Ambroxolhydrochlorid "Unither Pharmaceuticals"

Primær information

  • Handelsnavn:
  • Ambroxolhydrochlorid "Unither Pharmaceuticals" 30 mg oral opløsning i brev
  • Dosering:
  • 30 mg
  • Lægemiddelform:
  • oral opløsning i brev
  • Brugt til:
  • Mennesker
  • Medicin typen:
  • Allopatiske stof

Dokumenter

  • for den brede offentlighed:
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Lokation

  • Fås i:
  • Ambroxolhydrochlorid "Unither Pharmaceuticals" 30 mg oral opløsning i brev
    Danmark
  • Sprog:
  • dansk

Andre oplysninger

Status

  • Kilde:
  • Lægemiddelstyrelsen - Danish Medicines Agency
  • Autorisationsnummer:
  • 54317
  • Sidste ændring:
  • 31-01-2018

Produktresumé

19. juni 2017

PRODUKTRESUMÉ

for

Ambroxolhydrochlorid "Unither Pharmaceuticals", oral opløsning i brev

0.

D.SP.NR.

29329

1.

LÆGEMIDLETS NAVN

Ambroxolhydrochlorid "Unither Pharmaceuticals"

2.

KVALITATIV OG KVANTITATIV SAMMENSÆTNING

Hvert brev med 5 ml oral opløsning indeholder 30 mg ambroxolhydrochlorid.

Hjælpestof med kendt virkning

Hvert brev med 5 ml oral opløsning indeholder 1750 mg sorbitol, flydende (ikke-

krystalliserende).

Alle hjælpestoffer er anført under pkt. 6.1.

3.

LÆGEMIDDELFORM

Oral opløsning i brev.

Klar og farveløs opløsning.

4.

KLINISKE OPLYSNINGER

4.1

Terapeutiske indikationer

Sekrelytisk behandling af produktiv hoste ved akutte eller kroniske bronkopulmonære

sygdomme forbundet med unormal slimsekretion og nedsat slimtransport.

Ambroxolhydrochlorid "Unither Pharmaceuticals" er indiceret til voksne og unge over 12

år.

4.2

Dosering og indgivelsesmåde

Dosering og indgivelsesmåde

Ambroxolhydrochlorid "Unither Pharmaceuticals" må ikke anvendes til børn under 12 år.

1 brev (30 mg ambroxolhydrochlorid) administreret 3 gange dagligt (svarende til 90 mg

ambroxolhydrochlorid pr. dag) i løbet af de første 2 til 3 dage. Herefter administreres 1

brev to gange dagligt (svarende til 60 mg ambroxolhydrochlorid pr. dag).

Dosis kan ved behov øges til 60 mg ambroxolhydrochlorid (2 breve) to gange dagligt

54317_spc.docx

Side 1 af 7

(svarende til 120 mg ambroxolhydrochlorid pr. dag).

Ambroxolhydrochlorid "Unither Pharmaceuticals" kan administreres med eller uden føde.

I tilfælde af akutte respiratoriske tilstande skal der søges læge, hvis symptomerne ikke

forbedres, eller hvis de forværres.

4.3

Kontraindikationer

Ambroxolhydrochlorid "Unither Pharmaceuticals" er kontraindiceret til patienter med

overfølsomhed over for det aktive stof eller over for et eller flere af hjælpestofferne anført i

punkt 6.1, og til børn under 12 år.

4.4

Særlige advarsler og forsigtighedsregler vedrørende brugen

Der er ingen grund til at kombinere mukolytika med hostestillende medicin.

Det har været få indrapporteringer om alvorlige hudreaktioner, såsom erythema multiform,

Stevens-Johnson's syndrom (SJS)/toksisk epidermal nekrolyse (TEN) og akut generaliseret

eksantematøs pustulose (AGEP) forbundet med administration af ambroxolhydrochlorid.

Hvis der er symptomer eller tegn på et progressivt hududslæt (undertiden forbundet med

blister eller slimhindelæsioner), skal behandling med ambroxolhydrochlorid øjeblikkeligt

indstilles og der skal søges læge.

Der kan som ved ethvert andet lægemiddel, der metaboliseres af leveren og elimineres af

nyrerne, i tilfælde af alvorligt nyresvigt, ske en akkumulering af metabolitter genereret af

leveren.

