Carbomix

Glavne informacije

  • Zaščiteno ime:
  • Carbomix 50 g zrnca za peroralno suspenzijo
  • Farmacevtska oblika:
  • peroralna suspenzija
  • Sestava:
  • aktivno oglje 50 g / 1 vsebnik
  • Pot uporabe:
  • Peroralna uporaba
  • Enote v paketu:
  • plastenka s 50 g zrnc
  • Tip zastaranja:
  • BRp - Izdaja zdravila je brez recepta v lekarnah.
  • Uporabi za:
  • ljudje
  • Vrsta medicine:
  • Alopatska drog

Dokumentov

Lokalizacija

  • Na voljo v:
  • Carbomix 50 g zrnca za peroralno suspenzijo
    Slovenija
  • Jezik:
  • slovenščina

Terapevtski podatki

  • Terapevtska skupina:
  • aktivno oglje

Drugi podatki

Stanje

  • Source:
  • JAZMP - Javna agencija RS za zdravila in medicinske pripomočke - Slovenia Medicines Agency
  • Status dovoljenje:
  • Zdravilo z dovoljenjem za promet
  • Številka dovoljenja:
  • 5363-I-1781/12
  • Datum dovoljenje:
  • 06-09-2012
  • EAN koda:
  • 3837000136852
  • Zadnja posodobitev:
  • 26-05-2018

Podatki za bolnike

JAZMP-IA/013G-28.01.2014

NAVODILO ZA UPORABO

Carbomix 50 g zrnca za peroralno suspenzijo

Aktivno oglje

Pred začetkom uporabe zdravila natančno preberite navodilo, ker vsebuje za vas pomembne

podatke!

Zdravilo je na voljo brez recepta. Kljub temu morate zdravilo Carbomix uporabljati pazljivo in skrbno,

da vam bo kar najbolje koristilo.

- Navodilo shranite. Morda ga boste želeli ponovno prebrati.

Posvetujte se s farmacevtom, če potrebujete dodatne informacije ali nasvet.

V primeru akutne peroralne zastrupitve ali prekomernega odmerjanja zdravila nemudoma

obvestite zdravnika ali center za zastrupitve. Po posvetovanju suspenzijo zdravila Carbomix

uporabimo nemudoma.

Če kateri koli neželeni učinek postane resen ali če opazite kateri koli neželeni učinek, ki ni

omenjen v tem navodilu, obvestite svojega zdravnika ali farmacevta.

Kaj vsebuje navodilo:

1.

Kaj je zdravilo Carbomix in za kaj ga uporabljamo

2.

Kaj morate vedeti, preden boste uporabili zdravilo Carbomix

3.

Kako uporabljati zdravilo Carbomix

4.

Možni neželeni učinki

5.

Shranjevanje zdravila Carbomix

6.

Vsebina pakiranja in dodatne informacije

1. Kaj je zdravilo Carbomix in za kaj ga uporabljamo

Zdravilna učinkovina v zdravilu Carbomix, aktivno oglje, lahko veže (absorbira) škodljive ali neželene

snovi v prebavilih.

Zdravilo Carbomix uporabljamo v primeru nenadne zastrupitve z zaužitjem strupa in ob

čezmernem odmerku zdravil.

2. Kaj morate vedeti, preden boste uporabili zdravilo Carbomix

Ne uporabljajte zdravila Carbomix:

alergični

(preobčutljivi)

aktivno

oglje

katero

koli

sestavino

zdravila

Carbomix.

Če je ugotovljeno, da so zastrupitev povzročile jedke

snovi

(močne

kisline,

kot je

klorovodikova kislina, ali baze, kot je čistilo za odtoke). V teh primerih lahko moti pregled

požiralnika (ezofagoskopijo) ali pregled želodca (gastroskopijo).

Bodite posebno pozorni pri uporabi zdravila Carbomix

V primeru akutne peroralne zastrupitve ali čezmernega odmerka zdravila nemudoma obvestite

zdravnika ali center za zastrupitve. Zdravilo Carbomix je treba uporabiti takoj in v skladu s

prejetimi navodili.

