Tranexamsyre "Accord"

Primær information

  • Handelsnavn:
  • Tranexamsyre "Accord" 100 mg/ml injektionsvæske, opløsning
  • Dosering:
  • 100 mg/ml
  • Lægemiddelform:
  • injektionsvæske, opløsning
  • Brugt til:
  • Mennesker
  • Medicin typen:
  • Allopatiske stof

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Lokation

  • Fås i:
  • Tranexamsyre "Accord" 100 mg/ml injektionsvæske, opløsning
    Danmark
  • Sprog:
  • dansk

Andre oplysninger

Status

  • Kilde:
  • Lægemiddelstyrelsen - Danish Medicines Agency
  • Autorisationsnummer:
  • 56255
  • Sidste ændring:
  • 22-02-2018

Produktresumé

11. november 2016

PRODUKTRESUMÉ

for

Tranexamsyre "Accord", injektionsvæske, opløsning

0.

D.SP.NR.

29861

1.

LÆGEMIDLETS NAVN

Tranexamsyre "Accord"

2.

KVALITATIV OG KVANTITATIV SAMMENSÆTNING

Aktivt stof: tranexamsyre.

Hver ampul med 5 ml opløsning indeholder 500 mg tranexamsyre.

Hver ampul med 10 ml opløsning indeholder 1000 mg tranexamsyre.

Alle hjælpestoffer er anført under pkt. 6.1.

3.

LÆGEMIDDELFORM

Injektionsvæske, opløsning

En klar, farveløs opløsning, fri for synlige partikler.

4.

KLINISKE OPLYSNINGER

4.1

Terapeutiske indikationer

Forebyggelse og behandling af blødninger forårsaget af generel eller lokal fibrinolyse hos

voksne og børn over 1 år.

Specifikke indikationer omfatter:

Blødning forårsaget af generel eller lokal fibrinolyse såsom:

Menorragi og metrorragi

Gastrointestinal blødning

Hæmoragiske urinvejslidelser i fortsættelse af prostatakirurgi eller kirurgiske

indgreb i urinvejene

Øre-næse-halskirurgi (adenodektomi, tonsillektomi, tandudtrækning)

Gynækologisk operation eller fødselsrelaterede sygdomme

Thoraxkirurgi og abdominalkirurgi og andre større kirurgiske indgreb, f.eks.

kardiovaskulær kirurgi

Kontrol af blødning forårsaget af administration af fibrinolytika

4.2

Dosering og indgivelsesmåde

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Side 1 af 8

Dosering

Voksne

Medmindre andet er ordineret, anbefales følgende dosering:

1. Standardbehandling ved lokal fibrinolyse:

0,5 g (1 ampul med 5 ml) til 1 g (1 ampul med 10 ml eller 2 ampuller med 5 ml)

tranexamsyre som langsom intravenøs injektion (= 1 ml/min.) 2-3 gange daglig

2. Standardbehandling ved generel fibrinolyse:

1 g (1 ampul med 10 ml eller 2 ampuller med 5 ml) tranexamsyre som langsom intravenøs

injektion (= 1 ml/min.) hver 6.-8. time, svarende til 15 mg/kg.

Nedsat nyrefunktion

Tranexamsyre er kontraindiceret hos patienter med alvorligt nedsat nyrefunktion pga.

risiko for akkumulering (se pkt. 4.3). Hos patienter med let til moderat nedsat nyrefunktion

skal dosis nedsættes i henhold til serumkreatinin:

Serumkreatinin

Dosis i.v.

Administration

μmol/l

mg/10 ml

120 til 249

1,35 til 2,82

10 mg/kg

Hver 12. time

250 til 500

2,82 til 5,65

10 mg/kg

Hver 24. time

> 500

> 5,65

5 mg/kg

Hver 24. time

Nedsat leverfunktion

Dosisjustering er ikke nødvendig til patienter med nedsat leverfunktion.

Pædiatrisk population:

Dosis til børn over 1 år ved de godkendte indikationer, som er beskrevet i pkt. 4.1, er ca.

20 mg/kg/døgn. Data vedrørende virkning, dosering og sikkerhed ved disse indikationer er

dog begrænsede.

Tranexamsyres virkning, dosering og sikkerhed til børn i forbindelse med hjertekirurgi er

ikke fuldt klarlagt. De foreliggende data er begrænsede og er beskrevet i pkt. 5.1.

Ældre:

Dosisnedsættelse er ikke nødvendig, medmindre der er tegn på nedsat nyrefunktion.

Administration

Må udelukkende administreres som langsom intravenøs injektion.

4.3

Kontraindikationer

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

i pkt. 6.1.

Akut venetrombose eller arteriel trombose (se pkt. 4.4).

Fibrinolytiske forhold som følge af dissemineret intravaskulær koagulation undtagen

tilfælde med overvejende aktivering af det fibrinolytiske system med akut alvorlig

blødning (se pkt. 4.4).

Svær nedsat nyrefunktion (risiko for akkumulering).

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Side 2 af 8

Kramper i anamnesen.

Intratekal og intraventrikulær injektion, intracerebral applikation (risiko for cerebralt ødem

og kramper).

