Lacidipin "Double-E Pharma"

Primær information

  • Handelsnavn:
  • Lacidipin "Double-E Pharma" 6 mg filmovertrukne tabletter
  • Dosering:
  • 6 mg
  • Lægemiddelform:
  • filmovertrukne tabletter
  • Brugt til:
  • Mennesker
  • Medicin typen:
  • Allopatiske stof

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  • for den brede offentlighed:
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Lokation

  • Fås i:
  • Lacidipin "Double-E Pharma" 6 mg filmovertrukne tabletter
    Danmark
  • Sprog:
  • dansk

Andre oplysninger

Status

  • Kilde:
  • Lægemiddelstyrelsen - Danish Medicines Agency
  • Autorisationsnummer:
  • 52967
  • Sidste ændring:
  • 22-02-2018

Produktresumé

14. juni 2017

PRODUKTRESUMÉ

for

Lacidipin "Double-E Pharma", filmovertrukne tabletter 6 mg

0.

D.SP.NR.

28934

1.

LÆGEMIDLETS NAVN

Lacidipin "Double-E Pharma"

2.

KVALITATIV OG KVANTITATIV SAMMENSÆTNING

Hver filmovertrukket tablet indeholder 6 mg lacidipin.

Hjælpestof, som behandleren skal være opmærksom på

Hver filmovertrukket tablet indeholder 387,50 mg lactose.

Alle hjælpestoffer er anført under pkt. 6.1.

3.

LÆGEMIDDELFORM

Filmovertrukne tabletter.

Hvid, oval, bikonveks, filmovertrukket tablet med en diameter på 14,1 x 7,8 mm mærket

med “6” på den ene side.

Tabletten kan deles i to lige store doser.

4.

KLINISKE OPLYSNINGER

4.1

Terapeutiske indikationer

Lacidipin "Double-E Pharma" er indiceret til behandling af hypertension enten som

monoterapi eller i kombination med andre antihypertensiva, herunder β-receptorblokerende

midler, diuretika og ACE-hæmmere.

4.2

Dosering og indgivelsesmåde

Til oral anvendelse.

Voksne

Behandlingen af hypertension skal tilpasses sværhedsgraden af sygdomstilstanden og den

enkeltes respons.

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Side 1 af 8

Den anbefalede initialdosis er 2 mg givet en gang daglig. Dosis kan øges til 4 mg (og

herefter, om nødvendigt, til 6 mg), efter at der er givet tilstrækkelig tid til, at den fulde,

farmakologiske virkning er opnået. I praksis bør der som minimum gå 3-4 uger, før dosis

øges. Daglige doser over 6 mg har ikke vist sig at være signifikant mere effektive.

Lacidipin "Double-E Pharma" bør indtages på samme tidspunkt hver dag, helst om

morgenen.

Patienter med nedsat leverfunktion

Der kræves ingen dosisjustering hos patienter med nedsat leverfunktion.

Patienter med nedsat nyrefunktion

Lacidipin "Double-E Pharma" udskilles ikke via nyrerne, og dosisreduktion anses derfor

ikke for nødvendig hos patienter med nedsat nyrefunktion.

Børn og unge

På grund af manglende erfaring vedrørende sikkerhed og virkning i forbindelse med

lacidipin-behandling af børn og unge anbefales behandling med lacidipin ikke til børn og

unge under 18 år.

Ældre

Dosisjustering er ikke nødvendig. Behandlingen kan fortsættes tidsubegrænset.

4.3

Kontraindikationer

Lacidipin "Double-E Pharma" er kontraindiceret ved overfølsomhed over for det aktive

stof eller over for et eller flere af hjælpestofferne. Der skal udvises stor forsigtighed ved

anvendelsen af lacidipin til patienter, der tidligere har haft en allergisk reaktion over for

dihydropyridiner, da der er en teoretisk risiko for krydsreaktivitet.

Som med andre dihydropydiner er lacidipin kontraindiceret hos patienter med svær

aortastenose.

4.4

Særlige advarsler og forsigtighedsregler vedrørende brugen

Lacidipin har i specialstudier vist sig ikke at påvirke den spontane sinoatriale nodus (SA)

funktion eller at være årsag til forlænget overledning i nodus atrioventricularis (AV). Dog

er der en teoretisk mulighed for, at calciumantagonister kan påvirke aktiviteten af SA og

AV, og forsigtighed bør udvises hos patienter med abnorm aktivitet i SA og AV nodus.

