Nitro-Dur

Glavne informacije

  • Zaščiteno ime:
  • Nitro-Dur 0,6 mg/h transdermalni obliž
  • Farmacevtska oblika:
  • transdermalni obliž
  • Sestava:
  • gliceriltrinitrat 120 mg / 1 obliž
  • Pot uporabe:
  • Transdermalna uporaba
  • Enote v paketu:
  • škatla z 28 obliži
  • Tip zastaranja:
  • Rp - Predpisovanje in izdaja zdravila je le na recept
  • Uporabi za:
  • ljudje
  • Vrsta medicine:
  • Alopatska drog

Dokumentov

Lokalizacija

  • Na voljo v:
  • Nitro-Dur 0,6 mg/h transdermalni obliž
    Slovenija
  • Jezik:
  • slovenščina

Terapevtski podatki

  • Terapevtska skupina:
  • gliceriltrinitrat

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-2309/12
  • Datum dovoljenje:
  • 16-11-2012
  • EAN koda:
  • 3837000016376
  • Zadnja posodobitev:
  • 18-01-2018

Podatki za bolnike

Navodilo za uporabo

Nitro-Dur

0,2 mg/h transdermalni obliž

Nitro-Dur 0,4 mg/h transdermalni obliž

Nitro-Dur 0,6 mg/h transdermalni obliž

gliceriltrinitrat

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

podatke!

Navodilo shranite. Morda ga boste želeli ponovno prebrati.

Če imate dodatna vprašanja, se posvetujte z zdravnikom ali farmacevtom.

Zdravilo je bilo predpisano vam osebno in ga ne smete dajati drugim. Njim bi lahko celo

škodovalo, čeprav imajo znake bolezni, podobne vašim.

Če opazite kateri koli neželeni učinek, se posvetujte z zdravnikom ali farmacevtom. Posvetujte

se tudi, če opazite katere koli neželene učinke, ki niso navedeni v tem navodilu. Glejte

poglavje 4.

Kaj vsebuje navodilo

Kaj je zdravilo Nitro-Dur in za kaj ga uporabljamo

Kaj morate vedeti, preden boste uporabili zdravilo Nitro-Dur

Kako uporabljati zdravilo Nitro-Dur

Možni neželeni učinki

Shranjevanje zdravila Nitro-Dur

Vsebina pakiranja in dodatne informacije

1.

Kaj je zdravilo Nitro-Dur in za kaj ga uporabljamo

Zdravilo Nitro-Dur se uporablja za preprečevanje in zdravljenje angine pektoris (bolečine v prsih).

Samolepilni obliž vsebuje gliceriltrinitrat (nitroglicerin). Ob stiku s kožo prehaja gliceriltrinitrat počasi in

enakomerno iz obliža v kožo in naprej v krvni obtok.

Zdravnik lahko transdermalni obliž Nitro-Dur predpiše bodisi za samostojno uporabo ali v kombinaciji s

kakšnim drugim zdravilom proti angini pektoris.

2.

Kaj morate vedeti, preden boste uporabili zdravilo Nitro-Dur

Ne uporabljajte zdravila Nitro-Dur:

če ste alergični na gliceriltrinitrat ali katero koli sestavino tega zdravila (navedeno v

poglavju 6);

če imate zelo znižan krvni tlak;

če imate zelo izraženo anemijo (slabokrvnost);

če imate zelo zvišan intrakranialni tlak (povišan tlak v lobanjski votlini);

če imate insuficienco miokarda (nezadostna prekrvavitev srčne mišice) zaradi različnih

vzrokov.

Opozorila in previdnostni ukrepi

Bodite posebno pozorni pri uporabi zdravila Nitro-Dur:

če ste v preteklosti morda preboleli miokardni infarkt ali imeli kakšne druge težave s srcem;

imate

angino

pektoris,

posledica

prizadetosti

srčne

mišice

(hipertrofične

kardiomiopatije);

če vam je zdravnik poleg transdermalnega obliža Nitro-Dur predpisal tudi tablete

JAZMP-IB/2010 - 14.07.2016

gliceriltrinitrata (nitroglicerina) za pod jezik, morate sesti, preden si date tableto pod

jezik. Če se pojavi omotica, povejte svojemu zdravniku, saj lahko to pomeni, da je

treba zmanjšati odmerek tablet za pod jezik.