4.4

Særlige advarsler og forsigtighedsregler vedrørende brugen

Indikationer og administration angivet ovenfor skal overholdes meget nøje:

Intravenøs injektion skal gives meget langsomt

Tranexamsyre må ikke gives intramuskulært

Kramper

Der er set tilfælde af kramper i forbindelse med behandling med tranexamsyre. Ved

koronararterie-bypass-operation (CABG) ses de fleste tilfælde efter intravenøs (i.v.)

injektion af høje doser tranexamsyre. Ved administration af de anbefalede lavere doser af

tranexamsyre er hyppigheden af post-operative kramper på samme niveau som hos

ubehandlede patienter.

Synsforstyrrelser

Der bør udvises opmærksomhed over for mulige synsforstyrrelser, herunder nedsat syn,

sløret syn og påvirket farvesyn, og om nødvendigt skal behandlingen seponeres. Ved

kontinuerlig langtidsbehandling med tranexamsyre-injektionsvæske er regelmæssig

øjenkontrol (øjenundersøgelser herunder visuel skarphed, farvesyn, fundus, synsfelt etc.)

indiceret. Ved patologiske øjenforandringer, især ved sygdomme i retina, må lægen i hvert

enkelt tilfælde og efter at have konsulteret en specialist afgøre, om langtidsbehandling med

tranexamsyre-injektionsvæske er nødvendig.

Hæmaturi

Ved hæmaturi i de øvre urinveje er der øget risiko for obstruktion af ureter.

Tromboemboliske hændelser

Før administration af tranexamsyre skal risikofaktorer for tromboemboliske sygdomme

vurderes. Hos patienter med tromboemboliske sygdomme i anamnesen eller med øget

familiær forekomst af tromboemboliske hændelser (patienter med høj risiko for trombofili)

bør tranexamsyre-injektionsvæske kun anvendes, hvis der er tale om en stærk medicinsk

indikation ifølge vurdering af en læge med særlig kendskab til hæmostasiologi og kun

under nøje overvågning (se pkt. 4.3).

Tranexamsyre bør administreres med forsigtighed til patienter i behandling med orale

kontraceptiva på grund af øget risiko for tromboser (se pkt. 4.5).

Dissemineret intravaskulær koagulation

Patienter med dissemineret intravaskulær koagulation (DIC) bør i de fleste tilfælde ikke

behandles med tranexamsyre (se pkt. 4.3). Hvis tranexamsyre gives, skal det forbeholdes

patienter, som primært har aktivering af det fibrinolytiske system med akut alvorlig

blødning. Karakteristisk nærmer den hæmatologiske profil sig følgende: nedsat euglobulin

clot-lyse-tid; forlænget protrombintid; nedsat plasmaniveau af fibrinogen, faktor V og VIII,

plasminogenfibrinolysin og alfa-2 makroglobulin; normale plasmaniveauer af P og P-

kompleks, dvs. faktor II (protrombin), VIII og X; øgede plasmaniveauer af

fibrinogennedbrydningsprodukter; normal blodpladetælling. Det føromtalte forudsætter, at

den underliggende sygdomstilstand ikke i sig selv ændrer de forskellige elementer i

profilen. I sådanne akutte tilfælde er en enkelt dosis på 1 g tranexamsyre hyppigst

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Side 3 af 8

tilstrækkelig til at kontrollere blødningen. Administration af tranexamsyre ved DIC bør

kun overvejes, hvis passende hæmatologiske laboratoriefaciliteter og ekspertise er

tilgængelig.

4.5

Interaktion med andre lægemidler og andre former for interaktion

Der er ikke udført interaktionsstudier. Samtidig behandling med antikoagulantia skal ske

under nøje supervision af en læge med erfaring inden for området. Lægemidler, der

påvirker hæmostasen, bør gives med forsigtighed til patienter i behandling med

tranexamsyre. Der er en teoretisk risiko for øget trombedannelse, for eksempel med

østrogener. På den anden side kan den antifibrinolytiske virkning af lægemidlet

antagoniseres med trombolytika.

4.6

Graviditet og amning

Kvinder i den fertile alder skal anvende sikker kontraception under behandlingen.

Graviditet

Der er utilstrækkelige data fra anvendelse af tranexamsyre til gravide kvinder.

Som følge deraf bør tranexamsyre for en sikkerheds skyld ikke anvendes i første trimester,

heller ikke selvom dyrestudier ikke indikerer teratogene virkninger.

Begrænsede kliniske data fra anvendelse af tranexamsyre i forskellige kliniske

blødningssituationer under andet og tredje trimester viste ikke skadelige virkninger på

fosteret. Tranexamsyre bør kun anvendes under graviditet, hvis de forventede fordele

opvejer den mulige risiko.

Amning

Tranexamsyre udskilles i human mælk. Derfor frarådes amning.

Fertilitet

Der foreligger ingen kliniske data om tranexamsyres virkning på fertilitet.

4.7

Virkninger på evnen til at føre motorkøretøj eller betjene maskiner

Ikke mærkning.

Det er ikke undersøgt, om tranexamsyre påvirker evnen til at føre motorkøretøj eller

betjene maskiner.

