Carbomix

Primær information

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

Dokumenter

  • for den brede offentlighed:
  • Oplysningerne indlægssedlen for dette produkt er i øjeblikket ikke tilgængelig, kan du sende en anmodning til vores kundeservice, og vi vil give dig besked, så snart vi er i stand til at opnå det.


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Lokation

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

Andre oplysninger

Status

  • Kilde:
  • Lægemiddelstyrelsen - Danish Medicines Agency
  • Autorisationsnummer:
  • 59879
  • Sidste ændring:
  • 22-02-2018

Produktresumé

22. september 2017

PRODUKTRESUMÉ

for

Carbomix, granulat til oral suspension (Abacus Medicine A/S)

0.

D.SP.NR.

9660

1.

LÆGEMIDLETS NAVN

Carbomix 50g, granulat til oral suspension

2.

KVALITATIV OG KVANTITATIV SAMMENSÆTNING

Hver flaske indeholder 50 g aktivt kul. Efter opløsning i vand indeholder produktet ca.

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

Alle hjælpestoffer er anført under pkt. 6.1.

3.

LÆGEMIDDELFORM

Granulat til mikstur, suspension (Abacus Medicine A/S)

Sort granulat.

4.

KLINISKE OPLYSNINGER

4.1

Terapeutiske indikationer

Ved akut oral forgiftning og overdosering af medicinske produkter

4.2

Dosering og indgivelsesmåde

Voksne og børn over 12 år:

50-100 g aktivt kul (= 1-2 flasker Carbomix) indtages så hurtigt som muligt. Ved alvorlige

forgiftninger fortsættes behandlingen i et par dage med en dosis på 20 g hver 4-6 time (20

g aktivt kul svarer ca. til 160 ml af suspensionen).

Børn under 12 år:

Anbefalet dosis: ca. 1 g aktivt kul pr. kg legemsvægt.

I tilfælde af akut forgiftning hos børn under 12 år gives halv voksendosis (= 1/2 flaske). Til

børn under 4 år startes med en dosis på 1/4 flaske, hvilket gentages flere gange i samråd

med lægen.

59879_spc.doc

Side 1 af 5

Ved bevidstløse patienter skal en læge, eller en sygeplejerske under lægetilsyn, give

suspensionen ved hjælp af en sonde.

Carbomix kan også gives efter opkastning eller maveskylning.

For at modvirke optagelse af giftstoffer i kroppen og for at fjerne de allerede absorberede

giftstoffer er det vigtigt, at Carbomix indtages hurtigt. Dog kan langsom indtagelse også

have en positiv virkning.

Ved alvorlig forgiftning anbefales det at indtage flere doser aktivt kul.

Tilberedelse af suspension:

Ryst flasken grundigt for at løsne granulatet. Tilsæt vand til flaskens røde streg. Ryst

grundigt 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.

4.3

Kontraindikationer

Overfølsomhed over for det aktive stof eller et eller flere af hjælpestofferne anført i pkt. 6.

Carbomix må ikke anvendes, hvis forgiftningen helt sikkert skyldes ætsende stoffer (f.eks.

stærke syrer eller baser), da det i sådanne tilfælde kan vanskeliggøre oesofagoskopi og

gastroskopi.

4.4

Særlige advarsler og forsigtighedsregler vedrørende brugen

Ved akut oral forgiftning og overdosering af medicin skal der omgående tages kontakt til

læge eller giftcenter. Umiddelbart derefter indtages Carbomix suspensionen i henhold til

forskrifterne.

Aktivt kul adsorberer ikke organiske og uorganiske salte og opløsninger dvs. salte i jern-,

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

opløsninger. 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 stoffer relevante behandling:

Specific antidote:

Cyanid

Natriumnitrit/4-dimethylaminfenol

Jernforbindelser

Deferoxamin

Lithium

Kalciumpolystyrensulfonat

Methanol

Ethanol

Ethylenglykol

Ethanol

Ved mange typer forgiftning skal der ud over Carbomix indtages en bestemt modgift

(f.eks. ved paracetamolforgiftning: acetylcystein).

Når oral behandling eller en bestemt, oral modgift er meget vigtig for patienten, frarådes

indtagelse af aktivt kul.

Indtagelse af aktivt kul frarådes for patienter, der tager anti-peristaltisk medicin, eller der

har indtaget et giftstof med anti-peristaltisk virkning, pga. risiko for paralytisk ileus,

hvilket kan medføre tarmperforering (se 4.3).

Aktivt kul giver sort afføring.

4.5

Interaktion med andre lægemidler og andre former for interaktion

Indtagelse af aktivt kul vil normalt nedsætte virkningen af andre orale præparater pga.

virkningsforløbet.

Samtidig indtagelse af furosemide og aktivt kul har vist sig at resultere i en stor reduktion

af virkningen af furosemide.

Indtagelse af aktivt kul kan også reducere virkningen af ægløsningshæmmende medicin (se

4.6)

4.6

Graviditet og amning

Kvinder med risiko for graviditet / Svangerskabsforebyggelse

Aktivt kul kan nedsætte virkningen af p-piller. Derfor anbefales det at anvende alternativ,

effektiv og sikker prævention under behandlingen.