JAZMP-IA/013G-28.01.2014

Zdravilo Carbomix se lahko uporablja pri več vrstah zastrupitev. Vendar ne adsorbira dobro

številnih spojin in topil, kot so železove spojine, litij, talij, cianid, metiliran alkohol (metanol),

alkohol (etanol), antifriz (etilenglikol) in topila, ki vsebujejo petrolej. V primeru zastrupitev s

temi snovmi je treba uporabiti druge metode odstranjevanja strupa (npr. izpiranje želodca).

Glavni strupi, za katere obstaja specifičen protistrup, so navedeni spodaj:

Specifičen protistrup:

cianid

natrijev nitrit/4-dimetilaminofenol

železove spojine

deferoksamin

litij

kalcijev polistirensulfat

metanol / metiliran alkohol

alkohol (etanol)

etilenglikol / antifriz

alkohol (etanol)

Pri številnih zastrupitvah je treba uporabiti zdravilo Carbomix in specifični protistrup (npr.

zastrupitev s paracetamolom: Carbomix in acetilcistein).

Uporaba zdravila

Carbomix lahko povzroči črno obarvanje blata.

Uporaba drugih zdravil

V primeru, da jemljete ali ste nedavno vzeli katero drugo zdravilo, vključno z zdravili brez

recepta, o tem obvestite svojega zdravnika ali farmacevta.

Uporaba aktivnega oglja zaradi svojega mehanizma delovanja na splošno zmanjša učinek

peroralno uporabljenih zdravil. Učinek furosemida (diuretika) je v primeru hkratne uporabe z

aktivnim ogljem bistveno zmanjšan.

Hkratna uporaba aktivnega oglja in peroralnih kontraceptivov (tabletk) lahko zmanjša

učinkovitost peroralnih kontraceptivov. V tem primeru svetujemo dodatno kontracepcijo. V

primeru, da jemljete zdravila za zmanjšanje črevesnega gibanja, uporaba Carbomixa ni

priporočljiva.

Nosečnost in dojenje

Po dosedaj znanih podatkih se lahko zdravilo Carbomix v skladu z navodili med nosečnostjo

in dojenjem uporablja brez kakršne koli nevarnosti za plod oz. otroka. Preden vzamete katero

koli zdravilo, se posvetujte s svojim zdravnikom ali farmacevtom.

Vpliv na sposobnost upravljanja vozil in strojev

Uporaba aktivnega oglja ne vpliva na sposobnost vožnje in upravljanja s stroji.

3. Kako uporabljati zdravilo Carbomix

Odmerjanje in način uporabe

Odrasli bolniki in mladostniki, starejši od 12 let:

V primeru akutne zastrupitve ali prevelikega odmerjanja je treba čim prej dati 1 do 2 plastenki

zdravila Carbomix (tj. 50 – 100 g aktivnega oglja). V primeru hude zastrupitve je treba po prvem

zdravljenju

več dni

zapored

dati

odmerek

20 g zdravila

Carbomix

vsakih

4 do 6 ur

(20 g

aktivnega oglja je v približno 160 ml suspenzije). V primeru ponovnega dajanja plastenko znova

dobro pretresite pred uporabo. Bolnik mora suspenzijo vzeti oz. prejeti peroralno (= skozi usta).

Otroci, stari od 4 do 12 let:

V primeru akutne zastrupitve in prevelikega odmerjanja pri otrocih, mlajših od 12 let, je treba

uporabiti ½ plastenke peroralno.

Otroci, mlajši od 4 let:

JAZMP-IA/013G-28.01.2014

Pri otrocih, mlajših od 4 let, naj bo prvi odmerek ¼ plastenke. Odmerek ponavljamo toliko časa,

kolikor svetuje zdravnik.

Zdravila Carbomix ne uporabljajte peroralno, če ga bolnik ne more (ni pri zadostni zavesti) varno

popiti. Pri nezavestnem bolniku zdravnik ali medicinska sestra pod nadzorom uvedeta suspenzijo

skozi gastrično cevko.

