Heparin LEO

Primær information

  • Handelsnavn:
  • Heparin LEO 100 IE/ml injektionsvæske, opløsning
  • Dosering:
  • 100 IE/ml
  • Lægemiddelform:
  • injektionsvæske, opløsning
  • Brugt til:
  • Mennesker
  • Medicin typen:
  • Allopatiske stof

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Lokation

  • Fås i:
  • Heparin LEO 100 IE/ml injektionsvæske, opløsning
    Danmark
  • Sprog:
  • dansk

Andre oplysninger

Status

  • Kilde:
  • Lægemiddelstyrelsen - Danish Medicines Agency
  • Autorisationsnummer:
  • 51072
  • Sidste ændring:
  • 22-02-2018

Produktresumé: dosering, interaktioner, bivirkninger

22. august 2017

PRODUKTRESUMÉ

for

Heparin "LEO", injektionsvæske, opløsning (Orifarm)

0.0

D.sp.nr.

0501

1.0

LÆGEMIDLETS NAVN

Heparin "LEO"

2.0

KVALITATIV OG KVANTITATIV SAMMENSÆTNING

Heparinnatrium 100 IE/ml

Hjælpestoffer, som behandleren skal være opmærksom på:

Natrium (3,53 mg)

Benzylalkohol (10 mg)

Parahydroxybenzoat

Alle hjælpestoffer er anført under pkt. 6.1.

3.0

LÆGEMIDDELFORM

Injektionsvæske, opløsning (Orifarm).

4.

KLINISKE OPLYSNINGER

4.1

Terapeutiske indikationer

Forebyggelse af koagulation i venekanyler.

4.2

Dosering og indgivelsesmåde

Intravenøse katetre o.lign. lukkes med heparinprop. Anbefalet dosis: 0,5-2 ml af 100 IE/ml

afhængigt af størrelsen på kateteret, 1-2 gange dagligt eller efter behov. Ved anvendelse én

gang i døgnet eller sjældnere bruges 1.000 IE/ml.

4.3

Kontraindikationer

Overfølsomhed over for det aktive stof eller nogen af hjælpestofferne anført i pkt. 6.1.

Nuværende eller tidligere immunmedieret heparin-induceret trombocytopeni (type II) (se

pkt. 4.4).

Aktiv større blødning og risikofaktorer for større blødning. En blødning er defineret som

større, når den opfylder et af de følgende fire kriterier:

51072_spc.doc

Side 1 af 7

1) Fatal blødning. 2) Blødning i et kritisk område eller organ (f.eks. intrakranial,

intraspinal, intraokular, retroperitoneal, intra-artikulær, perikardial, intrauterin eller

intramuskulær med kompartmentsyndrom. 3) Blødning, der fremkalder et fald i

hæmoglobinkoncentrationen på 20 g/L (1,24 mmol/L) eller mere. 4) Blødning, der

medfører transfusion af 2 eller flere portioner fuldblod eller røde blodlegemer.

Septisk endocarditis.

Heparin “LEO” er kontraindiceret ved lokalanæstesi for patienter, der modtager heparin for

behandling snarere end for profylakse. Heparin “LEO” er desuden kontraindiceret ved

indsættelse af epidural kateter i patienter, der får behandlingsdoser af heparin. Fjernelse

eller manipulation af et epiduralkateter bør kun ske, når fordelen opvejer risikoen (se pkt.

4.4).

Heparin ”LEO” indeholder 10 mg/ml af konserveringsmidlet benzylalkohol. Det må ikke

gives til for tidligt fødte og nyfødte børn på grund af risikoen for gispende syndrom.

4.4

Særlige advarsler og forsigtighedsregler vedrørende brugen

Der bør udvises forsigtighed ved administration af Heparin ”LEO” til patienter med risiko

for blødning.

Kombination med lægemidler, der påvirker trombocytfunktionen eller

koagulationssystemet bør undgås eller overvåges nøje (se pkt. 4.5).

For patienter, der undergår epidural eller spinal anæstesi eller spinal punktur, kan

profylaktisk behandling med heparin meget sjældent være associeret med epidural eller

spinal hæmatom, som kan resultere i forlænget eller permanent paralyse. Risikoen forøges

ved brug af epidural eller spinal kateter til anæstesi, ved samtidig brug af stoffer der

influerer på hæmostasen som for eksempel non-steroide antiinflammatoriske stoffer

(NSAID), blodpladeinhibitorer eller antikoagulation og ved traumatisk eller gentagne

punkturer.

