Nicorandil "Double-E Pharma"

Primær information

  • Handelsnavn:
  • Nicorandil "Double-E Pharma" 10 mg tabletter
  • Dosering:
  • 10 mg
  • Lægemiddelform:
  • tabletter
  • Brugt til:
  • Mennesker
  • Medicin typen:
  • Allopatiske stof

Dokumenter

Lokation

  • Fås i:
  • Nicorandil "Double-E Pharma" 10 mg tabletter
    Danmark
  • Sprog:
  • dansk

Andre oplysninger

Status

  • Kilde:
  • Lægemiddelstyrelsen - Danish Medicines Agency
  • Autorisation status:
  • Markedsført
  • Autorisationsnummer:
  • 49385
  • Sidste ændring:
  • 22-02-2018

Indlægsseddel: sammensætning, indikationer, bivirkninger, dosering, interaktioner, bivirkninger, graviditet, amning

DOUBLE-E PHARMA

Patient Information Leaflet

Nicorandil 10 mg tablets

Rev 25.01.2016

Indlægsseddel: Information til brugeren

Nicorandil DOUBLE-E PHARMA 10 mg tabletter

nicorandil

Læs denne indlægsseddel grundigt, inden du begynder at tage dette lægemiddel, da den indeholder

vigtige oplysninger.

Gem indlægssedlen. Du kan få brug for at læse den igen.

Spørg lægen eller apotekspersonalet, hvis der er mere, du vil vide.

Lægen har ordineret dette lægemiddel til dig personligt. Lad derfor være med at give medicinen til

andre. Det kan være skadeligt for andre, selvom de har de samme symptomer, som du har.

Kontakt lægen eller apotekspersonalet, hvis du får bivirkninger, herunder bivirkninger, som ikke er

nævnt her. Se afsnit 4.

Se den nyeste indlægsseddel på www.indlaegsseddel.dk

Oversigt over indlægssedlen:

Virkning og anvendelse

Det skal du vide, før du begynder at tage Nicorandil DOUBLE-E PHARMA

Sådan skal du tage Nicorandil DOUBLE-E PHARMA

Bivirkninger

Opbevaring

Pakningsstørrelser og yderligere oplysninger

1.

Virkning og anvendelse

Nicorandil DOUBLE-E PHARMA indeholder et lægemiddel, der hedder nicorandil. Det tilhører en gruppe

lægemidler, der kaldes ”kaliumkanal-aktivatorer”. Det virker ved at øge blodgennemstrømningen i hjertets

blodkar. Dermed forbedres blodtilførslen og iltforsyningen til hjertet, og belastningen på hjertet mindskes.

Nicorandil DOUBLE-E PHARMA anvendes til at forebygge eller lindre de smertefulde, udmattende

symptomer (angina pectoris) på din hjertesygdom. Det anvendes til voksne patienter, som ikke tåler eller ikke

kan tage hjertemedicin som betablokkere og/eller calciumantagonister.

2.

Det skal du vide, før du begynder at tage Nicorandil DOUBLE-E PHARMA

Lægen kan have foreskrevet anden anvendelse eller dosering end angivet i denne information. Følg altid

lægens anvisning og oplysningerne på doseringsetiketten.

Tag ikke Nicorandil DOUBLE-E PHARMA:

- hvis du er allergisk over for nicorandil eller et af de øvrige indholdsstoffer i Nicorandil DOUBLE-E

PHARMA (angivet i afsnit 6).

- hvis du har lavt blodtryk (hypotension).

- hvis du har problemer med hjertet, f.eks. kardiogent shock, venstresidigt hjertesvigt med lavt fyldningstryk,

hjertesvigt eller shock.

hvis

tager

medicin

behandling

impotens

f.eks.

sildenafil,

tadalafil

eller

vardenafil

(fosfodiesterase-hæmmere) eller medicin til behandling af forhøjet blodtryk i lungerne som f.eks. riociguat

(guanylatcyklase-stimulatorer). Dette kan påvirke dit blodtryk alvorligt.

- hvis du har lavt blodvolumen.