Zdravilo Carbomix je treba dati hitro, da čimbolj preprečimo absorpcijo strupov v telo in

odstranimo že absorbirani strup. Vendar je lahko počasno dajanje včasih tudi koristno.

V primeru hude zastrupitve je priporočljivo večkratno dajanje aktivnega oglja.

Zdravilo Carbomix se lahko daje po bruhanju ali izpiranju želodca.

Priprava suspenzije:

Plastenko dobro pretresite, da pred odprtjem razrahljate zrnca. Odprite plastenko in zrncem

previdno dodajte vodo do rdeče oznake na plastenki. Plastenko zaprite in jo močno stresajte 1

minuto, da se zrnca ne držijo več skupaj. Zelo previdno odprite plastenko in suspenzijo

nemudoma porabite. V primeru večkratne uporabe pred uporabo steklenico spet dobro pretresite.

Plastenka ima poseben pokrovček, ki ga lahko uporabite kot nastavek za hitro in neposredno

namestitev na gastrično cevko. Nežno odvijte pokrovček, da sprostite nadtlak v plastenki,

zaprite plastenko in odrežite vrh nastavka, nato pa nanj namestite gastrično cevko.

Če opazite, da je učinek zdravila Carbomix prevelik ali premajhen, se posvetujte z zdravnikom

ali s farmacevtom.

Če ste vzeli večji odmerek zdravila Carbomix, kot bi smeli

Če ste vzeli večji odmerek zdravila Carbomix, kot bi smeli, nemudoma obvestite zdravnika ali

farmacevta. Pri uporabi več prevelikih odmerkov aktivnega oglja se lahko pojavijo bolečine v

trebuhu in resna obstrukcija črevesja.

Če ste pozabili vzeti zdravilo Carbomix

Če ste pozabili vzeti odmerek, vzemite pozabljeni odmerek čim prej. Če pa je skoraj že čas za

naslednji odmerek, pozabljeni odmerek izpustite in nadaljujte z običajnim urnikom odmerkov.

Ne vzemite dvojnega odmerka zdravila Carbomix, če ste pozabili vzeti prejšnjega. Če ste

negotovi, se posvetujte z zdravnikom ali farmacevtom.

4. Možni neželeni učinki

Kot vsa zdravila lahko tudi zdravilo Carbomix povzroči neželene učinke, ki pa se ne pojavijo

pri vseh bolnikih. Pogosteje so poročali o naslednjih neželenih učinkih: bruhanje, zaprtje,

nelagodje v trebuhu, driska, slabost, nenadno tiščanje na blato, analno draženje.

V posameznih primerih so poročali o obstrukciji črevesja, kjer je bila potrebna operacija, in

trdi masi ogljevega fecesa (sterkolit) s perforacijo črevesa. V vseh primerih so bolniki prejeli

več velikih odmerkov aktivnega oglja.

V primeru, da je kateri koli od stranskih učinkov resen, ali če opazite kateri koli stranski

učinek, ki ni naveden v teh navodilih, o tem obvestite svojega zdravnika ali farmacevta.

5. Shranjevanje zdravila Carbomix

Zdravilo shranjujte nedosegljivo otrokom!

JAZMP-IA/013G-28.01.2014

Shranjujte ga v originalni ovojnini, da ga zaščitite pred vlago. Za shranjevanje zdravila ni

posebnih temperaturnih omejitev. Zdravila Carbomix ne smete uporabljati po datumu izteka

roka uporabnosti, ki je naveden na ovojnini.

Pripravljeno suspenzijo morate shranjevati pri temperaturi 2 °C – 8 °C (v hladilniku) največ

3 dni po pripravi.

6. Vsebina pakiranja in dodatne informacije

Kaj vsebuje zdravilo Carbomix

Zdravilna

učinkovina

zdravilu

Carbomix

aktivno

oglje

rastlinskega

izvora

(„carbo

activatus“). Pomožne snovi so citronska kislina monohidrat (E330), glicerol (E422) in arabski

gumi (E414).

