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.

17-4-2018

Epic Products, LLC, Issues Voluntary Nationwide Recall of All Lots of Euphoric Capsules Due to Presence of Undeclared Sildenafil and Tadalafil

Epic Products, LLC, Issues Voluntary Nationwide Recall of All Lots of Euphoric Capsules Due to Presence of Undeclared Sildenafil and Tadalafil

Overland Park, KS, Epic Products, LLC is voluntarily recalling all lots of Euphoric capsules, packaged in 1 count blister cards, 3 count bottles, and 12 count bottles to the consumer level. FDA analysis found samples of Euphoric to be tainted with undeclared sildenafil and tadalafil, active ingredients in two FDA-approved prescription drug products, also known as phosphodiesterase 5-inhibitors (PDE-5 inhibitors), used to treat male erectile dysfunction (ED). The presence of sildenafil and tadalafil in E...

FDA - U.S. Food and Drug Administration

16-4-2018

Women taking birth control pills reminded to return any packages for replacement if the pills are missing or look unusual

Women taking birth control pills reminded to return any packages for replacement if the pills are missing or look unusual

In light of continuing complaints of quality issues involving certain prescription birth control pills, Health Canada is reminding women to check their packages of birth control pills. If you notice anything unusual in the package, such as missing or damaged pills, you should return the package to the pharmacy for replacement as soon as possible. Skipping a dose because the pill is missing, or taking a damaged (for example, chipped or fragmented) pill, may increase the risk of pregnancy because less acti...

Health Canada

14-4-2018

'Rhino 69 Extreme 50000' Recalled due to Presence of Active Ingredient 'Tadalafil'

'Rhino 69 Extreme 50000' Recalled due to Presence of Active Ingredient 'Tadalafil'

AMA Wholesale Inc. (Distributor/Re-seller), is voluntarily recalling Rhino 69 Extreme 50000 capsules to the consumer level. FDA analysis found the product to be tainted with undeclared tadalafil. Tadalafil is an active ingredient in a FDA-approved prescription drug that is used for erectile dysfunction.

FDA - U.S. Food and Drug Administration

10-7-2018

Raloxifene Teva (Teva B.V.)

Raloxifene Teva (Teva B.V.)

Raloxifene Teva (Active substance: Raloxifene hydrochloride) - Centralised - Yearly update - Commission Decision (2017)4939 of Tue, 10 Jul 2018

Europe -DG Health and Food Safety

23-4-2018

Volibris (Glaxo Group Ltd)

Volibris (Glaxo Group Ltd)

Volibris (Active substance: Ambrisentan) - Centralised - Yearly update - Commission Decision (2018)2514 of Mon, 23 Apr 2018

Europe -DG Health and Food Safety

23-4-2018

Sutent (Pfizer Limited)

Sutent (Pfizer Limited)

Sutent (Active substance: sunitinib) - Centralised - Yearly update - Commission Decision (2018)2512 of Mon, 23 Apr 2018

Europe -DG Health and Food Safety

23-4-2018

Deltyba (Otsuka Novel Products GmbH)

Deltyba (Otsuka Novel Products GmbH)

Deltyba (Active substance: delamanid) - Centralised - Annual renewal - Commission Decision (2018)2492 of Mon, 23 Apr 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2552/R/27

Europe -DG Health and Food Safety

23-4-2018

Xadago (Zambon S.p.A.)

Xadago (Zambon S.p.A.)

Xadago (Active substance: safinamide) - Centralised - Yearly update - Commission Decision (2018)2513 of Mon, 23 Apr 2018

Europe -DG Health and Food Safety

18-4-2018

EU/3/18/2007 (Dr Philippe Moullier)

EU/3/18/2007 (Dr Philippe Moullier)

EU/3/18/2007 (Active substance: Adeno-associated viral vector serotype 8 containing the human acid alpha-glucosidase gene) - Orphan designation - Commission Decision (2018)2403 of Wed, 18 Apr 2018 European Medicines Agency (EMA) procedure number: EMA/OD/255/17

Europe -DG Health and Food Safety

18-4-2018

EU/3/18/2013 (Roche Registration Limited)

EU/3/18/2013 (Roche Registration Limited)

EU/3/18/2013 (Active substance: Polatuzumab vedotin) - Orphan designation - Commission Decision (2018)2409 of Wed, 18 Apr 2018 European Medicines Agency (EMA) procedure number: EMA/OD/231/17

Europe -DG Health and Food Safety

18-4-2018

EU/3/18/2012 (IDEA Innovative Drug European Associates Limited)