I beslutningsprocessen om intervallet mellem den sidste indgift af heparin ved

profylaktiske doser (≤ 15,000 IE / dag) og placeringen eller fjernelse af et peridural eller

spinal kateter, bør produktkarakteristika og patientprofil tages i betragtning. Placering eller

fjernelse af et peridural eller spinal kateter bør ikke tillades, før 4-6 timer efter sidste

heparin administration og efterfølgende dosis ikke bør finde sted før mindst 1 time efter

procedure. For behandlingsdoser (> 15,000 IE / dag), bør anbringelse eller fjernelse af et

peridural eller spinal kateter ikke tillades, før 4-6 timer efter sidste intravenøs heparin

administration eller 8-12 timer efter sidste subkutan heparin administration. Re-

administration bør udsættes, indtil den kirurgiske procedure er afsluttet eller mindst 1 time

efter proceduren.

Hvis en læge beslutter at administrere antikoagulantia i forbindelse med peridural eller

spinal anæstesi, skal ekstrem årvågenhed og hyppig overvågning udvises for at afsløre

eventuelle tegn og symptomer på neurologisk svækkelse, såsom rygsmerter, sensorisk og

motorisk deficit (følelsesløshed og svaghed i underekstremiteterne) og dysfunktion af tarm

eller blære. Sygeplejersker bør trænes til at afsløre sådanne tegn og symptomer. Patienter

bør instrueres i at straks at informere en sygeplejerske eller en læge, hvis de mærker nogen

af disse. Øjeblikkelig diagnosticering og behandling herunder dekompression af rygmarven

bør initieres, hvis tegn eller symptomer på epidural eller spinal hæmatom mistænkes.

51072_spc.doc

Side 2 af 7

Heparin bør ikke indgives ved intramuskulær injektion på grund af risikoen for hæmatom.

På grund af risikoen for hæmatom bør samtidig intramuskulære injektioner også undgås

På grund af risikoen for immunmedieret heparininduceret trombocytopeni (type II), bør

trombocyttal måles før starten på behandlingen og regelmæssigt derefter. Heparin ”LEO”

skal seponeres hos patienter, som udvikler immunmedieret heparin-induceret

trombocytopeni (type II) (se pkt. 4.3 og 4.8). Trombocyttal vil normalt normaliseres inden

for 2 til 4 uger efter nedtrapningen.

Heparin med lav molekylevægt bør ikke anvendes som et alternativ til heparin i tilfælde af

heparin-induceret trombocytopeni (type II).

Heparinprodukter kan undertrykke adrenal sekretion af aldosteron, der fører til

hyperkaliæmi (se pkt. 4.8). Risikofaktorer omfatter diabetes mellitus, kronisk nyresvigt,

præ-eksisterende metabolisk acidose, forhøjet plasma-kalium ved forbehandling, samtidig

behandling med lægemidler, der kan ophøje plasma kalium og langvarig brug af heparin

(se pkt. 4.5).

Hos patienter i risikogruppen bør kaliumniveauerne måles før start med Heparin ”LEO”

og overvåges regelmæssigt derefter. Heparin-relateret hyperkaliæmi er som regel

reversibel ved behandlingsophør, selvom andre metoder kan være nødvendige at overveje,

hvis heparinbehandlingen vurderes at være livreddende (f.eks nedsætte kaliumindtagelse

og seponere andre lægemidler, der kan påvirke kaliumbalancen).

Heparin ”LEO” indeholder benzylalkohol, methyl-og propylhydrobenzoat og natrium som

hjælpestoffer.

Methyl-og propylhydroxybenzoat kan forårsage allergiske reaktioner (muligvis

forsinkede), og undtagelsesvis bronkospasme.

På grund af risikoen for fatale toksiske reaktioner som følge af eksponering for

benzylalkohol på over 90 mg / kg / dag, bør dette produkt anvendes med forsigtighed hos

spædbørn og børn op til 3 år (se pkt. 4.3).

Heparin ”LEO” indeholder 1,3 mmol natrium (eller 29 mg) per 10 ml hætteglas og dette

bør tages i betragtning hos patienter på en kontrolleret natrium diæt.

4.5

Interaktion med andre lægemidler og andre former for interaktion

Den antikoagulerende virkning af Heparin ”LEO” kan forstærkes ved samtidig

administration af andre lægemidler, der påvirker koagulationssystemet, såsom de, der

hæmmer trombocytfunktionen (f.eks acetylsalicylsyre, andre non-steroide anti-

inflammatoriske lægemidler (NSAID) og selektive serotonin reuptake hæmmere (SSRI-

præparater), trombolytika, vitamin K-antagonister, aktiveret protein C og direkte factor Xa

og IIa hæmmere. Sådanne kombinationer bør undgås eller overvåges nøje (se pkt. 4.4).

4.6

Graviditet og amning

Fertilitet

Der er ingen kliniske studier med heparin med hensyn til fertilitet.

Graviditet

Antikoagulerende behandling af gravide kvinder kræver inddragelse af en specialist.

51072_spc.doc

Side 3 af 7

En stor mængde data på gravide kvinder (mere end 1000 graviditeter) indikerer ingen

misdannelser eller føtal/neonatal toksicitet af heparin.

Heparin krydser ikke placenta og kan bruges i alle trimestre af graviditeten ved klinisk

behov.

