Protaminsulfat "LEO Pharma"

Primær information

  • Handelsnavn:
  • Protaminsulfat "LEO Pharma" 10 mg/ml injektions-/infusionsvæske, opløsning
  • Dosering:
  • 10 mg/ml
  • Lægemiddelform:
  • injektions-/infusionsvæske, opløsning
  • Brugt til:
  • Mennesker
  • Medicin typen:
  • Allopatiske stof

Dokumenter

Lokation

  • Fås i:
  • Protaminsulfat "LEO Pharma" 10 mg/ml injektions-/infusionsvæske, opløsning
    Danmark
  • Sprog:
  • dansk

Andre oplysninger

Status

  • Kilde:
  • Lægemiddelstyrelsen - Danish Medicines Agency
  • Autorisation status:
  • Ikke markedsført
  • Autorisationsnummer:
  • 46974
  • Sidste ændring:
  • 17-07-2018

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

Oversigt over indlægssedlen:

1. Virkning og anvendelse.

2. Det skal du vide om Protaminsulfat LEO

Pharma.

3. Sådan bliver du behandlet med

Protaminsulfat LEO Pharma.

4. Bivirkninger.

5. Opbevaring.

6. Yderligere oplysninger.

1. Virkning og anvendelse.

Det aktive stof er protaminsulfat, der bruges

som en anti-heparin, til at blokere virkningen

af heparin og lavmolekylær heparin og til at

nedsætte effekten af disse stoffer i kroppen.

Hepariner bruges til at forhindre dit blod i

at størkne og de kan fremkalde blødning.

Du kan få denne medicin:

For at hjælpe med at standse blødning som

er fremkaldt af heparin/lavmolekylær hepa-

rin.

For at forhindre øget blødning, hvis du

har været behandlet med heparin/ lavmole-

kylær

heparin og skal opereres.

For at ophæve virkningen af heparin,

brugt i nogle typer af hjertekirurgi.

Du skal have Protaminsulfat LEO Pharma

som en indsprøjtning. Det vil normalt

være en læge eller sygeplejerske, der

giver indsprøjtningen.

Lægen kan give dig Protaminsulfat LEO

Pharma for noget andet. Spørg lægen.

2. Det skal du vide om Prota-

minsulfat LEO Pharma

Du må ikke få Protaminsulfat LEO Pharma

hvis du er overfølsom over for protaminsul

fat, eller et af de øvrige indholdsstoffer.

Lægen eller sundhedspersonalet vil være

ekstra forsigtig med at behandle dig med

Protaminsulfat LEO Pharma

Selvom du måske allerede har fået din

indsprøjtning, skal du oplyse det til lægen

eller sygeplejersken, hvis du kan svare ja

til nogle af følgende spørgsmål. Hvis du er

usikker, spørg din egen læge.

Du skal fortælle din læge eller sygeplejerske:

hvis du er gravid eller ammer,

hvis du er diabetiker og bruger insulin

(især protamin insulin),

hvis du er allergisk over for fisk,

hvis du er en steril mand (ikke kan få børn)

eller har fået en vasektomi (en operation

som gør mænd sterile),

hvis du tidligere har været behandlet

med protaminsulfat, protamininsulin

eller protaminchlorid.

Brug af anden medicin

Fortæl det altid til lægen eller sundhedsperso-

nalet, hvis du bruger anden medicin eller har

brugt det for nylig. Dette gælder også medi-

cin, som ikke er købt på recept, medicin købt i

udlandet, naturlægemidler, stærke vitaminer

og mineraler samt kosttilskud.

Graviditet og amning

Spørg din læge eller apoteket til råds, før

du bruger nogen form for medicin.

Graviditet:

bør fremstillerens egen vejledning for hvert

LMWH konsulteres i tilfælde af overdosering.