EU/3/18/2012 (IDEA Innovative Drug European Associates Limited)

EU/3/18/2012 (Active substance: Genetically modified replication-incompetent herpes simplex virus-1 expressing collagen VII) - Orphan designation - Commission Decision (2018)2408 of Wed, 18 Apr 2018 European Medicines Agency (EMA) procedure number: EMA/OD/244/17

Europe -DG Health and Food Safety

18-4-2018

EU/3/18/2011 (Ultragenyx Germany GmbH)

EU/3/18/2011 (Ultragenyx Germany GmbH)

EU/3/18/2011 (Active substance: Burosumab) - Orphan designation - Commission Decision (2018)2407 of Wed, 18 Apr 2018 European Medicines Agency (EMA) procedure number: EMA/OD/026/17

Europe -DG Health and Food Safety

18-4-2018

EU/3/18/2010 (Novartis Europharm Limited)

EU/3/18/2010 (Novartis Europharm Limited)

EU/3/18/2010 (Active substance: Branaplam) - Orphan designation - Commission Decision (2018)2406 of Wed, 18 Apr 2018 European Medicines Agency (EMA) procedure number: EMA/OD/249/17

Europe -DG Health and Food Safety

18-4-2018

EU/3/18/2009 (SOTIO a.s)

EU/3/18/2009 (SOTIO a.s)

EU/3/18/2009 (Active substance: Autologous dendritic cells pulsed with killed ovarian cancer cells and matured by TLR3 ligand ex vivo) - Orphan designation - Commission Decision (2018)2405 of Wed, 18 Apr 2018 European Medicines Agency (EMA) procedure number: EMA/OD/246/17

Europe -DG Health and Food Safety

18-4-2018

EU/3/18/2008 (StolmAr and Partner PatentanwAlte PartG mbB)

EU/3/18/2008 (StolmAr and Partner PatentanwAlte PartG mbB)

EU/3/18/2008 (Active substance: Adeno-associated viral vector serotype 9 encoding miRNA against human superoxide dismutase 1) - Orphan designation - Commission Decision (2018)2404 of Wed, 18 Apr 2018 European Medicines Agency (EMA) procedure number: EMA/OD/254/17

Europe -DG Health and Food Safety

18-4-2018

Melatonin (haemorrhage) (Therapicon Srl)

Melatonin (haemorrhage) (Therapicon Srl)

Melatonin (haemorrhage) (Active substance: Melatonin) - Refusal of orphan designation - Commission Decision (2018)2410 of Wed, 18 Apr 2018 European Medicines Agency (EMA) procedure number: EMA/OD/127/17

Europe -DG Health and Food Safety

18-4-2018

Equilis West Nile (Intervet International B.V.)

Equilis West Nile (Intervet International B.V.)

Equilis West Nile (Active substance: Inactivated chimeric flavivirus strain YF-WN) - Centralised - Renewal - Commission Decision (2018)2390 of Wed, 18 Apr 2018 European Medicines Agency (EMA) procedure number: EMEA/V/2241/R/5

Europe -DG Health and Food Safety

18-4-2018

BTVPUR (Merial)

BTVPUR (Merial)

BTVPUR (Active substance: Bluetongue disease virus vaccine (containing either serotypes 1, 4 or 8) (inactivated)) - Centralised - Yearly update - Commission Decision (2018)2391 of Wed, 18 Apr 2018

Europe -DG Health and Food Safety

17-4-2018

Sialanar (Proveca Limited)

Sialanar (Proveca Limited)

Sialanar (Active substance: glycopyrronium bromide) - Centralised - Yearly update - Commission Decision (2018)2340 of Tue, 17 Apr 2018

Europe -DG Health and Food Safety

17-4-2018

EU/3/11/945 (Mallinckrodt Pharmaceuticals Ireland Limited)

EU/3/11/945 (Mallinckrodt Pharmaceuticals Ireland Limited)

EU/3/11/945 (Active substance: Ornithine phenylacetate) - Transfer of orphan designation - Commission Decision (2018)2355 of Tue, 17 Apr 2018 European Medicines Agency (EMA) procedure number: EMA/OD/105/11/T/03

Europe -DG Health and Food Safety

17-4-2018

PritorPlus (Bayer AG)

PritorPlus (Bayer AG)

PritorPlus (Active substance: Telmisartan / hydrochlorothiazide) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)2342 of Tue, 17 Apr 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/414/T/115

Europe -DG Health and Food Safety

17-4-2018

Pritor (Bayer AG)

Pritor (Bayer AG)

