Adrenalin "Martindale Pharma"

Primær information

  • Handelsnavn:
  • Adrenalin "Martindale Pharma" 0,1 mg/ml injektionsvæske, opløsning
  • Dosering:
  • 0,1 mg/ml
  • Lægemiddelform:
  • injektionsvæske, opløsning
  • Brugt til:
  • Mennesker
  • Medicin typen:
  • Allopatiske stof

Dokumenter

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Lokation

  • Fås i:
  • Adrenalin "Martindale Pharma" 0,1 mg/ml injektionsvæske, opløsning
    Danmark
  • Sprog:
  • dansk

Andre oplysninger

Status

  • Kilde:
  • Lægemiddelstyrelsen - Danish Medicines Agency
  • Autorisationsnummer:
  • 58718
  • Sidste ændring:
  • 31-01-2018

Produktresumé

15. marts 2017

PRODUKTRESUMÉ

for

Adrenalin "Martindale Pharma", injektionsvæske, opløsning

0.

D.SP.NR.

30550

1.

LÆGEMIDLETS NAVN

Adrenalin "Martindale Pharma"

2.

KVALITATIV OG KVANTITATIV SAMMENSÆTNING

1 ml injektionsvæske indeholder adrenalintartrat svarende til 0,1 mg adrenalin.

Hver 10 ml ampul indeholder adrenalintartrat svarende til 1 mg adrenalin.

Hjælpestof, som behandleren skal være opmærksom på

1,0 mg natriummetabisulfit pr. ml (E223).

Alle hjælpestoffer er anført under pkt. 6.1.

3.

LÆGEMIDDELFORM

Injektionsvæske, opløsning

Klar, farveløs opløsning. pH = 2,5 til 3,5.

4.

KLINISKE OPLYSNINGER

4.1

Terapeutiske indikationer

Kardiopulmonal genoplivning.

Akut anafylaksi.

4.2

Dosering og indgivelsesmåde

Kardiopulmonal genoplivning

Adrenalin bør doseres og administreres efter gældende behandlingsanbefalinger. Følgende

dosering af adrenalin er baseret på anbefalingerne fra ERC (European Resuscitation

Council) i 2015.

Voksne og børn over 12 år

1 mg adrenalin som intravenøs bolusdosis hver 3. - 5. minut.

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Hvis lægemidlet indgives via et perifert venekateter, skal det skylles ud med mindst 20 ml

% natriumchlorid til injektion (for at lette adgangen ind til det centrale kredsløb).

Hvis venøs adgang ikke er tilgængelig, anbefales intraossøs administration.

Børn under 12 år

0,01 mg/kg som intravenøs bolusdosis. Højeste enkeltdosis er 1 mg.

Nyfødte

0,01-0,03 mg/kg som intravenøs bolusdosis. Det anbefales at administrere lægemidlet via

et navlevenekateter.

Akut anafylaksi

Kontrollér altid, at den korrekte styrke af adrenalinopløsning anvendes ved behandling af

anafylaksi.

På udstyret til behandling af anafylaktisk shock, skal der være meget tydeligt forskel på

0,1 mg/ml og 1 mg/ml adrenalinopløsning.

Intramuskulær administration af 1 mg/ml adrenalinopløsning foretrækkes til behandling af

anafylaktisk shock. Det er også vigtigt, at der ikke spildes tid på at forsøge at finde en

intravenøs adgang, hvis intramuskulær injektion stadig er muligt.

Ved behandling af anafylaksi bør adrenalin for intravenøs administration kun anvendes af

erfarent personale og under observation af puls og blodtryk.

Hos voksne gives 0,1 mg/ml adrenalinopløsning som 0,05 mg i.v. bolusdosis og titreres

gennem øgning med bolusdoser på 0,05 mg i henhold til respons.

4.3

Kontraindikationer

Overfølsomhed over for det aktive stof eller over for et eller flere af hjælpestofferne anført

i pkt. 6.1.

Se pkt. 4.4. for yderligere information om sulfitter.