- hvis du har væske i lungerne (lungeødem).

Advarsler og forsigtighedsregler

Kontakt lægen eller apotekspersonalet, før du tager Nicorandil DOUBLE-E PHARMA.

DOUBLE-E PHARMA

Patient Information Leaflet

Nicorandil 10 mg tablets

Rev 25.01.2016

Du skal straks holde op med at tage nicorandil og tale med lægen, hvis du får en eller flere af følgende

bivirkninger:

Nicorandil kan forårsage skader på mave-tarm-kanalen som f.eks. sår. Dette kan medføre problemer som

f.eks. blødning, fistler (unormal rør-lignende passage fra et hulrum i kroppen til et andet eller til huden),

perforationer (huller) og bylder, især hvis du har en divertikelsygdom (en sygdom i fordøjelsessystemet,

som påvirker tyktarmen).

Hvis dine øjne bliver røde, begynder at klø eller hæve. Du har muligvis fået en øjenskade. Stop med at

tage Nicorandil DOUBLE-E PHARMA og kontakt straks lægen.

Disse bivirkninger kan opstå i begyndelsen af behandlingen eller senere i behandlingsforløbet. Den eneste

behandlingsmulighed er at stoppe med at tage nicorandil. Du må ikke tage acetylsalicylsyre eller medicin

mod betændelsestilstande (kortikosteroider).

Tal med lægen eller apotekspersonalet, inden du begynder at tage Nicorandil DOUBLE-E PHARMA:

Hvis du har lavt blodtryk.

Hvis du har et lavt indhold af kalium i blodet, og din læge har udskrevet kaliumtilskud til dig, hvis du har

nedsat nyrefunktion, eller hvis du tager anden medicin, der kan øge indholdet af kalium i kroppen.

Hvis du har problemer med hjertet som f.eks. hjertesvigt.

Hvis du har glucose-6-fosfatdehydrogenase-mangel.

Børn

Nicorandil DOUBLE-E PHARMA må ikke anvendes til børn.

Brug af anden medicin sammen med Nicorandil DOUBLE-E PHARMA

Fortæl altid lægen eller apotekspersonalet, hvis du tager anden medicin eller har gjort det for nylig. Dette

skyldes, at Nicorandil DOUBLE-E PHARMA kan påvirke virkningen af nogle typer medicin. Nogle typer

medicin kan også påvirke virkningen af Nicorandil DOUBLE-E PHARMA.

Tag ikke Nicorandil DOUBLE-E PHARMA og tal med lægen, hvis du tager:

Medicin mod impotens som f.eks. sildenafil, tadalafil eller vardenafil.

Medicin til behandling af forhøjet blodtryk i lungerne som f.eks. riociguat.

Fortæl det til lægen, hvis du tager en eller flere af følgende typer medicin:

Medicin mod forhøjet blodtryk.

Medicin, der udvider blodkarrene.

Medicin, der øger indholdet af kalium i blodet.

Dapoxetin, medicin til behandling af for tidlig sædafgang.

Medicin mod betændelsestilstande (kortikosterodier, non-steroide antiinflammatoriske lægemidler såsom

ibuprofen).

Medicin mod depression.

Acetylsalicylsyre.

Brug af Nicorandil DOUBLE-E PHARMA sammen med alkohol

Nicorandil

sænke

blodtryk.

Hvis

drikker

alkohol,

mens

tager

Nicorandil

DOUBLE-E

PHARMA, kan dit blodtryk blive sænket yderligere.

Graviditet, amning og fertilitet

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.

Du må ikke tage denne medicin, mens du er gravid.

Man ved ikke, om nicorandil udskilles i modermælken hos mennesker. Du må ikke amme, mens du tager

denne medicin.

Trafik- og arbejdssikkerhed

Nicorandil DOUBLE-E PHARMA kan forårsage svimmelhed eller svaghedsfølelse. Hvis du oplever dette,

DOUBLE-E PHARMA

Patient Information Leaflet

Nicorandil 10 mg tablets

Rev 25.01.2016

må du ikke køre bil, anvende værktøj eller betjene maskiner.

