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.

18-8-2018

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Torrent Pharmaceuticals Limited is voluntarily recalling 14 lots of Valsartan/Amlodipine/HCTZ tablets to the consumer level due to the detection of trace amounts of an unexpected impurity found in an active pharmaceutical ingredient (API) manufactured by Zhejiang Huahai Pharmaceuticals. The impurity detected in the API is N-nitrosodimethylamine (NDMA), which is a substance that occurs naturally in certain foods, drinking water, air pollution, and industrial processes, and has been classified as a probabl...

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Westminster Pharmaceuticals, LLC. Issues Voluntary Nationwide Recall of Levothyroxine and Liothyronine (Thyroid Tablets, USP) Due to Risk of Adulteration

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Westminster Pharmaceuticals, LLC is voluntarily recalling all lots, within expiry, of Levothyroxine and Liothyronine (Thyroid Tablets, USP) 15 mg, 30 mg, 60 mg, 90 mg, & 120 mg to the wholesale level. These products are being recalled as a precaution because they were manufactured using active pharmaceutical ingredients that were sourced prior to the FDA’s Import Alert of Sichuan Friendly Pharmaceutical Co., Ltd., which as a result of a 2017 inspection were found to have deficiencies with Current Good Ma...

FDA - U.S. Food and Drug Administration

9-8-2018

Camber Pharmaceuticals, Inc. Issues Voluntary Nationwide Recall of Valsartan Tablets, USP, 40mg, 80mg, 160mg and 320mg Due to The Detection of Trace Amounts of N-Nitrosodimethylamine (NDMA) Impurity, Found in an Active Pharmaceutical Ingredient (API)

Camber Pharmaceuticals, Inc. Issues Voluntary Nationwide Recall of Valsartan Tablets, USP, 40mg, 80mg, 160mg and 320mg Due to The Detection of Trace Amounts of N-Nitrosodimethylamine (NDMA) Impurity, Found in an Active Pharmaceutical Ingredient (API)

As a precautionary measure, Camber Pharmaceuticals, Inc. is voluntarily recalling all unexpired lots of Valsartan Tablets, USP, 40mg, 80mg, 160mg and 320mg to the hospital, retail and consumer level. This recall of multiple batches of Valsartan Tablets was prompted due to the detection of trace amounts of N-Nitrosodimethylamine (NDMA), a possible process impurity or contaminant in an active pharmaceutical ingredient, manufactured by Hetero Labs Limited, Unit – I (API manufacturer).

FDA - U.S. Food and Drug Administration

20-8-2018

News and press releases:  Update on medicines containing valsartan from Zhejiang Tianyu

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Company no longer authorised to manufacture valsartan active substance for EU medicines due to presence of NDMA

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18-8-2018

EU/3/16/1645 (Salzman Group Ltd)

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17-8-2018

EU/3/17/1870 (Pharma Gateway AB)

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Europe -DG Health and Food Safety

15-8-2018

Scientific guideline:  Draft guideline on quality of herbal medicinal products/traditional herbal medicinal products - Revision 3 , draft: consultation open

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15-8-2018

EU/3/18/1994 (Quality Regulatory Clinical Ireland Limited)

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15-8-2018

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Komboglyze (AstraZeneca AB)

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Ivabradine Zentiva (Zentiva, k.s.)

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Ivabradine Zentiva (Active substance: ivabradine) - Centralised - Yearly update - Commission Decision (2018)5558 of Wed, 15 Aug 2018

Europe -DG Health and Food Safety

15-8-2018

Scientific guideline:  Draft guideline on similar biological medicinal products containing recombinant granulocyte-colony stimulating factor (rG-CSF) - Revision 1, draft: consultation open

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14-8-2018

Nobivac LeuFel (Virbac)

Nobivac LeuFel (Virbac)

Nobivac LeuFel (Active substance: Feline leukaemia vaccine (inactivated)) - Centralised - 2-Monthly update - Commission Decision (2018)5535 of Tue, 14 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/V/C/4778/WS/1282/1

Europe -DG Health and Food Safety

14-8-2018

Leucofeligen FeLV/RCP (Virbac)

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Europe -DG Health and Food Safety

13-8-2018

EU/3/18/2045 (Dystrogen Therapeutics S.A.)

EU/3/18/2045 (Dystrogen Therapeutics S.A.)

EU/3/18/2045 (Active substance: Ex-vivo fused autologous human bone marrow-derived mesenchymal stem cell with allogenic human myoblast) - Orphan designation - Commission Decision (2018)5277 of Mon, 13 Aug 2018 European Medicines Agency (EMA) procedure number: EMA/OD/028/18

Europe -DG Health and Food Safety

10-8-2018

Torisel (Pfizer Europe MA EEIG)

Torisel (Pfizer Europe MA EEIG)

Torisel (Active substance: Temsirolimus) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)5521 of Fri, 10 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/799/T/71

Europe -DG Health and Food Safety

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Brinavess (Correvio)

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Lymphoseek (Norgine B.V.)