Graviditet

Aktivt kul kan, ifølge tidligere erfaringer, anvendes som foreskrevet uden risiko for

fosteret.

Amning

Aktivt kul kan, ifølge tidligere erfaringer, anvendes som foreskrevet uden risiko for barnet.

4.7

Virkninger på evnen til at føre motorkøretøjer eller betjene maskiner

Carbomix påvirker ikke køre- eller maskinbetjeningsevnen.

4.8

Bivirkninger

De fleste rapporterede bivirkninger i forbindelse med indtagelse af aktivt kul relaterer til

mavetarmsystemet. De fleste af disse kan dog også skyldes tilgrundliggende

omstændigheder.

Hændelsesfrekvensen kendes ikke (kan ikke vurderes ud fra forhåndenværende data).

Almindeligt rapporterede bivirkninger er: opkastning, forstoppelse, mavesmerter, diarré,

kvalme, pludselig afføringstrang, anal irritation.

Der har været enkelte rapporter (alle som følge af indtagelse af gentagne høje doser af

aktivt kul) om: (pseudo)forstoppelse af tyndtarmen, der har krævet operation og om hård

afføring med perforering af tyktarmen til følge (se 4.9)

Indberetning af formodede bivirkninger

Når lægemidlet er godkendt, er indberetning af formodede bivirkninger

vigtig. Det muliggør løbende overvågning af benefttriikkforholdet for

lægemidlet. Læger og iundhediperionale anmodei om at indberette

alle formodede bivirkninger via:

Lægemiddelityrelien

Axel Heidei Gade 1

DKk2300 København S

Webited: www.meldenbivirkning.dk

Ekmail: dkma@dkma.dk

4.9

Overdosering

Der kan opstå forstoppelse af tyndtarmen ved gentagen overdosering af medicinsk kul.

Dette kan undgå ved at indtage afføringsmiddel (f.eks. natriumsulfat).

4.3

Udlevering

5.

FARMAKOLOGISKE EGENSKABER

5.0

Terapeutisk klassifikation

Antidot, aktivt kul: ATC-kode: A 07 BA 01

5.1

Farmakodynamiske egenskaber

Farmakodynamisk gruppe: medicinsk kul.

ATC-kode: A07BA01.

Aktivt kul er et specielt carboniseret materiale baseret på plantestoffer og med en stor

indvendig overflade, som kan adsorbere skadelige, uønskede og sygdomsfremkaldende

stoffer i mavetarmkanalen. Ved forgiftning kan aktivt kul adsorbere de aktive stoffer fra

mavetarmkanalen.

Adsorbering i aktivt kul af et delvist optaget aktivt stof giver koncentrationsfald

mellem cirkulerende plasma og tarmindhold. Derfor kan passivt adsorberende stoffer på ny

diffundere i modsat retning mod tarmen. Herved kan gentagen indtagelse af aktivt kul også

være virksom efter indtagelse af et aktivt stof.

5.2

Farmakokinetiske egenskaber

Da aktivt kul ikke optages i mavetarmkanalen, opstår der ikke nogen distributionsfase eller

metabolisme.

Aktivt kul er et lokalt virkende middel, som efter oral indtagelse kan adsorbere opløste

aktive stoffer i mavetarmkanalen. Derfor skal det indtages så hurtigt som muligt i tilfælde

af indtagelse af giftstoffer eller medicinoverdosis.

For at modvirke desorption af adsorberende giftstoffer er det vigtigt, at det aktive kul

passerer hurtigst muligt gennem mavetarmkanalen, f.eks. ved at give et osmotisk laksantia

(natriumsulfat).

5.3

Prækliniske sikkerhedsdata

De prækliniske data viser ingen særlig fare for mennesker.

6.

FARMACEUTISKE OPLYSNINGER

6.1

Hjælpestoffer

Citronsyre-monohydrat, Glycerol, Acacia gummi

6.2

Uforligeligheder

Ikke relevant.

6.3

Opbevaringstid

5 år.

Færdig suspension: 3 dage.

6.4

Særlige opbevaringsforhold

Inden opblanding skal granulatet opbevares tørt.

Efter opblanding skal blandingen opbevares i køleskab (2

C - 8

6.5

Emballagetyper og pakningsstørrelser

HDPE-flaske (500 ml) med HDPE-skruelåg.

6.6

Regler for destruktion og anden håndtering

Ingen særlige krav.

7.

INDEHAVER Af MARKEDSFØRINGSTILLADELSEN

Abacus Medicine A/S

Vesterbrogade 149

1620 København V

8.

MARKEDSFØRINGSTILLADELSESNUMMER (NUMRE)

59879

9.

DATO FOR FØRSTE MARKEDSFØRINGSTILLADELSE

22. september 2017

10.

DATO FOR ÆNDRING AF TEKSTEN

  • Oplysningerne indlægssedlen for dette produkt er i øjeblikket ikke tilgængelig, kan du sende en anmodning til vores kundeservice, og vi vil give dig besked, så snart vi er i stand til at opnå det.

    Anmode informationsbrochure for offentligheden.



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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