4.8

Bivirkninger

Bivirkninger set i kliniske forsøg og efter markedsføring anføres nedenfor i henhold til

systemorganklasse.

Liste over bivirkninger i tabelform

Rapporterede bivirkninger fremgår af nedenstående tabel. Bivirkningerne er anført i

henhold til MedDRA's primære systemorganklasser. Inden for hver enkelt

systemorganklasse er bivirkningerne opstillet efter frekvens. Inden for hver frekvensgruppe

er bivirkningerne opstillet efter faldende alvorlighed. Hyppighed er defineret som følger:

Meget almindelig (≥ 1/10), almindelig (≥ 1/100 til < 1/10), ikke almindelig (≥ 1/1.000 til <

1/100), ikke kendt (kan ikke estimeres ud fra forhåndenværende data).

MedDRA systemorganklasse

Hyppighed

Bivirkninger

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Side 4 af 8

Immunsystemet

Ikke kendt

- Overfølsomhedsreaktioner

herunder anafylaksi

Nervesystemet

Ikke kendt

- Kramper især i forbindelse med

forkert anvendelse (se pkt. 4.3 og

4.4)

Øjne

Ikke kendt

- Synsforstyrrelser herunder påvirket

farvesyn

Vaskulære sygdomme

Ikke kendt

- Utilpashed med hypotension med

eller uden bevidsthedstab (normalt

som følge af for hurtig intravenøs

injektion, undtagelsesvist efter oral

administration)

- Arterie- eller veneemboli et hvilket

som helst sted

Mave-tarmkanalen

Almindelig

- Diarré

- Opkastning

- Kvalme

Hud og subkutane væv

Ikke

almindelig

- Allergisk dermatitis

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

Der er ikke rapporteret om tilfælde af overdosering.

Tegn og symptomer kan omfatte svimmelhed, hovedpine, hypotension og kramper. Det er

blevet påvist, at kramper optræder hyppigere ved øget dosering.

Behandling af overdosering skal være understøttende.

4.10

Udlevering

5.

FARMAKOLOGISKE EGENSKABER

5.0

Terapeutisk klassifikation

ATC-kode: B 02 AA 02. Hæmostatika, antifibrinolytika, aminosyrer.

5.1

Farmakodynamiske egenskaber

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Side 5 af 8

Tranexamsyre udøver en anti-hæmoragisk virkning ved at hæmme de fibrinolytiske

egenskaber af plasmin.

Et kompleks, der involverer tranexamsyre og plasminogen, dannes; tranexamsyre bindes til

plasminogen, når det omdannes til plasmin.

Aktiviteten af tranexamsyre-plasmin-komplekset på aktiviteten af fibrin er lavere end

aktiviteten af frit plasmin alene.

In vitro-studier viser, at høje tranexamsyredoser nedsætter komplementaktiviteten.

Pædiatrisk population

Børn over 1 år:

Ved gennemgang af litteraturen findes 12 studier med børn, der gennemgår hjertekirurgi.

1.073 børn var inkluderet, og heraf fik 631 tranexamsyre. De fleste studier var

placebokontrollerede. Den undersøgte population var heterogen, hvad angår alder,

operationstype og dosering. Studieresultaterne for tranexamsyre tyder på nedsat blodtab og

nedsat behov for blodprodukter ved hjertekirurgi på børn under kardiopulmonal bypass

(KPB), hvor der er en høj risiko for blødning, især hos cyanotiske patienter og hos

patienter, der opereres flere gange. Den hyppigst brugte dosering synes at være:

Første bolus på 10 mg/kg efter anæstesiinduktion og før incision af huden

Kontinuerlig infusion af 10 mg/kg/time eller injektion i hjertelungemaskinens primer med

en dosis tilpasset KPB-proceduren, enten i henhold til patientens vægt med 10

mg/kg/dosis, eller i henhold til hjertelungemaskinens volumen, sidste injektion på 10

mg/kg ved afslutningen af KPB.

Selvom der kun er undersøgt hos meget få patienter, tyder de begrænsede data på, at

kontinuerlig infusion er at foretrække, da det vil opretholde en terapeutisk

plasmakoncentration under hele operationen.

Der er ikke gennemført studier af dosis-virkning på børn.

5.2

Farmakokinetiske egenskaber

Absorption

Maksimal plasmakoncentration af tranexamsyre opnås hurtigt efter kortvarig intravenøs

infusion, hvorefter plasmakoncentrationen falder på multi-eksponentiel måde.

Fordeling

Tranexamsyres binding til plasmaproteiner er ca. 3 % ved terapeutiske plasmaniveauer, og

dette synes udelukkende at skyldes binding til plasminogen. Tranexamsyre bindes ikke til

serumalbumin. Det initiale fordelingsvolumen er ca. 9-12 liter.

