Carbomix

Primær information

  • Handelsnavn:
  • Carbomix granulat til oral suspension
  • Lægemiddelform:
  • granulat til oral suspension
  • Brugt til:
  • Mennesker
  • Medicin typen:
  • Allopatiske stof

Dokumenter

Lokation

  • Fås i:
  • Carbomix granulat til oral suspension
    Danmark
  • Sprog:
  • dansk

Andre oplysninger

Status

  • Kilde:
  • Lægemiddelstyrelsen - Danish Medicines Agency
  • Autorisation status:
  • Markedsført
  • Autorisationsnummer:
  • 56368
  • Sidste ændring:
  • 22-02-2018

Indlægsseddel

Indlægsseddel: Information til brugeren

Carbomix

®

50 g, granulat til oral suspension

Aktivt kul

Læs denne indlægsseddel grundigt, inden du begynder at tage dette

lægemiddel, da den indeholder vigtige oplysninger.

Tag altid dette lægemiddel nøjagtigt som beskrevet i denne

indlægsseddel eller efter de anvisninger lægen eller apotekspersonalet

har givet dig.

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

Spørg på apoteket, hvis der er mere, du vil vide.

Kontakt lægen eller apotekspersonalet, hvis du får bivirkninger,

herunder bivirkninger, som ikke er nævnt her. Se punkt 4

Kontakt lægen, hvis du får det værre, eller hvis du ikke får det bedre.

Den nyeste udgave af indlægssedlen findes på www.indlægsseddel.dk

Oversigt over indlægssedlen:

1. Virkning og anvendelse

2. Det skal du vide, før du begynder at tage Carbomix

3. Sådan skal du tage Carbomix

4. Bivirkninger

5. Opbevaring

6. Pakningsstørrelser og yderligere oplysninger

1. VIRKNING OG ANVENDELSE

Carbomix indeholder aktivt kul og anvendes i tilfælde af akut forgiftning og

overdosering af medicin indtaget gennem munden.

Det aktive kul i Carbomix kan binde (absorbere) skadelige eller uønskede

stoffer i mavetarmkanalen.

Kontakt lægen hvis de får det værre, eller hvis du ikke får det bedre.

2. DET SKAL DU VIDE, FØR DU BEGYNDER AT TAGE CARBOMIX

Lægen kan have foreskrevet anden anvendelse eller dosering end angivet

i denne information. Følg altid lægens anvisning og oplysningerne på

doseringsetiketten.

Tag ikke Carbomix, hvis:

Du er allergisk over for aktivt kul, eller et af de øvrige indholdsstoffer i

Carbomix (angivet i punkt 6).

Du ved, at forgiftningen helt sikkert skyldes ætsende stoffer (stærke

syrer som f.eks. saltsyre eller baser som f.eks. afløbsrens). Carbomix

må ikke anvendes til forgiftninger som skyldes ætsende stoffer, da

dette kan vanskeliggøre undersøgelse af spiserør og undersøgelse af

maven.

Advarsler og forsigtighedsregler

Kontakt straks lægen eller giftcenter før du tager Carbomix, hvis du:

har en akut forgiftning og overdosering af medicin taget gennem

munden. Du skal straks tage kontakt til læge eller giftcenter.

Umiddelbart derefter indtages Carbomix i henhold til forskrifterne (se

vejledning under punkt 3).

Vær opmærksom på følgende

Carbomix kan anvendes ved mange typer forgiftninger. Men nogle

forbindelser og opløsninger, som f.eks. jernforbindelser, lithium-, thallium-,

cyanid-, methanol-, ethanol-, ethylenglykol- og petroleumsholdige

opløsninger absorberes i mindre grad af Carbomix. I tilfælde af forgiftning

med sådanne stoffer skal anden form for afgiftning foretages (f.eks.

maveskylning). De mest almindelige forgiftninger af denne type er angivet

nedenfor med den for disse stoffers relevante behandling:

Stof

Særlig modgift:

Cyanid

Natriumnitrit/

4-dimethylaminfenol

Jernforbindelser

Deferoxamin

Lithium

Kalciumpolystyrensulfonat

Methanol/

denatureret alkohol

Ethanol

Ethylenglykol/

Frostvæske

Ethanol

Ved mange typer forgiftning anvendes både Carbomix og en særlig

modgift. F.eks. ved paracetamol-forgiftning anvendes også modgiften

acetylcystein.