På grund af en mulig sekretophobning bør ambroxolhydrochlorid anvendes med

forsigtighed ved forstyrret bronkomotorisk funktion og større sekretmængder (f.eks. ved

det sjældne immotile cilia-syndrom).

Dette lægemiddel indeholder sorbitol. Patienter med sjældne problemer med

fruktoseintolerans bør ikke anvende dette lægemiddel.

4.5

Interaktion med andre lægemidler og andre former for interaktion

Samtidig kombination af Ambroxolhydrochlorid "Unither Pharmaceuticals" med

hostestillende midler kan inducere en begrænset hosterefleks, og der kan dermed opstå en

farlig sekretophobning. Samtidig anvendelse bør kun ske efter omhyggelig undersøgelse af

risk-benefit-balancen.

4.6

Graviditet og amning

Fertilitet

Ikke-kliniske forsøg viser ingen direkte eller indirekte skadelige virkninger med hensyn til

fertilitet.

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Side 2 af 7

Graviditet

Ambroxolhydrochlorid krydser placenta. Ikke-kliniske forsøg indikerer ikke direkte eller

indirekte skadelige virkninger på graviditet, den embryonale eller føtale udvikling, fødsel

eller den postnatale udvikling.

Omfattende klinisk erfaring med ambroxolhydrochlorid efter graviditetens 28. uge har ikke

vist tegn på skadelige virkninger på fosteret.

Ikke desto mindre bør normal forsigtighed udvises med henblik på brug af lægemidler

under graviditet. Særligt i det første trimester anbefales det ikke at bruge

Ambroxolhydrochlorid "Unither Pharmaceuticals".

Amning

Ambroxolhydrochlorid udskilles i modermælk. Selv om der ikke forventes bivirkninger

hos ammende spædbørn, anbefales Ambroxolhydrochlorid "Unither Pharmaceuticals" ikke

til brug hos ammende mødre.

4.7

Virkninger på evnen til at føre motorkøretøj eller betjene maskiner

Ikke mærkning

Ambroxolhydrochlorid "Unither Pharmaceuticals" har ingen indflydelse på evnen til at

føre motorkøretøj og betjene maskiner.

Virkning på evnen til at føre motorkøretøj eller betjene maskiner er ikke undersøgt.

4.8

Bivirkninger

Bivirkningsfrekvenserne er anført nedenfor:

MedDRAs frekvenskonvention

Meget almindelig (≥ 1/10)

Almindelig (≥1/100 til <1/10)

Ikke almindelig (≥1/1000 til <1/100)

Sjælden (≥1/10.000 til <1/1000)

Meget sjælden (< 1/10.000)

Ikke kendt (kan ikke estimeres ud fra forhåndenværende data)

MedDRA -

Systemorganklasse

Frekvens

Symptomer

Immunsystemet

Sjælden

Overfølsomhedsreaktioner

Ikke kendt

Anafylaktiske reaktioner inklusive anafylaktisk

shock, angioødem og pruritus

Nervesystem

Almindelig

Dysgeusi

Luftveje, thorax og

mediastinum

Almindelig

Følelsesløshed i halsen

Meget

sjælden

Næseflåd

Ikke kendt

Dyspnø (som symptom på

hypersensitivitetsreaktion)

Mave-tarm-kanalen

Almindelig

Kvalme, oral og faryngal hypoæstesi.

Ikke

almindelig

Opkastning, diarré, fordøjelsesbesvær,

mavesmerter, mundtørhed

Sjælden

Halstørhed

Meget

Forstoppelse, sialorrhea

54317_spc.docx

Side 3 af 7

sjælden

Hud og subkutane væv

Sjælden

Udslæt, urticaria

Ikke kendt

Svære hudbivirkninger (inklusive erythema

multiforme, Stevens-Johnson syndrom/toksisk

epidermal nekrolyse og akut generaliseret

eksantematøs pustulose)

Nyrer og urinveje

Meget

sjælden

Dysuri

Almene symptomer og

reaktioner på

administrationsstedet

Ikke

almindelig

Feber, mukokutane reaktioner

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 indtil videre ikke rapporteret om specifikke symptomer på overdosering hos

mennesker.