Som det også har været rapporteret ved visse dihydropyridin-calciumkanalantagonister,

skal lacidipin anvendes med forsigtighed hos patienter med medfødt eller dokumenteret

erhvervet QT-forlængelse. Der skal også udvises forsigtighed ved anvendelse af lacidipin

til patienter, der samtidig behandles med medicin, der er kendt for at forlænge QT-

intervallet, såsom klasse I og III antiarytmika, tricykliske antidepressiva, visse

antipsykotika, antibiotika (f.eks. erythromycin) og visse antihistaminer (f.eks. terfenadin).

Som ved andre calciumantagonister bør lacidipin bruges med forsigtighed hos patienter

med en lille hjertereserve.

Som ved andre dihydropyridin-calciumantagonister, bør lacidipin bruges med forsigtighed

hos patienter med ustabil angina pectoris såvel som hos patienter, der udvikler ustabil

angina pectoris under behandlingen med lacidipin.

52967_spc.docx

Side 2 af 8

Lacidipin bør anvendes med forsigtighed hos patienter med nyligt myokardieinfarkt.

Der er ingen evidens for lacidipins virkning over for sekundær forebyggelse af

myokardieinfarkt.

Virkning og sikkerhed af Lacidipin "Double-E Pharma" er ikke undersøgt i behandlingen

af malign hypertension.

Der skal udvises forsigtighed ved anvendelse af Lacidipin hos patienter med nedsat

leverfunktion, da den antihypertensive virkning kan være forøget.

Der er ingen erfaringer, der viser, at lacidipin påvirker glucosetolerancen eller ændrer

diabeteskontrollen.

Dette lægemiddel indeholder 387,50 mg lactose. Patienter med arvelig galactoseintolerans,

en særlig form af hereditær lactasemangel (Lapp lactase deficiency) eller glucose- og

galactosemalabsorption bør ikke tage dette lægemiddel.

4.5

Interaktion med andre lægemidler og andre former for interaktion

Det er kendt, at lacidipin metaboliseres af CYP3A4 (f.eks. rifampicin, itraconazol) og

signifikante inhibitorer og induktorer af CYP3A4 (f.eks. rifampicin, itraconazol), som

administreres samtidig, kan derfor interagere med lacidipins metabolisme og elimination.

Samtidig administration af lacidipin med produkter, som har hypotensiv effekt herunder

andre antihypertensiva, f.eks. diuretika, betablokkere eller ACE-hæmmere, kan have en

additiv hypotensiv effekt. Der er dog ikke, i hypertensionsforsøg med almindeligt anvendte

antihypertensiva (såsom betablokkere og diuretika) eller med digoxin, tolbutamid eller

warfarin, set specifikke interaktionsproblemer.

Plasmaniveauet af lacidipin kan være forhøjet ved samtidig administration af cimetidin.

Alkohol

Som ved alle vasodilaterende antihypertensiva skal der udvises forsigtighed, hvis der

indtages alkohol samtidig, da alkohol kan forstærke virkningen af disse lægemidler.

Grapefrugtjuice

Som ved andre dihydropyridiner bør lacidipin ikke tages sammen med grapefrugtjuice, da

dette kan ændre biotilgængeligheden af lacidipin.

Lacidipin er stærkt proteinbundet (>95 %) til albumin og alpha-1-acid glycoprotein.

I kliniske studier med almindeligt anvendte antihypertensiva, eller med tolbutamid eller

warfarin, er der ikke set specifikke interaktionsproblemer.

I kliniske studier med nyretransplanterede, cyclosporinbehandlede patienter har lacidipin

forhindret et fald i renal plasma flow og glomerulær filtrationshastighed induceret med

ciclosporin.

Samtidig brug af lacidipin og kortikoider eller tetracosactid kan mindske den antihypertensive

effekt.

52967_spc.docx

Side 3 af 8

4.6

Graviditet og amning

Fertilitet

Hos nogle patienter behandlet med calciumkanalblokkere er der set reversible biokemiske

forandringer i hovedet af spermatozoer, hvilket kan nedsætte befrugtningsevnen.