Indtagelse af aktivt kul frarådes for patienter, som tager medicin der

hæmmer tarmens bevægelighed, eller har indtaget et giftstof med denne

virkning, på grund af risiko for tarmslyng der kan medføre hul på tarmen.

Carbomix giver sort afføring.

Brug af anden medicin sammen med Carbomix

Fortæl det altid til lægen eller apotekspersonalet, hvis du bruger anden

medicin eller har gjort det for nylig.

Tal med din læge, hvis du tager:

Medicin som indtages gennem munden. Carbomix normalt vil nedsætte

virkningen af denne medicin.

P-piller. Carbomix kan nedsætte virkningen af P-piller. Det er derfor

vigtigt at anvende alternativ og sikker prævention, så du ikke risikere at

blive gravid.

Vanddrivende medicin (f.eks. furosemid).

Graviditet og amning

Hvis du er gravid eller ammer, har mistanke om, at du er gravid, eller

planlægger at blive gravid, skal du spørge din læge eller

apotekspersonalet til råds, før du tager dette lægemiddel.

Graviditet

Du kan tage Carbomix hvis du er gravid.

Vær opmærksom på at Carbomix kan nedsætte virkningen af p-piller. Det

anbefales derfor at bruge, anden og sikker prævention, under

behandlingen med Carbomix.

Amning

Du kan tage Carbomix hvis du ammer.

Trafik- og arbejdssikkerhed

Carbomix påvirker ikke arbejdssikkerheden eller evnen til at færdes

sikkert i trafikken.

3. SÅDAN SKAL DU TAGE CARBOMIX

Tag altid Carbomix nøjagtigt som beskrevet i denne indlægsseddel eller

efter lægens eller apotekspersonalets anvisning. Er du i tvivl, så spørg

lægen eller på apoteket.

Den sædvanlige dosis er

Voksne og børn over 12 år: Ved akut forgiftning og overdosering

indtages 1-2 flasker Carbomix så hurtigt som muligt (= 50-100 g aktivt

kul).

Ved alvorlig forgiftning fortsættes behandlingen i et par dage med en

dosis på 20 g Carbomix hver 4-6 time (20 g aktivt kul svarer ca. til 160 ml

af suspensionen). Hvis indholdet indtages ad flere gange, skal flasken

rystes grundigt for hver gang. Suspensionen skal indtages gennem

munden.

Carbomix kan også gives efter opkastning og maveskylning

Børn under 12 år: Anbefalet dosis er ca. 1 g kul pr. kg legemsvægt. I

tilfælde af akut forgiftning hos børn under 12 år gives halv voksendosis (=

½ flaske). Til børn under 4 år startes med en dosis på en ¼ flaske, hvilket

gentages flere gange i samråd med lægen.

Børn under 2 år: Må ikke anvendes til børn under 2 år uden lægens

anvisning.

Tal med lægen.

BRUGSANVISNING

Sådan tager du Carbomix korrekt

Tilberedelse af suspensionen: Ryst flasken grundigt for at løsne

granulatet. Tilsæt vand til flaskens røde streg og ryst igen flasken i 1

minut. Herved fås ca. 400 ml suspension. Flasken åbnes forsigtigt og

indholdet indtages omgående. Hvis indholdet indtages ad flere gange,

skal flasken rystes for hver gang.

Flasken er udstyret med en speciel top, der kan bruges ved hurtig og

direkte sondetilslutning. Toppen løsnes forsigtigt for at frigøre evt. tryk i

flasken og lukkes igen. Derefter skæres toppen af inden sondetilslutning.

Hvis du har taget for meget Carbomix

Kontakt lægen, skadestuen eller apoteket, hvis du har taget mere

Carbomix, end der står i denne information eller mere end lægen har

foreskrevet (og du føler dig utilpas). Tag pakningen med.

Symptomer på en overdosis kan være forstoppelse. Dette kan undgås ved

at indtage et afføringsmiddel.

Carbomix, 2. udgave

Senest revideret januar 2017

Hvis du har glemt at tage Carbomix

Du må ikke tage en dobbeltdosis som erstatning for den glemte dosis.

