probavi masti.

Lijek se koristi u odraslih za tretman submentalnog masnog tkiva (neželjene masne nakupine ispod

brade) kada ono ima negativan utjecaj na psihu bolesnika.

Belkyra sadrži ne-ljudsku, ne-životinjsku verziju deoksikolatne kiseline koja je jednaka onoj

prirodnoj. Belkyra je lijek za ubrizgavanje koji primjenjuje liječnik ili medicinska sestra.

2.

Što morate znati prije nego počnete primjenjivati BELKYRU

Nemojte primjenjivati BELKYRU:

ako ste alergični na deoksikolatnu kiselinu ili neki drugi sastojak ovog lijeka (naveden u dijelu

6.).

ako imate infekciju u području brade ili vrata gdje treba ubrizgati lijek.

Upozorenja i mjere opreza

Obratite se svom liječniku, ljekarniku ili medicinskoj sestri prije nego primijenite Belkyru. Prije

svakog tretmana liječnik ili medicinska sestra provjerit će osjećate li se dobro. Pazite da liječnika ili

medicinsku sestru prije svakog tretmana obavijestite od čega bolujete.

Vaš liječnik ili medicinska sestra posebnu će pažnju posvetiti području oko vrata, jer je potreban oprez

ako slučajno od nečeg bolujete ili ste ranije bili podvrgnuti kirurškom zahvatu (npr. ožiljci,

liposukcija, otežano gutanje, povećanje štitne žlijezde ili limfnih žlijezda).

Može se dogoditi prolazna ozljeda živca čeljusti koja dovodi do iskrivljenog osmjeha ili slabosti

mišića lica.

Prolazno oštećenje tkiva (npr. erozija kože) može nastupiti ako se Belkyra ubrizga u druge

strukture osim potkožne masti. Stoga se Belkyra smije primjenjivati samo potkožno.

Ove nuspojave u potpunosti prolaze bez trajnih posljedica i bez liječenja.

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27 - 06 - 2017

O D O B R E N O

Djeca i adolescenti

Lijek nije indiciran za primjenu u djece i adolescenata.

Drugi lijekovi i BELKYRA

Obavijestite svog liječnika ili medicinsku sestru ako uzimate, nedavno ste uzeli ili biste mogli uzeti

bilo koje druge lijekove.

Trudnoća i dojenje

Učinak ovog lijeka na trudnice i žene koje doje nije poznat. Iz predostrožnosti ne preporučuje se

primjenjivati Belkyru tijekom trudnoće.

Ako ste trudni ili dojite, mislite da biste mogli biti trudni ili planirate imati dijete, obratite se svom

liječniku ili ljekarniku za savjet prije nego primijenite ovaj lijek.

Upravljanje vozilima i strojevima

Ne očekuje se da će Belkyra imati utjecaja na sposobnost upravljanja vozilima i rada sa strojevima.

BELKYRA sadrži natrij

Ovaj lijek sadrži 4,23 mg natrija po ml, što treba uzeti u obzir u bolesnika kojima je propisana

prehrana s ograničenim unosom natrija.

3.

Kako primjenjivati BELKYRU

Kako se BELKYRA primjenjuje

Belkyru će primijeniti zdravstveni radnik izravno pod kožu (potkožna primjena). Zdravstveni će

radnik primijeniti injekcije Belkyre u masno tkivo izravno ispod kože u području ispod Vaše brade.

Prije i nakon injekcije Vaš liječnik ili medicinska sestra mogu poduzeti odreĎene mjere za ublažavanje

boli.

Doziranje

Vaš liječnik ili medicinska sestra odredit će dozu koju treba primijeniti i nadgledat će ubrizgavanje.

Vaš liječnik ili medicinska sestra ubrizgat će malu količinu Belkyre na nekoliko mjesta u području

koje treba tretirati. Vaš liječnik ili medicinska sestra odlučit će koliko se Belkyre treba primijeniti i

koliko će Vam tretmana biti potrebno, a na osnovu količine masnog tkiva ispod brade.

Primit ćete više injekcija tijekom svakog tretmana. Ukupni broj injekcija i tretmana potrebnih da bi se

postigao zadovoljavajući učinak ovisi o Vašim individualnim potrebama. Tretman se može ponoviti

više puta, ali se ne smije prekoračiti 6 tretmana; 2 do 4 tretmana obično su dovoljna. Razmak izmeĎu

svakog tretmana mora iznositi najmanje 4 tjedna.

Ako je na Vama primijenjeno više BELKYRE nego je trebalo

Ako Vam je ubrizgano više Belkyre nego što je preporučeno, to može dovesti do mogućeg porasta

broja lokalnih nuspojava (vidjeti dio 4). Ako se to dogodi, porazgovarajte s Vašim liječnikom ili

medicinskom sestrom.

Dodatne informacije koje se odnose na primjenu i rukovanje ovim lijekom od strane zdravstvenih

radnika nalaze se na kraju ove upute o lijeku.

