Carbaglu

Primær information

  • Handelsnavn:
  • Carbaglu
  • Brugt til:
  • Mennesker
  • Medicin typen:
  • Allopatiske stof

Dokumenter

Lokation

  • Fås i:
  • Carbaglu
    Den Europæiske Union
  • Sprog:
  • dansk

Terapeutisk information

  • Terapeutisk gruppe:
  • Andre fordøjelseskanaler og stofskifteprodukter
  • Terapeutisk område:
  • Aminosyre-metabolisme, infødte fejl
  • Terapeutiske indikationer:
  • Carbaglu er indiceret til behandling af:.

Andre oplysninger

Status

  • Kilde:
  • EMA - European Medicines Agency
  • Autorisation status:
  • autoriseret
  • Autorisationsnummer:
  • EMEA/H/C/000461
  • Autorisation dato:
  • 24-01-2003
  • EMEA kode:
  • EMEA/H/C/000461
  • Sidste ændring:
  • 26-02-2018

Offentlige vurderingsrapport

Telephne

+44 (0)20 7418 8416

© European Medicines Agency, 2011. Reproduction is authorised provided the source is acknowledged.

EMA/348518/2011

EMEA/H/C/000461

EPAR – sammendrag for offentligheden

Carbaglu

cargluminsyre

Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for

Carbaglu. Det forklarer, hvordan Udvalget for Lægemidler til Mennesker (CHMP) vurderede lægemidlet

og nåede frem til sin udtalelse til fordel for udstedelse af en markedsføringstilladelse og til sine

anbefalinger om anvendelsesbetingelserne for Carbaglu.

Hvad er Carbaglu?

Carbaglu er et lægemiddel, der indeholder det aktive stof cargluminsyre. Det leveres som opløselige

tabletter. ”Opløselig” betyder, at tabletterne kan opløses (blandes) i vand.

Hvad anvendes Carbaglu til?

Carbaglu anvendes til behandling af hyperammonæmi (forhøjet ammoniumniveau i blodet) hos

patienter med de følgende stofskiftesygdomme:

N-acetylglutamatsyntasemangel (NAGS). Patienter med denne kroniske sygdom mangler et

leverenzym kaldet NAGS, som normalt er med til at nedbryde ammonium. Hvis enzymet ikke er til

stede, kan ammonium ikke blive nedbrudt, og det hober sig op i blodet.

Visse organiske acidæmier (isovalerianeacidæmi, methylmalonacidæmi og propionacidæmi), hvor

patienterne mangler visse enzymer, som er involveret i proteinstofskiftet.

Da antallet af patienter med disse sygdomme er lavt, betragtes de som ”sjældne”, og Carbaglu blev

udpeget som ”lægemiddel til sjældne sygdomme” på forskellige datoer (se nedenfor).

Lægemidlet udleveres kun efter recept.

Hvordan anvendes Carbaglu?

Behandling med Carbaglu bør indledes af en læge, som har erfaring i at behandle patienter med

stofskiftesygdomme.

Hos patienter med NAGS-mangel kan behandlingen indledes allerede den første levedag, og

lægemidlet anvendes igennem hele patientens levetid. Hos patienter med organisk acidæmi indledes

behandlingen, når patienten oplever kritiske tilfælde af hyperammonæmi, og fortsættes, indtil

tilfældene er ovre.

Den indledende dosis af Carbaglu bør være 100 mg pr. kilo legemsvægt, men en dosis på op til 250

mg/kg kan anvendes om nødvendigt. Dosen bør derefter justeres, så der opretholdes normale

ammoniumniveauer i blodet. Tabletterne skal opløses (blandes) i en lille mængde vand, inden de gives

til patienten. De kan nemt brækkes i to lige halvdele.

Hvordan virker Carbaglu?

Når ammonium ophobes i blodet, er det giftigt for kroppen og især for hjernen. Carbaglu har en

struktur, der i høj grad ligner N-acetylglutamat, som aktiverer et enzym, der nedbryder ammonium.