Tranexamsyre passerer placenta. Efter intravenøs injektion af 10 mg/kg til 12 gravide

kvinder lå koncentrationen af tranexamsyre i serum i intervallet 10-53 µg/ml, mens den i

navlestrengsblod lå mellem 4 og 31 µg/ml. Tranexamsyre diffunderer hurtigt ud i

ledvæsken og synovialmembranen. Hos 17 patienter, der gennemgik knæoperation, var

koncentrationen i ledvæsken den samme som i tilsvarende serumprøver, efter en intravenøs

injektion på 10 mg/kg. Koncentrationen af tranexamsyre i en række andre væv er lavere

56255_spc.docx

Side 6 af 8

end i blodet (i mælk 1/100; i cerebrospinalvæske 1/10; i kammervæske 1/10).

Tranexamsyre er fundet i sæd, hvor den hæmmer fibrinolytisk aktivitet, men ikke påvirker

spermatozomigration.

Elimination

Tranexamsyre udskilles overvejende i urinen i uomdannet form. Urinudskillelse via

glomerulær filtration er den primære eliminationsvej. Den renale clearance svarer til

plasma-clearance (110-116 ml/min). Udskillelsen af tranexamsyre er ca. 90 % inden for de

første 24 timer efter intravenøs administration af 10 mg/kg. Halveringstiden af

tranexamsyre er ca. 3 timer.

Særlige populationer

Plasmakoncentrationen øges hos patienter med nyresvigt.

Der er ikke udført specifikke farmakokinetiske studier hos børn.

5.3

Prækliniske sikkerhedsdata

Prækliniske data viser ingen særlig risiko for mennesker vurderet ud fra konventionelle

studier af sikkerhedsfarmakologi, toksicitet efter gentagen dosering, genotoksicitet,

karcinogenicitet samt reproduktions- og udviklingstoksicitet.

Epileptogen aktivitet er set hos dyr efter intratekal administration af tranexamsyre.

6.

FARMACEUTISKE OPLYSNINGER

6.1

Hjælpestoffer

Vand til injektionsvæsker

6.2

Uforligeligheder

Tranexamsyre injektionsvæske, opløsning, må ikke tilsættes til blod til transfusion eller til

injektioner, der indeholder penicillin.

6.3

Opbevaringstid

2 år.

Lægemidlet skal anvendes umiddelbart efter åbning.

6.4

Særlige opbevaringsforhold

Dette lægemiddel kræver ingen særlige forholdsregler vedrørende opbevaringen.

6.5

Emballagetyper og pakningsstørrelser

Type I glas-ampuller er pakket i en bakke eller blisterpakning og desuden i en papæske.

Pakningsstørrelser

1 x 5 ml

5 x 5 ml

10 x 5 ml

1 x 10 ml

5 x 10 ml

10 x 10 ml

56255_spc.docx

Side 7 af 8

Ikke alle pakningsstørrelser er nødvendigvis markedsført.

6.6

Regler for destruktion og anden håndtering

Dette lægemiddel er kun til engangsbrug. Ikke anvendt lægemiddel samt affald heraf skal

bortskaffes i henhold til lokale retningslinier.

7.

INDEHAVER AF MARKEDSFØRINGSTILLADELSEN

Accord Healthcare Limited

Sage House

319 Pinner Road

North Harrow

Middlesex HA1 4HF

Storbritannien

8.

MARKEDSFØRINGSTILLADELSESNUMMER (NUMRE)

56255

9.

DATO FOR FØRSTE MARKEDSFØRINGSTILLADELSE

11. november 2016

10.

DATO FOR ÆNDRING AF TEKSTEN

56255_spc.docx

Side 8 af 8

  • 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.

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Outcome of the consultation on confirmatory data used in risk assessment for the active substance copper (I), copper (II) variants

Published on: Wed, 26 Sep 2018 00:00:00 +0200 The European Food Safety Authority (EFSA) was asked by the European Commission to provide scientific assistance with respect to the risk assessment for an active substance in light of confirmatory data requested following the first approval in accordance with Article 6(1) of Directive 91/414/EEC and Article 6(f) of Regulation (EC) No 1107/2009. In this context EFSA's scientific views on the specific points raised during the commenting phase conducted with Me...

Europe - EFSA - European Food Safety Authority Publications

26-9-2018

Modification of the existing maximum residue level for flonicamid in various crops

Modification of the existing maximum residue level for flonicamid in various crops

Published on: Tue, 25 Sep 2018 00:00:00 +0200 In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant Dienstleistungszentrum Ländlicher Raum submitted a request to the competent national authority in Germany to modify the existing maximum residue level (MRL) for the active substance flonicamid in radishes. Furthermore, in accordance with Article 6 of Regulation (EC) No 396/2005, the applicant ISK Biosciences Europe N.V. submitted a request to the competent national authority in the Ne...

Europe - EFSA - European Food Safety Authority Publications

25-9-2018

Daiso Holdings Ltd. recalls Daiso Brand Consumer Chemical Products

Daiso Holdings Ltd. recalls Daiso Brand Consumer Chemical Products

The recalled products have not been properly classified according to the Consumer Chemicals and Containers Regulations, 2001, in order to ensure appropriate hazard labelling. These regulations are empowered by the Canada Consumer Product Safety Act. Improper labelling could result in unintentional exposure to these products and lead to serious illness, injury or death.