Graviditet

Der er ingen tilgængelige kliniske sikkerhedsdata vedrørende brug af lacidipin hos gravide.

I dyreforsøg har man ikke kunne vise nogen teratogen effekt eller vækstforringelse (se pkt.

5.3).

Lacidipin må udelukkende bruges under graviditet, når de potentielle fordele for moderen

opvejer den potentielle risiko for fosteret eller den nyfødte.

Risikoen for at lacidipin kan føre til afslapning af uterusmusklen under fødslen bør

overvejes (se pkt. 5.3).

Amning

Lacidipin og dets metabolitter udskilles sandsynligvis i modermælken. Derfor bør brug af

Lacidpin DOUBLE-E PHARMA undgås under amning.

Lacidipin bør kun bruges under amning, når den potentielle gavn for moderen opvejer den

potentielle risiko for fosteret eller det nyfødte barn.

4.7

Virkninger på evnen til at føre motorkøretøj eller betjene maskiner

Ikke mærkning.

Lacidipin kan forårsage svimmelhed. Patienter bør oplyses om, at de skal undgå at køre bil

eller betjene maskiner, hvis de føler sig svimle eller oplever lignende symptomer.

4.8

Bivirkninger

Der er anvendt data fra store kliniske forsøg (interne og publicerede) til bestemmelse af

frekvensen af meget almindelige til ikke almindelige bivirkninger.

Meget almindelig ≥1/10

Almindelig ≥1/100 til <1/10

Ikke almindelig ≥1/1.000 til <1/100

Sjælden ≥1/10.000 til <1/1.000

Meget sjælden <1/10.000

Ikke kendt (kan ikke estimeres ud fra forhåndenværende data).

Lacidipin er normalt veltolereret. Nogle patienter kan få mindre bivirkninger, som er

relateret til den kendte farmakologiske perifere, vasodilatatoriske virkning. De

bivirkninger, der er mærket med #, er normalt forbigående og forsvinder sædvanligvis ved

fortsat administration af lacidipin på samme dosisniveau.

Psykiske forstyrrelser

Meget sjælden

Depression

Nervesystemet

Almindelig

#Hovedpine, #svimmelhed

52967_spc.docx

Side 4 af 8

Meget sjælden

Tremor

Ikke kendt

Ekstrapyramidale syndromer er blevet

rapporteret i forbindelse med nogle

calciumhæmmere

Hjerte

Almindelig

#Palpitationer, takykardi

Ikke almindelig

Forværring af underliggende årsager til angina*,

synkope, hypotension

*Som det er tilfældet med andre dihydropyridiner er der specielt i starten af behandling

set få tilfælde af forværring af eksisterende angina. Dette ses dog hovedsagelig hos

patienter med symptomatisk iskæmisk hjertesygdom.

Vaskulære sygdomme

Almindelig

#Rødme

Mave-tarmkanalen

Almindelig

Gastriske gener, kvalme

Ikke almindelig

Gingival hyperplasi

Hud og subkutane væv

Almindelig

Udslæt (herunder erytem og kløe)

Sjælden

Angioødem, urticaria

Knogler, led, muskler og bindevæv

Sjælden

Muskelkramper

Nyrer og urinveje

Almindelig

Polyuri

Almene symptomer og reaktioner på administrationsstedet

Almindelig

Asteni, #ødem

Undersøgelser

Almindelig

Reversibel stigning i alkalisk fosfatase (klinisk

signifikante stigninger er ikke almindelige).

Indberetning af mistænkte bivirkninger

Når lægemidlet er godkendt, er indberetning af mistænkte bivirkninger vigtig. Det

muliggør løbende overvågning af benefit/risk-forholdet for lægemidlet. Læger og

sundhedspersonale anmodes om at indberette alle mistænkte bivirkninger via:.

Sundhedsstyrelsen

Axel Heides Gade 1

DK-2300 København S

Websted: www.meldenbivirkning.dk

E-mail: sst@sst.dk

52967_spc.docx

Side 5 af 8

4.9

Overdosering

Der er ikke rapporteret tilfælde af overdosering med lacidipin.

Symptomer og tegn

De mest sandsynlige problemer kunne være forlænget perifer vasodilatation i forbindelse

med hypotension og takykardi. Bradykardi eller forsinket AV-overledning kunne teoretisk

set forekomme.