3.

Sådan skal du tage Nicorandil DOUBLE-E PHARMA

Tag altid lægemidlet nøjagtigt efter lægens eller apotekspersonalets anvisning. Er du i tvivl, så spørg lægen

eller apotekspersonalet.

Den anbefalede dosis er:

Den sædvanlige startdosis er 10 mg to gange dagligt.

Hvis du har særlig tendens til at få hovedpine, kan lægen udskrive en lavere dosis på 5 mg to gange

dagligt til de første par dage (2 til 7 dage).

Din læge vil muligvis øge din dosis til højst 20 mg to gange dagligt afhængigt af dit behov, hvordan du

reagerer på behandlingen, og hvor godt du tåler behandlingen.

Det et bedst at tage en dosis om morgenen og en om aftenen. Synk tabletten (oral anvendelse).

Du må ikke tage tabletten ud af blisterpakningen, før du skal sluge den.

Tabletten kan deles i to lige store doser.

Du må ikke sluge tørremidlet, som er den store tablet i den ene ende af hvert blisterkort. Det er en del af

pakningen og skal beskytte Nicorandil DOUBLE-E PHARMA mod fugt. På blisterkortet er det vist tydeligt,

hvilken tablet der er tørremidlet. Hvis du ved et uheld kommer til at sluge tørremidlet, vil det sandsynligvis

ikke skade dig, men du bør alligevel kontakte din læge straks.

Hvis du har taget for meget Nicorandil DOUBLE-E PHARMA

Hvis du har taget for mange tabletter, eller hvis et barn har slugt en eller flere af dine tabletter, skal du straks

søge lægehjælp eller tage til nærmeste skadestue. Tag emballagen med. Du kan få symptomer på nedsat

blodtryk som f.eks. svimmelhed eller svaghedsfølelse. Du kan muligvis også mærke, at hjertet banker

uregelmæssigt og hurtigere.

Hvis du har glemt at tage Nicorandil DOUBLE-E PHARMA

Hvis du har glemt at tage en dosis, skal du tage den, så snart du kommer i tanke om det, medmindre

det snart er tid til den næste dosis.

Du må ikke tage en dobbeltdosis som erstatning for en glemt dosis.

Spørg lægen eller apotekspersonalet, hvis der er noget, du er i tvivl om.

4.

Bivirkninger

Dette lægemiddel kan som al anden medicin give bivirkninger, men ikke alle får bivirkninger.

Alvorlige bivirkninger

Tal straks med lægen, hvis du får en eller flere af følgende bivirkninger:

Nicorandil kan forårsage skader på mave-tarm-kanalen, som f.eks. sår i munden, på tungen, i maven, tarmene

(tyktarmen

tyndtarmen)

eller

endetarmen.

Dette

give

problemer

f.eks.

blødning

(blod

afføringen, opkast), fistler (unormal rør-lignende passage fra et hulrum i kroppen til et andet eller til huden),

perforation (huller), bylder og vægttab. Der kan også opstå sår andre steder: på huden, i urinvejene og i næsen

eller ved en stomi (kunstig åbning til afføring som f.eks. kolostomi eller ileostomi).

Øvrige bivirkninger

Meget almindelige bivirkninger (forekommer hos flere end 1 ud af 10 behandlede):

Hovedpine – dette forekommer især i de første par dage af behandlingen. Din læge vil muligvis øge din

dosis gradvist for at nedsætte risikoen for hovedpine.

DOUBLE-E PHARMA

Patient Information Leaflet

Nicorandil 10 mg tablets

Rev 25.01.2016

Almindelige bivirkninger (forekommer hos op til 1 ud af 10 behandlede):

Svimmelhed

Meget hurtige, uregelmæssige eller kraftige hjerteslag (hjertebanken)

Hudrødme

Kvalme

Opkastning

Svaghedsfølelse.

Ikke almindelige bivirkninger (forekommer hos op til 1 ud af 100 behandlede):

Nedsat blodtryk.

