Montelukast "Krka"

Primær information

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

Dokumenter

Lokation

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

Andre oplysninger

Status

  • Kilde:
  • Lægemiddelstyrelsen - Danish Medicines Agency
  • Autorisation status:
  • Markedsført
  • Autorisationsnummer:
  • 41292
  • Sidste ændring:
  • 22-02-2018

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

Indlægsseddel: Information til brugeren

Montelukast Krka 10 mg filmovertrukne 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 på apotekspersonalet, hvis der er mere, du vil vide.

Lægen har ordineret Montelukast Krka til dig personligt. Lad derfor være med at give det til

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

Tal med lægen eller apotekspersonalet, hvis en bivirkning bliver værre, eller du får

bivirkninger, som ikke er nævnt her. Se afsnit 4.

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

Oversigt over indlægssedlen

Virkning og anvendelse

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

Sådan skal du tage Montelukast Krka

Bivirkninger

Opbevaring

Pakningsstørrelser og yderligere oplysninger

1.

Virkning og anvendelse

Det aktive stof i Montelukast Krka er montelukast, som er en leukotrienreceptor- antagonist, der

blokerer naturligt forekommende stoffer (leukotriener) i lungerne. Leukotriener forårsager

forsnævring og betændelsestilstande i lungerne, hvilket kan give astmasymptomer. Leukotriener

bidrager også til symptomerne på allergi. Ved at blokere leukotriener nedsættes symptomerne på

sæsonbetinget allergi (også kaldet sæsonbetinget allergisk snue eller høfeber).

Montelukast Krka anvendes til behandling af voksne astmapatienter og teenagere fra 15 år og derover

med astma, der ikke er tilstrækkeligt kontrolleret med deres nuværende medicin, og som har brug for

yderligere behandling.

Hos patienter med astma og sæsonbetinget allergi kan Montelukast Krka også behandle symptomerne

på sæsonbetinget allergi.

Montelukast Krka kan også forebygge astmasymptomer opstået ved fysisk aktivitet hos voksne

patienter og teenagere fra 15 år og derover.

Hvad er astma

Astma er en kronisk sygdom

Astma omfatter:

vejrtrækningsbesvær på grund af forsnævrede luftveje. Denne forsnævring af luftvejene forværres

og forbedres som respons på forskellige tilstande.

følsomme luftveje, som reagerer på mange ting, såsom cigaretrøg, pollen eller kold luft eller

fysisk aktivitet.

Hævelse (inflammation) af slimhinden i luftvejene.

Astmasymptomer omfatter: hoste, hvæsende vejrtrækning og tæthed i brystet.

Hvad er sæsonbetinget allergisk snue?

Sæsonbetinget allergi (også kendt som høfeber eller sæsonbetinget allergisk snue) er en allergi, der

ofte skyldes luftbårne pollen fra træer, græs og korn. Symptomerne på sæsonbetingede allergier

omfatter typisk : tilstoppet, løbende, kløende næse, nysen, rindende, hævede, røde, kløende øjne.

2.

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

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

altid lægens anvisning og oplysningerne på doseringsetiketten.

Fortæl lægen om alle sygdomsrelaterede problemer eller allergier, som du har nu eller har haft.

Tag ikke Montelukast Krka

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

(angivet i pkt. 6).

Advarsler og forsigtighedsregler

Det er vigtigt at Montelukast Krka tages efter lægens anvisning, også selv om du ikke har nogle

symptomer, eller hvis du får et astmaanfald.

Montelukast Krka filmovertrukne tabletter er IKKE beregnet til behandling af akutte anfald af

åndenød. Det hjælper dig ikke i denne situation og bør aldrig anvendes til det formål. Hvis et anfald

opstår skal du nøjagtigt følge den instruktion lægen har givet. Det er meget vigtigt, at du altid har den

medicin, der er nødvendig ved sådanne anfald, klar til brug.

Kontakt hurtigst muligt lægen, hvis du hyppigere end normalt har brug for din beta-agonist inhalator

(også kaldet bronkieudvidende eller bronkieafslappende inhalator).

Montelukast Krka må ikke erstatte den behandling med steroider (hverken til inhalation eller som

tabletter), som du allerede får.