Behandling

Der findes ingen specifik antidot. Der bør tages generelle forholdsregler til monitorering af

hjertefunktion, ligesom der bør iværksættes passende og understøttende behandling.

4.10

Udlevering

5.

FARMAKOLOGISKE EGENSKABER

5.0

Terapeutisk klassifikation

ATC-kode: C 08 CA 09. Dihydropyridinderivater.

5.1

Farmakodynamiske egenskaber

Lacidipin er en specifik og potent calciumkanalantagonist med prædominant selektivitet

for calciumkanaler i den vaskulære glatte muskulatur. Den primære virkemåde er dilatation

af de perifere arterioler, reduktion af den perifere vaskulære resistens og nedsættelse af

blodtrykket.

Efter oral administration af 4 mg lacidipin til raske forsøgspersoner, har man set en

minimal forlængelse af QTc-intervallet (gennemsnitlig QTcF stigning på 3,44 til 9,60 ms

hos unge og ældre frivillige forsøgspersoner).

5.2

Farmakokinetiske egenskaber

Lacidipin er et meget lipofilt stof, det absorberes hurtigt, men dårligt fra mave-tarmkanalen

efter oral administration. Absolut biotilgængelighed er i gennemsnit 10 % på grund af

ekstensiv first-pass metabolisme i leveren.

Højeste plasmakoncentration opnås mellem 30 og 150 minutter efter administration.

Stoffet elimineres hovedsagelig ved metabolisme i leveren (som involverer P450

CYP3A4). Der er ingen erfaring med, at lacidipin forårsager hverken induktion eller

inhibering af leverenzymer.

Hovedemetabolitterne har ringe - om nogen - farmakodynamisk aktivitet.

Omkring 70 % af den administrerede dosis elimineres som metabolitter i fæces og den

resterende som metabolitter i urinen.

Den gennemsnitlige terminale plasmahalveringstid for lacidipin ligger på mellem 13 og 19

timer ved steady state.

52967_spc.docx

Side 6 af 8

5.3

Prækliniske sikkerhedsdata

De eneste væsentlige toksikologiske fund i undersøgelser med lacidipin var reversible og i

overensstemmelse med de kendte farmakologiske virkninger af calciumkanalantagonister

ved høje doser. Der sås nedsat myokardiekontraktilitet og gingival hyperplasi hos rotter og

hunde, samt forstoppelse hos rotter.

Man har ikke fundet tegn på udviklingstoksicitet efter administration af lacidipin til

gravide rotter eller kaniner.

Lacidipin var ikke genotoksisk i en serie af in vivo- og in vitro-forsøg. Der var ingen tegn

på karcinogenicitet hos mus. I lighed med andre calciumantagonister, var der en stigning i

benigne interstitielcelle tumorer i testiklerne i et karcinogenicitetsforsøg i rotter. Dog er de

endokrine mekanismer, som anses for at være årsag til produktionen af interstitiel

hyperplasi og adenomer i rotter, ikke relevante for mennesker.

6.

FARMACEUTISKE OPLYSNINGER

6.1

Hjælpestoffer

Tabletkerne

Povidon K-30

Lactosemonohydrat

Magnesiumstearat

Filmovertræk

Opadry OY-S-7335: Titandioxid (E171) og hypromellose

6.2

Uforligeligheder

Ikke relevant.

6.3

Opbevaringstid

36 måneder.

6.4

Særlige opbevaringsforhold

Opbevares i original emballage for at beskytte mod lys.

Der er ingen særlige krav vedrørende opbevaringstemperaturer for dette lægemiddel.

6.5

Emballagetyper og pakningsstørrelser

Aluminium/Aluminium blisterkort i æsker.

Pakningsstørrelser: 28, 56 og 98 stk.

Ikke alle pakningsstørrelser er nødvendigvis markedsført.

6.6

Regler for destruktion og anden håndtering

Ingen særlige krav.

52967_spc.docx

Side 7 af 8

7.

INDEHAVER AF MARKEDSFØRINGSTILLADELSEN

Double-E Pharma Limited

7th Floor, Hume House

Ballsbridge, Dublin 4

Irland

Repræsentant

Copharma ApS

Kanalholmen 14-18

2650 Hvidovre

8.

MARKEDSFØRINGSTILLADELSESNUMMER (NUMRE)

52967

9.