Protaminsulfat kan kun delvis neutralisere

anti-Xa aktiviteten forårsaget af LMWH, og

neutraliseringen vil ikke være mere effektiv,

hvis højere doser af protaminsulfat er indgivet

end dem der er anbefalet. Ved neutralisering

af subkutant indgivet LMWH, er der en risiko

for, at neutraliseringen ikke er komplet med

kun én indsprøjtning af protaminsulfat.

Absorptionsfasen fra injektionsstedet vil føre

til, at yderligere LMWH tilføres cirkulationen

(en såkaldt ‘depot effekt’).

I disse tilfælde kan gentagne indgivelser af

protaminsulfat være nødvendige, eller en

konstant, langsom intravenøs infusion kan

anvendes. Der skal også tages højde for hal-

veringstiden af LMWH, når man beregner

den nødvendige dosering af protaminsulfat i

relation til den tid, der er gået siden den sidste

LMWH dosering.

Kardiopulmonal bypass procedure

Det anbefales, at doser af protaminsulfat

styres af blodkoaguleringsanalyser.

Aktiveret partiel tromboplastintid (APTT),

aktiveret koagulationstid (ACT), anti Xa

og protamin neutraliseringstest foretaget

ved patientlejet er tilstrækkelige til dette

formål. Koagulationsprøver foretages normalt

5-15 minutter efter indgivelsen af protaminsul-

fat. Normalt indgives en dosis på 0,1 ml til 0,2

ml (1 – 2 mg) Protaminsulfat LEO Pharma intra-

venøst for hver 100 enheder af heparin.

Sikkerheds- og effektdata vedrørende brug til

nyfødte eller børn er ikke tilgængelige.

Der er ingen tilgængelige informationer ved-

rørende brug af protaminsulfat hos patienter

med nedsat nyrefunktion eller leversygdomme

eller hos ældre.

INDLÆGSSEDDEL: INFORMATION TIL BRUGEREN

PROTAMINSULFAT LEO PHARMA

10 mg/ml injektions- og infusionsvæske, opløsning

Protaminsulfat

Orifarm A/S, Energivej 15, 5260 Odense S

Tlf.: +45 6395 2700

1000098061-001-01

Læs denne indlægsseddel grundigt før du begynder at bruge medicinen. Gem indlægssedlen.

Du kan få brug for at læse den igen. Spørg lægen eller sundhedspersonalet, hvis der er mere

du vil vide. Tal med lægen eller sundhedspersonalet, hvis en bivirkning bliver værre, eller du

får bivirkninger, som ikke er nævnt her.

Nyeste indlægsseddel kan findes på www.indlaegsseddel.dk

Der er ingen tilgængelig information

vedrørende brug af dette produkt hos

gravide kvinder.

Du vil normalt ikke blive behandlet med

Protaminsulfat LEO Pharma, hvis du er

gravid. Lægen vil vurdere det for hver enkelt.

Amning:

Der er ingen tilgængelig information

vedrørende brug af dette produkt hos

kvinder der ammer.

Hvis behandling med Protaminsulfat LEO

Pharma er nødvendig, bør amning afbrydes i

denne periode.

Trafik- og arbejdssikkerhed

Protaminsulfat LEO Pharma har ingen

eller ubetydelig virkning på arbejdssikkerhe-

den og evnen til at færdes sikkert i trafikken.

3. Sådan bliver du behandlet

med Protaminsulfat LEO

Pharma

Den sædvanlige dosis er

Voksne:

Dosis bliver bestemt for hver enkelt patient

og er afhængig af din sygdom.

Du vil normalt få Protaminsulfat LEO Pharma

af en læge eller sygeplejerske.

Lægen kan fortælle dig, hvilken dosis du får

og hvor tit, du skal have den. Er du i tvivl, så

spørg lægen eller sundhedspersonalet.

Det er kun lægen der kan ændre dosis.

Hvis du har fået for meget Protaminsulfat

LEO Pharma

Kontakt lægen eller sundhedspersonalet,

hvis du tror du har fået for meget Protaminsul-

fat LEO Pharma.