Hvis du holder op med at tage Carbomix

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

Kontakt straks lægen, hvis dine symptomer bliver værre efter

behandlingen med Carbomix.

Ændring eller stop med behandlingen bør kun ske i samråd med lægen.

4. BIVIRKNINGER

Dette lægemiddel kan som al anden medicin give bivirkninger, men ikke

alle får bivirkninger.

De fleste bivirkninger i forbindelse med Carbomix er relateret til

mavetarmsystemet.

Bivirkningerne kan dog også skyldes selve forgiftningen.

Alvorlige bivirkninger

Bivirkninger, hvor hyppigheden ikke er kendt:

Som følge af gentagene høje doser af aktivt kul kan der opstå

forstoppelse af tyndtarmen som har krævet operation.

Hård afføring med hul på tyktarmen til følge.

Ikke alvorlige bivirkninger

Bivirkninger, hvor hyppigheden ikke er kendt:

Opkastning.

Forstoppelse.

Mavesmerter.

Diarré.

Kvalme.

Pludselig afføringstrang.

Anal irritation.

Indberetning af bivirkninger

Hvis du oplever bivirkninger, bør du tale med din læge, sygeplejerske eller

apotek. Dette gælder også mulige bivirkninger, som ikke er medtaget i

denne indlægsseddel. Du eller dine pårørende kan også indberette

bivirkninger direkte til Lægemiddelstyrelsen på www.meldenbivirkning.dk,

ved at kontakte Lægemiddelstyrelsen via mail sst@sst.dk eller med

almindeligt brev til Lægemiddelstyrelsen, Axel Heides Gade 1, 2300

København S.

Ved at indrapportere bivirkninger kan du hjælpe med at fremskaffe mere

information om sikkerheden af dette lægemiddel.

5. OPBEVARING

Opbevar Carbomix utilgængeligt for børn.

Granulatet opbevares tørt inden blanding.

Opbevar ikke Carbomix over 25 °C.

Efter opblanding skal Carbomix opbevares i køleskab (2 °C - 8 °C).

Efter opblanding skal Carbomix anvendes inden for 1 dag.

Brug ikke Carbomix efter den udløbsdato, der står på pakningen.

Spørg på apoteket, hvordan du skal bortskaffe medicinrester. Af hensyn

til miljøet må du ikke smide medicinrester i afløbet, toilettet eller

skraldespanden.

6. PAKNINGSSTØRRELSER OG YDERLIGERE OPLYSNINGER

Carbomix indeholder:

Aktivt stof: Aktivt kul 50 g (efter opløsning i vand, indeholder Carbomix

12,5 g aktivt kul pr. 100 ml homogen opløsning)

Øvrige indholdsstoffer: Citronsyremonohydrat, glycerol og akacie

gummi.

Udseende og pakningsstørrelser:

Plastflaske med skruelåg.

Carbomix fås i pakningsstørrelsen 10 x 50 g.

Indehaver af markedsføringstilladelsen:

EuroPharmaDK

Oddesundvej 39

6715 Esbjerg N

Frigivet af

Abacus Medicine B.V.

Herculesstraat 25

1812 PD Alkmaar

Holland

Carbomix er et registreret varemærke, som tilhører Norit International N.V.

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EU/3/17/1836 (Zogenix GmbH)

EU/3/17/1836 (Zogenix GmbH)

EU/3/17/1836 (Active substance: Fenfluramine hydrochloride) - Transfer of orphan designation - Commission Decision (2018)7576 of Tue, 13 Nov 2018 European Medicines Agency (EMA) procedure number: EMA/OD/233/16/T/01

Europe -DG Health and Food Safety

13-11-2018

EU/3/13/1219 (Zogenix GmbH)

EU/3/13/1219 (Zogenix GmbH)

EU/3/13/1219 (Active substance: Fenfluramine hydrochloride) - Transfer of orphan designation - Commission Decision (2018)7575 of Tue, 13 Nov 2018 European Medicines Agency (EMA) procedure number: EMA/OD/140/13/T/01

Europe -DG Health and Food Safety

13-11-2018

EU/3/17/1964 (Incyte Biosciences Distribution B.V.)

EU/3/17/1964 (Incyte Biosciences Distribution B.V.)