Der bør udvises forsigtighed i forhold til risikoen for blødning, især under fødsel og

epidural anæstesi (se pkt. 4.3 og 4.4).

På grund af risikoen for spinalt hæmatom er behandling med doser af heparin

kontraindiceret hos patienter, som får neuraxial anæstesi (se pkt. 4.3). Derfor bør epidural

anæstesi hos gravide kvinder altid forsinkes indtil mindst 4-6 timer efter intravenøs

administration af den sidste behandlingsdosis af heparin, og 8-12 timer efter subkutan

administration af den sidste behandlingsdosis heparin. Dog kan profylaktiske doser

anvendes, så længe der tillades en minimum forsinkelse på 4-6 timer mellem den sidste

indgift af heparin og nål- eller kateteranbringelsen (se pkt. 4.4).

Heparin ”LEO” indeholder benzylalkohol. Dette konserveringsmiddel kan passere

placentabarrieren.

Amning

Heparin udskilles ikke i modermælken og kan anvendes under amning.

4.7

Virkninger på evnen til at føre motorkøretøj eller betjene maskiner

Ikke mærkning.

Heparin ”LEO” påvirker ikke eller kun i ubetydelig grad evnen til at føre motorkøretøj

eller betjene maskiner.

4.8

Bivirkninger

Beregningen af hyppigheden af bivirkninger er baseret på en samlet analyse af data fra

kliniske studier og spontane rapporter.

De hyppigst rapporterede bivirkninger er blødning og erytem.

Blødning kan opstå i ethvert organ og har forskellige sværhedsgrader (se pkt. 4.4).

Komplikationer kan opstå især ved høje doser. Selv om de store blødninger er

ualmindelige, er død eller varig invaliditet rapporteret i nogle tilfælde.

Immun-medieret heparin-induceret trombocytopeni (type II) er en ualmindelig, men

velkendt bivirkning i forbindelse med heparinbehandling. Immun-medieret heparin-

induceret trombocytopeni (type II) manifesterer sig i vid udstrækning inden for 5 til 14

dage efter indgivelse af den første dosis. Endvidere er en hurtigt-virkende form, blevet

beskrevet hos patienter tidligere eksponeret for heparin. Immunmedierede heparininduceret

trombocytopeni (type II) kan være forbundet med arteriel og venøs trombose. Heparin skal

seponeres i alle tilfælde af immun-medieret heparin-induceret trombocytopeni (type II) (se

pkt. 4.4).

I sjældne tilfælde kan heparin forårsage hyperkaliæmi på grund af hypo-aldosteronisme.

Patienter med risiko omfatter dem med diabetes mellitus eller nedsat nyrefunktion (se pkt.

4.4).

51072_spc.doc

Side 4 af 7

Bivirkninger er listet efter MedDRA-systemorganklasse (SOC), og de enkelte bivirkninger

er listet efter hyppighed med den hyppigst rapporterede først. Inden for hver enkelt

frekvensgruppe er bivirkningerne opstillet i rækkefølge efter faldende alvorlighed.

Meget almindelig (≥ 1/10)

Almindelig (≥ 1/100 til <1/10)

Ikke almindelig (≥ 1/1.000 til <1/100)

Sjælden (≥ 1/10.000 til <1/1.000)

Meget sjælden (<1/10.000)

Blod og lymfesystem

Ikke almindelig (≥ 1/1.000 til <1/100)

Trombocytopeni, herunder ikke-immun

heparin associeret trombocytopeni (type I).

Immunsystemet

Ikke almindelig (≥ 1/1.000 til <1/100)

Anafylaktisk reaktion.

Heparininduceret trombocytopeni (type II).

Overfølsomhed.

Metabolisme og ernæring

Ikke almindelig (≥ 1/1.000 til <1/100)

Hyperkaliæmi

Vaskulære sygdomme

Almindelig (

1/100 til <1/10)

Blødning

Hæmatom

Hud og subkutane væv

Almindelig (

1/100 til <1/10)

Ikke almindelig (≥1/1.000 til <1/100)

Erythem

Hudnekrose

udslæt *

urticaria

pruritus

* Forskellige typer af udslæt som

erytematøst, general makulært

makulopapuløst, papuløst og kløe er blevet

rapporteret

Knogler, led, muskler og bindevæv

Ikke almindelig (

1/1.000 til <1/100)

Osteoporose (i forbindelse med langvarig

behandling).

Det reproduktive system og mammae

Ikke almindelig (

1/1.000 til <1/100)

Priapisme.

Almene symptomer og reaktioner på

administrationsstedet

Ikke almindelig (

1/1.000 til <1/100)

Reaktion på injektionsstedet.

51072_spc.doc

Side 5 af 7

Undersøgelser

Almindelig (

1/100 til <1/10)

Ikke almindelig (

1/1.000 til <1/100)

Forhøjede transaminaser.

