Montelukast "Orion"

Primær information

  • Handelsnavn:
  • Montelukast "Orion" 10 mg tabletter
  • Dosering:
  • 10 mg
  • Lægemiddelform:
  • tabletter
  • Brugt til:
  • Mennesker
  • Medicin typen:
  • Allopatiske stof

Dokumenter

Lokation

  • Fås i:
  • Montelukast "Orion" 10 mg tabletter
    Danmark
  • Sprog:
  • dansk

Andre oplysninger

Status

  • Kilde:
  • Lægemiddelstyrelsen - Danish Medicines Agency
  • Autorisation status:
  • Markedsført
  • Autorisationsnummer:
  • 45202
  • Sidste ændring:
  • 22-02-2018

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

Indlægsseddel: Information til brugeren

Montelukast Orion 10 mg tabletter

Montelukast

Læs denne indlægsseddel grundigt, inden du begynder at tage dette lægemiddel, da den indeholder

vigtige oplysninger.

Gem indlægssedlen. Du kan få brug for at læse den igen.

Spørg lægen eller apotekspersonalet, hvis der er mere, du vil vide.

Lægen har ordineret dette lægemiddel til dig personligt. Lad derfor være med at give medicinen til

andre. Det kan være skadeligt for andre, selvom de har de samme symptomer, som du har.

Kontakt lægen eller apotekspersonalet, hvis en bivirkning bliver værre, eller hvis du får bivirkninger,

som ikke er nævnt her. Se punkt 4.

Den senest reviderede indlægsseddel kan findes på www.indlaegsseddel.dk

Oversigt over indlægssedlen

Virkning og anvendelse

Det skal du vide, før du begynder at tage Montelukast Orion

Sådan skal du tage Montelukast Orion

Bivirkninger

Opbevaring

Pakningsstørrelser og yderligere oplysninger

1.

Virkning og anvendelse

Montelukast Orion er en leukotrienreceptor-antagonist, der blokerer visse stoffer, kaldet leukotriener.

Leukotriener forårsager forsnævring og hævelse af luftvejene i lungerne og er også årsag til allergiske

symptomer. Ved at blokere leukotrienernes virkning kan Montelukast Orion mindske astmasymptomer,

hjælpe med at kontrollere astmaen og bedre sæsonbetingede allergisymptomer (også kendt som høfeber eller

sæsonbetinget allergisk rinitis).

Lægen har foreskrevet Montelukast Orion til behandling af astma og til at forhindre astmasymptomer om

dagen og om natten.

Montelukast Orion er til behandling af voksne og unge fra 15 år og ældre, der ikke er tilstrækkeligt

behandlet med deres nuværende medicin, og som har brug for yderligere behandling.

Montelukast Orion hjælper også til at forebygge forsnævring af luftvejene ved fysisk aktivitet.

Til astmapatienter, hvor Montelukast Orion er indiceret til behandling af astma, kan Montelukast Orion

også anvendes symptomatisk lindring af sæsonbetinget allergisk rinitis.

Din læge vil beslutte, hvordan Montelukast Orion skal anvendes, afhængigt af symptomerne og hvor alvorlig

astmaen er.

Hvad er astma?

Astma er en kronisk sygdom.

Særlige kendetegn for astma er:

forsnævring af luftvejene, som gør vejrtrækningen besværlig. Denne forsnævring kan forværres eller

bedres som reaktion på forskellige forhold.

følsomme luftveje, som reagerer på mange ting, for eksempel cigaretrøg, pollen, kold luft eller fysisk

aktivitet.

hævelse (betændelse) i slimhinden i luftvejene.

Symptomer på astma er: hoste, hvæsende vejrtrækning og trykken for brystet.

Hvad er sæsonbetinget allergi?

Sæsonbetinget allergi (også kendt som høfeber eller sæsonbetinget allergisk rinitis) er en allergisk reaktion

som ofte skyldes luftbårne pollen fra træer, græs og korn. Symptomerne på sæsonbetinget allergi kan typisk

omfatte: tilstoppet næse, løbende næse, kløende næse, nysen, hævede øjne, røde øjne, kløende øjne, der løber

i vand.