če jemljete kakršno koli drugo zdravilo na recept ali brez recepta, še posebej takšno, ki znižuje

krvni tlak ali kakšno drugo zdravilo za srce;

če imate pomanjkanje kisika v arterijski krvi (arterijsko hipoksemijo) zaradi hude slabokrvnosti;

če imate pomanjkanje kisika v krvi in neravnovesje med predihanostjo in prekrvavljenostjo pljuč

zaradi pljučne bolezni ali srčnega popuščanja.

Druga zdravila in zdravilo Nitro-Dur

Obvestite zdravnika ali farmacevta, če jemljete, ste pred kratkim jemali ali pa boste morda začeli

jemati katero koli drugo zdravilo, tudi če ste ga dobili brez recepta.

Sočasna uporaba drugih nitratov, diuretikov (zdravila za odvajanje vode) ali drugih zdravil, ki vplivajo na

krvni tlak (antihipertenzivi, antagonisti adrenergičnih receptorjev beta, zaviralci ACE, zaviralci kalcijevih

kanalčkov ali fenotiazini) lahko povzroči dodatno znižanje krvnega tlaka in omotico.

Sočasno jemanje zdravil za zdravljenje erektilne disfunkcije (sildenafil, tadalafil ali vardenafil) lahko

povzroči hud padec krvnega tlaka.

Zdravilo Nitro-Dur skupaj z alkoholom

Pitje alkohola v času uporabe obliža lahko povzroči znižanje krvnega tlaka in omotico.

Nosečnost in dojenje

Če ste noseči ali dojite, menite, da bi lahko bili noseči ali načrtujete zanositev, se posvetujte z

zdravnikom ali farmacevtom, preden vzamete to zdravilo.

Ni znano, ali lahko transdermalni obliž Nitro-Dur vpliva na sposobnost razmnoževanja ali povzroči

poškodbo ploda, zato se ga sme nosečim ženskam predpisati le, če pričakovana korist zdravljenja za

mater zagotovo presega morebitno nevarnost za plod.

Ni znano, ali se gliceriltrinitrat izloča v materino mleko pri človeku, zato svetujemo previdnost

uporabe pri doječih materah.

Vpliv na sposobnost upravljanja vozil in strojev

Ne vozite avtomobila , upravljajte z orodji ali stroji, če se med uporabo tega zdravila pojavi omotica ali

občutek slabosti.

3.

Kako uporabljati zdravilo Nitro-Dur

Pri uporabi tega zdravila natančno upoštevajte navodila zdravnika. Če ste negotovi, se posvetujte z

zdravnikom ali farmacevtom.

Obliža ne smete obrezati ali razrezati, da bi sami spremenili odmerek zdravila. Če menite, da ne deluje

tako, kot bi moral, se morate posvetovati z zdravnikom. Pomembno je, da ne izpustite niti enega dne

terapije z obližem. Če pa je potrebna sprememba režima odmerjanja, boste natančnejša navodila za to

dobili od svojega zdravnika.

Zdravnik vam bo predpisal ustrezen odmerek zdravila Nitro-Dur. Naročil vam bo, da morate obliž na

kožo nalepiti vsak dan, bodisi vseh 24 ur brez prekinitve, ali le določeno število ur na dan. Zdravnik vam

bo dal natančna navodila, kdaj v teku dneva ali večera si morate nalepiti obliž, in tudi glede dolžine

nošenja obliža.

Pomembno opozorilo: Preden si nalepite transdermalni obliž Nitro-Dur, natančno preberite ta

navodila.

JAZMP-IB/2010 - 14.07.2016

Uporaba obliža

Izberite čisto in suho mesto na delu kože z malo ali nič dlak. Priporočamo, da

transdermalni obliž Nitro-Dur nalepite bodisi na zunanji del nadlahti ali na prsni koš.

Izogibajte se uporabi obliža na mestih pod pasom ali komolcem, na kožnih gubah,

brazgotinah ali na opečeni ali razdraženi koži. Ne pozabite, da morate pred uporabo

novega obliža vedno najprej odstraniti starega.