Carbaglu hjælper derfor med til at nedbryde ammonium, hvorved ammoniumniveauet i blodet og den

giftige virkning reduceres.

Hvordan blev Carbaglu undersøgt?

Carbaglu blev undersøgt hos 20 patienter, hvoraf 12 havde NAGS-mangel og var blevet behandlet

gennemsnitligt cirka tre år. De resterende otte patienter blev behandlet for hyperammonæmi af anden

årsag. Virksomheden fremlagde også oplysninger fra den offentliggjorte faglitteratur om yderligere fire

patienter, der blev behandlet med det aktive stof i Carbaglu.

Carbaglu blev desuden undersøgt hos 57 patienter (hvoraf cirka to tredjedele var nyfødte) med

isovalerianeacidæmi, methylmalonacidæmi eller propionacidæmi, som blev behandlet med Carbaglu

under kritiske tilfælde af hyperammonæmi.

I alle undersøgelserne blev virkningen hovedsagelig målt på ændringen i mængden af ammonium i

blodet.

Hvilken fordel viser undersøgelserne, at der er ved Carbaglu?

Hos patienter med NAGS-mangel blev ammoniumniveauerne bragt tilbage til normalområdet efter

Carbaglu-behandling. Patienter, som fik Carbaglu, kunne holdes stabile, uden at der var behov for

kostmæssige begrænsninger eller andre lægemidler.

Hos patienter med isovalerianeacidæmi, methylmalonacidæmi eller propionacidæmi reducerede

Carbaglu desuden mængden af ammonium i blodet efter en gennemsnitlig behandlingstid på 5,5 dage.

Hvilken risiko er der forbundet med Carbaglu?

Den hyppigste bivirkning ved Carbaglu (som optræder hos mellem 1 og 10 patienter ud af 100) er øget

svedtendens. Den fuldstændige liste over indberettede bivirkninger ved Carbaglu fremgår af

indlægssedlen.

Carbaglu bør ikke anvendes af personer, der kan være overfølsomme (allergiske) over for

cargluminsyre eller et andre af indholdsstofferne. Carbaglu må ikke gives til ammende kvinder.

EMA/348518/2011

Carbaglu

Side 2/3

EMA/348518/2011

Carbaglu

Side 3/3

Hvorfor blev Carbaglu godkendt?

CHMP konkluderede, at Carbaglu var effektivt til at reducere ammoniumsniveauerne i blodet til

normale niveauer, og besluttede, at fordelene ved Carbaglu opvejer risiciene. Udvalget anbefalede

udstedelse af en markedsføringstilladelse for Carbaglu.

Andre oplysninger om Carbaglu:

Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske

Union for Carbaglu til Orphan Europe den 24. januar 2003. Markedsføringstilladelsen er gyldig på

ubegrænset tid.

Sammendragene af udtalelsen fra Udvalget for Lægemidler til Sjældne Sygdomme om Carbaglu findes

på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/Rare disease

designations (NAGS-mangel

: den 18. oktober 2000; isovalerianeacidæmi: den 7. november 2008;

methylmalonacidæmi

: den 7. november 2008; propionacidæmi: den 7. november 2008).

Den fuldstændige EPAR for Carbaglu findes på agenturets websted under: ema.europa.eu/Find

medicine/Human medicines/European Public Assessment Reports. Hvis du ønsker yderligere

oplysninger om behandling med Carbaglu, kan du læse indlægssedlen (også en del af denne EPAR)

eller kontakte din læge eller dit apotek.

Dette sammendrag blev sidst ajourført i 05-2011.

Indlægsseddel

B. INDLÆGSSEDDEL

INDLÆGSSEDDEL: INFORMATION TIL BRUGEREN

Carbaglu 200 mg dispergibel tabletter

Cargluminsyre

Læs hele denne indlægsseddel grundigt, inden De begynder at tage dette lægemiddel.