4.4

Særlige advarsler og forsigtighedsregler vedrørende brugen

Adrenalin bør anvendes med forsigtighed hos patienter med hjerte-kar-sygdomme,

herunder angina pectoris, obstruktiv kardiomyopati, hjertearytmi, cor pulmonale,

aterosklerose og hypertension på grund af øget risiko for bivirkninger efter indgivelse.

Adrenalin bør anvendes med forsigtighed hos patienter med hyperthyroidisme,

fæokromocytomer, snævervinklet glaukom, svært nedsat nyrefunktion, prostatahyperplasi

med urinretention, hypercalcæmi, hypokaliæmi og diabetes.

Adrenalin bør anvendes med forsigtighed hos ældre og gravide patienter.

Virkningen af beta-agonister kan være helt eller delvist hæmmet ved samtidig behandling

med ikke-selektive beta-blokkere.

Adrenalin "Martindale Pharma" indeholder natriummetabisulfit som kan forårsage

allergiske reaktioner, herunder anafylaksi og livstruende eller mindre alvorlige astmatiske

reaktioner hos særligt modtagelige patienter.

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Forekomsten af natriummetabisulfit i parenteral adrenalin og risikoen for allergiske

reaktioner bør ikke hindre brugen af lægemidlet, når det er indiceret til behandling af

alvorlige allergiske reaktioner eller andre nødsituationer.

4.5

Interaktion med andre lægemidler og andre former for interaktion

Adrenalin interagerer med:

Beta-blokkere

Der er et dusin rapporter om svær hypertension og bradykardi hos patienter behandlet med

ikke-selektive beta-receptor blokkere (herunder pindolol og propanolol), som har fået

adrenalin. Disse kliniske observationer er blevet bekræftet i studier med raske frivillige

forsøgspersoner. Det er også blevet foreslået, at adrenalin, som tilsættes til en

lokalbedøvelse, kan udløse disse reaktioner ved intravaskulær administration. Risikoen bør

være betydeligt mindre med kardioselektive beta-blokkere.

Inhalationsanæstetika (inklusiv kloroform)

Adrenalin og muligvis andre beta-receptor stimulerende sympatomimetiske midler, så som

isoprenalin, injiceret under narkose med ethylchlorid, halothan, enfluran, trichlorethylen og

chloroform, kan udløse alvorlige hjertearytmier.

Ikke-selektive MAO-hæmmere

Normal dosering af tricykliske antidepressiva har vist sig at øge adrenalin

pressorvirkningen 2-3 gange ved akut i.v. administration af høje doser adrenalin.

Vedvarende hypertension er blevet observeret hos en patient behandlet med protriptylin

efter administration af 0,5 mg adrenalin subkutant. Isoprenalin, orciprenalin, fenoterol,

terbutalin eller salbutamol kan anvendes ved astma.

Ved lokalbedøvelse i tandlægepraksis er der ikke rapporteret udtalte reaktioner, men i de

senere år har felypressin været brugt profylaktisk som en vasokonstriktor.

Maprotilin

Risiko for forstærkede kardiovaskulære virkninger af adrenalin hos patienter behandlet

med tetracykliske antidepressiva. Isoprenalin, orciprenalin, fenoterol, terbutalin eller

salbutamol kan anvendes ved astma. I en tandlægepraksis er felypressin en egnet

vasokonstriktor.

Skal anvendes med forsigtighed hos patienter som behandles med lægemidler, der kan

udløse arytmier, herunder digitalis og kinidin.

Adrenalin hæmmer udskillelsen af insulin og øger dermed blodsukkeret. Det være

nødvendigt at øge doseringen af insulin eller orale hypoglykæmiske lægemidler ved

adrenalinbehandling af diabetikere.

Lægemidler, der indeholder mono-amino-oxidase (MAO) hæmmere, catechol-O-

methyltransferase (COMT) hæmmere eller tricykliske antidepressiva kan potensere

virkningen af adrenalin.

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4.6

Graviditet og amning

Fertilitet

Der er ikke udført dyreforsøg med henblik på adrenalins virkning på fertilitet.

Graviditet

Klinisk erfaring med behandling af gravide kvinder er begrænset. Data fra dyreforsøg er

utilstrækkelige.

Amning

Adrenalin går over i modermælken. Mødre, der behandles med adrenalin, bør ikke amme.