Navodilo za uporabo

Pred uporabo obliža si umijte roke.

Obliž držite tako, da je stran z rjavimi črtami obrnjena proti vam in da črte

potekajo v smeri od zgoraj navzdol.

Robova obliža prepognite stran od sebe, potem pa še proti sebi, da zaslišite pok.

Odlepite eno stran plastične zaščitne folije.

Drugo polovico zaščitne folije uporabite za oporo in nalepite samolepilno stran

obliža na kožo nadlahti ali prsnega koša.

Pritisnite samolepilno stran obliža na kožo in ga zgladite.

JAZMP-IB/2010 - 14.07.2016

Prepognite preostali del obliža nazaj. Snemite plastično zaščitno folijo in obliž

temeljito zgladite.

Temeljito si umijte roke, da izperete morebitne ostanke zdravila.

Pomembno je, da vsak dan uporabite drugo mesto za postavitev obliža.

Predlagamo naslednji vrstni red:

• 1. dan – desna nadlaht

• 2. dan – desna stran prsi zgoraj

• 3. dan – leva stran prsi zgoraj

• 4. dan – leva nadlaht – zdaj nadaljujte od 1. dne naprej

Odstranjevanje obliža

Pritisnite na osrednji del obliža, da se zunanji rob obliža dvigne in odstopi s

kože.

Previdno primite rob obliža in ga počasi odlepite s kože.

Obliž zavrzite na primeren način, da ne bi kdo nenamerno prišel v stik z zdravilom.

Kožo, na kateri je bil nalepljen obliž, umijte z milom in vodo ter posušite z

brisačo. Tudi roke si temeljito umijte, da izperete morebitne ostanke zdravila z

njih.

Nega kože

Po odstranitvi transdermalnega obliža Nitro-Dur bo koža na tem mestu

morda toplejša, suha in pordela, kar je normalno. Pordelost bo kmalu

izginila, če pa je koža suha, jo lahko namažete z blažilno kremo za

kožo.

Če pordelost kože ali izpuščaj ne izgineta, na to opozorite zdravnika.

Druge informacije:

Transdermalni obliž Nitro-Dur naj ostane na koži tako dolgo, kot je predpisal

zdravnik.

JAZMP-IB/2010 - 14.07.2016

V času, ko imate na koži transdermalni obliž Nitro-Dur, se lahko prhate in

kopate.

Če ste uporabili večji odmerek zdravila Nitro-Dur, kot bi smeli

Preveliko odmerjanje transdermalnega obliža Nitro-Dur je malo verjetno. Če pa do tega kljub temu pride,

se posvetujte z zdravnikom ali farmacevtom.

Če ste pozabili uporabiti zdravilo Nitro-Dur

Ne vzemite dvojnega odmerka, če ste pozabili uporabiti prejšnji odmerek. Če pozabite vzeti odmerek

zdravila ob določenem času, ga vzemite kolikor hitro je mogoče in se potem vrnite na svoj redni režim

odmerjanja.

Pomembno je, da ne izpustite niti enega dne terapije s transdermalnim obližem.

Če ste prenehali uporabljati zdravilo Nitro-Dur

Zdravljenja ne smete prekiniti naglo. Obliže uporabljajte, dokler vam zdravnik ne naroči, da prenehajte.

Če je potrebna sprememba režima odmerjanja, boste natančnejša navodila za to dobili od zdravnika.

Če imate dodatna vprašanja o uporabi zdravila, se posvetujte z zdravnikom ali farmacevtom.

4.

Možni neželeni učinki

Kot vsa zdravila ima lahko tudi to zdravilo neželene učinke, ki pa se ne pojavijo pri vseh bolnikih.

Pogosti (pojavijo se lahko pri največ 1 od 10 bolnikov):

draženje na mestu namestitve obliža;

glavobol, rdečica.

Občasni (pojavijo se lahko pri največ 1 od 100 bolnikov):

hipotenzija (nizek krvni tlak), sinkopa (morebitna nezavest zaradi prenizkega krvnega tlaka) in

refleksna tahikardija (refleksno pospešeno bitje srca);

omotica/vrtoglavica, preobčutljivostne reakcije (npr. pordelost in srbenje kože).