Symptomer:

Blødning, kløe, rødme, træthed, utilpashed,

kvalme/opkastning, hovedpine, hyperventila-

tion og temperaturstigning.

Hvis en dosis er glemt

Spørg lægen eller sundhedspersonalet, hvis du

tror du mangler at få en dosis.

Hvis behandlingen bliver stoppet

Spørg lægen eller apoteket hvis der er noget,

du er i tvivl om eller føler dig usikker på.

4. Bivirkninger

Protaminsulfat LEO Pharma kan som al

anden medicin give bivirkninger, men ikke

alle får bivirkninger.

Alvorlige bivirkninger

Hyppigheden er ikke kendt:

Kortåndethed / Vejrtrækningsbesvær /

Astmalignende anfald / Åndenød.

Kontakt straks læge eller skadestue.

Ring evt. 112.

Pludseligt hududslæt, åndedrætsbesvær

og besvimelse (inden for minutter til timer),

pga. overfølsomhed (anafylaktisk shock ).

Kan være livsfarligt. Ring 112.

Bevidsthedstab, hjertestop. Ring 112.

Blødning. Kontakt straks læge eller skade-

stue. Ring evt. 112.

Åndenød pga. forhøjet blodtryk i lungerne.

Kontakt straks læge eller skadestue.

Ring evt. 112.

Hvis du får alvorlige bivirkninger, skal du

straks kontakte lægen eller sundhedspersona-

let.

Ikke alvorlige bivirkninger

Hyppigheden er ikke kendt:

Åndenød / åndedrætsbesvær. Kan være

eller blive alvorligt. Tal med lægen.

Udslæt (nældefeber) og hævelser. Kan

være alvorligt. Tal med lægen. Hvis der er

hævelse af ansigt, læber og tunge, kan det

være livsfarligt. Ring 112.

Allergiske reaktioner.

Svimmelhed, evt. besvimelse pga. lavt blod-

tryk evt. ledsaget af langsom puls. Kan blive

alvorligt. Hvis du får meget langsom puls

eller bliver utilpas eller besvimer, skal du kon-

takte læge eller skadestue. Ring evt. 112.

Besvimelse. Ved normal puls og vejrtrækning

og hurtig opvågning, tal med læge. I alle

andre tilfælde ring 112.

Blåmarmorering af hud og slimhinder.

Sløvhedstilstand evt. medførende ubevæge-

lighed.

Rødme, nældefeber.

Kvalme, opkastning.

Rygsmerter, varmefølelse.

Tal med lægen eller apoteket, hvis en bivirk-

ning er generende eller bliver værre, eller hvis

du får bivirkninger, som ikke er nævnt her.

Bivirkninger som ikke er nævnt her, bør ind-

berettes til Lægemiddelstyrelsen, så viden om

bivirkninger kan blive bedre. Du eller dine

pårørende kan selv indberette bivirkninger

direkte til Lægemiddelstyrelsen. Du finder

skema og vejledning under bivirkninger på

Lægemiddelstyrelsens netsted:

www.meldenbivirkning.dk

5. Opbevaring

Opbevar Protaminsulfat LEO Pharma

utilgængeligt for børn.

Du kan opbevare Protaminsulfat LEO

Pharma ved almindelig temperatur.

Brug ikke Protaminsulfat LEO Pharma

efter den udløbsdato, der står på pakningen.

Hvis pakningen er mærket med EXP betyder

det at udløbsdatoen er den sidste dag i den

anførte måned.

Aflever altid medicinrester på apoteket.

Af hensyn til miljøet må du ikke smide

medicinrester i afløbet, toilettet eller

skraldespanden.

6. Yderligere oplysninger

Protaminsulfat LEO Pharma, 10 mg/ml,

injektions- og infusionsvæske, opløsning

indeholder:

1400 anti-heparin IE protaminsulfat (svarer

til 10 mg).