Pritor (Active substance: telmisartan) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)2344 of Tue, 17 Apr 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/210/T/124

Europe -DG Health and Food Safety

17-4-2018

Autologous skeletal myoblasts expanded ex vivo (Assistance Publique - Hopitaux de Paris (APHP))

Autologous skeletal myoblasts expanded ex vivo (Assistance Publique - Hopitaux de Paris (APHP))

Autologous skeletal myoblasts expanded ex vivo (Active substance: Autologous skeletal myoblasts expanded ex vivo) - Refusal of orphan designation - Commission Decision (2018)2354 of Tue, 17 Apr 2018 European Medicines Agency (EMA) procedure number: EMA/OD/144/17

Europe -DG Health and Food Safety

17-4-2018

Clevor (Orion Corporation)

Clevor (Orion Corporation)

Clevor (Active substance: Ropinirole) - Centralised - Authorisation - Commission Decision (2018)2338 of Tue, 17 Apr 2018 European Medicines Agency (EMA) procedure number: EMEA/V/C/4417

Europe -DG Health and Food Safety

17-4-2018

Bretaris Genuair (AstraZeneca AB)

Bretaris Genuair (AstraZeneca AB)

Bretaris Genuair (Active substance: aclidinium bromide) - Centralised - Yearly update - Commission Decision (2018)2345 of Tue, 17 Apr 2018

Europe -DG Health and Food Safety

17-4-2018

Alpivab (BioCryst UK Ltd.)

Alpivab (BioCryst UK Ltd.)

Alpivab (Active substance: peramivir) - New authorisation - Commission Decision (2018)2370 of Tue, 17 Apr 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4299

Europe -DG Health and Food Safety

17-4-2018

Eklira Genuair (AstraZeneca AB)

Eklira Genuair (AstraZeneca AB)

Eklira Genuair (Active substance: aclidinium bromide) - Centralised - Yearly update - Commission Decision (2018)2347 of Tue, 17 Apr 2018

Europe -DG Health and Food Safety

17-4-2018

Equip WNV (Zoetis Belgium S.A.)

Equip WNV (Zoetis Belgium S.A.)

Equip WNV (Active substance: West Nile fever vaccine (inactivated recombinant)) - Centralised - Yearly update - Commission Decision (2018)2339 of Tue, 17 Apr 2018

Europe -DG Health and Food Safety

17-4-2018

Memantine ratiopharm (ratiopharm GmbH)

Memantine ratiopharm (ratiopharm GmbH)

Memantine ratiopharm (Active substance: memantine) - Centralised - Renewal - Commission Decision (2018)2369 of Tue, 17 Apr 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2671/R/11

Europe -DG Health and Food Safety

16-4-2018

Kinzalkomb (Bayer AG)

Kinzalkomb (Bayer AG)

Kinzalkomb (Active substance: Telmisartan / hydrochlorothiazide) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)2294 of Mon, 16 Apr 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/415/T/105

Europe -DG Health and Food Safety

16-4-2018

Lumigan (Allergan Pharmaceuticals Ireland)

Lumigan (Allergan Pharmaceuticals Ireland)

Lumigan (Active substance: Bimatoprost) - Centralised - Yearly update - Commission Decision (2018)2300 of Mon, 16 Apr 2018

Europe -DG Health and Food Safety

16-4-2018

Ravicti (Horizon Pharma Ireland Limited)

Ravicti (Horizon Pharma Ireland Limited)

Ravicti (Active substance: Glycerol phenylbutyrate) - Centralised - Yearly update - Commission Decision (2018)2302 of Mon, 16 Apr 2018

Europe -DG Health and Food Safety

16-4-2018

Actrapid (Novo Nordisk A/S)

Actrapid (Novo Nordisk A/S)

Actrapid (Active substance: Insulin human (rDNA)) - Centralised - Yearly update - Commission Decision (2018)2301 of Mon, 16 Apr 2018

Europe -DG Health and Food Safety

16-4-2018

Vidaza (Celgene Europe Limited)

Vidaza (Celgene Europe Limited)

Vidaza (Active substance: Azacitidine) - Centralised - Yearly update - Commission Decision (2018)2305 of Mon, 16 Apr 2018

Europe -DG Health and Food Safety

16-4-2018

Signifor (Novartis Europharm Limited)

Signifor (Novartis Europharm Limited)

Signifor (Active substance: pasireotide) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)2304 of Mon, 16 Apr 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2052/T/37

Europe -DG Health and Food Safety

16-4-2018

Sebivo (Novartis Europharm Limited)

Sebivo (Novartis Europharm Limited)