Poročanje o neželenih učinkih

Če opazite katerega koli izmed neželenih učinkov, se posvetujte z zdravnikom ali farmacevtom.

Posvetujte se tudi, če opazite neželene učinke, ki niso navedeni v tem navodilu. O neželenih učinkih

lahko poročate tudi neposredno na

Univerzitetni klinični center Ljubljana, Interna klinika

Center za zastrupitve

Zaloška cesta 2

SI-1000 Ljubljana

Faks: + 386 (0)1 434 76 46

e-pošta:

farmakovigilanca@kclj.si

S tem, ko poročate o neželenih učinkih, lahko prispevate k zagotovitvi več informacij o varnosti tega

zdravila.

5.

Shranjevanje zdravila Nitro-Dur

Zdravilo shranjujte nedosegljivo otrokom!

Shranjujte pri temperaturi do 30 °C! Ne zamrzujte.

Ne uporabljajte zdravila, če ste opazili kakršne koli spremembe.

JAZMP-IB/2010 - 14.07.2016

Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli poleg

oznake »Uporabno do«. Rok uporabnosti zdravila se izteče na zadnji dan navedenega meseca.

Zdravila ne smete odvreči v odpadne vode ali med gospodinjske odpadke. O načinu odstranjevanja

zdravila, ki ga ne uporabljate več, se posvetujte s farmacevtom. Taki ukrepi pomagajo varovati okolje.

6.

Vsebina pakiranja in dodatne informacije

Kaj vsebuje zdravilo Nitro-Dur

-

Učinkovina je gliceriltrinitrat.

1 obliž (10 cm

) vsebuje 40 mg gliceriltrinitrata, sprosti 0,2 mg gliceriltrinitrata na uro.

1 obliž (20 cm

) vsebuje 80 mg gliceriltrinitrata, sprosti 0,4 mg gliceriltrinitrata na uro.

1 obliž (30 cm

) vsebuje 120 mg gliceriltrinitrata, sprosti 0,6 mg gliceriltrinitrata na uro.

-

Druge sestavine zdravila so:

adhezivne snovi

: polibutilakrilat (polimer C), polibutilakrilat (polimer D), natrijev poliakrilat

(polimer A), melaminsko-formaldehidna smola (polimer B), prečiščena voda

nosilec:

petslojni vinilni film (LDPE/EVA/PVDC/EVA/LDPE)

Izgled zdravila Nitro-Dur in vsebina pakiranja

Transdermalni obliž, okrogle oblike, kožne barve z zaščitno folijo na eni strani in z vtisnjenim imenom.

Škatla z 28 transdermalnimi obliži Nitro-Dur, pakiranimi posamično v večplastne vrečke iz papirja,

polietilena in folije.

Način in režim izdajanja zdravila

Predpisovanje in izdaja zdravila je le na recept.

Imetnik dovoljenja za promet z zdravilom in izdelovalec

Imetnik dovoljenja za promet:

Merck Sharp & Dohme, inovativna zdravila d.o.o., Šmartinska cesta

140, 1000 Ljubljana, Slovenija

Izdelovalec:

Schering-Plough, Labo NV, Industriepark 30, Heist-op-den Berg, B-2220, Belgija

Navodilo je bilo nazadnje revidirano dne 14.07.2016

JAZMP-IB/2010 - 14.07.2016

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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

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

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

25-10-2018

Xtandi (Astellas Pharma Europe B.V.)

Xtandi (Astellas Pharma Europe B.V.)

Xtandi (Active substance: enzalutamide) - Centralised - 2-Monthly update - Commission Decision (2018)7132 of Thu, 25 Oct 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2639/II/39G

Europe -DG Health and Food Safety

22-10-2018

NEXGARD SPECTRA (Merial)

NEXGARD SPECTRA (Merial)

NEXGARD SPECTRA (Active substance: Afoxolaner / milbemycin oxime) - Centralised - 2-Monthly update - Commission Decision (2018)6977 of Mon, 22 Oct 2018 European Medicines Agency (EMA) procedure number: EMEA/V/C/003842/WS1338/0015/G

Europe -DG Health and Food Safety

22-10-2018

EU/3/16/1640 (Celgene Europe B.V.)