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Sivextro (Merck Sharp and Dohme B.V.)

Sivextro (Merck Sharp and Dohme B.V.)

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Europe -DG Health and Food Safety

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Cubicin (Merck Sharp and Dohme B.V.)

Cubicin (Merck Sharp and Dohme B.V.)

Cubicin (Active substance: Daptomycin) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)5519 of Fri, 10 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/637/T/69

Europe -DG Health and Food Safety

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Thalidomide Celgene (Celgene Europe B.V.)

Thalidomide Celgene (Celgene Europe B.V.)

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CANCIDAS (Merck Sharp and Dohme B.V.)

CANCIDAS (Merck Sharp and Dohme B.V.)

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10-8-2018

Tesavel (Merck Sharp and Dohme B.V.)

Tesavel (Merck Sharp and Dohme B.V.)

Tesavel (Active substance: sitagliptin) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)5518 of Fri, 10 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/910/T/65

Europe -DG Health and Food Safety

10-8-2018

Januvia (Merck Sharp and Dohme B.V.)

Januvia (Merck Sharp and Dohme B.V.)

Januvia (Active substance: sitagliptin) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)4511 of Fri, 10 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/722/T/65

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10-8-2018

Bortezomib Hospira (Pfizer Europe MA EEIG)

Bortezomib Hospira (Pfizer Europe MA EEIG)

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9-8-2018

Arava (Sanofi-Aventis Deutschland GmbH)

Arava (Sanofi-Aventis Deutschland GmbH)

Arava (Active substance: leflunomide) - Centralised - Yearly update - Commission Decision (2018)5231 of Thu, 09 Aug 2018

Europe -DG Health and Food Safety

8-8-2018

GONAL-f (Merck Europe B.V.)

GONAL-f (Merck Europe B.V.)

GONAL-f (Active substance: Follitropin alfa) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)5445 of Wed, 08 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/71/T/140

Europe -DG Health and Food Safety

7-8-2018

Inovelon (Eisai Limited)

Inovelon (Eisai Limited)

Inovelon (Active substance: Rufinamide) - Centralised - 2-Monthly update - Commission Decision (2018)5424 of Tue, 07 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/660/II/45

Europe -DG Health and Food Safety

7-8-2018

Tadalafil Mylan (Mylan S.A.S.)

Tadalafil Mylan (Mylan S.A.S.)

Tadalafil Mylan (Active substance: tadalafil) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)5422 of Tue, 07 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/3787/T/11

Europe -DG Health and Food Safety

7-8-2018

Cerenia (Zoetis Belgium S.A.)

Cerenia (Zoetis Belgium S.A.)

Cerenia (Active substance: Maropitant) - Centralised - Yearly update - Commission Decision (2018)5414 of Tue, 07 Aug 2018

Europe -DG Health and Food Safety

7-8-2018

Intanza (Sanofi Pasteur Europe)

Intanza (Sanofi Pasteur Europe)

Intanza (Active substance: Influenza Vaccine (split virion, inactivated)) - Centralised - Withdrawal - Commission Decision (2018)5426 of Tue, 07 Aug 2018

Europe -DG Health and Food Safety

7-8-2018

Novem (Boehringer Ingelheim Vetmedica GmbH)

Novem (Boehringer Ingelheim Vetmedica GmbH)

Novem (Active substance: Meloxicam) - Centralised - Yearly update - Commission Decision (2018)5413 of Tue, 07 Aug 2018

Europe -DG Health and Food Safety

7-8-2018

Vyndaqel (Pfizer Europe MA EEIG)

Vyndaqel (Pfizer Europe MA EEIG)

Vyndaqel (Active substance: tafamidis) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)5427 of Tue, 07 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2294/T/45

Europe -DG Health and Food Safety

7-8-2018

Crixivan (Merck Sharp and Dohme B.V.)

Crixivan (Merck Sharp and Dohme B.V.)

Crixivan (Active substance: Indinavir) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)5425 of Tue, 07 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/128/T/104

Europe -DG Health and Food Safety

7-8-2018

Inlyta (Pfizer Europe MA EEIG)

Inlyta (Pfizer Europe MA EEIG)

Inlyta (Active substance: Axitinib) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)5429 of Tue, 07 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2406/T/24

Europe -DG Health and Food Safety

7-8-2018

Accofil (Accord Healthcare Limited)

Accofil (Accord Healthcare Limited)

Accofil (Active substance: Filgrastim) - Centralised - Yearly update - Commission Decision (2018)5428 of Tue, 07 Aug 2018

Europe -DG Health and Food Safety

7-8-2018

Ribavirin Mylan (Mylan S.A.S.)