Sjældne bivirkninger (forekommer hos op til 1 ud af 1.000 behandlede):

Udslæt

Kløe

Ømme muskler, som ikke skyldes fysisk aktivitet (myalgi).

Meget sjældne bivirkninger (forekommer hos op til 1 ud af 10.000 behandlede):

Højt indhold af kalium i blodet (hyperkalæmi)

Røde, kløende, hævede eller rindende øjne (konjunktivitis)

Øjenskader

Skader på hornhinden

Gulfarvning af huden og øjnene, lys afføring, mørkfarvet urin – Dette kan være tegn på leverproblemer

Hævelse af ansigt, læber, mund, tunge, svælg eller hals, som kan give synkebesvær eller

vejrtrækningsbesvær

Mavesmerter.

Bivirkninger, hvor hyppigheden ikke er kendt:

Dobbeltsyn (diplopi).

Indberetning af bivirkninger

Hvis du oplever bivirkninger, bør du tale med din læge, sygeplejerske eller apoteket. Dette gælder også

mulige bivirkninger, som ikke er medtaget i denne indlægsseddel. Du eller dine pårørende kan også

indberette bivirkninger direkte til Lægemiddelstyrelsen via de oplysninger, der fremgår herunder.

Lægemiddelstyrelsen

Axel Heides Gade 1

DK-2300 København S

Websted: www.meldenbivirkning.dk

E-mail: dkma@dkma.dk

Ved at indrapportere bivirkninger kan du hjælpe med at fremskaffe mere information om sikkerheden af

dette lægemiddel.

5.

Opbevaring

Opbevar lægemidlet utilgængeligt for børn.

Må ikke opbevares ved temperaturer over 25 °C. Opbevares i den originale blisterpakning for at beskytte

mod fugt.

Brug ikke lægemidlet efter den udløbsdato, der står på pakningen. Udløbsdatoen er den sidste dag i den

nævnte måned.

Slug ikke og fjern ikke tørremidlet fra pakningen. Tørremidlet er mærket med rødt i enden af blisterkortet.

DOUBLE-E PHARMA

Patient Information Leaflet

Nicorandil 10 mg tablets

Rev 25.01.2016

Et blisterkort skal anvendes inden for 30 dage efter den første tablet er fjernet.

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

Nicorandil DOUBLE-E PHARMA 10 mg indeholder:

- Aktivt stof: Nicorandil 10 mg.

- Øvrige indholdsstoffer: Majsstivelse, croscarmellosenatrium, stearinsyre, mannitol.

Udseende og pakningsstørrelser

Udseende

Nicorandil DOUBLE-E PHARMA 10 mg er en hvid og rund tablet, der har delekærv på den ene side og er

præget med ”10” på den anden side.

Pakningsstørrelser

Blisterpakninger: 30 og 60 tabletter.

Ikke alle pakningsstørrelser er nødvendigvis markedsført.

Indehaver af markedsføringstilladelsen og fremstiller

Indehaver af markedsføringstilladelsen

DOUBLE-E PHARMA LIMITED, 7th Floor, Hume House, Ballsbridge, Dublin 4, Irland

Fremstiller

Laboratoires BTT, ZI de Krafft, 67150 ERSTEIN, Frankrig

Repræsentant i Danmark

Alternova A/S, Lodshusvej 11, 4230 Skælskør, Danmark

Denne indlægsseddel blev senest ændret 25.01.2016.

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18-1-2019


Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 14-17 January 2019

Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 14-17 January 2019

Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 14-17 January 2019

Europe - EMA - European Medicines Agency

16-1-2019

EU/3/12/1062 (EUSA Pharma (Netherlands) B.V.)

EU/3/12/1062 (EUSA Pharma (Netherlands) B.V.)