EU/3/16/1640 (Celgene Europe B.V.)

EU/3/16/1640 (Active substance: 2-methyl-1-[(4-[6-(trifluoromethyl)pyridin-2-yl]-6-{[2-(trifluoromethyl)pyridin-4-yl]amino}-1,3,5-triazin-2-yl)amino]propan-2-ol methanesulfonate) - Transfer of orphan designation - Commission Decision (2018)6989 of Mon, 22 Oct 2018 European Medicines Agency (EMA) procedure number: EMA/OD/253/15/T/01

Europe -DG Health and Food Safety

22-10-2018

EU/3/16/1689 (Alan Boyd Consultants Ltd)

EU/3/16/1689 (Alan Boyd Consultants Ltd)

EU/3/16/1689 (Active substance: Teriparatide) - Transfer of orphan designation - Commission Decision (2018)6987 of Mon, 22 Oct 2018 European Medicines Agency (EMA) procedure number: EMA/OD/031/16/T/01

Europe -DG Health and Food Safety

22-10-2018

EU/3/01/075 (Eisai GmbH)

EU/3/01/075 (Eisai GmbH)

EU/3/01/075 (Active substance: Denileukin diftitox) - Transfer of orphan designation - Commission Decision (2018)6991 of Mon, 22 Oct 2018 European Medicines Agency (EMA) procedure number: EMA/OD/038/01/T/02

Europe -DG Health and Food Safety

22-10-2018

Pemetrexed Hospira (Pfizer Europe MA EEIG)

Pemetrexed Hospira (Pfizer Europe MA EEIG)

Pemetrexed Hospira (Active substance: pemetrexed) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)6971 of Mon, 22 Oct 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/3970/T/14

Europe -DG Health and Food Safety

22-10-2018

EU/3/05/264 (Roche Registration GmbH)

EU/3/05/264 (Roche Registration GmbH)

EU/3/05/264 (Active substance: Cholest-4-en-3-one, oxime) - Transfer of orphan designation - Commission Decision (2018)6995 of Mon, 22 Oct 2018 European Medicines Agency (EMA) procedure number: EMEA/OD/081/04/T/02

Europe -DG Health and Food Safety

22-10-2018

EU/3/11/901 (Merck Sharp and Dohme B.V.)

EU/3/11/901 (Merck Sharp and Dohme B.V.)

EU/3/11/901 (Active substance: Dinaciclib) - Transfer of orphan designation - Commission Decision (2018)6990 of Mon, 22 Oct 2018 European Medicines Agency (EMA) procedure number: EMA/OD/052/11/T/01

Europe -DG Health and Food Safety

22-10-2018

EU/3/15/1495 (Ultragenyx Netherlands B.V.)

EU/3/15/1495 (Ultragenyx Netherlands B.V.)

EU/3/15/1495 (Active substance: Triheptanoin) - Transfer of orphan designation - Commission Decision (2018)6992 of Mon, 22 Oct 2018 European Medicines Agency (EMA) procedure number: EMA/OD/007/15/T/02

Europe -DG Health and Food Safety

22-10-2018

EU/3/16/1704 (Drug Development and Regulation S.L.)

EU/3/16/1704 (Drug Development and Regulation S.L.)

EU/3/16/1704 (Active substance: Sirolimus) - Transfer of orphan designation - Commission Decision (2018)6988 of Mon, 22 Oct 2018 European Medicines Agency (EMA) procedure number: EMA/OD/045/16/T/01

Europe -DG Health and Food Safety

22-10-2018

EU/3/10/815 (Pfizer Europe MA EEIG)

EU/3/10/815 (Pfizer Europe MA EEIG)

EU/3/10/815 (Active substance: Sildenafil citrate) - Transfer of orphan designation - Commission Decision (2018)6993 of Mon, 22 Oct 2018 European Medicines Agency (EMA) procedure number: EMA/OD/068/10/T/01