Øvrige indholdsstoffer:

Natriumchlorid, saltsyre, natriumhydroxid,

vand til injektionsvæsker.

Pakningsstørrelser:

Protaminsulfat LEO Pharma 10 mg/ml

injektions- og infusionsvæske, opløsning

fås i pakninger med 5 x 5 ml ampuller.

Indehaver af markedsføringstilladelsen

Orifarm A/S, Energivej 15, 5260 Odense S

Mail: info@orifarm.com

Fremstiller

Orifarm Supply s.r.o.

Palouky 1366, 25301 Hostivice, CZ

For yderligere oplysninger om denne medicin

og ved reklamationer kan du henvende dig til

Orifarm A/S.

Denne indlægsseddel blev sidst revideret

07/2015.

Teknisk brugervejledning til sundheds-

personalet

Følgende oplysninger er kun til læger og

sundhedspersonale

1 ml indeholder 1400 anti-heparin IE protamin-

sulfat (svarer til 10 mg)

5 ml indeholder 7000 anti-heparin IE protamin-

sulfat (svarer til 50 mg)

Se komplet produktresumé for yderligere

detaljer.

Therapeutiske indikationer:

Protaminsulfat kan anvendes til at modvirke

de antikoagulerende virkninger af

heparin eller LMWH (se produktresumé).

Dosering og indgivelsesmåde

Protaminsulfat indgives som en langsom

intravenøs injektion over en periode på ca. 10

minutter eller som en konstant, langsom intra-

venøs infusion. Den største enkelte injektion

(bolus dosis) bør ikke overstige 5 ml (7000 anti-

heparin IU/50 mg protaminsulfat). Ideelt bør

dosen være styret af blodkoagulationsanalyser.

Aktiveret partiel tromboplastintid (APTT)

aktiveret koagulationstid (ACT), anti Xa og

protamin neutraliseringstest foretaget ved

patientlejet er tilstrækkelige til dette formål.

Koaguleringsprøver foretages normalt 5-15

minutter efter indgivelsen af protaminsulfat.

Yderligere doser kan være nødvendige, fordi

protaminsulfat forlader blodet hurtigere end

heparin og især LMWH. Den forlængede

absorption efter subkutan administration

af heparin eller LMWH kan også indikere, at

flere doser skal indgives.

Neutralisering af heparin

1 ml Protaminsulfat LEO Pharma (10 mg

protaminsulfat) vil neutralisere ca. 1400 IE

af heparin. Da heparin har en relativ kort

halveringstid når den er givet intravenøst

(30 minutter - 2 timer), bør dosis af protamin-

sulfat justeres, baseret på den tid der er gået,

siden den intravenøse indgivelse af heparin er

stoppet. Dosis af protaminsulfat, relateret til

den indgivne mængde af heparin, bør redu-

ceres, hvis der er gået mere end 15 minutter,

siden intravenøs injektion af heparin er stop-

pet.

Neutralisering af lavmolekylær heparin

(LMWH) Den normalt anbefalede dosis er

1 ml Protaminsulfat LEO Pharma (10 mg

protaminsulfat) per 1000 anti Xa IE

LMWH. Protaminsulfat neutraliserer de

forskellige LMWHer i forskellig grad; derfor

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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

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

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

26-9-2018

Sileo (Orion Corporation)

Sileo (Orion Corporation)

Sileo (Active substance: Dexmedetomidine hydrochloride) - Centralised - Yearly update - Commission Decision (2018)6325 of Wed, 26 Sep 2018

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

29-8-2018

Cometriq (Ipsen Pharma)

Cometriq (Ipsen Pharma)

Cometriq (Active substance: cabozantinib) - PSUSA - Modification - Commission Decision (2018)5761 of Wed, 29 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/PSUSA/10180/201711

Europe -DG Health and Food Safety

29-8-2018

Rasilez HCT (Noden Pharma DAC)

Rasilez HCT (Noden Pharma DAC)