Izgled zdravila Carbomix in vsebina pakiranja

Zrnca z aktivnim ogljem, ki so črna do temnosiva, so pakirana v plastenki s pokrovčkom

z navojem. Plastenka z 61,5 g zrnc vsebuje 50 g aktivnega oglja.

Način in režim izdaje zdravila Carbomix

BRp-Izdaja zdravila je brez recepta v lekarnah.

Imetnik dovoljenja za promet z zdravilom in izdelovalec

Imetnik dovoljenja za promet z zdravilom:

Cabot Norit Nederland B.V., Nijverheidsweg-

Noord 72, 3812 PM Amersfoort,

Nizozemska

Izdelovalec

:

Cabot Norit Nederland B.V., Nijverheidsweg-Noord 72, 3812 PM Amersfoort,

Nizozemska

Zdravilo

je

v

državah

članicah

EGP

pridobilo

dovoljenje

za

promet

z

zdravilom

z naslednjimi imeni:

Avstrija

Norit Carbomix®

Danska

Norit Carbomix®

Italija

Carbomix®

Latvija

Norit Carbomix®

Nemčija

Ultracarbon®

Nizozemska

Norit Carbomix®

Portugalska

Norit Carbomix®

Slovenija

Carbomix®

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16-11-2018

Daptomycin Hospira (Hospira UK Limited)

Daptomycin Hospira (Hospira UK Limited)

Daptomycin Hospira (Active substance: daptomycin) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)7678 of Fri, 16 Nov 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/004310/T/0008

Europe -DG Health and Food Safety

14-11-2018

Jinarc (Otsuka Pharmaceutical Netherlands B.V.)

Jinarc (Otsuka Pharmaceutical Netherlands B.V.)

Jinarc (Active substance: tolvaptan) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)7604 of Wed, 14 Nov 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2788/T/20

Europe -DG Health and Food Safety

14-11-2018

Clopidogrel ratiopharm (Teva B.V.)

Clopidogrel ratiopharm (Teva B.V.)

Clopidogrel ratiopharm (Active substance: clopidogrel) - Centralised - Yearly update - Commission Decision (2018)7602 of Wed, 14 Nov 2018

Europe -DG Health and Food Safety

14-11-2018

Desloratadine ratiopharm (ratiopharm GmbH)

Desloratadine ratiopharm (ratiopharm GmbH)

Desloratadine ratiopharm (Active substance: desloratadine) - Centralised - Yearly update - Commission Decision (2018)7603 of Wed, 14 Nov 2018

Europe -DG Health and Food Safety

14-11-2018

Ebymect (AstraZeneca AB)

Ebymect (AstraZeneca AB)

Ebymect (Active substance: dapagliflozin / metformin) - Centralised - 2-Monthly update - Commission Decision (2018)7605 of Wed, 14 Nov 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4162/WS/1380

Europe -DG Health and Food Safety

13-11-2018

EU/3/17/1863 (Celgene Europe B.V.)

EU/3/17/1863 (Celgene Europe B.V.)

EU/3/17/1863 (Active substance: Autologous T lymphocyte-enriched population of cells transduced with a lentiviral vector encoding a chimeric antigen receptor targeting human B cell maturation antigen with 4-1BB and CD3-zeta intracellular signalling domains) - Transfer of orphan designation - Commission Decision (2018)7574 of Tue, 13 Nov 2018 European Medicines Agency (EMA) procedure number: EMA/OD/270/16/02

Europe -DG Health and Food Safety

13-11-2018

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

25-10-2018

Canigen L4 (Intervet International B.V.)

Canigen L4 (Intervet International B.V.)

Canigen L4 (Active substance: Leptospira interrogans serogroup Canicola serovar Portland-vere/Leptospira interrogans serogroup Icterohaemorrhagiae serovar Copenhageni/Leptospira interrogans serogroup Australis serovar Bratislava/Leptospira kirschneri serogroup Grippotyphosa serovar Dadas) - Centralised - Yearly update - Commission Decision (2018)7138 of Thu, 25 Oct 2018

Europe -DG Health and Food Safety