Europe -DG Health and Food Safety

22-10-2018

NexGard (Merial)

NexGard (Merial)

NexGard (Active substance: afoxolaner) - Centralised - 2-Monthly update - Commission Decision (2018)6976 of Mon, 22 Oct 2018 European Medicines Agency (EMA) procedure number: EMEA/V/C/002729/WS1338/0018/G

Europe -DG Health and Food Safety

19-10-2018

Recocam (Bimeda Animal Health Limited)

Recocam (Bimeda Animal Health Limited)

Recocam (Active substance: Meloxicam) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)6954 of Fri, 19 Oct 2018 European Medicines Agency (EMA) procedure number: EMEA/V/C/2247/T/10

Europe -DG Health and Food Safety

18-10-2018

Kivexa (ViiV Healthcare BV)

Kivexa (ViiV Healthcare BV)

Kivexa (Active substance: abacavir / Lamivudine) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)6924 of Thu, 18 Oct 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/000581/T/0076

Europe -DG Health and Food Safety

18-10-2018

Leflunomide Zentiva (Zentiva k.s.)

Leflunomide Zentiva (Zentiva k.s.)

Leflunomide Zentiva (Active substance: leflunomide) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)6923 of Thu, 18 Oct 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/001129/T/0032

Europe -DG Health and Food Safety

18-10-2018

Sutent (Pfizer Europe MA EEIG)

Sutent (Pfizer Europe MA EEIG)

Sutent (Active substance: sunitinib) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)6922 of Thu, 18 Oct 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/687/T/72

Europe -DG Health and Food Safety

18-10-2018

ABILIFY MAINTENA (Otsuka Pharmaceutical Netherlands B.V.)

ABILIFY MAINTENA (Otsuka Pharmaceutical Netherlands B.V.)

ABILIFY MAINTENA (Active substance: Aripiprazole) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)6925 of Thu, 18 Oct 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/002755/T/0026

Europe -DG Health and Food Safety

18-10-2018

Rapamune (Pfizer Europe MA EEIG)

Rapamune (Pfizer Europe MA EEIG)

Rapamune (Active substance: sirolimus) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)6921 of Thu, 18 Oct 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/273/T/168

Europe -DG Health and Food Safety

16-10-2018

Dexxience (Portola Pharma UK Limited)

Dexxience (Portola Pharma UK Limited)

Dexxience (Active substance: betrixaban) - Refusal of authorisation - Commission Decision (2018)6226 of Tue, 16 Oct 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4309

Europe -DG Health and Food Safety

12-10-2018

Irbesartan Zentiva (Zentiva k.s.)

Irbesartan Zentiva (Zentiva k.s.)

Irbesartan Zentiva (Active substance: Irbesartan) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)6772 of Fri, 12 Oct 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/785T/79

Europe -DG Health and Food Safety

8-10-2018

Palonosetron Hospira (Pfizer Europe MA EEIG)

Palonosetron Hospira (Pfizer Europe MA EEIG)

Palonosetron Hospira (Active substance: palonosetron) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)6606 of Mon, 08 Oct 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4069/T/04

Europe -DG Health and Food Safety

2-10-2018

Zavesca (Janssen-Cilag International NV)

Zavesca (Janssen-Cilag International NV)

Zavesca (Active substance: Miglustat) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)5472 of Tue, 02 Oct 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/000435/T/0063

Europe -DG Health and Food Safety

2-10-2018

Dynastat (Pfizer Europe MA EEIG)

Dynastat (Pfizer Europe MA EEIG)

Dynastat (Active substance: Parecoxib ) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)6471 of Tue, 02 Oct 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/000381/T/0073

Europe -DG Health and Food Safety

2-10-2018

Retacrit (Pfizer Europe MA EEIG)

Retacrit (Pfizer Europe MA EEIG)

Retacrit (Active substance: epoetin zeta) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)6481 of Tue, 02 Oct 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/872/T/86

Europe -DG Health and Food Safety

2-10-2018

HALAVEN (Eisai GmbH)

HALAVEN (Eisai GmbH)

HALAVEN (Active substance: eribulin) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)6457 of Tue, 02 Oct 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2084/T/46