Rasilez HCT (Active substance: aliskiren hemifumarate / hydrochlorothiazide) - Centralised - Renewal - Commission Decision (2018)5769 of Wed, 29 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/964/R/87

Europe -DG Health and Food Safety

28-8-2018

EU/3/18/2056 (Nogra Pharma Limited)

EU/3/18/2056 (Nogra Pharma Limited)

EU/3/18/2056 (Active substance: (S)-(-)-3-(4-aminophenyl)-2-methoxypropanoic acid) - Orphan designation - Commission Decision (2018)5728 of Tue, 28 Aug 2018 European Medicines Agency (EMA) procedure number: EMA/OD/075/18

Europe -DG Health and Food Safety

28-8-2018

EU/3/18/2061 (Pharma Gateway AB)

EU/3/18/2061 (Pharma Gateway AB)

EU/3/18/2061 (Active substance: Autologous glioma tumour cells treated with antisense molecule directed against the insulin-like growth factor type 1 receptor) - Orphan designation - Commission Decision (2018)5739 of Tue, 28 Aug 2018 European Medicines Agency (EMA) procedure number: EMA/OD/049/18

Europe -DG Health and Food Safety

27-8-2018

Yescarta (Kite Pharma EU B.V.)

Yescarta (Kite Pharma EU B.V.)

Yescarta (Active substance: axicabtagene ciloleucel) - Centralised - Authorisation - Commission Decision (2018)5718 of Mon, 27 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4480

Europe -DG Health and Food Safety

27-8-2018

Entyvio (Takeda Pharma A/S)

Entyvio (Takeda Pharma A/S)

Entyvio (Active substance: vedolizumab) - PSUSA - Modification - Commission Decision (2018)5712 of Mon, 27 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/PSUSA/10186/201711

Europe -DG Health and Food Safety

27-8-2018

Arixtra (Aspen Pharma Trading Limited)

Arixtra (Aspen Pharma Trading Limited)

Arixtra (Active substance: Fondaparinux sodium) - PSUSA - Modification - Commission Decision (2018)5708 of Mon, 27 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/403/PSUSA/1467-201712

Europe -DG Health and Food Safety

17-8-2018

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

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

EU/3/17/1870 (Active substance: Thymidine and deoxycytidine) - Transfer of orphan designation - Commission Decision (2018)5403 of Fri, 17 Aug 2018 European Medicines Agency (EMA) procedure number: EMA/OD/317/16/T/01

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

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

2-8-2018

EU/3/18/2048 (Pharma Gateway AB)

EU/3/18/2048 (Pharma Gateway AB)

EU/3/18/2048 (Active substance: N-acetylgalactosamine-conjugated synthetic double-stranded oligomer specific to serpin family A member 1 gene) - Orphan designation - Commission Decision (2018)5280 of Thu, 02 Aug 2018 European Medicines Agency (EMA) procedure number: EMA/OD/061/18

Europe -DG Health and Food Safety

2-8-2018

EU/3/18/2051 (Wave life Sciences Ireland Limited)

EU/3/18/2051 (Wave life Sciences Ireland Limited)

EU/3/18/2051 (Active substance: Synthetic antisense oligonucleotide directed against human dystrophin pre-mRNA) - Orphan designation - Commission Decision (2018)5283 of Thu, 02 Aug 2018 European Medicines Agency (EMA) procedure number: EMA/OD/032/18

Europe -DG Health and Food Safety

2-8-2018

EU/3/18/2041 (Ionis USA Limited)

EU/3/18/2041 (Ionis USA Limited)

EU/3/18/2041 (Active substance: 2'-O-(2-methoxyethyl) antisense oligonucleotide targeting microtubule-associated protein tau pre-mRNA) - Orphan designation - Commission Decision (2018)5273 of Thu, 02 Aug 2018 European Medicines Agency (EMA) procedure number: EMA/OD/050/18

Europe -DG Health and Food Safety