Aktiveret partiel thromboplastintid

forlænget ud over terapeutiske område.

Pædiatrisk population

Den observerede sikkerhedsprofil er ens hos børn og voksne.

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 til

Lægemiddelstyrelsen

Axel Heides Gade 1

DK-2300 København S

Websted: www.meldenbivirkning.dk

E-mail: dkma@dkma.dk.

4.9

Overdosering

Blødning er den vigtigste komplikation af overdosis.

Da heparin elimineres hurtigt, er en afbrydelse af behandlingen tilstrækkelig i tilfælde af

mindre blødninger.

Alvorlig blødning kan kræve administration af modgiften protaminsulfat. Patienter bør

overvåges nøje.

4.10

Udlevering

5.

FARMAKOLOGISKE EGENSKABER

5.0

Terapeutisk klassifikation

B 01 AB 01 – Antithrombosemidler – Heparingruppen.

5.1

Farmakodynamiske egenskaber

Heparin “Leo” er et præparat af porcin oprindelse, der består af en heterogen blanding af

polysaccharidkæder. Heparin virker antikoagulerende ved at potensere antitrombins

hæmning af aktiverede koagulationsfaktorer, primært faktor IIa og Xa.

5.2.

Farmakokinetiske egenskaber

Hepariner virker straks efter intravenøs indgift. Efter subkutan injektion er den

koagulationshæmmende effekt i plasma maksimal efter 4-6 timer og biotilgængeligheden

er ca. 30%. Elimineringshalveringstiden er 60-90 minutter, længst ved store doser. Heparin

metaboliseres i leveren og udskilles gennem urinen.

5.3

Prækliniske sikkerhedsdata

51072_spc.doc

Side 6 af 7

Heparin kan ved overdosering øge blødningstendensen på grund af den farmakodynamiske

effekt, men er i øvrigt meget lidt toksisk.

6.

FARMACEUTISKE OPLYSNINGER

6.1

Hjælpestoffer

Natriumchlorid; natriumcitrat; benzylalkohol; methylparahydroxybenzoat (E 218); propyl-

parahydroxybenzoat (E 216); saltsyre, fortyndet; vand til injektionsvæsker.

6.2

Uforligeligheder

Heparin bør ikke tilsættes infusionsvæsker indeholdende aminoglykosider, tetracykliner,

erythromycin, vancomycin, polymyxin, meticillin, hydrokortisionsuccinat, promazinklorid og

prometazinklorid.

6.3

Opbevaringstid

3 år.

Efter åbning af pakning: 4 uger.

6.4

Særlige opbevaringsforhold

Må ikke opbevares over 25

6.5

Emballagetyper og pakningsstørrelser.

Hætteglas.

6.6

Regler for destruktion og anden håndtering

Ingen særlige forholdsregler

ved bortskaffelse.

Ikke anvendt lægemiddel samt affald heraf skal bortskaffes i henhold til lokale retningslinjer.

7.

INDEHAVER AF MARKEDSFØRINGSTILLADELSEN

Orifarm A/S

Energivej 15

5260 Odense S

8.

MARKEDSFØRINGSTILLADELSESNUMMER (NUMRE)

51072

9.

DATO FOR FØRSTE MARKEDSFØRINGSTILLADELSE

6. september 2012

10.

DATO FOR ÆNDRING AF TEKSTEN

22. august 2017

51072_spc.doc

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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Donorweek 2018: Orgaandonor worden. Dat doe je voor elkaar

Donorweek 2018: Orgaandonor worden. Dat doe je voor elkaar

De donorweek is gestart. Minister Bruno Bruins (Medische Zorg) heeft in dat kader een bezoek gebracht aan de Goudse Scholengemeenschap, Leo Vroman. Tijdens de donorweek is er aandacht voor orgaandonatie en de oproep om te registreren als orgaandonor. Op dit moment staan er nog ruim 1800 patiënten op de wachtlijst voor een orgaan.

Netherlands - Ministerie van Volksgezondheid, Welzijn en Sport

22-9-2018

Risk assessment of new sequencing information on genetically modified carnation FLO‐40689‐6

Risk assessment of new sequencing information on genetically modified carnation FLO‐40689‐6

Published on: Fri, 21 Sep 2018 00:00:00 +0200 The GMO Panel has previously assessed genetically modified (GM) carnation FLO‐40689‐6 and concluded that there is no scientific reason to consider that the import, distribution and retailing in the EU of carnation FLO‐40689‐6 cut flowers for ornamental use will cause any adverse effects on human health or the environment. On 27 October 2017, the European Commission requested EFSA to analyse new nucleic acid sequencing data and updated bioinformatics data for...