Europe -DG Health and Food Safety

2-10-2018

Imraldi (Samsung Bioepis UK Limited)

Imraldi (Samsung Bioepis UK Limited)

Imraldi (Active substance: adalimumab) - Centralised - 2-Monthly update - Commission Decision (2018)6458 of Tue, 02 Oct 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4279/IB/14

Europe -DG Health and Food Safety

2-10-2018

Nexium Control (Pfizer Healthcare Ireland)

Nexium Control (Pfizer Healthcare Ireland)

Nexium Control (Active substance: esomeprazole) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)6474 of Tue, 02 Oct 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/002618/T/0023

Europe -DG Health and Food Safety

2-10-2018

Uptravi (Janssen-Cilag International NV)

Uptravi (Janssen-Cilag International NV)

Uptravi (Active substance: selexipag) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)6470 of Tue, 02 Oct 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/3774/T/19

Europe -DG Health and Food Safety

2-10-2018

NexoBrid (MediWound Germany GmbH)

NexoBrid (MediWound Germany GmbH)

NexoBrid (Active substance: Concentrate of proteolytic enzymes enriched in bromelain) - PSUSA - Modification - Commission Decision (2018)6460 of Tue, 02 Oct 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/PSUSA/10028/201712

Europe -DG Health and Food Safety

2-10-2018

EU/3/14/1242 (Neurolixis SAS)

EU/3/14/1242 (Neurolixis SAS)

EU/3/14/1242 (Active substance: 3-Chloro-4-fluorophenyl-[4-fluoro-4-{[(5-methylpyrimidin-2-ylmethyl) amino]methyl}piperidin-1-yl]methanone) - Transfer of orphan designation - Commission Decision (2018)6436 of Tue, 02 Oct 2018 European Medicines Agency (EMA) procedure number: EMA/OD/163/13/T/01

Europe -DG Health and Food Safety

2-10-2018

Trizivir (ViiV Healthcare BV)

Trizivir (ViiV Healthcare BV)

Trizivir (Active substance: abacavir, lamivudine, zidovudine) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)6483 of Tue, 02 Oct 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/338/T/108

Europe -DG Health and Food Safety

2-10-2018

EU/3/16/1786 (Voisin Consulting S.A.R.L.)

EU/3/16/1786 (Voisin Consulting S.A.R.L.)

EU/3/16/1786 (Active substance: Recombinant adeno-associated viral vector serotype 2 carrying the gene for the human aromatic L-amino acid decarboxylase protein) - Transfer of orphan designation - Commission Decision (2018)6427 of Tue, 02 Oct 2018 European Medicines Agency (EMA) procedure number: EMA/OD/183/16/T/02

Europe -DG Health and Food Safety

2-10-2018

Telzir (ViiV Healthcare BV)

Telzir (ViiV Healthcare BV)

Telzir (Active substance: Fosamprenavir) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)6468 of Tue, 02 Oct 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/534/T/93

Europe -DG Health and Food Safety

2-10-2018

Pemetrexed Pfizer (Pfizer Europe MA EEIG)

Pemetrexed Pfizer (Pfizer Europe MA EEIG)

Pemetrexed Pfizer (Active substance: pemetrexed) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)6464 of Tue, 02 Oct 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4488/T/04

Europe -DG Health and Food Safety

2-10-2018

Rebetol (Merck Sharp and Dohme B.V.)

Rebetol (Merck Sharp and Dohme B.V.)

Rebetol (Active substance: ribavirin) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)6479 of Tue, 02 Oct 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/246/T83

Europe -DG Health and Food Safety

2-10-2018

PegIntron (Merck Sharp and Dohme B.V.)

PegIntron (Merck Sharp and Dohme B.V.)

PegIntron (Active substance: Peginterferon alfa-2b) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)6484 of Tue, 02 Oct 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/280/T/135

Europe -DG Health and Food Safety

2-10-2018

Xigduo (AstraZeneca AB)

Xigduo (AstraZeneca AB)

Xigduo (Active substance: dapagliflozin/metformin) - Centralised - Renewal - Commission Decision (2018)6462 of Tue, 02 Oct 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2672/R/44

Europe -DG Health and Food Safety