Sebivo (Active substance: telbivudine) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)2317 of Mon, 16 Apr 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/713/T/50

Europe -DG Health and Food Safety

16-4-2018

Farydak (Novartis Europharm Limited)

Farydak (Novartis Europharm Limited)

Farydak (Active substance: panobinostat) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)2322 of Mon, 16 Apr 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/3725/T/11

Europe -DG Health and Food Safety

16-4-2018

Extavia (Novartis Europharm Limited)

Extavia (Novartis Europharm Limited)

Extavia (Active substance: Interferon beta-1b) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)2321 of Mon, 16 Apr 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/933/T/90

Europe -DG Health and Food Safety

16-4-2018

Galafold (Amicus Therapeutics UK Ltd)

Galafold (Amicus Therapeutics UK Ltd)

Galafold (Active substance: migalastat) - Centralised - Yearly update - Commission Decision (2018)2318 of Mon, 16 Apr 2018

Europe -DG Health and Food Safety

13-4-2018

Zulvac 8 Ovis (Zoetis Belgium S.A.)

Zulvac 8 Ovis (Zoetis Belgium S.A.)

Zulvac 8 Ovis (Active substance: Inactivated bluetongue virus, serotype 8, strain BTV-8/BEL2006/02 RP* = 1) - Centralised - Yearly update - Commission Decision (2018)2244 of Fri, 13 Apr 2018

Europe -DG Health and Food Safety

10-4-2018

Kineret (Swedish Orphan Biovitrum AB (publ))

Kineret (Swedish Orphan Biovitrum AB (publ))

Kineret (Active substance: Anakinra) - Centralised - 2-Monthly update - Commission Decision (2018)2188 of Tue, 10 Apr 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/363/II/56

Europe -DG Health and Food Safety

10-4-2018

Tamiflu (Roche Registration GmbH)

Tamiflu (Roche Registration GmbH)

Tamiflu (Active substance: Oseltamivir) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)2185 of Tue, 10 Apr 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/402/T/131

Europe -DG Health and Food Safety

10-4-2018

Zelboraf (Roche Registration GmbH)

Zelboraf (Roche Registration GmbH)

Zelboraf (Active substance: vemurafenib) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)2184 of Tue, 10 Apr 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2409/T/47

Europe -DG Health and Food Safety

10-4-2018

Stronghold Plus (Zoetis Belgium S.A.)

Stronghold Plus (Zoetis Belgium S.A.)

Stronghold Plus (Active substance: selamectin / sarolaner) - Centralised - Yearly update - Commission Decision (2018)2164 of Tue, 10 Apr 2018

Europe -DG Health and Food Safety

10-4-2018

Tarceva (Roche Registration GmbH)

Tarceva (Roche Registration GmbH)

Tarceva (Active substance: Erlotinib) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)2186 of Tue, 10 Apr 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/618/T/57

Europe -DG Health and Food Safety

10-4-2018

Apoquel (Zoetis Belgium S.A.)

Apoquel (Zoetis Belgium S.A.)

Apoquel (Active substance: Oclacitinib maleate) - Centralised - Yearly update - Commission Decision (2018)2165 of Tue, 10 Apr 2018

Europe -DG Health and Food Safety

10-4-2018

Fuzeon (Roche Registration GmbH)

Fuzeon (Roche Registration GmbH)

Fuzeon (Active substance: Enfuvirtide) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)2181 of Tue, 10 Apr 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/514/T/50

Europe -DG Health and Food Safety

10-4-2018

Herceptin (Roche Registration GmbH)

Herceptin (Roche Registration GmbH)

Herceptin (Active substance: trastuzumab) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)2180 of Tue, 10 Apr 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/278/T/142

Europe -DG Health and Food Safety

10-4-2018

RoActemra (Roche Registration GmbH)

RoActemra (Roche Registration GmbH)

RoActemra (Active substance: tocilizumab) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)2179 of Tue, 10 Apr 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/955/T/75

Europe -DG Health and Food Safety

10-4-2018

Gazyvaro (Roche Registration GmbH)

Gazyvaro (Roche Registration GmbH)

Gazyvaro (Active substance: obinutuzumab) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)2178 of Tue, 10 Apr 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2799/T/24

Europe -DG Health and Food Safety

10-4-2018

Revolade (Novartis Europharm Limited)

Revolade (Novartis Europharm Limited)

Revolade (Active substance: Eltrombopag) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)2182 of Tue, 10 Apr 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/1110/T/47

Europe -DG Health and Food Safety

6-4-2018

Bonviva (Atnahs Pharma UK Limited)