4.7

Virkninger på evnen til at føre motorkøretøj eller betjene maskiner

Ikke mærkning.

Ikke relevant under normale anvendelsesforhold.

4.8

Bivirkninger

De mest almindelige bivirkninger af adrenalin er påvirkning af kredsløbet og

centralnervesystemet. Ca. en tredjedel af patienterne oplever bivirkninger.

Almindelige (>1/100):

Alment:

Hovedpine, svimmelhed.

Kredsløb:

Takykardi, hypertension (ved høje doser),

ventrikulær arytmi.

CNS:

Angst, tremor.

Takykardi og hypertension kan medføre mulige risici ved hjerte-kar-sygdomme.

Ventrikulære arytmier kan fremkaldes, især hvis adrenalin indgives under anæstesi med

inhalationsanæstetika, hvilket øger hjertets følsomhed over for katekolaminer, for

eksempel alkylhalogenider, så som halothan og trichlorethylen.

Indberetning af formodede bivirkninger

Når lægemidlet er godkendt, er indberetning af formodede bivirkninger vigtig. Det

muliggør løbende overvågning af benefit/risk-forholdet for lægemidlet. Læger og

sundhedspersonale anmodes om at indberette alle formodede bivirkninger via:

Lægemiddelstyrelsen

Axel Heides Gade 1

DK-2300 København S

Websted: www.meldenbivirkning.dk

E-mail: dkma@dkma.dk

4.9

Overdosering

Symptomer på overdosering

Ved moderate doser

Ophidselse, angst, tremor, hovedpine takykardi, palpitationer, bleghed, koldsved, kvalme,

opkastning.

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Ved høje doser

Mydriasis, øget blodtryk, ventrikulære arytmier, hjerteinsufficiens, lungeødem.

Behandling

EKG overvågning. I udtalte tilfælde af sinustakykardi og ventrikulær arytmi, behandles

med propranolol (hos astmatikere hellere metoprolol eller alternativt atenolol). Alternativ

behandling af ventrikulær arytmi er lidokain. Ved alfa-adrenerge symptomer (såsom

vasospasme, hypertension) behandles med phentolamin 2,5-5 mg (børn 0,05-0,1 mg/kg)

i.v. hvert 5. minut efter behov, derefter eventuelt som infusion. Alternativt kan der

behandles med glyceryltrinitrat 0,5-1 mg sublingualt i gentagne doser eller intravenøs

infusion af 0,5 mcg/kg/minut initialt og med en øgning af dosis med 0,5 mcg/kg/min hver

5 - 10 minutter, indtil den ønskede effekt er opnået. Furosemid ved lungeødem. Ellers

symptomatisk behandling.

Toksicitet

Inhalation kan forårsage systemiske virkninger, da det bliver deaktiveret i mave-tarm-

kanalen. Laveste dødelige dosis angives som 4 mg, men generelt 7-8 mg. 4 mg indgivet

subkutant til en 12-årig medførte alvorlig forgiftning. Hos voksne medførte 3 mg subkutant

moderat forgiftning, 16 mg subkutant medførte alvorlig forgiftning og 30 mg indgivet

intravenøst i 1 minut medførte meget alvorlig forgiftning. 50 mg indgivet intravenøst til en

2-årig medførte irreversibelt nyresvigt.

4.10

Udlevering

5.

FARMAKOLOGISKE EGENSKABER

5.0

Terapeutisk klassifikation

ATC-kode: C 01 CA 24. Adrenerge og dopaminerge midler, adrenalin.

5.1

Farmakodynamiske egenskaber

Adrenalin er et direkte virkende sympatomimetisk middel, som har effekt på både α- og β

receptorer. Det udviser mindre selektivitet mellem

- og

-receptorer men er betydelig

mere selektiv for β

end på β

De vigtigste virkninger omfatter øget systolisk blodtryk, nedsat diastolisk blodtryk,

takykardi, hyperglykæmi og hypokaliæmi.

5.2

Farmakokinetiske egenskaber

Farmakologisk aktive koncentrationer af adrenalin opnås ikke efter oral administration, da

adrenalin hurtigt oxideres og konjugeres i mave-tarm-kanalens slimhinde og i leveren.