Europe - EFSA - European Food Safety Authority Publications

22-9-2018

Risk assessment of new sequencing information for genetically modified soybean BPS‐CV127‐9

Risk assessment of new sequencing information for genetically modified soybean BPS‐CV127‐9

Published on: Fri, 21 Sep 2018 00:00:00 +0200 The GMO Panel has previously assessed genetically modified (GM) soybean BPS‐CV127‐9. This soybean was found to be as safe and nutritious as its conventional counterpart and commercial soybean varieties with respect to potential effects on human and animal health and the environment in the context of its intended uses. On 16 February 2018, European Commission requested EFSA to analyse new nucleic acid sequencing data and updated bioinformatics data for GM soy...

Europe - EFSA - European Food Safety Authority Publications

18-9-2018

Peer review of the pesticide risk assessment of the active substance sodium hydrogen carbonate

Peer review of the pesticide risk assessment of the active substance sodium hydrogen carbonate

Published on: Fri, 14 Sep 2018 00:00:00 +0200 The conclusions of EFSA following the peer review of the initial risk assessments carried out by the competent authority of the rapporteur Member State Austria for the pesticide active substance sodium hydrogen carbonate are reported. The context of the peer review was that required by Regulation (EC) No 1107/2009 of the European Parliament and of the Council. The conclusions were reached on the basis of the evaluation of the representative use of sodium hyd...

Europe - EFSA - European Food Safety Authority Publications

7-9-2018

Camber Pharmaceuticals, Inc. Issues Voluntary Nationwide Recall of Montelukast Tablets USP, 10mg 30Ct. due to Product/Label Mix-Up

Camber Pharmaceuticals, Inc. Issues Voluntary Nationwide Recall of Montelukast Tablets USP, 10mg 30Ct. due to Product/Label Mix-Up

Camber Pharmaceuticals, Inc. is voluntarily recalling one single lot of Montelukast Sodium Tablets, USP 10mg, to the consumer level. This recall of one batch of Montelukast Sodium Tablets, USP 10mg, lot# MON17384 Exp. 12/31/2019, was prompted because a complaint of a sealed bottle labeled as Montelukast 10mg 30 ct found to contain 90 tablets of Losartan Potassium Tablets, USP 50mg

FDA - U.S. Food and Drug Administration

7-9-2018

SCA Pharmaceuticals LLC. Issues Voluntary Nationwide Recall of Furosemide 100 mg in 0.9% Sodium Chloride due to Presence of Precipitate

SCA Pharmaceuticals LLC. Issues Voluntary Nationwide Recall of Furosemide 100 mg in 0.9% Sodium Chloride due to Presence of Precipitate

, SCA Pharmaceuticals LLC (“SCA Pharma”) is voluntarily recalling 7 lots of the injectable product Furosemide 100 mg in 0.9% Sodium Chloride 100 mg bag to the consumer level. This product is being recalled for visible particulate matter believed to be furosemide precipitate.

FDA - U.S. Food and Drug Administration

31-8-2018

FDA announces voluntary recall of Montelukast tablets by Camber Pharmaceuticals due to incorrect drug in bottles

FDA announces voluntary recall of Montelukast tablets by Camber Pharmaceuticals due to incorrect drug in bottles

FDA is warning the public about a voluntary recall of one lot of montelukast sodium tablets made by Camber Pharmaceuticals due to incorrect drug in bottles

FDA - U.S. Food and Drug Administration

29-8-2018

SGLT2(sodium-glucose cotransporter-2) Inhibitors for Diabetes: Drug Safety Communication - Regarding Rare Occurrences of a Serious Infection of the Genital Area

SGLT2(sodium-glucose cotransporter-2) Inhibitors for Diabetes: Drug Safety Communication - Regarding Rare Occurrences of a Serious Infection of the Genital Area

Requiring a new warning about this risk to be added to the prescribing information of all SGLT2 inhibitors and to the patient Medication Guide.

FDA - U.S. Food and Drug Administration

15-2-2019


Opinion/decision on a Paediatric investigation plan (PIP): Zeftera (previously Zevtera),Ceftobiprole medocaril (sodium), decision type: , therapeutic area: , PIP number: P/0406/2018

Opinion/decision on a Paediatric investigation plan (PIP): Zeftera (previously Zevtera),Ceftobiprole medocaril (sodium), decision type: , therapeutic area: , PIP number: P/0406/2018

Opinion/decision on a Paediatric investigation plan (PIP): Zeftera (previously Zevtera),Ceftobiprole medocaril (sodium), decision type: , therapeutic area: , PIP number: P/0406/2018

Europe - EMA - European Medicines Agency

15-2-2019


Opinion/decision on a Paediatric investigation plan (PIP): Rabeprazole (sodium), decision type: , therapeutic area: , PIP number: P/0401/2018

Opinion/decision on a Paediatric investigation plan (PIP): Rabeprazole (sodium), decision type: , therapeutic area: , PIP number: P/0401/2018

Opinion/decision on a Paediatric investigation plan (PIP): Rabeprazole (sodium), decision type: , therapeutic area: , PIP number: P/0401/2018

Europe - EMA - European Medicines Agency

13-2-2019


Orphan designation: P-ethoxy growth factor receptor-bound protein 2 antisense oligonucleotide, Treatment of acute myeloid leukaemia, 14/10/2016, Positive

Orphan designation: P-ethoxy growth factor receptor-bound protein 2 antisense oligonucleotide, Treatment of acute myeloid leukaemia, 14/10/2016, Positive

Orphan designation: P-ethoxy growth factor receptor-bound protein 2 antisense oligonucleotide, Treatment of acute myeloid leukaemia, 14/10/2016, Positive

Europe - EMA - European Medicines Agency

4-2-2019

EU/3/16/1758 (Clinical Network Services (NL) B.V.)