Baseret på rapporter, der vedrører overdosis ved et uheld og/eller medicineringsfejl, svarer

de observerede symptomer til de kendte bivirkninger ved Ambroxolhydrochlorid "Unither

Pharmaceuticals". Der kan være behov for symptomatisk behandling.

4.10

Udlevering

5.

FARMAKOLOGISKE EGENSKABER

5.0

Terapeutisk klassifikation

ATC-kode: R 05 CB 06. Præparater mod hoste og forkølelse, Mucolytiske midler.

5.1

Farmakodynamiske egenskaber

Ambroxolhydrochlorid øger sekretion i luftvejene, produktion af pulmonalt overfladeaktivt

stof, og stimulerer mucociliær aktivitet.

Dette fører til forbedret transport af sekretog bevægelse (mucociliær clearance), hvilket er

påvist i farmakologiske studier. De øgede sekretioner og den øgede mucociliære clearance

booster ekspektoration og hoste.

Den lokalanæstetiske virkning af ambroxolhydrochlorid er observeret hos i en

kaninøjemodel og resulterer sandsynligvis fra dets natriumkanalblokerende egenskaber:

ambroxol blokerer neuronale natriumkanaler in vitro. Bindingen er reversibel og

koncentrationsafhængig. Denne farmakologiske egenskaber er overensstemmende med den

hurtige smertelindring og lindring af andet observeret ubehag, når ambroxolhydrochlorid

inhaleres i den symptomatiske behandling af andre sygdomme i de øvre åndedrætsveje.

54317_spc.docx

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Det er påvist, at ambroxolhydrochlorid in vitro væsentligt reducerer frigivelse af cytokiner

fra monomukleære og polymorfonuklære celler i både blod og væv.

I kliniske studier er der påvist en væsentligt reduktion af halssmerter og rødmen hos

patienter med ondt i halsen.

Administrationen af ambroxolhydrochlorid øger koncentrationen af antibiotika, såsom

amoxicillin, cefuroxim og erythromycin i bronkiesekret og opspyt.

5.2

Farmakokinetiske egenskaber

Absorption

Orale former af ambroxolhydrochlorid med øjeblikkelig frigivelse absorberes hurtigt og

næsten fuldstændigt.

Absorption er dosisafhængig ved terapeutiske doser.

Peakplasmakoncentrationer opnås inden for 1 til 2½ time efter oral administration af

formuleringen med øjeblikkelig frigivelse.

Fordeling

Vævsfordelingen efter administration er hurtig og omfattende.

De højeste koncentrationer observeres i lungerne.

Fordelingsvolumenet efter oral administration estimeres til 552 liter. Ved terapeutiske

doser estimeres plasmaproteinbindingen til ca. 90 %.

Biotransformation og eliminering

Ved oral administration elimineres ca. 30 % af dosen ved førstepassage-effekten.

Ambroxolhydrochlorid metaboliseres primært i leveren ved glukuronidering og spaltning

til dibromanthranilinsyre (ca. 10 % af dosis) og mindre metabolitter.

Studier af humane levermikrosomer har vist, at cytochrom P450 3A4 er ansvarligt for

metabolisering af ambroxolhydrochlorid til dibromanthranilinsyre. Efter tre dages

anvendelse genfindes ca. 6 % af en dosis i fri form, mens ca. 26 % genfindes i en

konjugeret form i urinen.

Ambroxolhydrochlorid har en halveringstid på ca. 10 timer. Total clearance er ca. 660

ml/min, hvoraf er den renale clearance ca. 83 %.

Farmakokinetik hos særlige befolkningsgrupper

Hos patienter med nedsat leverfunktion er elimineringen af ambroxolhydrochlorid nedsat,

hvilket resulterer i plasmakoncentrationer, de er ca. 1,3 til 2 gange højere.

Dosisjustering er ikke nødvendigt grundet det høje terapeutiske doseringsinterval med

ambroxolhydrochlorid.

Øvrige

Alder og køn påvirker ikke væsentligt farmakokinetikken for ambroxolhydrochlorid.

Dosisjustering er således ikke nødvendig.

Det er ikke påvist, at føde påvirker biotilgængeligheden af ambroxolhydrochlorid.

5.3

Prækliniske sikkerhedsdata

Ambroxolhydrochlorid har et meget lavt indeks for akut toksicitet.