EU/3/17/1964 (Active substance: Itacitinib) - Transfer of orphan designation - Commission Decision (2018)7573 of Tue, 13 Nov 2018 European Medicines Agency (EMA) procedure number: EMA/OD/169/17/T/01

Europe -DG Health and Food Safety

12-11-2018

Efavirenz/Emtricitabine/Tenofovir disoproxil Zentiva (Zentiva, k.s.)

Efavirenz/Emtricitabine/Tenofovir disoproxil Zentiva (Zentiva, k.s.)

Efavirenz/Emtricitabine/Tenofovir disoproxil Zentiva (Active substance: efavirenz / emtricitabine / tenofovir disoproxil) - Centralised - Yearly update - Commission Decision (2018)7547 of Mon, 12 Nov 2018

Europe -DG Health and Food Safety

12-11-2018

Ruconest (Pharming Group N.V.)

Ruconest (Pharming Group N.V.)

Ruconest (Active substance: Conestat alfa) - Centralised - Yearly update - Commission Decision (2018)7548 of Mon, 12 Nov 2018

Europe -DG Health and Food Safety

12-11-2018

Spinraza (Biogen Netherlands B.V.)

Spinraza (Biogen Netherlands B.V.)

Spinraza (Active substance: nusinersen) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)7550 of Mon, 12 Nov 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4312/T/10

Europe -DG Health and Food Safety

6-11-2018

Symkevi (Vertex Pharmaceuticals (Europe) Limited)

Symkevi (Vertex Pharmaceuticals (Europe) Limited)

Symkevi (Active substance: tezacaftor/ivacaftor) - Centralised - Authorisation - Commission Decision (2018)7415 of Tue, 06 Nov 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4682

Europe -DG Health and Food Safety

6-11-2018

Trelegy Ellipta (GlaxoSmithKline Trading Services Limited)

Trelegy Ellipta (GlaxoSmithKline Trading Services Limited)

Trelegy Ellipta (Active substance: fluticasone furoate/umeclidinium/vilanterol) - Centralised - 2-Monthly update - Commission Decision (2018)7416 of Tue, 06 Nov 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4363/WS/1369

Europe -DG Health and Food Safety

6-11-2018

Elebrato Ellipta (GlaxoSmithKline Trading Services Limited)

Elebrato Ellipta (GlaxoSmithKline Trading Services Limited)

Elebrato Ellipta (Active substance: fluticasone furoate/umeclidinium/vilanterol) - Centralised - 2-Monthly update - Commission Decision (2018)7417 of Tue, 06 Nov 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4781/WS/1369

Europe -DG Health and Food Safety

6-11-2018

Neulasta (Amgen Europe B.V.)

Neulasta (Amgen Europe B.V.)

Neulasta (Active substance: Pegfilgrastim) - Centralised - Yearly update - Commission Decision (2018)7420 of Tue, 06 Nov 2018

Europe -DG Health and Food Safety

6-11-2018

Samsca (Otsuka Pharmaceutical Netherlands B.V.)

Samsca (Otsuka Pharmaceutical Netherlands B.V.)

Samsca (Active substance: tolvaptan) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)7419 of Tue, 06 Nov 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/980/T/36

Europe -DG Health and Food Safety

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

5-11-2018

Improvac (Zoetis Belgium S.A.)

Improvac (Zoetis Belgium S.A.)

Improvac (Active substance: Not available) - Centralised - Yearly update - Commission Decision (2018)7381 of Mon, 05 Nov 2018

Europe -DG Health and Food Safety

1-11-2018

Zolvix (Elanco GmbH)

Zolvix (Elanco GmbH)

Zolvix (Active substance: monepantel) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)7383 of Thu, 01 Nov 2018 European Medicines Agency (EMA) procedure number: EMEA/V/C/000154/T/0024

Europe -DG Health and Food Safety

1-11-2018

Protopic (Leo Pharma A/S)

Protopic (Leo Pharma A/S)

Protopic (Active substance: Tacrolimus) - Centralised - Yearly update - Commission Decision (2018)7343 of Thu, 01 Nov 2018

Europe -DG Health and Food Safety

1-11-2018

Dexdomitor (Orion Corporation)

Dexdomitor (Orion Corporation)