DATO FOR FØRSTE MARKEDSFØRINGSTILLADELSE

18. juni 2015

10.

DATO FOR ÆNDRING AF TEKSTEN

14. juni 2017

52967_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.

    Anmode informationsbrochure for offentligheden.



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Scientific Opinion about the Guidance of the Chemical Regulation Directorate (UK) on how aged sorption studies for pesticides should be conducted, analysed and used in regulatory assessments

Scientific Opinion about the Guidance of the Chemical Regulation Directorate (UK) on how aged sorption studies for pesticides should be conducted, analysed and used in regulatory assessments

Published on: Mon, 27 Aug 2018 00:00:00 +0200 The EFSA Panel on Plant Protection Products and their Residues reviewed the guidance on how aged sorption studies for pesticides should be conducted, analysed and used in regulatory assessment. The inclusion of aged sorption is a higher tier in the groundwater leaching assessment. The Panel based its review on a test with three substances taken from a data set provided by the European Crop Protection Association. Particular points of attention were the quali...

Europe - EFSA - European Food Safety Authority Publications

28-8-2018

New recommendations for use of Xofigo for treatment of prostate cancer which has spread to the bones

New recommendations for use of Xofigo for treatment of prostate cancer which has spread to the bones

The EU's Pharmacovigilance Risk Assessment Committee (PRAC) has adopted new recommendations for use of Xofigo for treatment of prostate cancer which has spread to the bones (bone metastases). Xofigo should only be used in symptomatic patients who have had two previous treatments for prostate cancer and who cannot be treated with other medicines.

Danish Medicines Agency

20-8-2018

August 17, 2018: Unlicensed Pharmacy Technician Pleads Guilty to Working at New England Compounding Center

August 17, 2018: Unlicensed Pharmacy Technician Pleads Guilty to Working at New England Compounding Center

August 17, 2018: Unlicensed Pharmacy Technician Pleads Guilty to Working at New England Compounding Center

FDA - U.S. Food and Drug Administration

31-7-2018

AuroMedics Pharma LLC Issues Voluntary Nationwide Recall of Piperacillin and Tazobactam for Injection 3.375 grams per vial, Due to Presence of Particulates Identified as Glass and Silicone Material

AuroMedics Pharma LLC Issues Voluntary Nationwide Recall of Piperacillin and Tazobactam for Injection 3.375 grams per vial, Due to Presence of Particulates Identified as Glass and Silicone Material

East Windsor, New Jersey, AuroMedics Pharma LLC is voluntarily recalling two lots of Piperacillin and Tazobactam for injection, USP 3.375 g (Piperacillin Sodium equivalent to 3 g of Piperacillin USP and Tazobactam Sodium equivalent to 0.375 g of Tazobactam USP. Each vial contains 7.05 mEq (162 mg) of Sodium) in a Single-Dose vial, to the hospital level. One vial from lot# PP0317012-A was found to contain particulate matter, identified as glass within the vial and another vial from lot# PP0317059-A was fo...

FDA - U.S. Food and Drug Administration

28-7-2018

Ranier’s Rx Laboratory Issues Voluntary Recall of All Sterile Compounded Products Within Expiry Due to Lack of Sterility Concerns

Ranier’s Rx Laboratory Issues Voluntary Recall of All Sterile Compounded Products Within Expiry Due to Lack of Sterility Concerns

Ranier’s Rx Laboratory is voluntarily recalling all sterile compounded drug products within expiry to the hospital or consumer level. These drug products are being voluntarily recalled due to concerns that practices at the pharmacy have the potential to pose a risk of contamination to products that are intended to be sterile. These concerns arose following a routine inspection of the pharmacy by FDA.

FDA - U.S. Food and Drug Administration

13-7-2018

Scientific guideline:  Guideline on good pharmacogenomic practice - First version, adopted

Scientific guideline: Guideline on good pharmacogenomic practice - First version, adopted

This guideline provides recommendations for the conduct of genomic studies in relation to medical therapy in order to provide high quality information on the impact of genomic variability on drug response. Primary focus is on the analysis of genomic germline DNA. The analysis of somatic DNA and genomic biomarkers for cancer treatment is not being discussed and might be developed as an Annex or in separate guidance.