I gentagne doseringsforsøg var de identificerede orale doser på 150 mg/kg/d (hos mus, 4

uger), 50 mg/kg/d (hos rotter, 52 til 78 uger), 40 mg/kg/d (hos kaniner, 26 uger) og 10

mg/kg/d (hos hunde, 52 uger) det niveau, hvor der ikke sås bivirkninger (no-observed-

adverse-effect levels).

Der blev ikke påvist målorgantoksicitet.

54317_spc.docx

Side 5 af 7

Intravenøse toksicitetsforsøg over 4 uger med ambroxolhydrochlorid i rotter (4, 16 og 64

mg/kg/dag) og i hunde (45, 90 og 120 mg/kg/dag (infusion 3 timer/dag)) viste ingen

alvorlig lokal og systemisk toksicitet (inklusive i histopatologiske resultater). Alle

bivirkninger var reversible.

Ambroxolhydrochlorid var hverken embryotoksisk eller teratogent, når det blev testet ved

orale doser på op til 3000 mg/kg/dag i rotter og op til 200 mg/kg/dag i kaniner.

Fertiliteten hos han- og hunrotter var ikke påvirket ved op til 500 mg/kg/dag.

NOAEL i et peri- og postnatal udviklingsstudie var 50 mg/kg/dag.

Ved 500 mg/kg/dag, var ambroxolhydrochlorid lettere toksisk for mødre og unger, hvilket

sås ved en hæmmet udvikling i kropsvægt og formindsket kuldstørrelse.

Genotoksicitetsstudier in vitro (Ames og kromosomafvigelsestest) og in vivo

(mikronucleustest i mus) viste intet mutagent potentiale for ambroxolhydrochlorid.

Ambroxolhydrochlorid viste ikke noget tumorigent potentiale i carcinogenicitetsstudier i

mus (50, 200 og 800 mg/kg/dag) og rotter (65, 250 og 1000 mg/kg/dag) ved behandling

som et kosttilskud i henholdsvis 105 og 116 uger.

6.

FARMACEUTISKE OPLYSNINGER

6.1

Hjælpestoffer

Acesulfamkalium

Benzoesyre

Citrussmag (indeholder naturlige smagsstoffer, naturlige smagsgivende stoffer, ethanol 96

procent og vand)

Glycerol

Hydroxyethylcellulose

Renset vand

Sorbitol, flydende (ikke-krystalliserende)

6.2

Uforligeligheder

Ikke relevant.

6.3

Opbevaringstid

3 år.

6.4

Særlige opbevaringsforhold

Dette lægemiddel kræver ingen særlige forholdsregler vedrørende opbevaringen.

6.5

Emballagetyper og pakningsstørrelser

5 ml oral opløsning i enkeltdosisbrev fremstillet af en PET12/AL12/PE50-film, der er

varmeforseglet, i æske.

Pakningsstørrelser: 15 stk.

6.6

Regler for destruktion og anden håndtering

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

retningslinjer.

7.

INDEHAVER AF MARKEDSFØRINGSTILLADELSEN

Unither Pharmaceuticals

151 rue André Durouchez

54317_spc.docx

Side 6 af 7

Espace Industriel Nord

80084 Amiens cedex 2

Frankrig

8.

MARKEDSFØRINGSTILLADELSESNUMMER (NUMRE)

54317

9.

DATO FOR FØRSTE MARKEDSFØRINGSTILLADELSE

5. januar 2016

10.

DATO FOR ÆNDRING AF TEKSTEN

19. juni 2017

54317_spc.docx

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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FDA - U.S. Food and Drug Administration

2-10-2018

Intuniv (Shire Pharmaceuticals Ireland Limited)

Intuniv (Shire Pharmaceuticals Ireland Limited)

Intuniv (Active substance: guanfacine) - Centralised - Yearly update - Commission Decision (2018)6473 of Tue, 02 Oct 2018

Europe -DG Health and Food Safety

25-9-2018

Slenyto (RAD Neurim Pharmaceuticals EEC Limited)

Slenyto (RAD Neurim Pharmaceuticals EEC Limited)

Slenyto (Active substance: melatonin) - Centralised - Authorisation - Commission Decision (2018)6223 of Tue, 25 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4425

Europe -DG Health and Food Safety

24-9-2018

Xerava (Tetraphase Pharmaceuticals Ireland Limited)