Absorptionen fra subkutant og intramuskulært væv sker langsomt på grund af lokal

vasokonstriktion. Absorptionen er hurtigere efter intramuskulær injektion end efter

subkutan injektion.

Adrenalins binding til plasmaproteiner er cirka 20-30 %.

Adrenalin distribueres hurtigt til hjertet, milten, flere kirtelvæv og adrenerge nerver. Det

krydser let placenta og ca. 50 % er bundet til plasmaproteiner. Adrenalin inaktiveres

58718_spc.docx

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hurtigt i kroppen, mest af enzymerne catechol-O-methyltransferase (COMT) og mono-

amino-oxidase

MAO). En stor del af dosis udskilles som metabolitter i urinen.

Kun små mængder udskilles uændret. Cirkulerende adrenalin, der ikke inaktiveres

enzymatisk, inaktiveres gennem genoptag i nærheden af synaptiske receptorer.

Der foreligger ikke farmakokinetiske data for patienter med nedsat lever- eller

nyrefunktion. Farmakokinetiske data med hensyn til køn, race, vægt eller ældre er ikke

tilgængelig. Farmakokinetiske data for børn er begrænset.

5.3

Prækliniske sikkerhedsdata

Der foreligger ikke yderligere prækliniske data af relevans for den ordinerende læge ud

over, hvad der allerede er inkluderet i produktresuméet.

6.

FARMACEUTISKE OPLYSNINGER

6.1

Hjælpestoffer

Natriumchlorid

Citronsyremonohydrat

Natriumcitrat

Natriummetabisulfit (E223)

Saltsyre (til justering af pH)

Vand til injektionsvæsker

6.2

Uforligeligheder

I kompatibilitetsstudier har dette lægemiddel vist sig at være kompatibelt med 0,9 %

natriumchlorid.

6.3

Opbevaringstid

1 år.

6.4

Særlige opbevaringsforhold

Opbevares ved temperaturer under 25 °C.

Opbevar ampullerne i den ydre karton for at beskytte mod lys.

6.5

Emballagetyper og pakningsstørrelser

Glas ampuller (type 1)

Pakningsstørrelser: 10×10 ml.

Ikke alle pakningsstørrelser er nødvendigvis markedsført.

6.6

Regler for destruktion og anden håndtering

Kun til engangsbrug.

7.

INDEHAVER AF MARKEDSFØRINGSTILLADELSEN

Martindale Pharma

Bampton Road, Herold Hill

Romford RM3 8UG

Storbritannien

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Repræsentant

Unimedic Pharma AB

Sundbybergsvägen 1

171 73 Solna

Sverige

8.

MARKEDSFØRINGSTILLADELSESNUMMER (NUMRE)

58718

9.

DATO FOR FØRSTE MARKEDSFØRINGSTILLADELSE

15. marts 2017

10.

DATO FOR ÆNDRING AF TEKSTEN

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Side 7 af 7

  • Oplysningerne indlægssedlen for dette produkt er i øjeblikket ikke tilgængelig, kan du sende en anmodning til vores kundeservice, og vi vil give dig besked, så snart vi er i stand til at opnå det.

    Anmode informationsbrochure for offentligheden.



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Compounded Products Containing Triamcinolone-Moxifloxacin by Guardian Pharmacy Services (Dallas, Texas): Alert to Health Professionals - Adverse Events Reported After Receiving Eye Injections

Compounded Products Containing Triamcinolone-Moxifloxacin by Guardian Pharmacy Services (Dallas, Texas): Alert to Health Professionals - Adverse Events Reported After Receiving Eye Injections

At least 43 patient reported adverse event after receiving eye injections of Guardian’s Pharmacy Services compounded triamcinolone-moxifloxacin product during cataract surgery. The patients reportedly experienced various symptoms, including vision impairment, poor night vision, loss of color perception, and significant reductions in best-corrected visual acuity and visual fields. FDA identified multiple substances in Guardian’s product, including poloxamer 407 and poloxamer 407 degradants. FDA prepared i...