Gem indlægssedlen. De kan få brug for at læse den igen.

Spørg lægen eller på apoteket, hvis der er mere, De vil vide.

Lægen har ordineret Carbaglu til Dem personligt. Lad derfor være med at give det til andre. Det

kan være skadeligt for andre, selvom de har de samme symptomer, som De/du har.

Tal med lægen eller apoteket, hvis en bivirkning bliver værre, eller De får bivirkninger, som

ikke er nævnt her

Oversigt over indlægssedlen:

Carbaglus virkning og hvad De skal bruge det til

Det skal De vide, før De begynder at tage Carbaglu

Sådan skal De tage Carbaglu

Bivirkninger

Sådan opbevarer De Carbaglu

Yderligere oplysninger

1.

CARBAGLUS VIRKNING OG HVAD DE SKAL BRUGE DET TIL

Carbaglu kan medvirke til eliminere usædvanligt høje niveauer af ammoniak i blodet

(hyperammonæmi). Ammoniak er især toksisk for hjernen og fører i alvorlige tilfælde til nedsat

bevidsthed og koma.

Hyperammonæmi kan skyldes

mangel på et specifikt leverenzym, N-acetylglutamatsyntase. Patienter med denne sjældne

lidelse er ikke istand til at udskille nitrogen (kvælstof), der hober sig op efter indtagelse af

protein.

Denne lidelse kan ikke kureres, og behovet for behandling er derfor livslangt.

isovaleriansyreæmi, methylmalonsyreæmi eller propionacidæmi. Patienter, der lider af en af

disse sygdomme, har behov for behandling under hyperammonæmi-krisen.

2.

DET SKAL DE VIDE, FØR DE BEGYNDER AT TAGE CARBAGLU

Tag ikke Carbaglu :

-hvis De er overfølsom (allergisk) over for cargluminsyre eller et af de øvrige indholdsstoffer.

De må ikke tage Carbaglu, mens De ammer.

Vær ekstra forsigtig med at tage Carbaglu:

Carbaglubehandling skal indledes under overvågning af en læge, der har erfaring i behandlingen af

metaboliske sygdomme.

Deres læge vil vurdere, hvordan De reagerer på behandling med cargluminsyre, inden længerevarende

behandling indledes.

Dosis skal justeres individuelt for at kunne opretholde normale ammoniakniveauer i blodet.

Deres læge kan ordinere tilskud af arginin eller begrænse Deres indtagelse af protein.

For at følge op på Deres tilstand og behandling vil Deres læge måske regelmæssigt undersøge leveren,

nyrerne, hjertet og blodet.

Brug af anden medicin

Fortæl det altid til lægen eller apoteket, hvis De/du bruger anden medicin eller har brugt det for nylig.

Dette gælder også medicin, som ikke er købt på recept.

Brug af Carbaglu sammen med mad og drikke

Carbaglu skal tages gennem munden inden måltider eller fødeindtagelse.

Tabletterne skal opløses i mindst 5 til 10 ml vand og tages med det samme. Opslæmningen har en let

syrlig smag.

Graviditet og amning

Carbaglus effekt på graviditet og det ufødte barn er ukendt. Få rådgivning af Deres læge, hvis De er

gravid eller planlægger at blive gravid.

Det er ikke undersøgt , om cargluminsyre udskilles i brystmælk hos kvinder. Ikke desto mindre bør De

ikke amme Deres barn, hvis De tager Carbaglu, da tilstedeværelse af cargluminsyre er blevet påvist i

mælken hos ammende rotter med potentielt toksiske virkninger for ungerne.

Trafik- og arbejdssikkerhed

Virkninger på evnen til at køre bil og betjene maskiner er ukendt.

3.