Health Canada

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

21-9-2018

Outcome of the consultation with Member States, the applicant and EFSA on the pesticide risk assessment for sulfoxaflor in light of confirmatory data

Outcome of the consultation with Member States, the applicant and EFSA on the pesticide risk assessment for sulfoxaflor in light of confirmatory data

Published on: Thu, 20 Sep 2018 00:00:00 +0200 The European Food Safety Authority (EFSA) was asked by the European Commission to provide scientific assistance with respect to the risk assessment for an active substance in light of confirmatory data requested following approval in accordance with Article 6(1) of Directive 91/414/EEC and Article 6(f) of Regulation (EC) No 1107/2009. In this context EFSA's scientific views on the specific points raised during the commenting phase conducted with Member State...

Europe - EFSA - European Food Safety Authority Publications

21-9-2018

Modification of the existing maximum residue level for clothianidin in potatoes

Modification of the existing maximum residue level for clothianidin in potatoes

Published on: Thu, 20 Sep 2018 00:00:00 +0200 In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant Bayer CropScience AG submitted a request to the competent national authority in Germany to modify the existing maximum residue level (MRL) for the active substance clothianidin to accommodate the use on potatoes imported from Canada. The data submitted in support of the request were found to be sufficient to derive a MRL proposal. Adequate analytical methods for enforcement are availa...

Europe - EFSA - European Food Safety Authority Publications

19-9-2018

Modification of the existing maximum residue levels for potassium phosphonates in certain berries and small fruits

Modification of the existing maximum residue levels for potassium phosphonates in certain berries and small fruits

Published on: Tue, 18 Sep 2018 00:00:00 +0200 In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant LTZ Augustenberg submitted a request to the competent national authority in Germany to modify the existing maximum residue levels (MRLs) for the active substance potassium phosphonates in raspberries, blackberries, currants, blueberries, gooseberries and elderberries. The data submitted in support of the request were found to be sufficient to derive MRL proposals for all crops under c...

Europe - EFSA - European Food Safety Authority Publications

19-9-2018

Modification of the existing maximum residue levels for flonicamid in various root crops

Modification of the existing maximum residue levels for flonicamid in various root crops

Published on: Tue, 18 Sep 2018 00:00:00 +0200 In accordance with Article 6 of Regulation (EC) No 396/2005, the Agriculture and Horticulture Development Council submitted a request to the competent national authority in the United Kingdom to modify the existing maximum residue levels (MRL) for the active substance flonicamid in beetroots, carrots, celeriacs/turnip rooted celeries, horseradishes, Jerusalem artichokes, parsnips, parsley roots/Hamburg roots parsley, radishes, salsifies, swedes/rutabagas, tu...

Europe - EFSA - European Food Safety Authority Publications

13-9-2018

Review of the existing maximum residue levels for fluquinconazole according to Article 12 of Regulation (EC) No 396/2005

Review of the existing maximum residue levels for fluquinconazole according to Article 12 of Regulation (EC) No 396/2005

Published on: Wed, 12 Sep 2018 00:00:00 +0200 According to Article 12 of Regulation (EC) No 396/2005, EFSA has reviewed the maximum residue levels (MRLs) currently established at European level for the pesticide active substance fluquinconazole. Considering the information provided by Member States, neither EU uses nor import tolerances are currently authorised for fluquinconazole within the European Union. Furthermore, no MRLs are established by the Codex Alimentarius Commission (codex maximum residue ...

Europe - EFSA - European Food Safety Authority Publications

11-9-2018

Risk assessment of substances used in food supplements: the example of the botanical Gymnema sylvestre

Risk assessment of substances used in food supplements: the example of the botanical Gymnema sylvestre

Published on: Tue, 28 Aug 2018 00:00:00 +0200 Botanicals and preparations derived from these are among the substances frequently added to foods and food supplements, yet the safety of many botanicals has not been systematically assessed. In the context of the EU‐FORA fellowship programme, the fellow performed an assessment on the safety of the botanical Gymnema sylvestre, in accordance with EFSA's guidance on the assessment of safety of botanicals. Although preparations of G. sylvestre are marketed as f...

Europe - EFSA - European Food Safety Authority Publications

11-9-2018

Modelling of inactivation through heating for quantitative microbiological risk assessment (QMRA)

Modelling of inactivation through heating for quantitative microbiological risk assessment (QMRA)

Published on: Mon, 27 Aug 2018 00:00:00 +0200 EFSA regards the household as a stage in the food chain that is important for the final number of food‐borne infections. The fate of a pathogen in the private kitchen largely depends on consumer hygiene during preparation of food and on its proper cooking, especially in the case of meat. Unfortunately, detailed information on the microbiological survival in meat products after heating in the consumer kitchen is lacking. The aim of the study was to improve th...

Europe - EFSA - European Food Safety Authority Publications

11-9-2018

Assessment of occupational and dietary exposure to pesticide residues

Assessment of occupational and dietary exposure to pesticide residues

Published on: Mon, 27 Aug 2018 00:00:00 +0200 Plant protection products (PPPs) are pesticides containing at least one active substance that drives specific actions against pests (diseases). PPPs are regulated in the EU and cannot be placed on the market or used without prior authorisation. EFSA assesses the possible risks of the use of active substances to humans and environment. Member States decide whether or not to approve their use at EU level. Furthermore, Member States decide at national level on ...