2.

Det skal du vide, før du begynder at tage Montelukast Orion

Lægen kan have foreskrevet anden anvendelse eller dosering end angivet i denne information. Følg altid

lægens anvisning og oplysningerne på doseringsetiketten.

Fortæl din læge om alle helbredsproblemer eller allergier du har eller tidligere har haft.

Tag ikke Montelukast Orion

hvis du er allergisk over for montelukast eller et af de øvrige indholdsstoffer i

Montelukast Orion (angivet i punkt 6).

Advarsler og forsigtighedsregler

Kontakt lægen eller apotekspersonalet, før du tager Montelukast Orion.

Fortæl det straks til lægen, hvis din astma eller vejrtrækning bliver værre.

Montelukast Orion-tabletter er ikke beregnet til behandling af akutte astmaanfald. Hvis der opstår

et astmaanfald, så følg den instruktion lægen har givet. Du skal altid have din inhalationsmedicin til

astmaanfald med dig.

Det er vigtigt, at du eller dit barn tager den astmamedicin, som lægen har udskrevet. Montelukast Orion

må ikke erstatte eventuel anden medicin mod astma, som lægen har udskrevet til dig.

Alle patienter, som er i behandling med astmamedicin, skal være opmærksomme på at kontakte lægen,

hvis der udvikles en kombination af influenzalignende symptomer, stikkende og prikkende eller sovende

fornemmelser i arme eller ben og/eller udslæt.

Du bør ikke tage acetylsalicylsyre eller anden betændelseshæmmende medicin (også kendt som ikke-

steroid anti-inflammatorisk medicin eller NSAID), hvis de forværrer din astma.

Børn og unge

Giv ikke dette lægemiddel til børn under 15 år.

Til børn i alderen 2 – 5 år findes montelukast som 4 mg tyggetabletter.

Til børn i alderen 6 – 14 år findes montelukast som 5 mg tyggetabletter.

Brug af anden medicin sammen med Montelukast Orion

Fortæl det altid til lægen eller apotekspersonalet, hvis du tager anden medicin eller har gjort det for nylig

inklusiv håndkøbslægemidler.

Nogle former for medicin kan påvirke virkningen af Montelukast Orion, eller Montelukast Orion kan

indvirke på, hvordan anden medicin virker.

Fortæl det til lægen, hvis du tager følgende medicin, før du begynder at give Montelukast Orion:

phenobarbital (mod epilepsi)

phenytoin (mod epilepsi)

rifampicin (mod tuberkulose og andre infektioner)

gemfibrozil (mod høje lipidniveauer i plasma)

Brug af Montelukast Orion sammen med mad og drikke

Montelukast Orion 10 mg tabletter kan tages sammen med eller uden mad.

Graviditet, amning og fertilitet

Spørg din læge eller apoteket til råds, før du bruger nogen form for medicin.

Hvis du er gravid eller ammer, har mistanke om, at du er gravid, eller planlægger at blive gravid, skal du

spørge din læge til råds, før du tager dette lægemiddel.

Graviditet

Din læge vil vurdere, om du kan tage Montelukast Orion under graviditeten.

Amning

Det vides ikke, om Montelukast Orion udskilles i modermælk. Hvis du ammer eller planlægger at amme,

bør du kontakte lægen, før du tager Montelukast Orion.

Trafik- og arbejdssikkerhed

Det er ikke sandsynligt, at Montelukast Orion påvirker evnen til at køre bil eller betjene maskiner. Det er dog

forskelligt, hvordan man reagerer på medicin. Der er set bivirkninger (såsom svimmelhed og døsighed) med

Montelukast Orion, som kan påvirke evnen til at køre bil eller

betjene maskiner.