Europe - EFSA - European Food Safety Authority EFSA Journal

11-7-2018

July 10, 2018: Former Des Moines Pharmacy Technician Sentenced for Illegally Tampering with Fentanyl

July 10, 2018: Former Des Moines Pharmacy Technician Sentenced for Illegally Tampering with Fentanyl

July 10, 2018: Former Des Moines Pharmacy Technician Sentenced for Illegally Tampering with Fentanyl

FDA - U.S. Food and Drug Administration

11-7-2018

July 10: 2018: Former Pharmacy Technician Indicted for Stealing Fentanyl, Morphine

July 10: 2018: Former Pharmacy Technician Indicted for Stealing Fentanyl, Morphine

July 10: 2018: Former Pharmacy Technician Indicted for Stealing Fentanyl, Morphine

FDA - U.S. Food and Drug Administration

1-11-2018

Protopic (Leo Pharma A/S)

Protopic (Leo Pharma A/S)

Protopic (Active substance: Tacrolimus) - Centralised - Yearly update - Commission Decision (2018)7343 of Thu, 01 Nov 2018

Europe -DG Health and Food Safety

25-10-2018

Xtandi (Astellas Pharma Europe B.V.)

Xtandi (Astellas Pharma Europe B.V.)

Xtandi (Active substance: enzalutamide) - Centralised - 2-Monthly update - Commission Decision (2018)7132 of Thu, 25 Oct 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2639/II/39G

Europe -DG Health and Food Safety

22-10-2018

Velphoro (Vifor Fresenius Medical Care Renal Pharma France)

Velphoro (Vifor Fresenius Medical Care Renal Pharma France)

Velphoro (Active substance: mixture of polynuclear iron(iii)-oxyhydroxide, sucrose and starches) - Centralised - Yearly update - Commission Decision (2018)6972 of Mon, 22 Oct 2018

Europe -DG Health and Food Safety

16-10-2018

Dexxience (Portola Pharma UK Limited)

Dexxience (Portola Pharma UK Limited)

Dexxience (Active substance: betrixaban) - Refusal of authorisation - Commission Decision (2018)6226 of Tue, 16 Oct 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4309

Europe -DG Health and Food Safety

2-10-2018

Lamivudine Teva Pharma B.V. (Teva B.V.)

Lamivudine Teva Pharma B.V. (Teva B.V.)

Lamivudine Teva Pharma B.V. (Active substance: Lamivudine) - Centralised - Yearly update - Commission Decision (2018)6476 of Tue, 02 Oct 2018

Europe -DG Health and Food Safety

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

24-9-2018

NeuroBloc (Sloan Pharma S.a.r.l.)

NeuroBloc (Sloan Pharma S.a.r.l.)

NeuroBloc (Active substance: Botulinum Toxin Type B) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)6221 of Mon, 24 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/000301/T/0101

Europe -DG Health and Food Safety

24-9-2018

Rasilez (Noden Pharma DAC)

Rasilez (Noden Pharma DAC)

Rasilez (Active substance: aliskiren) - Centralised - Yearly update - Commission Decision (2018)6229 of Mon, 24 Sep 2018

Europe -DG Health and Food Safety

24-9-2018

Kigabeq (ORPHELIA Pharma SAS)

Kigabeq (ORPHELIA Pharma SAS)

Kigabeq (Active substance: vigabatrin) - Centralised - Authorisation - Commission Decision (2018)6224 of Mon, 24 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4534

Europe -DG Health and Food Safety

24-9-2018

INCRELEX (Ipsen Pharma)

INCRELEX (Ipsen Pharma)

INCRELEX (Active substance: Mecasermin) - Centralised - Yearly update - Commission Decision (2018)6240 of Mon, 24 Sep 2018

Europe -DG Health and Food Safety

19-9-2018

Pregabalin Mylan Pharma (Mylan S.A.S.)

Pregabalin Mylan Pharma (Mylan S.A.S.)

Pregabalin Mylan Pharma (Active substance: pregabalin) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018) 6097 of Wed, 19 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/3962/T/08

Europe -DG Health and Food Safety

19-9-2018

Agenda:  Agenda – 12th Pharmacovigilance stakeholder forum

Agenda: Agenda – 12th Pharmacovigilance stakeholder forum

Europe - EMA - European Medicines Agency

19-9-2018

 12th Pharmacovigilance stakeholder forum, European Medicines Agency, London, UK, From: 24-Sep-2018, To: 24-Sep-2018

12th Pharmacovigilance stakeholder forum, European Medicines Agency, London, UK, From: 24-Sep-2018, To: 24-Sep-2018

This forum brings together regulators with patients, healthcare professionals and industry, to take stock of what we have achieved and what needs to be the focus over the coming years.