Europe - EFSA - European Food Safety Authority Publications

10-9-2018

Kangaroo Manufacturing Inc. recalls Kangaroo's Super Cool Slime

Kangaroo Manufacturing Inc. recalls Kangaroo's Super Cool Slime

Health Canada's sampling and evaluation program has determined the Super Cool Slime products donot meet the Canadian toy safety requirements related to boric acid content.

Health Canada

4-9-2018

Outcome of the consultation with Member States and EFSA on the basic substance application for milk for use in plant protection as fungicide

Outcome of the consultation with Member States and EFSA on the basic substance application for milk for use in plant protection as fungicide

Published on: Mon, 03 Sep 2018 00:00:00 +0200 The European Food Safety Authority (EFSA) was asked by the European Commission to provide scientific assistance with respect to the evaluation of applications received by the European Commission concerning basic substances. In this context, EFSA's scientific views on the specific points raised during the commenting phase conducted with Member States and EFSA on the basic substance application for milk are presented. The context of the evaluation was that req...

Europe - EFSA - European Food Safety Authority Publications

1-9-2018

Multiple “Dr. King’s” homeopathic and “Natural Pet” veterinary products recalled due to potential microbial contamination

Multiple “Dr. King’s” homeopathic and “Natural Pet” veterinary products recalled due to potential microbial contamination

Health Canada is advising consumers and pet owners not to use homeopathic and veterinary products made by King Bio Inc. and labeled as "Dr. King's," "Dr King's Natural Pet" or "Natural Pet." These products may pose a health risk to people and pets, especially children, pregnant women and those with compromised immune systems, because of potential microbial contamination. According to the United States Food and Drug Administration, high levels of microbial contamination were identified at the manufacturin...

Health Canada

1-9-2018

Acknowledgement:EFSA  wishes  to  thank  the  rapporteur  Member  State  Denmark  for  thepreparatory work on this scientific output.Suggested citation:EFSA (European Food Safety Authority), Brancato A, Brocca D, Carrasco Cabrera L,De Lentdecker C, Erdos

Acknowledgement:EFSA wishes to thank the rapporteur Member State Denmark for thepreparatory work on this scientific output.Suggested citation:EFSA (European Food Safety Authority), Brancato A, Brocca D, Carrasco Cabrera L,De Lentdecker C, Erdos

Published on: Fri, 31 Aug 2018 00:00:00 +0200 According to Article 12 of Regulation (EC) No 396/2005, EFSA has reviewed the maximum residue levels (MRLs) currently established at European level for the pesticide active substance napropamide. To assess the occurrence of napropamide residues in plants, processed commodities, rotational crops and livestock, EFSA considered the conclusions derived in the framework of Directive 91/414/EEC as well as the European authorisations reported by Member States (incl...

Europe - EFSA - European Food Safety Authority Publications

1-9-2018

Review of the existing MRLs for fenbuconazole

Review of the existing MRLs for fenbuconazole

Published on: Fri, 31 Aug 2018 00:00:00 +0200 According to Article 12 of Regulation (EC) No 396/2005, EFSA has reviewed the maximum residue levels (MRLs) currently established at European level for the pesticide active substance fenbuconazole. To assess the occurrence of fenbuconazole residues in plants, processed commodities, rotational crops and livestock, EFSA considered the conclusions derived in the framework of Directive 91/414/EEC, the MRLs established by the Codex Alimentarius Commission as well...

Europe - EFSA - European Food Safety Authority Publications

30-8-2018

National summary reports on pesticide residue analysis performed in 2016

National summary reports on pesticide residue analysis performed in 2016

Published on: Tue, 07 Aug 2018 00:00:00 +0200 In accordance with Article 31 of Regulation (EC) No 396/2005, European Union (EU) Member States have to communicate to the European Food Safety Authority (EFSA) the results of their official controls on pesticide residues in food. In the framework of this communication, the EU Member States, Iceland and Norway provided a short summary report outlining the main findings of the control activities during the reference year. This technical report is the compilat...

Europe - EFSA - European Food Safety Authority Publications

29-8-2018

Review of the existing maximum residue levels for sintofen according to Article 12 of Regulation (EC) No 396/2005

Review of the existing maximum residue levels for sintofen according to Article 12 of Regulation (EC) No 396/2005

Published on: Tue, 28 Aug 2018 00:00:00 +0200 According to Article 12 of Regulation (EC) No 396/2005, EFSA has reviewed the maximum residue levels (MRLs) currently established at European level for the pesticide active substance sintofen. To assess the occurrence of sintofen residues in plants, processed commodities, rotational crops and livestock, EFSA considered the conclusions derived in the framework of Commission Regulation (EC) No 33/2008, as well as the European authorisations reported by Member ...

Europe - EFSA - European Food Safety Authority Publications

29-8-2018

Review of the existing maximum residue levels for prochloraz according to Article 12 of Regulation (EC) No 396/2005

Review of the existing maximum residue levels for prochloraz according to Article 12 of Regulation (EC) No 396/2005

Published on: Mon, 27 Aug 2018 00:00:00 +0200 According to Article 12 of Regulation (EC) No 396/2005, EFSA has reviewed the maximum residue levels (MRLs) currently established at European level for the pesticide active substance prochloraz. To assess the occurrence of prochloraz residues in plants, processed commodities, rotational crops and livestock, EFSA considered the conclusions derived in the framework of Directive 91/414/EEC, the MRLs established by the Codex Alimentarius Commission as well as th...