Montelukast Orion indeholder aspartam

Montelukast Orion tabletter indeholder aspartam, en phenylalaninkilde. Kan være skadelig for patient

fenylketonuri (PKU, Føllings sygdom). Hvis du har fenylketonuri (en sjælden, arvelig stofskiftesygdom), bør

du være opmærksom på, at hver 10 mg tablet indeholder phenylalanin (svarende til 0,421 mg phenylalanin

pr. 10 mg tablet).

3.

Sådan skal du tage Montelukast Orion

Tag altid lægemidlet nøjagtigt efter lægens anvisning. Er du i tvivl, så spørg lægen eller på apoteket.

Du må kun tage én Montelukast Orion tablet dagligt som foreskrevet af lægen.

Du skal også tage tabletten, selvom du ikke har symptomer eller har et akut astmaanfald.

Voksne og unge fra 15 år og ældre:

Den anbefalede dosis er én Montelukast Orion 10 mg tablet dagligt om aftenen. Montelukast Orion kan tages

sammen med eller uden mad. Dette lægemiddel er til oralt brug.

Hvis du er i behandling med Montelukast Orion, må du ikke få andre lægemidler, der indeholder det samme

aktive stof, montelukast.

Hvis du har taget for mange Montelukast Orion

Kontakt lægen, skadestuen eller apoteket, hvis du har mere af Montelukast Orion, end der står i denne

information, eller mere end lægen har foreskrevet, og du føler dig utilpas.

Tag pakningen med.

I de fleste tilfælde med overdosering er der ikke indberettet bivirkninger. De mest almindelige

symptomer set i forbindelse med overdosering hos voksne og børn er mavesmerter, søvnighed, tørst,

hovedpine, opkastning og hyperaktivitet.

Hvis du har glemt at tage Montelukast Orion

Tag Montelukast Orion, som lægen har foreskrevet. Hvis du har glemt at en dosis, skal du blot genoptage

behandlingen og fortsætte med én tablet én gang dagligt.

Du må ikke tage en dobbeltdosis som erstatning for den glemte dosis.

Hvis du holder op med at tage Montelukast Orion

Montelukast Orion kan kun behandle din astma, hvis du fortsætter med at tage det.

Det er vigtigt, at fortsætte med at tage Montelukast Orion, så længe lægen foreskriver det for at bevare

kontrollen med din astma.

Spørg lægen eller på apoteket, hvis der er noget, du er i tvivl om.

4.

Bivirkninger

Dette lægemiddel kan som al anden medicin give bivirkninger, men ikke alle får bivirkninger.

Hvis du oplever nogen af følgende alvorlige bivirkninger, som er rapporteret i forbindelse med

montelukast, skal du stoppe med at tage Montelukast Orion og straks kontakte lægen:

Pludselig hiven efter vejret, hævelser af læber, tunge og svælg eller på kroppen, udslæt, besvimelse eller

vejrtræknings- eller synkebesvær (alvorlig allergisk reaktion). Denne bivirkning er ikke almindelig (kan

forekomme hos op til 1 ud af 100 personer).

Influenzalignende sygdom, stikken og prikken eller følelsesløshed i arme og ben, forværrede

lungesymptomer og/eller udslæt (Churg-Strauss syndrom). Denne bivirkning er meget sjælden (kan

forekomme hos op til 1 ud af 10.000 personer).

I kliniske undersøgelser var de meget almindelige bivirkninger: (kan forekomme hos flere end l ud af 10

personer):

mavesmerter

hovedpine.

Disse var sædvanligvis normalt lette og sås hyppigere hos patienter behandlet med montelukast end hos

patienter, der fik placebo (tablet uden virkning).