Bonviva (Atnahs Pharma UK Limited)

Bonviva (Active substance: Ibandronic acid) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)2137 of Fri, 06 Apr 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/501/T/64

Europe -DG Health and Food Safety

6-4-2018

Kinzalmono (Bayer AG)

Kinzalmono (Bayer AG)

Kinzalmono (Active substance: telmisartan) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)2138 of Fri, 06 Apr 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/211/T/111

Europe -DG Health and Food Safety

6-4-2018

Marixino (KRKA, d.d., Novo mesto)

Marixino (KRKA, d.d., Novo mesto)

Marixino (Active substance: Memantine) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)2136 of Fri, 06 Apr 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2658/T/13

Europe -DG Health and Food Safety

6-4-2018

Convenia (Zoetis Belgium S.A.)

Convenia (Zoetis Belgium S.A.)

Convenia (Active substance: Cefovecin) - Centralised - Yearly update - Commission Decision (2018)2126 of Fri, 06 Apr 2018

Europe -DG Health and Food Safety

6-4-2018

Zulvac 1 Bovis (Zoetis Belgium S.A.)

Zulvac 1 Bovis (Zoetis Belgium S.A.)

Zulvac 1 Bovis (Active substance: Inactivated Bluetongue Virus, serotype 1, strain BTV-1/ALG2006/01 E1 RP = 1) - Centralised - Yearly update - Commission Decision (2018)2127 of Fri, 06 Apr 2018

Europe -DG Health and Food Safety

6-4-2018

Zulvac 1 Ovis (Zoetis Belgium S.A.)

Zulvac 1 Ovis (Zoetis Belgium S.A.)

Zulvac 1 Ovis (Active substance: Inactivated Bluetongue Virus, serotype 1, strain BTV-1/ALG2006/01 E1 RP = 1) - Centralised - Yearly update - Commission Decision (2018)2128 of Fri, 06 Apr 2018

Europe -DG Health and Food Safety

6-4-2018

Zulvac 8 Bovis (Zoetis Belgium S.A.)

Zulvac 8 Bovis (Zoetis Belgium S.A.)

Zulvac 8 Bovis (Active substance: Inactivated bluetongue virus, serotype 8, strain BTV-8/BEL2006/02 RP* = 1) - Centralised - Yearly update - Commission Decision (2018)2129 of Fri, 06 Apr 2018

Europe -DG Health and Food Safety

6-4-2018

Stronghold (Zoetis Belgium S.A.)

Stronghold (Zoetis Belgium S.A.)

Stronghold (Active substance: Selamectin) - Centralised - Yearly update - Commission Decision (2018)2125 of Fri, 06 Apr 2018

Europe -DG Health and Food Safety

6-4-2018

Bondronat (Atnahs Pharma UK Limited)

Bondronat (Atnahs Pharma UK Limited)

Bondronat (Active substance: Ibandronic acid) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)2135 of Fri, 06 Apr 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/101/T/79

Europe -DG Health and Food Safety

6-4-2018

Esbriet (Roche Registration GmbH)

Esbriet (Roche Registration GmbH)

Esbriet (Active substance: Pirfenidone) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)2132 of Fri, 06 Apr 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2154/T/52

Europe -DG Health and Food Safety

6-4-2018

EU/3/12/1072 (Le4D Limited)

EU/3/12/1072 (Le4D Limited)

EU/3/12/1072 (Active substance: Encapsulated human retinal pigment epithelial cell line transfected with plasmid vector expressing human ciliary neurotrophic factor) - Transfer of orphan designation - Commission Decision (2018)2008 of Fri, 06 Apr 2018 European Medicines Agency (EMA) procedure number: EMA/OD/160/11/T/01

Europe -DG Health and Food Safety

3-4-2018

EU/3/12/1080 (AbbVie Deutschland GmbH and Co. KG)

EU/3/12/1080 (AbbVie Deutschland GmbH and Co. KG)

EU/3/12/1080 (Active substance: 4-(4-{[2-(4-chlorophenyl)-4,4-dimethylcyclohex-1-en-1-yl]methyl}piperazin-1-yl)-N-({3-nitro-4-[(tetrahydro-2H-pyran-4-ylmethyl)amino]phenyl}sulfonyl)-2-(1H-pyrrolo[2,3-b]pyridin-5-yloxy)benzamide) - Transfer of orphan designation - Commission Decision (2018)2056 of Tue, 03 Apr 2018 European Medicines Agency (EMA) procedure number: EMA/OD/124/12/T/01

Europe -DG Health and Food Safety