EU/3/12/1062 (Active substance: Chimeric monoclonal antibody against GD2) - Transfer of orphan designation - Commission Decision (2019)238 of Wed, 16 Jan 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000003198

Europe -DG Health and Food Safety

16-1-2019

EU/3/18/2132 (Silence Therapeutics GmbH)

EU/3/18/2132 (Silence Therapeutics GmbH)

EU/3/18/2132 (Active substance: Synthetic double-stranded siRNA oligonucleotide directed against TMPRSS6 mRNA and covalently linked to a ligand containing three N-acetylgalactosamine residues) - Orphan designation - Commission Decision (2019)226 of Wed, 16 Jan 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000001845

Europe -DG Health and Food Safety

16-1-2019

EU/3/14/1309 (Pharma Gateway AB)

EU/3/14/1309 (Pharma Gateway AB)

EU/3/14/1309 (Active substance: 17a,21-dihydroxy-16a-methyl-pregna-1,4,9(11)-triene-3,20-dione) - Transfer of orphan designation - Commission Decision (2019)232 of Wed, 16 Jan 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000002736

Europe -DG Health and Food Safety

15-1-2019

EU/3/16/1680 (Chugai Pharma France)

EU/3/16/1680 (Chugai Pharma France)

EU/3/16/1680 (Active substance: Humanised anti-IL-6 receptor monoclonal antibody) - Transfer of orphan designation - Commission Decision (2019)229 of Tue, 15 Jan 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000003065

Europe -DG Health and Food Safety

20-12-2018

Ravicti (Horizon Pharma Ireland Limited)

Ravicti (Horizon Pharma Ireland Limited)

Ravicti (Active substance: Glycerol phenylbutyrate) - Centralised - 2-Monthly update - Commission Decision (2018)9126 of Thu, 20 Dec 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/3822/II/19

Europe -DG Health and Food Safety

19-12-2018

Macugen (PharmaSwiss CeskA republika s.r.o.)

Macugen (PharmaSwiss CeskA republika s.r.o.)

Macugen (Active substance: pegaptanib sodium) - Withdrawal - Commission Decision (2018)9064 of Wed, 19 Dec 2018

Europe -DG Health and Food Safety

19-12-2018

EU/3/18/2120 (Takeda Pharma A/S)

EU/3/18/2120 (Takeda Pharma A/S)

EU/3/18/2120 (Active substance: Pevonedistat) - Orphan designation - Commission Decision (2018)9035 of Wed, 19 Dec 2018 European Medicines Agency (EMA) procedure number: EMA/OD/164/18

Europe -DG Health and Food Safety

18-12-2018


Scientific recommendation on classification of advanced therapy medicinal products: Live-attenuated, double-deleted Listeria monocytogenes expressing prostate antigens

Scientific recommendation on classification of advanced therapy medicinal products: Live-attenuated, double-deleted Listeria monocytogenes expressing prostate antigens

Scientific recommendation on classification of advanced therapy medicinal products: Live-attenuated, double-deleted Listeria monocytogenes expressing prostate antigens

Europe - EMA - European Medicines Agency

18-12-2018


Scientific recommendation on classification of advanced therapy medicinal products: Live-attenuated, double-deleted Listeria monocytogenes expressing human mesothelin

Scientific recommendation on classification of advanced therapy medicinal products: Live-attenuated, double-deleted Listeria monocytogenes expressing human mesothelin

Scientific recommendation on classification of advanced therapy medicinal products: Live-attenuated, double-deleted Listeria monocytogenes expressing human mesothelin

Europe - EMA - European Medicines Agency

18-12-2018

EU/3/18/2108 (Pharma Gateway AB)

EU/3/18/2108 (Pharma Gateway AB)

EU/3/18/2108 (Active substance: Adeno-associated viral vector expressing human 21-hydroxylase) - Orphan designation - Commission Decision (2018)9023 of Tue, 18 Dec 2018 European Medicines Agency (EMA) procedure number: EMA/OD/140/18

Europe -DG Health and Food Safety

18-12-2018

EU/3/18/2106 (AudioCure Pharma GmbH)

EU/3/18/2106 (AudioCure Pharma GmbH)

EU/3/18/2106 (Active substance: 6-fluoro-9-methyl-9H-pyrido[3,4-b]-indole) - Orphan designation - Commission Decision (2018)9021 of Tue, 18 Dec 2018 European Medicines Agency (EMA) procedure number: EMA/OD/170/18

Europe -DG Health and Food Safety

18-12-2018

EU/3/16/1731 (Alnylam Netherlands B.V.)