Patienter med astma, som forværres af acetylsalicylsyre, og som tager Montelukast Krka, skal fortsat

undgå at tage acetylsalicylsyre eller andre non-steroide anti-inflammatoriske lægemidler (visse former

for smertestillende medicin).

En sjælden tilstand er set hos et meget lille antal patienter i behandling med astmamedicin, heriblandt

montelukast, selv om det ikke er vist, at montelukast er årsag hertil. Søg straks lægehjælp, hvis du får

en kombination af nogle af følgende symptomer, især hvis de vedvarer eller bliver værre:

influenzalignende symptomer

tiltagende åndenød

stikkende og prikkende eller sovende fornemmelse i arme og ben, og/eller hududslæt

Børn

Til børn i alderen 2-5 år fås Montelukast Krka 4 mg tyggetabletter.

Til børn i alderen 6-14 år fås Montelukast Krka 5 mg tyggetabletter.

Brug af anden medicin sammen med Montelukast Krka

Fortæl altid lægen eller apoteket, hvis du tager anden medicin eller har gjort det for nylig.

Det er især vigtigt, at du fortæller lægen, hvis du tager phenobarbital eller phenytoin (mod epilepsi),

rifampicin (mod tuberkulose og visse andre infektioner) eller gemfibrozil (mod forhøjet fedtindhold i

blodet)

fordi disse kan påvirke virkningen af Montelukast Krka.

Montelukast Krka kan tages sammen med anden astmamedicin.

Brug af Montelukast Krka sammen med mad

Du kan tage Montelukast Krka sammen med eller uden mad.

Graviditet og amning

Graviditet

Hvis du er gravid eller ammer, har mistanke om, at du er gravid, skal du spørge din læge eller apoteket

til råds, før du tager dette lægemiddel.

Amning

Det vides ikke, om montelukast udskilles i modermælk. Kontakt lægen, før du tager Montelukast

Krka, hvis du ammer eller har til hensigt at amme.

Trafik- og arbejdssikkerhed

Montelukast Krka forventes ikke at påvirke din evne til at føre motorkøretøj eller betjene maskiner.

Det er dog forskelligt, hvordan man reagerer på medicinen. Visse bivirkninger, som er indberettet i

meget sjældne tilfælde i forbindelse med Montelukast Krka, kan påvirke nogle patienters evne til at

køre bil eller betjene maskiner.

Montelukast Krka indeholder lactose

Kontakt lægen, før du tager denne medicin, hvis lægen har fortalt dig, at du ikke tåler visse

sukkerarter.

3.

Sådan skal du tage Montelukast Krka

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

apoteket.

Tag Montelukast Krka én gang dagligt, gennem munden og

om aftenen

, sammen med eller uden mad,

som lægen har foreskrevet.

Den sædvanlige dosis til voksne og unge fra 15 år og derover er én tablet à 10 mg dagligt.

Uanset om du har symptomer eller ej, er det vigtigt at fortsætte med at tage Montelukast Krka, så

længe som lægen foreskriver det for at bevare kontrollen over din astma. Montelukast Krka kan kun

behandle astma ved fortsat brug.

Montelukast Krka må ikke anvendes samtidigt med andre lægemidler, der indeholder samme aktive

stof, montelukast.

Anvendelse til børn

Det frarådes at anvende Montelukast Krka til børn under 15 år.

Hvis du har taget for mange Montelukast Krka

Kontakt lægen, skadestuen eller apoteket, hvis du har taget flere Montelukast Krka filmovertrukne

tabletter, end der står i denne information, eller flere end lægen har foreskrevet og du af den grund

føler dig utilpas. Tag pakningen med.

I de fleste tilfælde er der ikke blevet indberettet bivirkninger. De mest almindelige symptomer var:

tørst, træthed, hovedpine, overaktivitet og mavesmerter.

Hvis du har glemt at tage Montelukast Krka

Tag aldrig dobbelt dosis, hvis De har glemt at tage en dosis filmovertrukne tabletter. Fortsæt blot med

den sædvanlige dosis.

Hvis du holder op med at tage Montelukast Krka

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

Det er vigtigt at fortsætte med at tage Montelukast Krka, så længe som din læge ordinerer det.

Det hjælper med at få kontrol over 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.