Europe - EFSA - European Food Safety Authority Publications

29-8-2018

Modification of the existing maximum residue levels for prohexadione in various oilseeds

Modification of the existing maximum residue levels for prohexadione in various oilseeds

Published on: Mon, 27 Aug 2018 00:00:00 +0200 In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant BASF SE submitted a request to the competent national authority in France to modify the existing maximum residue levels (MRL) for the active substance prohexadione in linseeds, poppy seeds, sunflower seeds, rape seeds, mustard seeds and gold of pleasure seeds. The data submitted in support of the request were found to be sufficient to derive MRL proposals for all oilseeds under consid...

Europe - EFSA - European Food Safety Authority Publications

29-8-2018

Review of the existing maximum residue levels for napropamide according to Article 12 of Regulation (EC) No 396/2005

Review of the existing maximum residue levels for napropamide according to Article 12 of Regulation (EC) No 396/2005

Published on: Fri, 24 Aug 2018 00:00:00 +0200 According to Article 12 of Regulation (EC) No 396/2005, EFSA has reviewed the maximum residue levels (MRLs) currently established at European level for the pesticide active substance napropamide. To assess the occurrence of napropamide residues in plants, processed commodities, rotational crops and livestock, EFSA considered the conclusions derived in the framework of Directive 91/414/EEC as well as the European authorisations reported by Member States (incl...

Europe - EFSA - European Food Safety Authority Publications

29-8-2018

Explanatory note on the determination of newly expressed protein levels in the context of genetically modified plant applications for EU market authorisation

Explanatory note on the determination of newly expressed protein levels in the context of genetically modified plant applications for EU market authorisation

Published on: Mon, 20 Aug 2018 00:00:00 +0200 Genetically modified organisms are subject to a risk assessment and regulatory approval before entering the European market. According to legislation (Directive 2001/18/EC, Regulation (EC) No 1829/2003 and Regulation (EU) No 503/2013) and the EFSA guidance documents on the risk assessment of food and feed from genetically modified (GM) plants and on the environmental risk assessment of GM plants, applicants need to perform a molecular characterisation of any...

Europe - EFSA - European Food Safety Authority Publications

29-8-2018

Setting of import tolerances for mandestrobin in strawberries and table and wine grapes

Setting of import tolerances for mandestrobin in strawberries and table and wine grapes

Published on: Thu, 16 Aug 2018 00:00:00 +0200 In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant Sumitomo Chemical Agro Europe SAS submitted a request to the competent national authority in Austria to set an import tolerance for the active substance mandestrobin in strawberries, table grapes and wine grapes. The data submitted in support of the request were found to be sufficient to derive maximum residue level (MRL) proposals for the crops under consideration. Adequate analytica...

Europe - EFSA - European Food Safety Authority Publications

29-8-2018

Modification of the existing maximum residue levels for fluoxastrobin in oilseeds

Modification of the existing maximum residue levels for fluoxastrobin in oilseeds

Published on: Mon, 13 Aug 2018 00:00:00 +0200 In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant Arysta LifeSciences SAS submitted a request to the competent national authority in the United Kingdom to modify the existing maximum residue levels (MRL) for the active substance fluoxastrobin in certain oilseeds. The data submitted in support of the request were found to be sufficient to derive MRL proposals for the oilseeds for which a modification was requested. Adequate analytical...

Europe - EFSA - European Food Safety Authority Publications

29-8-2018

Review of the existing maximum residue levels for myclobutanil according to Article 12 of Regulation (EC) No 396/2005

Review of the existing maximum residue levels for myclobutanil according to Article 12 of Regulation (EC) No 396/2005

Published on: Mon, 13 Aug 2018 00:00:00 +0200 According to Article 12 of Regulation (EC) No 396/2005, EFSA has reviewed the maximum residue levels (MRLs) currently established at European level for the pesticide active substance myclobutanil. To assess the occurrence of myclobutanil residues in plants, processed commodities, rotational crops and livestock, EFSA considered the conclusions derived in the framework of Commission Regulation (EC) No 33/2008, the MRLs established by the Codex Alimentarius Com...

Europe - EFSA - European Food Safety Authority Publications

29-8-2018

Evaluation of data concerning the necessity of bromoxynil as herbicide to control a serious danger to plant health which cannot be contained by other available means, including non‐chemical methods

Evaluation of data concerning the necessity of bromoxynil as herbicide to control a serious danger to plant health which cannot be contained by other available means, including non‐chemical methods

Published on: Mon, 13 Aug 2018 00:00:00 +0200 EFSA was requested by the European Commission to provide scientific assistance under Article 31 of Regulation (EC) No 178/2002 regarding the evaluation of data concerning the necessity of bromoxynil as a herbicide to control a serious danger to plant health which cannot be contained by other available means including non‐chemical methods, in accordance with Article 4(7) of Regulation (EC) No 1107/2009. In this context, EFSA organised a commenting phase with ...