FDA - U.S. Food and Drug Administration

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

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

1-8-2018

Ucedane (Lucane Pharma)

Ucedane (Lucane Pharma)

Ucedane (Active substance: carglumic acid) - Centralised - Yearly update - Commission Decision (2018)5230 of Wed, 01 Aug 2018

Europe -DG Health and Food Safety

1-8-2018

Opdivo (Bristol-Myers Squibb Pharma EEIG)

Opdivo (Bristol-Myers Squibb Pharma EEIG)

Opdivo (Active substance: nivolumab) - Centralised - 2-Monthly update - Commission Decision (2018)5204 of Wed, 01 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/3985/II/41

Europe -DG Health and Food Safety

30-7-2018

Ceplene (Noventia Pharma Srl)

Ceplene (Noventia Pharma Srl)

Ceplene (Active substance: Histamine dihydrochloride) - Centralised - Renewal - Commission Decision (2018)5116 of Mon, 30 Jul 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/796/R/36

Europe -DG Health and Food Safety

23-7-2018

Dificlir (Astellas Pharma Europe B.V.)

Dificlir (Astellas Pharma Europe B.V.)

Dificlir (Active substance: fidaxomicin) - Centralised - Yearly update - Commission Decision (2018)4889 of Mon, 23 Jul 2018

Europe -DG Health and Food Safety

23-7-2018

Qarziba (EUSA Pharma (UK) Limited)

Qarziba (EUSA Pharma (UK) Limited)

Qarziba (Active substance: dinutuximab beta) - Centralised - Yearly update - Commission Decision (2018)4886 of Mon, 23 Jul 2018

Europe -DG Health and Food Safety

19-7-2018

Aplidin (Pharma Mar S.A.)

Aplidin (Pharma Mar S.A.)

Aplidin (Active substance: plitidepsin) - Refusal of authorisation - Commission Decision (2018)4831 of Thu, 19 Jul 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4354

Europe -DG Health and Food Safety

13-7-2018

Briviact (UCB Pharma S.A.)

Briviact (UCB Pharma S.A.)

Briviact (Active substance: brivaracetam) - Centralised - 2-Monthly update - Commission Decision (2018)4715 of Fri, 13 Jul 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/3898/II/10/G

Europe -DG Health and Food Safety

10-7-2018

Ninlaro (Takeda Pharma A/S)

Ninlaro (Takeda Pharma A/S)

Ninlaro (Active substance: ixazomib) - Centralised - Yearly update - Commission Decision (2018)4463 of Tue, 10 Jul 2018

Europe -DG Health and Food Safety

4-7-2018

Prialt (RIEMSER Pharma GmbH)

Prialt (RIEMSER Pharma GmbH)

Prialt (Active substance: ziconotide) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)4334 of Wed, 04 Jul 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/551/T/56

Europe -DG Health and Food Safety

29-6-2018

EU/3/18/2036 (PharmaKrysto Ltd)

EU/3/18/2036 (PharmaKrysto Ltd)

EU/3/18/2036 (Active substance: L-cystine bis(N'-methylpiperazide)) - Orphan designation - Commission Decision (2018)4181 of Fri, 29 Jun 2018 European Medicines Agency (EMA) procedure number: EMA/OD/012/18

Europe -DG Health and Food Safety

27-6-2018

Yondelis (Pharma Mar S.A.)

Yondelis (Pharma Mar S.A.)

Yondelis (Active substance: Trabectedin) - PSUSA - Modification - Commission Decision (2018)4096 of Wed, 27 Jun 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/PSUSA/3001/201709

Europe -DG Health and Food Safety

19-6-2018

Xyrem (UCB Pharma S.A.)

Xyrem (UCB Pharma S.A.)

Xyrem (Active substance: Sodium oxybate) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)3912 of Tue, 19 Jun 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/593/T/74

Europe -DG Health and Food Safety

11-6-2018

Cimzia (UCB Pharma S.A.)

Cimzia (UCB Pharma S.A.)

Cimzia (Active substance: certolizumab pegol ) - Centralised - 2-Monthly update - Commission Decision (2018)3768 of Mon, 11 Jun 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/1037/II/65

Europe -DG Health and Food Safety