Xerava (Tetraphase Pharmaceuticals Ireland Limited)

Xerava (Active substance: Eravacycline) - Centralised - Authorisation - Commission Decision (2018)6231 of Mon, 24 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4237

Europe -DG Health and Food Safety

10-9-2018

Akynzeo (Helsinn Birex Pharmaceuticals Ltd)

Akynzeo (Helsinn Birex Pharmaceuticals Ltd)

Akynzeo (Active substance: netupitant / palonosetron) - Centralised - Yearly update - Commission Decision (2018)5947 of Mon, 10 Sep 2018

Europe -DG Health and Food Safety

29-8-2018

Lojuxta (Amryt Pharmaceuticals DAC)

Lojuxta (Amryt Pharmaceuticals DAC)

Lojuxta (Active substance: Lomitapide) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)5762 of Wed, 29 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2578/T/31

Europe -DG Health and Food Safety

28-8-2018

Kalydeco (Vertex Pharmaceuticals (Europe) Limited)

Kalydeco (Vertex Pharmaceuticals (Europe) Limited)

Kalydeco (Active substance: ivacaftor) - PASS - Modification - Commission Decision (2018)5693 of Tue, 28 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2494/RSR/S/14

Europe -DG Health and Food Safety

28-8-2018

Orkambi (Vertex Pharmaceuticals (Europe) Limited)

Orkambi (Vertex Pharmaceuticals (Europe) Limited)

Orkambi (Active substance: Lumacaftor/Ivacaftor) - PSUSA - Modification - Commission Decision (2018)5710 of Tue, 28 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/PSUSA/10455/201711

Europe -DG Health and Food Safety

27-8-2018

Firazyr (Shire Pharmaceuticals Ireland Limited)

Firazyr (Shire Pharmaceuticals Ireland Limited)

Firazyr (Active substance: icatibant) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)5697 of Mon, 27 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/899T/41

Europe -DG Health and Food Safety

27-8-2018

Vyxeos (Jazz Pharmaceuticals Ireland Ltd)

Vyxeos (Jazz Pharmaceuticals Ireland Ltd)

Vyxeos (Active substance: daunorubicin / cytarabine) - Centralised - Authorisation - Commission Decision (2018)5695 of Mon, 27 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4282

Europe -DG Health and Food Safety

27-8-2018

Evicel (Omrix Biopharmaceuticals N.V.)

Evicel (Omrix Biopharmaceuticals N.V.)

Evicel (Active substance: human fibrinogen / human thrombin) - Centralised - Renewal - Commission Decision (2018)5689 of Mon, 27 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/898/R/54

Europe -DG Health and Food Safety

25-8-2018

Xagrid (Shire Pharmaceuticals Ireland Limited)

Xagrid (Shire Pharmaceuticals Ireland Limited)

Xagrid (Active substance: anagrelide) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)5682 of Sat, 25 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/480/T/82

Europe -DG Health and Food Safety

2-8-2018

EU/3/18/2054 (Mallinckrodt Specialty Pharmaceuticals Ireland Limited)

EU/3/18/2054 (Mallinckrodt Specialty Pharmaceuticals Ireland Limited)

EU/3/18/2054 (Active substance: Tetracosactide) - Orphan designation - Commission Decision (2018)5286 of Thu, 02 Aug 2018 European Medicines Agency (EMA) procedure number: EMA/OD/043/18

Europe -DG Health and Food Safety

1-8-2018

Myalepta (Aegerion Pharmaceuticals B.V.)

Myalepta (Aegerion Pharmaceuticals B.V.)

Myalepta (Active substance: metreleptin) - Centralised - Authorisation - Commission Decision (2018)5202 of Wed, 01 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4218

Europe -DG Health and Food Safety

30-7-2018

Nityr (Cycle Pharmaceuticals Ltd)

Nityr (Cycle Pharmaceuticals Ltd)

Nityr (Active substance: nitisinone) - Centralised - Authorisation - Commission Decision (2018)5446 of Mon, 30 Jul 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4582

Europe -DG Health and Food Safety

27-7-2018

EU/3/06/363 (Telix Pharmaceuticals Holdings Germany GmbH)

EU/3/06/363 (Telix Pharmaceuticals Holdings Germany GmbH)