EU/3/16/1731 (Alnylam Netherlands B.V.)

EU/3/16/1731 (Active substance: Synthetic double-stranded siRNA oligonucleotide directed against delta-aminolevulinic acid synthase 1 mRNA covalently linked to a ligand containing three N-acetylgalactosamine residues) - Transfer of orphan designation - Commission Decision (2018)9015 of Tue, 18 Dec 2018 European Medicines Agency (EMA) procedure number: EMA/OD/0000002858

Europe -DG Health and Food Safety

17-12-2018

OCALIVA (Intercept Pharma Ltd)

OCALIVA (Intercept Pharma Ltd)

OCALIVA (Active substance: obeticholic acid) - Centralised - Annual renewal - Commission Decision (2018)8909 of Mon, 17 Dec 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4093/R/9

Europe -DG Health and Food Safety

13-12-2018


Guideline on the reporting of physiologically based pharmacokinetic (PBPK) modelling and simulation

Guideline on the reporting of physiologically based pharmacokinetic (PBPK) modelling and simulation

Guideline on the reporting of physiologically based pharmacokinetic (PBPK) modelling and simulation

Europe - EMA - European Medicines Agency

12-12-2018

Daklinza (Bristol-Myers Squibb Pharma EEIG)

Daklinza (Bristol-Myers Squibb Pharma EEIG)

Daklinza (Active substance: daclatasvir) - Centralised - Yearly update - Commission Decision (2018)8758 of Wed, 12 Dec 2018

Europe -DG Health and Food Safety

12-12-2018

EVOTAZ (Bristol-Myers Squibb Pharma EEIG)

EVOTAZ (Bristol-Myers Squibb Pharma EEIG)

EVOTAZ (Active substance: atazanavir / cobicistat) - Centralised - Yearly update - Commission Decision (2018)8679 of Wed, 12 Dec 2018

Europe -DG Health and Food Safety

11-12-2018

Xermelo (Ipsen Pharma)

Xermelo (Ipsen Pharma)

Xermelo (Active substance: telotristat) - Centralised - Yearly update - Commission Decision (2018)8684 of Tue, 11 Dec 2018

Europe -DG Health and Food Safety

30-11-2018

Keppra (UCB Pharma S.A.)

Keppra (UCB Pharma S.A.)

Keppra (Active substance: levetiracetam) - Centralised - Yearly update - Commission Decision (2018)8160 of Fri, 30 Nov 2018

Europe -DG Health and Food Safety

30-11-2018

Pioglitazone Teva Pharma (Teva B.V.)

Pioglitazone Teva Pharma (Teva B.V.)

Pioglitazone Teva Pharma (Active substance: pioglitazone) - Centralised - Yearly update - Commission Decision (2018)8158 of Fri, 30 Nov 2018

Europe -DG Health and Food Safety

26-11-2018

Wakix (Bioprojet Pharma)

Wakix (Bioprojet Pharma)

Wakix (Active substance: Pitolisant hydrochloride) - Centralised - Yearly update - Commission Decision (2018)7974 of Mon, 26 Nov 2018

Europe -DG Health and Food Safety

26-11-2018

Alunbrig (Takeda Pharma A/S)

Alunbrig (Takeda Pharma A/S)

Alunbrig (Active substance: brigatinib) - Centralised - Authorisation - Commission Decision (2018)7976 of Mon, 26 Nov 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4248/

Europe -DG Health and Food Safety

21-11-2018

EU/3/18/2081 (Pharma Gateway AB)

EU/3/18/2081 (Pharma Gateway AB)

EU/3/18/2081 (Active substance: 3-(3-(3,5-dimethyl-1H-pyrazol-4-yl)propoxy)-4-fluorobenzoic acid) - Orphan designation - Commission Decision (2018)7790 of Wed, 21 Nov 2018 European Medicines Agency (EMA) procedure number: EMA/OD/096/18