EU/3/16/1758 (Clinical Network Services (NL) B.V.)

EU/3/16/1758 (Active substance: P-ethoxy growth factor receptor-bound protein 2 antisense oligonucleotide) - Transfer of orphan designation - Commission Decision (2019)816 of Mon, 04 Feb 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000003048

Europe -DG Health and Food Safety

4-2-2019

Elmiron (bene-Arzneimittel GmbH)

Elmiron (bene-Arzneimittel GmbH)

Elmiron (Active substance: pentosan polysulfate sodium) - Centralised - Yearly update - Commission Decision (2019)848 of Mon, 04 Feb 2019

Europe -DG Health and Food Safety

31-1-2019


Opinion/decision on a Paediatric investigation plan (PIP): Macrogol 3350,sodium sulfate,sodium chloride,sodium ascorbate,potassium chloride (NER1006),Ascorbic acid, decision type: , therapeutic area: , PIP number: P/0315/2018

Opinion/decision on a Paediatric investigation plan (PIP): Macrogol 3350,sodium sulfate,sodium chloride,sodium ascorbate,potassium chloride (NER1006),Ascorbic acid, decision type: , therapeutic area: , PIP number: P/0315/2018

Opinion/decision on a Paediatric investigation plan (PIP): Macrogol 3350,sodium sulfate,sodium chloride,sodium ascorbate,potassium chloride (NER1006),Ascorbic acid, decision type: , therapeutic area: , PIP number: P/0315/2018

Europe - EMA - European Medicines Agency

29-1-2019


Opinion/decision on a Paediatric investigation plan (PIP): Synthetic ribonucleic acid oligonucleotide directed against superoxide dismutase 1 (SOD1) messenger ribonucleic acid, decision type: , therapeutic area: , PIP number: P/0337/2018

Opinion/decision on a Paediatric investigation plan (PIP): Synthetic ribonucleic acid oligonucleotide directed against superoxide dismutase 1 (SOD1) messenger ribonucleic acid, decision type: , therapeutic area: , PIP number: P/0337/2018

Opinion/decision on a Paediatric investigation plan (PIP): Synthetic ribonucleic acid oligonucleotide directed against superoxide dismutase 1 (SOD1) messenger ribonucleic acid, decision type: , therapeutic area: , PIP number: P/0337/2018

Europe - EMA - European Medicines Agency

28-1-2019


Opinion/decision on a Paediatric investigation plan (PIP): Sodium thiosulfate, decision type: , therapeutic area: , PIP number: P/0312/2018

Opinion/decision on a Paediatric investigation plan (PIP): Sodium thiosulfate, decision type: , therapeutic area: , PIP number: P/0312/2018

Opinion/decision on a Paediatric investigation plan (PIP): Sodium thiosulfate, decision type: , therapeutic area: , PIP number: P/0312/2018

Europe - EMA - European Medicines Agency

24-1-2019


Patent blue V sodium: List of nationally authorised medicinal products - PSUSA/00002320/201804

Patent blue V sodium: List of nationally authorised medicinal products - PSUSA/00002320/201804

Patent blue V sodium: List of nationally authorised medicinal products - PSUSA/00002320/201804

Europe - EMA - European Medicines Agency

21-1-2019

Diclofenac Sodium Spray Gel 4 % Cutaneous Spray, Solution and associated names

Diclofenac Sodium Spray Gel 4 % Cutaneous Spray, Solution and associated names

Diclofenac Sodium Spray Gel 4 % Cutaneous Spray, Solution and associated names (Active substance: Diclofenac sodium) - Community Referrals - Art 29 - Commission Decision (2019)589 of Mon, 21 Jan 2019 European Medicines Agency (EMA) procedure number: EMEA/H/A-29(4)/1467

Europe -DG Health and Food Safety

17-1-2019


Opinion/decision on a Paediatric investigation plan (PIP): Inclisiran sodium, decision type: , therapeutic area: , PIP number: P/0321/2018

Opinion/decision on a Paediatric investigation plan (PIP): Inclisiran sodium, decision type: , therapeutic area: , PIP number: P/0321/2018

Opinion/decision on a Paediatric investigation plan (PIP): Inclisiran sodium, decision type: , therapeutic area: , PIP number: P/0321/2018