Europe - EFSA - European Food Safety Authority Publications

29-8-2018

Grant agreement for piloting the Framework Partnership Agreement between the National data provider organisations in Slovakia and EFSA – Final report

Grant agreement for piloting the Framework Partnership Agreement between the National data provider organisations in Slovakia and EFSA – Final report

Published on: Tue, 07 Aug 2018 00:00:00 +0200 Presented document is the final report of the project GA/EFSA/DATA/2017/01: “Strategic Partnership with Slovakia on Data Quality (Pilot project)”. The report describes national processes and tools in order to implement internal validation and quality control of collected data according to EFSA requirements. A description of the data transmission processes from the National Databases to the EFSA databases, terminology, data mapping and data transformations fo...

Europe - EFSA - European Food Safety Authority Publications

28-8-2018

Accord Healthcare Inc. Issues Voluntary Nationwide Recall of Hydrochlorothiazide Tablets USP 12.5 Mg Due to Labeling Mix-up

Accord Healthcare Inc. Issues Voluntary Nationwide Recall of Hydrochlorothiazide Tablets USP 12.5 Mg Due to Labeling Mix-up

A 100 count bottle of Hydrochlorothiazide Tablets USP 12.5 mg has been found to contain 100 Spironolactone Tablets USP 25 mg. Since the individual lot, PW05264, of the product is involved in a potential mix-up of labeling, Accord is recalling this individual lot from the market.

FDA - U.S. Food and Drug Administration

14-8-2018

Genius Premium Craft Boxes recalls Do-It-Yourself Slime Kits

Genius Premium Craft Boxes recalls Do-It-Yourself Slime Kits

Health Canada’s sampling and evaluation program has determined the Do-It-Yourself Slime Kits do not meet the Canadian toy safety requirements related to boric acid content.

Health Canada

10-8-2018

FDA approves first-of-its kind targeted RNA-based therapy to treat a rare disease

FDA approves first-of-its kind targeted RNA-based therapy to treat a rare disease

FDA approves new drug for treatment of polyneuropathy caused by hereditary transthyretin-mediated amyloidosis (hATTR). This is the first FDA-approved treatment for this rare, debilitating and often fatal genetic disease and the first FDA approval of a new class of drugs called small interfering ribonucleic acid (siRNA) treatment.

FDA - U.S. Food and Drug Administration

3-8-2018

Scientific guideline:  Cholic acid capsules 50 mg and 250 mg product-specific bioequivalence guidance, adopted

Scientific guideline: Cholic acid capsules 50 mg and 250 mg product-specific bioequivalence guidance, adopted

Cholic acid capsules 50 mg and 250 mg product-specific bioequivalence guidance

Europe - EFSA - European Food Safety Authority EFSA Journal

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

25-9-2018

Pelgraz (Accord Healthcare Limited)

Pelgraz (Accord Healthcare Limited)

Pelgraz (Active substance: pegfilgrastim) - Centralised - Authorisation - Commission Decision (2018)6288 of Tue, 25 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/003961/0000

Europe -DG Health and Food Safety

24-9-2018

Lenalidomide Accord (Accord Healthcare Limited)

Lenalidomide Accord (Accord Healthcare Limited)

Lenalidomide Accord (Active substance: lenalidomide) - Centralised - Authorisation - Commission Decision (2018)6237 of Mon, 24 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4857

Europe -DG Health and Food Safety

24-9-2018

Zoledronic acid Hospira (Pfizer Europe MA EEIG)

Zoledronic acid Hospira (Pfizer Europe MA EEIG)

Zoledronic acid Hospira (Active substance: zoledronic acid) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)6243 of Mon, 24 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2365/T/33

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

7-8-2018

Accofil (Accord Healthcare Limited)

Accofil (Accord Healthcare Limited)

Accofil (Active substance: Filgrastim) - Centralised - Yearly update - Commission Decision (2018)5428 of Tue, 07 Aug 2018

Europe -DG Health and Food Safety

7-8-2018

Memantine Accord (Accord Healthcare Limited)

Memantine Accord (Accord Healthcare Limited)

Memantine Accord (Active substance: memantine) - Centralised - Renewal - Commission Decision (2018)5421 of Tue, 07 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2766/R/10

Europe -DG Health and Food Safety

6-8-2018

Zoledronic acid Accord (Accord Healthcare Limited)

Zoledronic acid Accord (Accord Healthcare Limited)

Zoledronic acid Accord (Active substance: zoledronic acid) - Centralised - Yearly update - Commission Decision (2018)5386 of Mon, 06 Aug 2018

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

27-7-2018

EU/3/17/1932 (Millendo Therapeutics SAS)

EU/3/17/1932 (Millendo Therapeutics SAS)

EU/3/17/1932 (Active substance: Synthetic cyclic 8 amino acid analogue of human unacylated ghrelin) - Transfer of orphan designation - Commission Decision (2018)5049 of Fri, 27 Jul 2018 European Medicines Agency (EMA) procedure number: EMA/OD/066/17/T/01

Europe -DG Health and Food Safety