SÅDAN SKAL DE/DU TAGE CARBAGLU

Tag altid Carbaglu nøjagtigt efter lægens anvisning. Er De i tvivl, så spørg lægen eller apoteket

Den sædvanlige dosis:

Den indledende daglige dosis er sædvanligvis 100 mg pr. kilo legemsvægt, op til maksimalt

250 mg pr. kilo legemsvægt (f.eks. hvis De vejer 10 kg, skal De tage 1 g om dagen, eller 5

tabletter),

Til patienter, der lider af N-acetylglutamatsyntasemangel, vil den daglige dosis sædvanligvis ligge

i intervallet fra 10 mg til 100 mg pr. kilo legemsvægt.

Deres læge vil fastlægge den dosis, der er passende for Dem for at kunne opretholde normale

ammoniakniveauer i Deres blod.

Carbaglu må KUN indtages gnnem munden eller via en ernæringssonde ned i maven (ved brug af en

sprøjte, hvis det er nødvendigt).

Når patienten er i hyperammonæmisk coma, gives Carbaglu ved et hurtigt tryk gennem en sprøjte via

den sonde, der er lagt for at ernære Dem.

Hvis De har taget for meget Carbaglu

Spørg lægen eller apoteket til råds.

Hvis De har glemt at tage Carbaglu

Tag ikke en dobbelt dosis for at udligne for den glemte individuelle dosis.

Hvis De holder op med at tage Carbaglu

De må ikke holde op med at tage Carbaglu uden at informere lægen.

Spørg lægen eller på apoteket, hvis der er noget, De er i tvivl om.

4.

BIVIRKNINGER

Som alle lægemidler kan Carbaglu have bivirkninger, men ikke alle får bivirkninger.

Følgende bivirkninger blev rapporteret som følger: meget almindelig (forekommer hos mindst en af

10 patienter), almindelig (forekommer hos mindst en af 100 patienter), ikke almindelig (forekommer

hos mindst en af 1.000 patienter), sjælden (forekommer hos mindst en af 10.000 patienter), meget

sjælden (forekommer hos mindst en af 100.000 patienter) og ikke kendt (hyppigheden kan ikke

estimeres ud fra forhåndenværende data).

Almindelig: øget svedtendends

Ikke almindelig: langsom hjerteaktion (puls), diarré, feber, forhøjede aminotransferaser,

opkastning

Ikke kendt: udslæt

Tal med lægen eller apoteket, hvis en bivirkning er generende eller bliver værre, eller De får

bivirkninger, som ikke er nævnt her.

Indberetning af bivirkninger

Hvis du oplever bivirkninger, bør du tale med din læge, sygeplejerske eller apoteket. Dette gælder

også mulige bivirkninger, som ikke er medtaget i denne indlægsseddel. Du eller dine pårørende kan

også indberette bivirkninger direkte til Sundhedsstyrelsen via det nationale rapporteringssystem anført

i Appendiks V. Ved at indrapportere bivirkninger kan du hjælpe med at fremskaffe mere information

om sikkerheden af dette lægemiddel.

5.

SÅDAN OPBEVARER DE CARBAGLU

Opbevares utilgængeligt for børn.

Brug ikke Carbaglu efter den udløbsdato, der står på tabletbeholderen. .

Opbevares i køleskab (2°C - 8°C)

Efter første åbning af tabletbeholderen: Må ikke nedkøles. Må ikke opbevares ved temperaturer over

Hold beholderen tæt tillukket som beskyttelse mod fugt.

Skriv datoen for åbning på tabletbeholderen. Bortskaffes 1 måned efter første åbning.

6.

YDERLIGERE OPLYSNINGER

Carbaglu indeholder:

Aktivt stof: cargluminsyre. Hver tablet indeholder 200 mg cargluminsyre

Øvrige indholdsstoffer: mikrokrystallinsk cellulose, natriumlaurilsulfat, hypromellose,

croscarmelosenatrium, silica, kolloid vandfri, natriumstearylfumarat.

Udseende og pakningsstørrelser

Carbaglu 200 mg tablet er en aflang tablet med 4 huller på den ene side og med 3 brudriller.