Europe - EMA - European Medicines Agency

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

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

18-12-2018


Calcium chloride / glutamic acid / glutathione / histidine / lactobionic acid / magnesium chloride / mannitol / potassium chloride / sodium hydroxide: List of nationally authorised medicinal products - PSUSA/00010390/201801

Calcium chloride / glutamic acid / glutathione / histidine / lactobionic acid / magnesium chloride / mannitol / potassium chloride / sodium hydroxide: List of nationally authorised medicinal products - PSUSA/00010390/201801

Calcium chloride / glutamic acid / glutathione / histidine / lactobionic acid / magnesium chloride / mannitol / potassium chloride / sodium hydroxide: List of nationally authorised medicinal products - PSUSA/00010390/201801

Europe - EMA - European Medicines Agency

18-12-2018

EU/3/18/2121 (Ability Pharmaceuticals SL)

EU/3/18/2121 (Ability Pharmaceuticals SL)

EU/3/18/2121 (Active substance: Sodium 2-hydroxylinoleate) - Orphan designation - Commission Decision (2018)9036 of Tue, 18 Dec 2018 European Medicines Agency (EMA) procedure number: EMA/OD/142/18

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


Orphan designation: Polyphenyl(disodium 3-O-sulfo-beta-D-glucopyranuronate)-(1->3)-beta-D-galactopyranoside, Treatment of anti-MAG neuropathy, 17/07/2017, Positive

Orphan designation: Polyphenyl(disodium 3-O-sulfo-beta-D-glucopyranuronate)-(1->3)-beta-D-galactopyranoside, Treatment of anti-MAG neuropathy, 17/07/2017, Positive

Orphan designation: Polyphenyl(disodium 3-O-sulfo-beta-D-glucopyranuronate)-(1->3)-beta-D-galactopyranoside, Treatment of anti-MAG neuropathy, 17/07/2017, Positive

Europe - EMA - European Medicines Agency

14-12-2018


Referral: Fosfomycin-containing medicinal products, fosfomycin calcium, fosfomycin disodium, fosfomycin sodium, fosfomycin trometamol, Article 31 referrals, Procedure started, 13/12/2018

Referral: Fosfomycin-containing medicinal products, fosfomycin calcium, fosfomycin disodium, fosfomycin sodium, fosfomycin trometamol, Article 31 referrals, Procedure started, 13/12/2018

Referral: Fosfomycin-containing medicinal products, fosfomycin calcium, fosfomycin disodium, fosfomycin sodium, fosfomycin trometamol, Article 31 referrals, Procedure started, 13/12/2018

Europe - EMA - European Medicines Agency

12-12-2018


Magnesium sulphate heptahydrate, sodium sulphate anhydrous, potassium sulphate: CMDh scientific conclusions and grounds for variation, amendments to the product information and timetable for the implementation - EMEA/H/N/PSR/S/0016

Magnesium sulphate heptahydrate, sodium sulphate anhydrous, potassium sulphate: CMDh scientific conclusions and grounds for variation, amendments to the product information and timetable for the implementation - EMEA/H/N/PSR/S/0016

Magnesium sulphate heptahydrate, sodium sulphate anhydrous, potassium sulphate: CMDh scientific conclusions and grounds for variation, amendments to the product information and timetable for the implementation - EMEA/H/N/PSR/S/0016

Europe - EMA - European Medicines Agency

12-12-2018


Magnesium sulphate heptahydrate, sodium sulphate anhydrous, potassium sulphate: List of nationally authorised medicinal products - EMEA/H/N/PSR/S/0016

Magnesium sulphate heptahydrate, sodium sulphate anhydrous, potassium sulphate: List of nationally authorised medicinal products - EMEA/H/N/PSR/S/0016

Magnesium sulphate heptahydrate, sodium sulphate anhydrous, potassium sulphate: List of nationally authorised medicinal products - EMEA/H/N/PSR/S/0016

Europe - EMA - European Medicines Agency

10-12-2018

EU/3/17/1893 (SFL Regulatory Services GmbH)

EU/3/17/1893 (SFL Regulatory Services GmbH)

EU/3/17/1893 (Active substance: Polyphenyl(disodium 3-O-sulfo-beta-D-glucopyranuronate)-(1?3)-beta-D-galactopyranoside) - Transfer of orphan designation - Commission Decision (2018)8628 of Mon, 10 Dec 2018 European Medicines Agency (EMA) procedure number: EMA/OD/048/17/T/01

Europe -DG Health and Food Safety

3-12-2018


Withdrawn application: Zydax, glucuronoxylan sulfate sodium, Date of withdrawal: 03/12/2018, Initial authorisation

Withdrawn application: Zydax, glucuronoxylan sulfate sodium, Date of withdrawal: 03/12/2018, Initial authorisation

Withdrawn application: Zydax, glucuronoxylan sulfate sodium, Date of withdrawal: 03/12/2018, Initial authorisation