Europe - EMA - European Medicines Agency

17-9-2018

 European Medicines Agency (EMA) Human Scientific Committees' Working Parties with Patients’ and Consumers’ Organisations (PCWP) and with Healthcare Professionals’ Organisations (HCPWP), European Medicines Agency, London, UK, From: 25-Sep-2018, To: 25-Sep

European Medicines Agency (EMA) Human Scientific Committees' Working Parties with Patients’ and Consumers’ Organisations (PCWP) and with Healthcare Professionals’ Organisations (HCPWP), European Medicines Agency, London, UK, From: 25-Sep-2018, To: 25-Sep

This joint Patients' and Consumers' Working Party (PCWP) and Healthcare Professionals' Working Party (HCPWP) meeting will include results of the 2017 EMA perception survey. EMA regulatory science to 2025 will be discussed together with updates on Good Pharmacovigilance Practices (GVP). The Topic Group on Digital media and health will feedback to the working parties’ members. Participants will also receive an update on ongoing work on electronic product information and on availability of authorised med...

Europe - EMA - European Medicines Agency

12-9-2018

 Risk management plan information day, European Medicines Agency, London, UK, From: 25-Oct-2018, To: 25-Oct-2018

Risk management plan information day, European Medicines Agency, London, UK, From: 25-Oct-2018, To: 25-Oct-2018

This information day will update participants on the Agency’s medicine risk management activities and provide advice to marketing authorisation holders and applicants on drafting a risk management plan (RMP) in view of the full implementation of the second revision of the RMP template after the transitional period has elapsed. It will also provide an opportunity for an exchange of experiences with this template between regulators and industry. A dedicated session will discuss the streamlining of safety s...

Europe - EMA - European Medicines Agency

12-9-2018

ADCETRIS (Takeda Pharma A/S)

ADCETRIS (Takeda Pharma A/S)

ADCETRIS (Active substance: Brentuximab vedotin) - Centralised - Annual renewal - Commission Decision (2018)5973 of Wed, 12 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2455/R/58

Europe -DG Health and Food Safety

29-8-2018

Cometriq (Ipsen Pharma)

Cometriq (Ipsen Pharma)

Cometriq (Active substance: cabozantinib) - PSUSA - Modification - Commission Decision (2018)5761 of Wed, 29 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/PSUSA/10180/201711

Europe -DG Health and Food Safety

29-8-2018

Rasilez HCT (Noden Pharma DAC)

Rasilez HCT (Noden Pharma DAC)

Rasilez HCT (Active substance: aliskiren hemifumarate / hydrochlorothiazide) - Centralised - Renewal - Commission Decision (2018)5769 of Wed, 29 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/964/R/87

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

28-8-2018

EU/3/18/2061 (Pharma Gateway AB)

EU/3/18/2061 (Pharma Gateway AB)

EU/3/18/2061 (Active substance: Autologous glioma tumour cells treated with antisense molecule directed against the insulin-like growth factor type 1 receptor) - Orphan designation - Commission Decision (2018)5739 of Tue, 28 Aug 2018 European Medicines Agency (EMA) procedure number: EMA/OD/049/18

Europe -DG Health and Food Safety

27-8-2018

Yescarta (Kite Pharma EU B.V.)

Yescarta (Kite Pharma EU B.V.)