Ribavirin Mylan (Mylan S.A.S.)

Ribavirin Mylan (Active substance: Ribavirin ) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)5423 of Tue, 07 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/1185/T/29

Europe -DG Health and Food Safety

7-8-2018

EU/3/18/2049 (Inozyme Pharma Ireland Ltd)

EU/3/18/2049 (Inozyme Pharma Ireland Ltd)

EU/3/18/2049 (Active substance: Recombinant human ectonucleotide pyrophosphatase/phosphodiesterase 1 fused to the Fc fragment of IgG1) - Orphan designation - Commission Decision (2018)5281 of Tue, 07 Aug 2018 European Medicines Agency (EMA) procedure number: EMA/OD/053/18

Europe -DG Health and Food Safety

7-8-2018

EU/3/16/1756 (Kyowa Kirin Holdings B.V.)

EU/3/16/1756 (Kyowa Kirin Holdings B.V.)

EU/3/16/1756 (Active substance: Mogamulizumab) - Transfer of orphan designation - Commission Decision (2018)5404 of Tue, 07 Aug 2018 European Medicines Agency (EMA) procedure number: EMA/OD/091/16/T/01

Europe -DG Health and Food Safety

7-8-2018

EU/3/16/1694 (GlaxoSmithKline Trading Services Limited)

EU/3/16/1694 (GlaxoSmithKline Trading Services Limited)

EU/3/16/1694 (Active substance: Autologous CD4+ and CD8+ T-cells transduced with lentiviral vector containing an affinity-enhanced T-cell receptor targeting the New York esophageal antigen-1) - Transfer of orphan designation - Commission Decision (2018)5405 of Tue, 07 Aug 2018 European Medicines Agency (EMA) procedure number: EMA/OD/064/16/T/01

Europe -DG Health and Food Safety

7-8-2018

Memantine Accord (Accord Healthcare Limited)

Memantine Accord (Accord Healthcare Limited)

Memantine Accord (Active substance: memantine) - Centralised - Renewal - Commission Decision (2018)5421 of Tue, 07 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2766/R/10

Europe -DG Health and Food Safety

7-8-2018

EU/3/16/1683 (Worphmed Srl)

EU/3/16/1683 (Worphmed Srl)

EU/3/16/1683 (Active substance: Melatonin) - Transfer of orphan designation - Commission Decision (2018)5407 of Tue, 07 Aug 2018 European Medicines Agency (EMA) procedure number: EMA/OD/007/16/T/01

Europe -DG Health and Food Safety

7-8-2018

EU/3/16/1682 (Worphmed Srl)

EU/3/16/1682 (Worphmed Srl)

EU/3/16/1682 (Active substance: Melatonin) - Transfer of orphan designation - Commission Decision (2018)5406 of Tue, 07 Aug 2018 European Medicines Agency (EMA) procedure number: EMA/OD/001/16/T/01

Europe -DG Health and Food Safety

7-8-2018

LETIFEND (Laboratorios LETI, S.L.unipersonal)

LETIFEND (Laboratorios LETI, S.L.unipersonal)

LETIFEND (Active substance: Recombinant Protein Q from L. infantum MON-1) - Centralised - Yearly update - Commission Decision (2018)5415 of Tue, 07 Aug 2018

Europe -DG Health and Food Safety

7-8-2018

EU/3/18/1996 (Worphmed Srl)

EU/3/18/1996 (Worphmed Srl)

EU/3/18/1996 (Active substance: Melatonin) - Transfer of orphan designation - Commission Decision (2018)5409 of Tue, 07 Aug 2018 European Medicines Agency (EMA) procedure number: EMA/OD/227/17/T/01

Europe -DG Health and Food Safety

7-8-2018

EU/3/16/1755 (Worphmed Srl)

EU/3/16/1755 (Worphmed Srl)

EU/3/16/1755 (Active substance: Melatonin) - Transfer of orphan designation - Commission Decision (2018)5408 of Tue, 07 Aug 2018 European Medicines Agency (EMA) procedure number: EMA/OD/127/16/T/01

Europe -DG Health and Food Safety

7-8-2018

Onsior (Elanco Europe Ltd)

Onsior (Elanco Europe Ltd)

Onsior (Active substance: Robenacoxib) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)5416 of Tue, 07 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/V/C/127/T/19

Europe -DG Health and Food Safety

7-8-2018

Duloxetine Mylan (Generics [UK] Limited)

Duloxetine Mylan (Generics [UK] Limited)

Duloxetine Mylan (Active substance: Duloxetine) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)5417 of Tue, 07 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/3981/T/14