Dexdomitor (Active substance: dexmedetomidine hydrochloride) - Centralised - Yearly update - Commission Decision (2018)7380 of Thu, 01 Nov 2018

Europe -DG Health and Food Safety

1-11-2018

Taxespira (Hospira UK Limited)

Taxespira (Hospira UK Limited)

Taxespira (Active substance: docetaxel) - Centralised - Withdrawal - Commission Decision (2018)7368 of Thu, 01 Nov 2018

Europe -DG Health and Food Safety

31-10-2018

Integrilin (GlaxoSmithKline (Ireland) Limited)

Integrilin (GlaxoSmithKline (Ireland) Limited)

Integrilin (Active substance: Eptifibatide) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)7340 of Wed, 31 Oct 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/230/T/79

Europe -DG Health and Food Safety

31-10-2018

Volibris (GlaxoSmithKline (Ireland) Limited)

Volibris (GlaxoSmithKline (Ireland) Limited)

Volibris (Active substance: Ambrisentan) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)7339 of Wed, 31 Oct 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/839/T/56

Europe -DG Health and Food Safety

31-10-2018

AMGEVITA (Amgen Europe B.V.)

AMGEVITA (Amgen Europe B.V.)

AMGEVITA (Active substance: adalimumab) - Centralised - Yearly update - Commission Decision (2018)7341 of Wed, 31 Oct 2018

Europe -DG Health and Food Safety

31-10-2018

Imraldi (Samsung Bioepis NL B.V.)

Imraldi (Samsung Bioepis NL B.V.)

Imraldi (Active substance: adalimumab) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)7344 of Wed, 31 Oct 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4279/T/15

Europe -DG Health and Food Safety

31-10-2018

Evista (Daiichi Sankyo Europe GmbH)

Evista (Daiichi Sankyo Europe GmbH)

Evista (Active substance: Raloxifene hydrochloride) - Centralised - Yearly update - Commission Decision (2018)7342 of Wed, 31 Oct 2018

Europe -DG Health and Food Safety

30-10-2018

EU/3/14/1250 (Akcea Therapeutics UK Ltd)

EU/3/14/1250 (Akcea Therapeutics UK Ltd)

EU/3/14/1250 (Active substance: Phosphorothioate oligonucleotide targeted to transthyretin) - Transfer of orphan designation - Commission Decision (2018)7282 of Tue, 30 Oct 2018 European Medicines Agency (EMA) procedure number: EMA/OD/098/13/T/01

Europe -DG Health and Food Safety

30-10-2018

EU/3/18/2080 (Freeline Therapeutics Ltd)

EU/3/18/2080 (Freeline Therapeutics Ltd)

EU/3/18/2080 (Active substance: Recombinant adeno-associated viral vector serotype S3 containing codon-optimised expression cassette encoding human coagulation factor IX variant) - Orphan designation - Commission Decision (2018)7281 of Tue, 30 Oct 2018 European Medicines Agency (EMA) procedure number: EMA/OD/127/18

Europe -DG Health and Food Safety

30-10-2018

EU/3/18/2079 (Spark Therapeutics Ireland Ltd)

EU/3/18/2079 (Spark Therapeutics Ireland Ltd)

EU/3/18/2079 (Active substance: Recombinant adeno-associated viral vector containing a bioengineered capsid and a codon-optimised expression cassette to drive the expression of the SQ form of a B-domain deleted human coagulation factor VIII) - Orphan designation - Commission Decision (2018)7280 of Tue, 30 Oct 2018 European Medicines Agency (EMA) procedure number: EMA/OD/104/18

Europe -DG Health and Food Safety

30-10-2018

EU/3/18/2078 (Sellas Life Sciences Limited)

EU/3/18/2078 (Sellas Life Sciences Limited)

EU/3/18/2078 (Active substance: Peptides YMFPNAPYL, SGQAYMFPNAPYLPSCLES, RSDELVRHHNMHQRNMTKL and PGCNKRYFKLSHLQMHSRKHTG) - Orphan designation - Commission Decision (2018)7279 of Tue, 30 Oct 2018 European Medicines Agency (EMA) procedure number: EMA/OD/091/18

Europe -DG Health and Food Safety

30-10-2018

EU/3/18/2077 (Worphmed Srl)

EU/3/18/2077 (Worphmed Srl)

EU/3/18/2077 (Active substance: Melatonin) - Orphan designation - Commission Decision (2018)7278 of Tue, 30 Oct 2018 European Medicines Agency (EMA) procedure number: EMA/OD/077/18

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

30-10-2018

EU/3/18/2075 (Consorcio Centro de InvestigaciOn BiomEdica en Red M.P.)