Derudover er der, mens medicinen har været på markedet, set:

Meget almindelige bivirkninger: (kan forekomme hos flere end l ud af 10 personer):

infektion i de øvre luftveje

Almindelige bivirkninger: (kan forekomme hos op til 1 ud af 10 personer):

diarré, kvalme, opkastning

udslæt

feber.

forhøjede levertal (transaminaser: ALAT, ASAT)

Ikke almindelige bivirkninger: (kan forekomme hos op til 1 ud af 100 personer):

ændringer i adfærd og humør såsom ændret drømmemønster, herunder mareridt, søvnbesvær,

søvngængeri, irritabilitet, angstfølelse, rastløshed, uro herunder aggressiv opførsel eller fjendtlighed,

depression

svimmelhed, døsighed, stikkende og prikkende fornemmelse eller følelsesløshed, krampeanfaldnæseblod

mundtørhed, fordøjelsesbesvær

blå mærker, kløe, nældefeber

led- eller muskelsmerter, muskelkramper

svaghed/træthed, utilpashed, hævelser

Sjældne bivirkninger: (kan forekomme hos op til 1 ud af 1.000 personer):

øget blødningstendens

rysten, opmærksomhedsforstyrrelser, nedsat hukommelse

hjertebanken

hævelse under huden (ødem)

Meget sjældne bivirkninger: (kan forekomme hos op til 1 ud af 10.000 personer):

leverproblemer (hepatisk eosinofilinfiltration)

hallucinationer, forvirring, selvmordstanker og adfærd

hævelse (inflammation) af lungerne

hepatitis (leverbetændelse)

ømme, røde knuder under huden oftest på skinnebenene (erythema nodosum), alvorlige hudreaktioner

(erythema multiforme) der kan forekomme uden forudgående tegn.

Indberetning af bivirkninger

Hvis du oplever bivirkninger, bør du tale med din læge, sygeplejerske eller apoteket. Dette gælder også

mulige bivirkninger, som ikke er medtaget i denne indlægsseddel. Du eller dine pårørende kan også

indberette bivirkninger direkte til:

Lægemiddelstyrelsen

Axel Heides Gade 1

DK-2300 København S

Websted: www.meldenbivirkning.dk

E-mail: dkma@dkma.dk

Ved at indrapportere bivirkninger kan du hjælpe med at fremskaffe mere information om sikkerheden af

dette lægemiddel.

5.

Opbevaring

Opbevar lægemidlet utilgængeligt for børn.

Brug ikke lægemidlet efter den udløbsdato, der står på æsken og blisterkortet efter EXP. Udløbsdatoen er

den sidste dag i den nævnte måned.

Der er ingen særlige krav vedrørende opbevaringstemperaturen for dette lægemiddel. Opbevares i den

originale emballage for at beskytte mod lys og fugt.

Spørg på apoteket, hvordan du skal bortskaffe medicinrester. Af hensyn til miljøet må du ikke smide

medicinrester i afløbet eller skraldespanden.

6.

Pakningsstørrelser og yderligere oplysninger

Montelukast Orion indeholder

Aktivt stof: montelukast. Hver tablet indeholder 10,4 mg montelukast natrium svarende til 10 mg

montelukast.

Øvrige indholdsstoffer: mannitol (E421), mikrokrystallinsk cellulose, croscarmellosenatrium,

magnesiumstearat, aspartam (E951), kirsebæraroma (Firmenich CHERRY 501027 AP0551), gul

jernoxid (E172), rød jernoxid (E172).

Udseende og pakningsstørrelser

Lysebrune, runde, hvælvede, uovertrukne tabletter, med delekærv på begge sider. Tabletten kan deles i to

lige store doser.

Tabletterne er pakket i Alu/Alu-blisterkort. Blisterkortene er pakket i æsker.

Pakningsstørrelser:

28, 56 og 98 tabletter

Ikke alle pakningsstørrelser er nødvendigvis markedsført.