Europe -DG Health and Food Safety

7-8-2018

Numient (Impax Laboratories Ireland Limited)

Numient (Impax Laboratories Ireland Limited)

Numient (Active substance: levodopa / carbidopa) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)5418 of Tue, 07 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2611/T/5

Europe -DG Health and Food Safety

7-8-2018

Duaklir Genuair (AstraZeneca AB)

Duaklir Genuair (AstraZeneca AB)

Duaklir Genuair (Active substance: aclidinium bromide / formoterol fumarate dihydrate) - Centralised - Yearly update - Commission Decision (2018)5419 of Tue, 07 Aug 2018

Europe -DG Health and Food Safety

7-8-2018

Brimica Genuair (AstraZeneca AB)

Brimica Genuair (AstraZeneca AB)

Brimica Genuair (Active substance: aclidinium bromide / formoterol fumarate dihydrate) - Centralised - Yearly update - Commission Decision (2018)5420 of Tue, 07 Aug 2018

Europe -DG Health and Food Safety

6-8-2018

Kyntheum (Leo Pharma A/S)

Kyntheum (Leo Pharma A/S)

Kyntheum (Active substance: brodalumab) - Centralised - Yearly update - Commission Decision (2018)5383 of Mon, 06 Aug 2018

Europe -DG Health and Food Safety

6-8-2018

Siklos (Addmedica)

Siklos (Addmedica)

Siklos (Active substance: hydroxycarbamide) - Centralised - Yearly update - Commission Decision (2018)5382 of Mon, 06 Aug 2018

Europe -DG Health and Food Safety

6-8-2018

Insulin lispro Sanofi (Sanofi-Aventis groupe)

Insulin lispro Sanofi (Sanofi-Aventis groupe)

Insulin lispro Sanofi (Active substance: insulin lispro) - Centralised - Yearly update - Commission Decision (2018)5375 of Mon, 06 Aug 2018

Europe -DG Health and Food Safety

6-8-2018

Fampyra (Biogen Netherlands B.V.)

Fampyra (Biogen Netherlands B.V.)

Fampyra (Active substance: fampridine) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)5385 of Mon, 06 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2097/T/43

Europe -DG Health and Food Safety

6-8-2018

Rapamune (Pfizer Limited)

Rapamune (Pfizer Limited)

Rapamune (Active substance: sirolimus) - Centralised - 2-Monthly update - Commission Decision (2018)5384 of Mon, 06 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/273/II/164

Europe -DG Health and Food Safety

6-8-2018

DUAVIVE (Pfizer Europe MA EEIG)

DUAVIVE (Pfizer Europe MA EEIG)

DUAVIVE (Active substance: oestrogens conjugated / bazedoxifene) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)5379 of Mon, 06 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2314/T/18

Europe -DG Health and Food Safety

6-8-2018

Tepadina (ADIENNE S.r.l.)

Tepadina (ADIENNE S.r.l.)

Tepadina (Active substance: Thiotepa) - Centralised - Yearly update - Commission Decision (2018)5378 of Mon, 06 Aug 2018

Europe -DG Health and Food Safety

6-8-2018

Dexdor (Orion Corporation)

Dexdor (Orion Corporation)

Dexdor (Active substance: dexmedetomidine) - Centralised - 2-Monthly update - Commission Decision (2018)5377 of Mon, 06 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2268/II/26

Europe -DG Health and Food Safety

6-8-2018

Otezla (Celgene Europe B.V.)

Otezla (Celgene Europe B.V.)

Otezla (Active substance: apremilast) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)5391 of Mon, 06 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/3746/T/20

Europe -DG Health and Food Safety

6-8-2018

Conbriza (Pfizer Europe MA EEIG)

Conbriza (Pfizer Europe MA EEIG)

Conbriza (Active substance: bazedoxifene) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)5388 of Mon, 06 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/913/T/47

Europe -DG Health and Food Safety

6-8-2018

Tysabri (Biogen Netherlands B.V.)

Tysabri (Biogen Netherlands B.V.)

Tysabri (Active substance: Natalizumab) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)5390 of Mon, 06 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/603/T/110

Europe -DG Health and Food Safety

6-8-2018

Avonex (Biogen Netherlands B.V.)

Avonex (Biogen Netherlands B.V.)

Avonex (Active substance: Interferon Beta - 1a) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)5392 of Mon, 06 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/102/T/178

Europe -DG Health and Food Safety

6-8-2018

Temomedac (medac Gesellschaft fUr klinische SpezialprAparate mbH)

Temomedac (medac Gesellschaft fUr klinische SpezialprAparate mbH)

Temomedac (Active substance: temozolomide) - Centralised - Yearly update - Commission Decision (2018)5389 of Mon, 06 Aug 2018

Europe -DG Health and Food Safety