EU/3/18/2075 (Consorcio Centro de InvestigaciOn BiomEdica en Red M.P.)

EU/3/18/2075 (Active substance: Gefitinib) - Orphan designation - Commission Decision (2018)7276 of Tue, 30 Oct 2018 European Medicines Agency (EMA) procedure number: EMA/OD/090/18

Europe -DG Health and Food Safety

30-10-2018

EU/3/18/2074 (PhaRA bvba)

EU/3/18/2074 (PhaRA bvba)

EU/3/18/2074 (Active substance: Avapritinib) - Orphan designation - Commission Decision (2018)7275 of Tue, 30 Oct 2018 European Medicines Agency (EMA) procedure number: EMA/OD/079/18

Europe -DG Health and Food Safety

30-10-2018

EU/3/18/2073 (Fondazione Telethon)

EU/3/18/2073 (Fondazione Telethon)

EU/3/18/2073 (Active substance: Autologous CD34+ haematopoietic stem and progenitor cells genetically modified with the lentiviral vector IDUA LV, encoding for the alpha-L-iduronidase cDNA) - Orphan designation - Commission Decision (2018)7274 of Tue, 30 Oct 2018 European Medicines Agency (EMA) procedure number: EMA/OD/113/18

Europe -DG Health and Food Safety

30-10-2018

EU/3/18/2071 (Loxo Oncology Limited)

EU/3/18/2071 (Loxo Oncology Limited)

EU/3/18/2071 (Active substance: 6-(2-hydroxy-2-methylpropoxy)-4-(6-(6-((6-methoxypyridin-3-yl)methyl)-3,6-diazabicyclo[3.1.1]heptan-3-yl)pyridin-3-yl)pyrazolo[1,5-a]pyridine-3-carbonitrile) - Orphan designation - Commission Decision (2018)7272 of Tue, 30 Oct 2018 European Medicines Agency (EMA) procedure number: EMA/OD/125/18

Europe -DG Health and Food Safety

30-10-2018

EU/3/18/2072 (FGK Representative Service GmbH)

EU/3/18/2072 (FGK Representative Service GmbH)

EU/3/18/2072 (Active substance: 6'-(R)-methyl-5-O-(5-amino-5,6-dideoxy-alpha-L-talofuranosyl)-paromamine sulfate) - Orphan designation - Commission Decision (2018)7273 of Tue, 30 Oct 2018 European Medicines Agency (EMA) procedure number: EMA/OD/102/18

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

Replagal (Shire Human Genetic Therapies AB)

Replagal (Shire Human Genetic Therapies AB)

Replagal (Active substance: Agalsidase alfa) - Centralised - Yearly update - Commission Decision (2018)7250 of Mon, 29 Oct 2018

Europe -DG Health and Food Safety

29-10-2018

Synflorix (GlaxoSmithKline Biologicals S.A.)

Synflorix (GlaxoSmithKline Biologicals S.A.)

Synflorix (Active substance: Pneumococcal polysaccharide conjugate vaccine (adsorbed)) - Centralised - Yearly update - Commission Decision (2018)7257 of Mon, 29 Oct 2018

Europe -DG Health and Food Safety

29-10-2018

Cyltezo (Boehringer Ingelheim International GmbH)

Cyltezo (Boehringer Ingelheim International GmbH)

Cyltezo (Active substance: adalimumab) - Centralised - 2-Monthly update - Commission Decision (2018)7251 of Mon, 29 Oct 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4319/IB/05/G

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

29-10-2018

Sustiva (Bristol-Myers Squibb Pharma EEIG)

Sustiva (Bristol-Myers Squibb Pharma EEIG)

Sustiva (Active substance: efavirenz) - Centralised - 2-Monthly update - Commission Decision (2018)7252 of Mon, 29 Oct 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/249/II/145/G

Europe -DG Health and Food Safety