Indehaver af markedsføringstilladelsen

Orion Corporation

Orionintie 1

FI-02200 Espoo

Finland

Fremstiller

Orion Corporation Orion Pharma

Orionintie 1

FI-02200 Espoo

Finland

For yderligere oplysning om dette lægemiddel, bedes henvendelse rettet til den lokale repræsentant for

indehaveren af markedsføringstilladelsen:

Orion Pharma A/S

medinfo@orionpharma.com

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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

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

4-2-2019

Stalevo (Orion Corporation)

Stalevo (Orion Corporation)

Stalevo (Active substance: Levodopa,carbidopa,entacapone) - Centralised - Yearly update - Commission Decision (2019)847 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

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

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

19-12-2018

EU/3/14/1319 (Richardson Associates Regulatory Affairs Ltd)

EU/3/14/1319 (Richardson Associates Regulatory Affairs Ltd)

EU/3/14/1319 (Active substance: Recombinant factor VIIa modified with three terminal repeats derived from the beta chain of human chorionic gonadotropin) - Transfer of orphan designation - Commission Decision (2018)9010 of Wed, 19 Dec 2018 European Medicines Agency (EMA) procedure number: EMA/OD/0000002648

Europe -DG Health and Food Safety

19-12-2018

EU/3/14/1316 (Richardson Associates Regulatory Affairs Ltd)

EU/3/14/1316 (Richardson Associates Regulatory Affairs Ltd)

EU/3/14/1316 (Active substance: Recombinant factor VIIa modified with three terminal repeats derived from the beta chain of human chorionic gonadotropin) - Transfer of orphan designation - Commission Decision (2018)9011 of Wed, 19 Dec 2018 European Medicines Agency (EMA) procedure number: EMA/OD/0000002649

Europe -DG Health and Food Safety

19-12-2018

EU/3/14/1312 (Richardson Associates Regulatory Affairs Ltd)

EU/3/14/1312 (Richardson Associates Regulatory Affairs Ltd)

EU/3/14/1312 (Active substance: Recombinant factor VIIa modified with three terminal repeats derived from the beta chain of human chorionic gonadotropin) - Transfer of orphan designation - Commission Decision (2018)9012 of Wed, 19 Dec 2018 European Medicines Agency (EMA) procedure number: EMA/OD/0000002650

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

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

Dexdomitor (Orion Corporation)

Dexdomitor (Orion Corporation)

Dexdomitor (Active substance: dexmedetomidine hydrochloride) - Centralised - Yearly update - Commission Decision (2018)7380 of Thu, 01 Nov 2018

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

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

Dexdor (Orion Corporation)

Dexdor (Orion Corporation)

Dexdor (Active substance: dexmedetomidine) - Centralised - 2-Monthly update - Commission Decision (2018)5377 of Mon, 06 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2268/II/26

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/3/18/2043 (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

11-7-2018

Fosavance (Merck Sharp and Dohme B.V.)

Fosavance (Merck Sharp and Dohme B.V.)

Fosavance (Active substance: Alendronate Sodium / Colecalciferol) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)4518 of Wed, 11 Jul 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/619/T/42

Europe -DG Health and Food Safety

10-7-2018

Corbilta (Orion Corporation)

Corbilta (Orion Corporation)

Corbilta (Active substance: levodopa / carbidopa / entacapone) - Centralised - Renewal - Commission Decision (2018)4468 of Tue, 10 Jul 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2785/R/15

Europe -DG Health and Food Safety

10-7-2018

Adrovance (Merck Sharp and Dohme B.V.)

Adrovance (Merck Sharp and Dohme B.V.)

Adrovance (Active substance: Alendronate sodium / Colecalciferol) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)4477 of Tue, 10 Jul 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/759/T/39

Europe -DG Health and Food Safety

10-7-2018

Ammonaps (Swedish Orphan Biovitrum International AB)

Ammonaps (Swedish Orphan Biovitrum International AB)

Ammonaps (Active substance: Sodium phenylbutyrate) - Centralised - Yearly update - Commission Decision (2018)4483 of Tue, 10 Jul 2018

Europe -DG Health and Food Safety

5-7-2018

Withdrawn application:  Prohippur, sodium benzoate, Initial authorisation

Withdrawn application: Prohippur, sodium benzoate, Initial authorisation

Europe - EMA - European Medicines Agency