EU/3/06/363 (Active substance: 4-[131I]iodo-L-phenylalanine) - Transfer of orphan designation - Commission Decision (2018)5036 of Fri, 27 Jul 2018 European Medicines Agency (EMA) procedure number: EMA/OD/110/05/T/02

Europe -DG Health and Food Safety

16-7-2018

Reconcile (Nexcyon Pharmaceuticals Ltd)

Reconcile (Nexcyon Pharmaceuticals Ltd)

Reconcile (Active substance: Fluoxetine) - Centralised - Renewal - Commission Decision (2018)4770 of Mon, 16 Jul 2018 European Medicines Agency (EMA) procedure number: EMEA/V/C/133/R-18

Europe -DG Health and Food Safety

29-6-2018

EU/3/07/505 (Faron Pharmaceuticals Limited)

EU/3/07/505 (Faron Pharmaceuticals Limited)

EU/3/07/505 (Active substance: Interferon beta) - Amendment of orphan designation - Commission Decision (2018)4186 of Fri, 29 Jun 2018 European Medicines Agency (EMA) procedure number: EMA/OD/080/17

Europe -DG Health and Food Safety

12-6-2018

EU/3/17/1834 (Santhera Pharmaceuticals (Deutschland) GmbH)

EU/3/17/1834 (Santhera Pharmaceuticals (Deutschland) GmbH)

EU/3/17/1834 (Active substance: Cyclo[L-alanyl-L-seryl-L-isoleucyl-L-prolyl-L-prolyl-L-glutaminyl-L-lysyl-L-tyrosyl-D-prolyl-L-prolyl-(2S)-2-aminodecanoyl-L-alpha-glutamyl-L-threonyl]acetate salt) - Transfer of orphan designation - Commission Decision (2018)3797 of Tue, 12 Jun 2018 European Medicines Agency (EMA) procedure number: EMA/OD/244/16/T/01

Europe -DG Health and Food Safety

12-6-2018

EU/3/13/1114 (Santhera Pharmaceuticals (Deutschland) GmbH)

EU/3/13/1114 (Santhera Pharmaceuticals (Deutschland) GmbH)

EU/3/13/1114 (Active substance: Cyclo[L-alanyl-L-seryl-L-isoleucyl-L-prolyl-L-prolyl-L-glutaminyl-L-lysyl-L-tyrosyl-D-prolyl-L-prolyl-(2S)-2-aminodecanoyl-L-alpha-glutamyl-L-threonyl] acetate salt) - Transfer of orphan designation - Commission Decision (2018)3798 of Tue, 12 Jun 2018 European Medicines Agency (EMA) procedure number: EMA/OD/166/12/T/01

Europe -DG Health and Food Safety

11-6-2018

Constella (Allergan Pharmaceuticals International Limited)

Constella (Allergan Pharmaceuticals International Limited)

Constella (Active substance: linaclotide) - Centralised - Yearly update - Commission Decision (2018)3777 of Mon, 11 Jun 2018

Europe -DG Health and Food Safety

30-5-2018

Sevohale (Chanelle Pharmaceuticals Manufacturing Limited)

Sevohale (Chanelle Pharmaceuticals Manufacturing Limited)

Sevohale (Active substance: sevoflurane) - Centralised - 2-Monthly update - Commission Decision (2018)3407 of Wed, 30 May 2018 European Medicines Agency (EMA) procedure number: EMEA/V/C/4199/IB/3

Europe -DG Health and Food Safety

15-5-2018

Rekovelle (Ferring Pharmaceuticals A/S)

Rekovelle (Ferring Pharmaceuticals A/S)

Rekovelle (Active substance: follitropin delta) - Centralised - Yearly update - Commission Decision (2018)2998 of Tue, 15 May 2018

Europe -DG Health and Food Safety

17-4-2018

EU/3/11/945 (Mallinckrodt Pharmaceuticals Ireland Limited)

EU/3/11/945 (Mallinckrodt Pharmaceuticals Ireland Limited)

EU/3/11/945 (Active substance: Ornithine phenylacetate) - Transfer of orphan designation - Commission Decision (2018)2355 of Tue, 17 Apr 2018 European Medicines Agency (EMA) procedure number: EMA/OD/105/11/T/03

Europe -DG Health and Food Safety