U slučaju bilo kakvih pitanja u vezi s primjenom ovog lijeka, obratite se liječniku ili medicinskoj

sestri.

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O D O B R E N O

4.

Moguće nuspojave

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

Može se pojaviti prolazna ozljeda živca čeljusti koja dovodi do iskrivljenog osmjeha ili

slabosti mišića lica.

Prolazno oštećenje tkiva (npr. erozija kože) može nastupiti ako se Belkyra ubrizga u druge

strukture osim u potkožnu mast. Stoga se Belkyra smije primjenjivati samo potkožno.

Ako primijetite neku od nuspojava, odmah se obratite liječniku ili medicinskoj sestri.

U nastavku je popis nuspojava, koje su primijećene prema sljedećoj učestalosti:

Vrlo često (mogu se javiti u više od 1 na 10 ljudi):

Reakcije na mjestu injekcije:

zadržavanje vode u tkivu (edem) i oticanje

simptomi poremećenog osjeta (parestezije): gubitak osjeta, smanjena osjetljivost, utrnulost,

trnci, neuobičajene osjetne senzacije

malo okruglo područje lokalizirane tvrdoće (nodul)

stvaranje modrica

čvrstoća i zadebljanje tkiva (induracija)

crvenilo kože (eritem)

svrbež

Često (mogu se javiti u najviše 1 na 10 ljudi):

Reakcije na mjestu injekcije:

krvarenje

osjećaj neugode

osjećaj topline

promjena boje kože

Ozljeda živca u blizini čeljusti

Napetost kože

Poteškoće s gutanjem (disfagija)

Osjećaj mučnine

Glavobolja

Manje često (mogu se javiti u najviše 1 na 100 ljudi):

Neobičan okus u ustima (disgeuzija)

Poteškoće s govorom (disfonija)

Reakcije na mjestu injekcije:

gubitak kose (alopecija)

koprivnjača (urtikarija)

rane po koži (ulceracije)

alergijska reakcija (reakcija preosjetljivosti)

Prijavljivanje nuspojava

Ako primijetite bilo koju nuspojavu, potrebno je obavijestiti liječnika ili medicinsku sestru. To

uključuje i svaku moguću nuspojavu koja nije navedena u ovoj uputi. Nuspojave možete prijaviti

izravno putem nacionalnog sustava za prijavu nuspojava: navedenog u Dodatku V. Prijavljivanjem

nuspojava možete pridonijeti u procjeni sigurnosti ovog lijeka.

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O D O B R E N O

5.

Kako čuvati BELKYRU

Lijek čuvajte izvan pogleda i dohvata djece.

Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na naljepnici i kutiji iza

oznake „Rok valjanosti“ ili "EXP". Rok valjanosti odnosi se na zadnji dan navedenog mjeseca.

Lijek ne zahtijeva posebne uvjete čuvanja. Nakon otvaranja preporučuje se otopinu za injekciju odmah

upotrijebiti.

Nemojte primijeniti ovaj lijek ako u njemu primijetite vidljive čestice.

6.

Sadržaj pakiranja i druge informacije

Što BELKYRA sadrži

Djelatna tvar je deoksikolatna kiselina.

1 ml otopine za injekciju (injekcija) sadrži 10 mg deoksikolatne kiseline. Jedna bočica s 2 ml

sadrži 20 mg deoksikolatne kiseline.

Drugi sastojci su: voda za injekciju, natrijev klorid, natrijev hidroksid (za podešavanje pH),

kloridna kiselina (za podešavanje pH) i natrijev hidrogenfosfat (bezvodni).

Kako BELKYRA izgleda i sadržaj pakiranja

Belkyra je bistra, bezbojna i sterilna otopina za injekciju.

Veličina pakiranja:

Kutija s 4 bočice (od stakla tipa I s čepom od klorbutilne gume, zatvaračem od aluminija i „flip-top“

poklopcem od polipropilena).

Jedna bočica sadrži 2 ml otopine za injekciju.

Nositelj odobrenja za stavljanje lijeka u promet

Allergan Pharmaceutical International Ltd.

Clonshaugh Industrial Estate

Coolock

Dublin 17

Irska

ProizvoĎač

Almac Pharma Services, Ltd.

22 Seagoe Industrial Estate,

Portadown,

Craigavon,

County Armagh, BT63 5QD

Ujedinjeno Kraljevstvo

Predstavnik nositelja odobrenja za Republiku Hrvatsku

Ewopharma d.o.o., Zadarska 80, 10000 Zagreb, Hrvatska

Tel: +385 1 6646 563

Ovaj lijek je odobren u državama članicama Europskog gospodarskog prostora (EGP) pod

sljedećim nazivima:

Švedska

BELKYRA

Austrija

BELKYRA

Bugarska

BELKYRA

Češka

BELKYRA 10 mg/ml

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27 - 06 - 2017

O D O B R E N O

Estonija

BELKYRA

Grčka

BELKYRA

Španjolska

BELKYRA

Finska

BELKYRA

Hrvatska

BELKYRA 10 mg/ml otopina za injekciju

MaĎarska

BELKYRA

Island

BELKYRA

Italija

BELKYRA

Litva

BELKYRA

Luksemburg

BELKYRA

Latvija

BELKYRA

Malta

BELKYRA

Norveška

Belkyra

Poljska

BELKYRA

Portugal

BELKYRA

Rumunjska

BELKYRA

Slovenija

BELKYRA 10 mg/ml raztopina za injiciranje

Slovačka

BELKYRA 10 mg/ml

Način i mjesto izdavanja lijeka

Lijek se izdaje na recept, u ljekarni.