Europe -DG Health and Food Safety

21-11-2018

EU/3/15/1567 (TMC Pharma (EU) Limited)

EU/3/15/1567 (TMC Pharma (EU) Limited)

EU/3/15/1567 (Active substance: Recombinant human interleukin-3 truncated diphtheria toxin fusion protein) - Transfer of orphan designation - Commission Decision (2018)7816 of Wed, 21 Nov 2018 European Medicines Agency (EMA) procedure number: EMA/OD/064/15/T/02

Europe -DG Health and Food Safety

21-11-2018

EU/3/18/2101 (TMC Pharma Services Ltd)

EU/3/18/2101 (TMC Pharma Services Ltd)

EU/3/18/2101 (Active substance: Setmelanotide) - Orphan designation - Commission Decision (2018)7811 of Wed, 21 Nov 2018 European Medicines Agency (EMA) procedure number: EMA/OD/143/18

Europe -DG Health and Food Safety

21-11-2018

EU/3/18/2091 (Pharma Gateway AB)

EU/3/18/2091 (Pharma Gateway AB)

EU/3/18/2091 (Active substance: Glucagon) - Orphan designation - Commission Decision (2018)7801 of Wed, 21 Nov 2018 European Medicines Agency (EMA) procedure number: EMA/OD/108/18

Europe -DG Health and Food Safety

21-11-2018

EU/3/18/2083 (MaaT PHARMA)

EU/3/18/2083 (MaaT PHARMA)

EU/3/18/2083 (Active substance: Allogeneic faecal microbiota, pooled) - Orphan designation - Commission Decision (2018)7792 of Wed, 21 Nov 2018 European Medicines Agency (EMA) procedure number: EMA/OD/123/18

Europe -DG Health and Food Safety

21-11-2018

EU/3/18/2082 (Takeda Pharma A/S)

EU/3/18/2082 (Takeda Pharma A/S)

EU/3/18/2082 (Active substance: 5-{(1R,2R)-2-[(cyclopropylmethyl)amino]cyclopropyl}-N-(tetrahydro-2H-pyran-4-yl)thiophene-3-carboxamide monohydrochloride) - Orphan designation - Commission Decision (2018)7791 of Wed, 21 Nov 2018 European Medicines Agency (EMA) procedure number: EMA/OD/040/18

Europe -DG Health and Food Safety

12-11-2018

Neupro (UCB Pharma S.A.)

Neupro (UCB Pharma S.A.)

Neupro (Active substance: Rotigotine) - Centralised - Yearly update - Commission Decision (2018)7551 of Mon, 12 Nov 2018

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

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

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

Velphoro (Vifor Fresenius Medical Care Renal Pharma France)

Velphoro (Vifor Fresenius Medical Care Renal Pharma France)

Velphoro (Active substance: mixture of polynuclear iron(iii)-oxyhydroxide, sucrose and starches) - Centralised - Yearly update - Commission Decision (2018)6972 of Mon, 22 Oct 2018

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

2-10-2018

Lamivudine Teva Pharma B.V. (Teva B.V.)

Lamivudine Teva Pharma B.V. (Teva B.V.)

Lamivudine Teva Pharma B.V. (Active substance: Lamivudine) - Centralised - Yearly update - Commission Decision (2018)6476 of Tue, 02 Oct 2018

Europe -DG Health and Food Safety

1-10-2018

EU/3/16/1762 (Pharma Gateway AB)

EU/3/16/1762 (Pharma Gateway AB)

EU/3/16/1762 (Active substance: Synthetic 15-amino-acid macrocyclic peptide acylated with a polyethyleneglycol palmitoylated linker) - Transfer of orphan designation - Commission Decision (2018)6399 of Mon, 01 Oct 2018 European Medicines Agency (EMA) procedure number: EMA/OD/107/16/T/01

Europe -DG Health and Food Safety

24-9-2018

NeuroBloc (Sloan Pharma S.a.r.l.)

NeuroBloc (Sloan Pharma S.a.r.l.)