Europe - EMA - European Medicines Agency

28-11-2018

PHEBURANE (Eurocept International BV)

PHEBURANE (Eurocept International BV)

PHEBURANE (Active substance: Sodium Phenylbutyrate) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)8043 of Wed, 28 Nov 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2500/T/20

Europe -DG Health and Food Safety

22-11-2018


Opinion/decision on a Paediatric investigation plan (PIP): Exviera,Dasabuvir (sodium monohydrate), decision type: , therapeutic area: , PIP number: P/0174/2018

Opinion/decision on a Paediatric investigation plan (PIP): Exviera,Dasabuvir (sodium monohydrate), decision type: , therapeutic area: , PIP number: P/0174/2018

Opinion/decision on a Paediatric investigation plan (PIP): Exviera,Dasabuvir (sodium monohydrate), decision type: , therapeutic area: , PIP number: P/0174/2018

Europe - EMA - European Medicines Agency

22-11-2018


Opinion/decision on a Paediatric investigation plan (PIP): Citric acid (as citric acid anhydrous) / sodium chloride / simeticone / macrogol 4000 / sodium citrate /sodium sulfate (as sodium sulfate anhydrous) / potassium chloride (PMF104), decision type:

Opinion/decision on a Paediatric investigation plan (PIP): Citric acid (as citric acid anhydrous) / sodium chloride / simeticone / macrogol 4000 / sodium citrate /sodium sulfate (as sodium sulfate anhydrous) / potassium chloride (PMF104), decision type:

Opinion/decision on a Paediatric investigation plan (PIP): Citric acid (as citric acid anhydrous) / sodium chloride / simeticone / macrogol 4000 / sodium citrate /sodium sulfate (as sodium sulfate anhydrous) / potassium chloride (PMF104), decision type: , therapeutic area: , PIP number: P/0223/2018

Europe - EMA - European Medicines Agency

21-11-2018

EU/3/13/1184 (Pfizer Europe MA EEIG)

EU/3/13/1184 (Pfizer Europe MA EEIG)

EU/3/13/1184 (Active substance: (1R,3R,4R,5S)-3-O-[2-O-benzoyl-3-O-(sodium(2S)-3-cyclohexyl-propanoate-2-yl)-beta-D-galactopyranosyl]-4-O-(a-L-fucopyranosyl)-5-orothylamido-cyclohexane-1-carboxylic acid ethyl-2-amidyl-ethyloxy-2-acetyl-(8-amino-1,3,6-naphthalene-tris sodium sulfonate) amide) - Transfer of orphan designation - Commission Decision (2018)7836 of Wed, 21 Nov 2018 European Medicines Agency (EMA) procedure number: EMA/OD/084/13/T/01

Europe -DG Health and Food Safety

19-11-2018


Questions and answers on sodium laurilsulfate used as an excipient in medicinal products for human use

Questions and answers on sodium laurilsulfate used as an excipient in medicinal products for human use

Questions and answers on sodium laurilsulfate used as an excipient in medicinal products for human use

Europe - EMA - European Medicines Agency

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

26-9-2018

Kexxtone (Elanco GmbH)

Kexxtone (Elanco GmbH)

Kexxtone (Active substance: Monensin sodium) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)6324 of Wed, 26 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/V/C/2235/T/10

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

Inhixa (Techdow Europe AB)

Inhixa (Techdow Europe AB)

Inhixa (Active substance: enoxaparin sodium) - Centralised - Variation - Commission Decision (2018)6101 of Mon, 24 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4264/X/18, 26

Europe -DG Health and Food Safety

19-9-2018

#FDA issues final guidance with recommendations for labeling and safety testing of #heparin  containing medical devices and device-led combination products to help  reduce the risk of patient injury. To read the guidance, click here:  https://go.usa.gov/x

#FDA issues final guidance with recommendations for labeling and safety testing of #heparin containing medical devices and device-led combination products to help reduce the risk of patient injury. To read the guidance, click here: https://go.usa.gov/x

#FDA issues final guidance with recommendations for labeling and safety testing of #heparin containing medical devices and device-led combination products to help reduce the risk of patient injury. To read the guidance, click here: https://go.usa.gov/xP2VB  #MedicalDevice pic.twitter.com/hsdX5ylKPu

FDA - U.S. Food and Drug Administration

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

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

3-8-2018

Sodium oxybate

Sodium oxybate

Sodium oxybate (Active substance: Sodium oxybate) - Centralised - Art 28 - (PSUR - Commission Decision (2018)5381 of Fri, 03 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/PSUSA/10612/201710

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/3/18/2043 (Dr Ulrich Granzer)

EU/3/18/2043 (Dr Ulrich Granzer)

EU/3/18/2043 (Active substance: Combination of carboplatin and sodium valproate) - Orphan designation - Commission Decision (2018)5275 of Thu, 02 Aug 2018 European Medicines Agency (EMA) procedure number: EMA/OD/036/18

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