Ova uputa je zadnji puta revidirana u lipnju 2017.

------------------------------------------------------------------------------------------------------------------------

Sljedeće informacije namijenjene su samo zdravstvenim radnicima:

Prije primjene otopinu za injekciju potrebno je vizualno pregledati. Smiju se primijeniti samo bistre,

bezbojne otopine, bez vidljivih čestica.

Doziranje

Ukupni injicirani volumen i broj tretmana potrebno je prilagoditi prema distribuciji submentalnog

masnog tkiva za svakog bolesnika ponaosob i prema željenim ciljevima tretmana.

Injicirajte 0,2 ml (2 mg) po mjestu injekcije, s meĎusobnim razmakom od 1 cm. Tijekom jednog

tretmana ne smije se prekoračiti maksimalna doza od 10 ml (100 mg, što odgovara ukupnoj dozi 50

injekcija).

Najviše se može provesti 6 tretmana. Većina bolesnika primjećuje poboljšanje nakon 2 do 4 tretmana.

Razmak izmeĎu tretmana mora biti najmanje 4 tjedna.

Radi smanjenja nelagode bolesnika tijekom injiciranja mogu se primijeniti peroralni analgetici ili

nesteroidni antireumatici, topikalna primjena i/ili injekcije lokalnog anestetika (npr. lidokain) i/ili

hlaĎenje područja injekcija primjenom hladnih gel-obloga, po nahoĎenju zdravstvenog radnika.

Način primjene

Lijek je indiciran samo za supkutanu primjenu.

Belkyra se isporučuje u bočicama spremnim za jednokratnu uporabu. Prije primjene bočicu nekoliko

puta nježno okrenite naopako. Nemojte razrjeĎivati.

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O D O B R E N O

Belkyru smiju primjenjivati samo zdravstveni radnici s odgovarajućom kvalifikacijom, iskustvom i

poznavanjem anatomije submentalne regije. Sigurna i učinkovita primjena Belkyre ovisi o

odgovarajućem izboru bolesnika, što uključuje poznavanje bolesnikove anamneze i povijesti ranijih

intervencija i njihovog mogućeg utjecaja na anatomiju površinskog sloja cervikalnog područja. Pri

primjeni Belkyre potrebna je posebna pažnja u bolesnika s prekomjerno rastezljivom kožom,

izbočenim naborima m. platizme ili drugim stanjima kod kojih redukcija submentalne masti može

imati neželjeni ishod.

Iglu za primjenu Belkyre okomito ubodite u kožu.

Postavljanje igle u odnosu na mandibulu vrlo je važno jer se time smanjuje mogućnost ozljede

marginalnog ogranka mandibularnog živca, motorne grane facijalnog živca. Ozljeda živca prepoznat

će se po asimetričnom osmjehu zbog pareze mišića m. depressor labii inferioris.

Kako biste izbjegli ozljedu marginalnog ogranka mandibularnog živca:

nemojte injicirati iznad donjeg ruba mandibule.

nemojte injicirati unutar područja odreĎenog linijom koja prolazi 1-1,5 cm ispod donjeg ruba

mandibule (od angulusa mandibule do mentuma).

injicirajte Belkyru samo u submentalnu mast unutar ciljnog područja tretmana (vidjeti slike 1.

i 3.).

Slika 1. Izbjegavajte područje marginalnog ogranka mandibularnog živca

Izbjegavajte injiciranje u platizmu. Prije svakog tretmana palpirajte submentalno područje kako biste

provjerili ima li dovoljno submentalne masti i kako biste utvrdili potkožnu mast izmeĎu dermisa i

platizme (preplatizmalna mast) unutar ciljnog područja tretmana (slika 2.).

Slika 2. Sagitalni presjek područja platizme

retro-platizmalna mast

platizma

pre-platizmalna mast

gornja

tiroidna

incizura

Područje tretmana

Ne injicirati

H A L M E D

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O D O B R E N O

Označite područje planiranog tretmana kirurškom olovkom i nacrtajte mrežu s kvadratićima površine

1 cm

kako biste označili mjesta za injekciju (slike 2. i 3.).

Slika 3. Područje tretmana i shema injiciranja

Nemojte injicirati Belkyru izvan zadanih parametara.

Svaka bočica je za primjenu samo za jednog bolesnika. Nakon primjene, neiskorišteni lijek bacite.

gornja

tiroidna

incizura

Područje tretmana

Raspored injekcija

H A L M E D

27 - 06 - 2017

O D O B R E N O

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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