I kliniske undersøgelser med montelukast 10 mg filmovertrukne tabletter var de mest almindeligt

indberettede bivirkninger (forekommer hos mellem 1 og 10 ud af 100 behandlede), som menes at

hænge sammen med behandling med montelukast:

mavesmerter

hovedpine

Disse var sædvanligvis lette og forekom med større hyppighed hos patienter behandlet Montelukast

Krka end placebo (tabletter der ikke indeholder medicin).

Hyppigheder for mulige bivirkninger er anført nedenunder og defineres på følgende måde:

Meget almindelig: kan påvirke flere end 1 ud af 10 personer

Almindelig: kan påvirke op til 1 ud af 10 personer

Ikke almindelig: kan påvirke op til 1 ud af 100 personer

Sjælden: kan påvirke op til 1 ud af 1.000 personer

Meget sjælden: kan påvirke op til 1 ud af 10.000 personer

Mens tabletterne har været på markedet er der desuden indberettet følgende:

infektion i de øvre luftveje (meget almindelig)

øget blødningstendens (sjælden)

allergiske reaktioner med hævelse af ansigt, læber, tunge og/eller svælg, som kan medføre

vejrtræknings- eller synkebesvær (ikke almindelig)

ændringer i humør eller adfærd [unormale drømme, herunder mareridt, søvnbesvær, søvngængeri,

irritabilitet, angst, rastløshed, uro herunder aggressiv opførsel eller fjendtlighed, depression, (ikke

almindelig): rysten (sjælden: hallucination, desorientering, selvmordstanker og –forsøg (Meget

sjældne tilfælde)]

svimmelhed, døsighed, stikken/prikken/følelsesløshed, kramper (ikke almindelig)

hjertebanken (sjælden)

næseblod (ikke almindelig)

diarré, kvalme, opkastning (almindelig): mundtørhed, fordøjelsesbesvær (ikke almindelig)

leverbetændelse (hepatitis) (meget sjælden)

udslæt (almindelig), blå mærker, kløe, nældefeber (ikke almindelig), ømme røde knuder under

huden, oftest på skinnebenene (erythema nodosum), alvorlige hudreaktioner (erythema

multiforme), der kan forekomme uden varsel (meget sjælden)

led- eller muskelsmerter, muskelkramper (ikke almindelig)

feber (almindelig), træthed, utilpashed, hævelser, (ikke almindelig)

Hos astmapatienter, der behandles med montelukast, er der i meget sjældne indberettet en kombination

af symptomer såsom influenzalignende sygdom, stikken, prikken eller følelsesløshed i arme eller ben,

forværring af lungesymptomer og/eller udslæt (Churg-Strauss syndrom). Du skal straks fortælle det til

lægen, hvis du får et eller flere af disse symptomer.

Tal med lægen eller apotekspersonalet, hvis du får bivirkninger, herunder bivirkninger, som ikke

fremgår af denne indlægsseddel.

Indberetning af bivirkninger til Sundhedsstyrelsen

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 Sundhedsstyrelsen via:

Sundhedsstyrelsen

Axel Heides Gade 1

DK-2300 København S

Websted: www.meldenbivirkning.dk

E-mail: sst@sst.dk

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

af dette lægemiddel.

5.

Opbevaring

Opbevar dette lægemiddel utilgængelig for børn.

Brug ikke dette lægemiddel efter den udløbsdato, der står på blisterkort og pakning efter EXP.

Udløbsdatoen er den sidste dag i den nævnte måned.

Opbevares i den originale yderpakning for at beskytte mod lys.

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

medicinrester i afløbet, toilettet eller skraldespanden.

6.

Pakningsstørrelser og yderligere oplysninger

Montelukast Krka indeholder:

Aktivt stof: montelukast. Hver filmovertrukket tablet indeholder 10 mg montelukast som

montelukastnatrium.

Øvrige indholdsstoffer:

Tabletkerne: lactosemonohydrat, cellulose, mikrokrystallinsk cellulose, croscarmellosenatrium

og magnesiumstearat.

Tabletfilm: hypromellose, titandioxid (E171), talcum, propylenglycol, rød jernoxid (E172) og

gul jernoxid (E172).

Udseende og pakningsstørrelser

De filmovertrukne tabletter er abrikosfarvede, runde, let hvælvede og med skrå kanter.