NeuroBloc (Active substance: Botulinum Toxin Type B) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)6221 of Mon, 24 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/000301/T/0101

Europe -DG Health and Food Safety

24-9-2018

Rasilez (Noden Pharma DAC)

Rasilez (Noden Pharma DAC)

Rasilez (Active substance: aliskiren) - Centralised - Yearly update - Commission Decision (2018)6229 of Mon, 24 Sep 2018

Europe -DG Health and Food Safety

24-9-2018

Kigabeq (ORPHELIA Pharma SAS)

Kigabeq (ORPHELIA Pharma SAS)

Kigabeq (Active substance: vigabatrin) - Centralised - Authorisation - Commission Decision (2018)6224 of Mon, 24 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4534

Europe -DG Health and Food Safety

24-9-2018

INCRELEX (Ipsen Pharma)

INCRELEX (Ipsen Pharma)

INCRELEX (Active substance: Mecasermin) - Centralised - Yearly update - Commission Decision (2018)6240 of Mon, 24 Sep 2018

Europe -DG Health and Food Safety

19-9-2018

Pregabalin Mylan Pharma (Mylan S.A.S.)

Pregabalin Mylan Pharma (Mylan S.A.S.)

Pregabalin Mylan Pharma (Active substance: pregabalin) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018) 6097 of Wed, 19 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/3962/T/08

Europe -DG Health and Food Safety

19-9-2018

Agenda:  Agenda – 12th Pharmacovigilance stakeholder forum

Agenda: Agenda – 12th Pharmacovigilance stakeholder forum

Europe - EMA - European Medicines Agency

19-9-2018

 12th Pharmacovigilance stakeholder forum, European Medicines Agency, London, UK, From: 24-Sep-2018, To: 24-Sep-2018

12th Pharmacovigilance stakeholder forum, European Medicines Agency, London, UK, From: 24-Sep-2018, To: 24-Sep-2018

This forum brings together regulators with patients, healthcare professionals and industry, to take stock of what we have achieved and what needs to be the focus over the coming years.

Europe - EMA - European Medicines Agency

17-9-2018

 European Medicines Agency (EMA) Human Scientific Committees' Working Parties with Patients’ and Consumers’ Organisations (PCWP) and with Healthcare Professionals’ Organisations (HCPWP), European Medicines Agency, London, UK, From: 25-Sep-2018, To: 25-Sep

European Medicines Agency (EMA) Human Scientific Committees' Working Parties with Patients’ and Consumers’ Organisations (PCWP) and with Healthcare Professionals’ Organisations (HCPWP), European Medicines Agency, London, UK, From: 25-Sep-2018, To: 25-Sep

This joint Patients' and Consumers' Working Party (PCWP) and Healthcare Professionals' Working Party (HCPWP) meeting will include results of the 2017 EMA perception survey. EMA regulatory science to 2025 will be discussed together with updates on Good Pharmacovigilance Practices (GVP). The Topic Group on Digital media and health will feedback to the working parties’ members. Participants will also receive an update on ongoing work on electronic product information and on availability of authorised med...

Europe - EMA - European Medicines Agency

12-9-2018

 Risk management plan information day, European Medicines Agency, London, UK, From: 25-Oct-2018, To: 25-Oct-2018

Risk management plan information day, European Medicines Agency, London, UK, From: 25-Oct-2018, To: 25-Oct-2018

This information day will update participants on the Agency’s medicine risk management activities and provide advice to marketing authorisation holders and applicants on drafting a risk management plan (RMP) in view of the full implementation of the second revision of the RMP template after the transitional period has elapsed. It will also provide an opportunity for an exchange of experiences with this template between regulators and industry. A dedicated session will discuss the streamlining of safety s...

Europe - EMA - European Medicines Agency

12-9-2018

ADCETRIS (Takeda Pharma A/S)

ADCETRIS (Takeda Pharma A/S)

ADCETRIS (Active substance: Brentuximab vedotin) - Centralised - Annual renewal - Commission Decision (2018)5973 of Wed, 12 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2455/R/58

Europe -DG Health and Food Safety