Carbaglu leveres i en plastbeholder med 5, 15 og 60 tabletter, som er lukket med et børnesikkert låg.

Indehaveren af markedsføringstilladelsen

Orphan Europe SARL

Immeuble “Le Wilson”

70, avenue du Général de Gaulle

F-92800 Puteaux

Frankrig

Tel: + 33 1 4773 6458

Fax: + 33 1 4900 1800

Fremstiller

Orphan Europe SARL

Immeuble “Le Wilson”

70, avenue du Général de Gaulle

F-92800 Puteaux

Frankrig

Eller

Orphan Europe SARL

Eco River Parc

30, rue des Peupliers

F-92000 Nanterre

Frankrig

Hvis De vil have yderligere oplysninger om Carbaglu skal De henvende Dem til den lokale

repræsentant:

Belgique/België/Belgien

Orphan Europe Benelux

Tél/Tel: +32 2 46101 36

Lietuva

Orphan Europe AB

Tel: + 46 8 545 80 230

Švedija

България

Orphan Europe SARL

Teл.: +33 (0)1 47 73 64 58

Франция

Luxembourg/Luxemburg

Orphan Europe Benelux

Belgique/Belgien

Tél/Tel: +32 2 46101 36

Česká republika

Orphan Europe SARL

Tel: +33 (0)1 47 73 64 58

Francie

Magyarország

Orphan Europe SARL

Tel: +33 (0)1 47 73 64 58

Franciaország

Danmark

Orphan Europe AB

Tlf : +46 8 545 80 230

Sverige

Malta

Orphan Europe SARL

Tel: +33 1 47 73 64 58

Franza

Deutschland

Orphan Europe (Germany) GmbH

Tel: +49 731 140 554 0

Nederland

Orphan Europe Benelux

Tel: +32 2 46101 36

België

Eesti

Orphan Europe AB

Tel: + 46 8 545 80 230

Norge

Orphan Europe AB

Tlf : +46 8 545 80 230

Rootsi

Sverige

Ελλάδα

Recordati Hellas

Τηλ: +30 210 6773822

Österreich

Orphan Europe (Germany) GmbH

Tel: +49 731 140 554 0

Deutschland

España

Orphan Europe S.L.U.

Tel: + 34 91 659 28 90

Polska

Orphan Europe SARL

Tel: +33 (0)1 47 73 64 58

Francja

France

Orphan Europe SARL

Tél: +33 (0)1 47 73 64 58

Portugal

Orphan Europe Portugal Lda.

Tel: +351 21 432 95 00

Hrvatska

Orphan Europe SARL

Tél: +33 (0)1 47 73 64 58

Francuska

România

Orphan Europe SARL

Tel: +33 (0)1 47 73 64 58

Franţa

Ireland

Orphan Europe (UK) Ltd.

Tel: +44 1491 414333

Slovenija

Orphan Europe SARL

Tel: +33 (0)1 47 73 64 58

Francija

Ísland

Orphan Europe AB

Simi:+46 8 545 80 230

Svíþjóð

Slovenská republika

Orphan Europe SARL

Tel: +33 (0)1 47 73 64 58

Francúzsko

Italia

Orphan Europe (Italy) Srl

Tel: +39 02 487 87 173

Suomi/Finland

Orphan Europe AB

Puh/Tel : +46 8 545 80 230

Sverige

Κύπρος

Orphan Europe SARL

Τηλ : +33 1 47 73 64 58

Γαλλία

Sverige

Orphan Europe AB

Tel : +46 8 545 80 230

Latvija

Orphan Europe AB

Tel: + 46 8 545 80 230

Zviedrija

Orphan Europe (UK) Ltd.

Tel: +44 (0)1491 414333

Denne indlægsseddel blev senest godkendt {dato}

De kan finde yderligere information om Carbaglu på Det Europæiske Lægemiddelagenturs

hjemmeside http://www.ema.europa.eu/. Der er også links til websites om sjældne sygdomme, og

hvordan de behandles.

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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