Pakningsstørrelser: blisterkort med 7, 10, 14, 20, 28, 30, 49, 50, 56, 84, 90, 98, 100, 140 eller 200

filmovertrukne tabletter i æske.

Ikke alle pakningsstørrelser er nødvendigvis markedsført.

Indehaver af markedsføringstilladelsen og fremstiller

Indehaver af markedsføringstilladelsen

KRKA Sverige AB, Göta Ark 175, 118 72 Stockholm, Sverige

Fremstiller

KRKA, d.d. Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenien

KRKA Polska Sp. z.o.o., ul. Równoległa 5, Warszawa, Polen

TAD Pharma GmbH , Heinz-Lohmann-Straße 5, 27472 Cuxhaven, Tyskland

Denne indlægsseddel blev senest revideret 03/2014

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FDA - U.S. Food and Drug Administration

31-8-2018

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FDA - U.S. Food and Drug Administration

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FDA - U.S. Food and Drug Administration

31-7-2018

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12-7-2018

Montelukast

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Safety review

Therapeutic Goods Administration - Australia

15-2-2019


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

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Europe - EMA - European Medicines Agency

11-2-2019

Dasselta (Krka d. d., Novo mesto)

Dasselta (Krka d. d., Novo mesto)

Dasselta (Active substance: desloratadine) - Centralised - Yearly update - Commission Decision (2019)1072 of Mon, 11 Feb 2019

Europe -DG Health and Food Safety

11-2-2019

Tolucombi (Krka d. d., Novo mesto)

Tolucombi (Krka d. d., Novo mesto)

Tolucombi (Active substance: telmisartan/hydrochlorothiazide) - Centralised - Yearly update - Commission Decision (2019)1040 of Mon, 11 Feb 2019

Europe -DG Health and Food Safety

4-2-2019

Vizarsin (Krka d. d., Novo mesto)

Vizarsin (Krka d. d., Novo mesto)

Vizarsin (Active substance: sildenafil) - Centralised - Yearly update - Commission Decision (2019)860 of Mon, 04 Feb 2019

Europe -DG Health and Food Safety

4-2-2019

Elmiron (bene-Arzneimittel GmbH)

Elmiron (bene-Arzneimittel GmbH)

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

Europe -DG Health and Food Safety

1-2-2019


Summary of opinion: Atazanavir Krka,atazanavir,  31/01/2019,  Positive

Summary of opinion: Atazanavir Krka,atazanavir, 31/01/2019, Positive

Summary of opinion: Atazanavir Krka,atazanavir, 31/01/2019, Positive

Europe - EMA - European Medicines Agency

1-2-2019


Summary of opinion: Febuxostat Krka,febuxostat,  01/02/2019,  Positive

Summary of opinion: Febuxostat Krka,febuxostat, 01/02/2019, Positive

Summary of opinion: Febuxostat Krka,febuxostat, 01/02/2019, Positive

Europe - EMA - European Medicines Agency

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

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

28-11-2018

Darunavir Krka d.d. (Krka d. d., Novo mesto)

Darunavir Krka d.d. (Krka d. d., Novo mesto)

Darunavir Krka d.d. (Active substance: darunavir) - Centralised - 2-Monthly update - Commission Decision (2018)8046 of Wed, 28 Nov 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4891/IB/2/G

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

22-11-2018

Emtricitabine/Tenofovir disoproxil Krka (Krka d. d., Novo mesto)

Emtricitabine/Tenofovir disoproxil Krka (Krka d. d., Novo mesto)

Emtricitabine/Tenofovir disoproxil Krka (Active substance: emtricitabine / tenofovir disoproxil) - Centralised - 2-Monthly update - Commission Decision (2018)7884 of Thu, 22 Nov 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4215/IB/10G

Europe -DG Health and Food Safety

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

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

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

4-9-2018

Efavirenz/Emtricitabine/Tenofovir disoproxil Krka (Krka d. d., Novo mesto)

Efavirenz/Emtricitabine/Tenofovir disoproxil Krka (Krka d. d., Novo mesto)

Efavirenz/Emtricitabine/Tenofovir disoproxil Krka (Active substance: efavirenz / emtricitabine / tenofovir disoproxil) - Centralised - 2-Monthly update - Commission Decision (2018)5859 of Tue, 04 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4274/IB/02/G

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

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

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