Yescarta (Active substance: axicabtagene ciloleucel) - Centralised - Authorisation - Commission Decision (2018)5718 of Mon, 27 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4480

Europe -DG Health and Food Safety

27-8-2018

Entyvio (Takeda Pharma A/S)

Entyvio (Takeda Pharma A/S)

Entyvio (Active substance: vedolizumab) - PSUSA - Modification - Commission Decision (2018)5712 of Mon, 27 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/PSUSA/10186/201711

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

17-8-2018

EU/3/17/1870 (Pharma Gateway AB)

EU/3/17/1870 (Pharma Gateway AB)

EU/3/17/1870 (Active substance: Thymidine and deoxycytidine) - Transfer of orphan designation - Commission Decision (2018)5403 of Fri, 17 Aug 2018 European Medicines Agency (EMA) procedure number: EMA/OD/317/16/T/01

Europe -DG Health and Food Safety

7-8-2018

EU/3/18/2049 (Inozyme Pharma Ireland Ltd)

EU/3/18/2049 (Inozyme Pharma Ireland Ltd)

EU/3/18/2049 (Active substance: Recombinant human ectonucleotide pyrophosphatase/phosphodiesterase 1 fused to the Fc fragment of IgG1) - Orphan designation - Commission Decision (2018)5281 of Tue, 07 Aug 2018 European Medicines Agency (EMA) procedure number: EMA/OD/053/18

Europe -DG Health and Food Safety

6-8-2018

Kyntheum (Leo Pharma A/S)

Kyntheum (Leo Pharma A/S)

Kyntheum (Active substance: brodalumab) - Centralised - Yearly update - Commission Decision (2018)5383 of Mon, 06 Aug 2018

Europe -DG Health and Food Safety

2-8-2018

EU/3/18/2048 (Pharma Gateway AB)

EU/3/18/2048 (Pharma Gateway AB)

EU/3/18/2048 (Active substance: N-acetylgalactosamine-conjugated synthetic double-stranded oligomer specific to serpin family A member 1 gene) - Orphan designation - Commission Decision (2018)5280 of Thu, 02 Aug 2018 European Medicines Agency (EMA) procedure number: EMA/OD/061/18

Europe -DG Health and Food Safety

2-8-2018

EU/3/18/2052 (Dicerna EU Limited)

EU/3/18/2052 (Dicerna EU Limited)

EU/3/18/2052 (Active substance: Synthetic double-stranded siRNA oligonucleotide directed against lactate dehydrogenase A mRNA and containing four modified nucleosides which form a ligand cluster of four N-acetylgalactosamine residues) - Orphan designation - Commission Decision (2018)5284 of Thu, 02 Aug 2018 European Medicines Agency (EMA) procedure number: EMA/OD/052/18

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

1-8-2018

Opdivo (Bristol-Myers Squibb Pharma EEIG)

Opdivo (Bristol-Myers Squibb Pharma EEIG)

Opdivo (Active substance: nivolumab) - Centralised - 2-Monthly update - Commission Decision (2018)5204 of Wed, 01 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/3985/II/41

Europe -DG Health and Food Safety

30-7-2018

Ceplene (Noventia Pharma Srl)

Ceplene (Noventia Pharma Srl)

Ceplene (Active substance: Histamine dihydrochloride) - Centralised - Renewal - Commission Decision (2018)5116 of Mon, 30 Jul 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/796/R/36

Europe -DG Health and Food Safety

23-7-2018

Dificlir (Astellas Pharma Europe B.V.)

Dificlir (Astellas Pharma Europe B.V.)

Dificlir (Active substance: fidaxomicin) - Centralised - Yearly update - Commission Decision (2018)4889 of Mon, 23 Jul 2018

Europe -DG Health and Food Safety

23-7-2018

Qarziba (EUSA Pharma (UK) Limited)

Qarziba (EUSA Pharma (UK) Limited)

Qarziba (Active substance: dinutuximab beta) - Centralised - Yearly update - Commission Decision (2018)4886 of Mon, 23 Jul 2018

Europe -DG Health and Food Safety

19-7-2018

Aplidin (Pharma Mar S.A.)

Aplidin (Pharma Mar S.A.)

Aplidin (Active substance: plitidepsin) - Refusal of authorisation - Commission Decision (2018)4831 of Thu, 19 Jul 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4354

Europe -DG Health and Food Safety

13-7-2018

Briviact (UCB Pharma S.A.)

Briviact (UCB Pharma S.A.)

Briviact (Active substance: brivaracetam) - Centralised - 2-Monthly update - Commission Decision (2018)4715 of Fri, 13 Jul 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/3898/II/10/G

Europe -DG Health and Food Safety

11-7-2018

Hiprabovis IBR Marker Live (Laboratorios Hipra, S.A.)

Hiprabovis IBR Marker Live (Laboratorios Hipra, S.A.)

Hiprabovis IBR Marker Live (Active substance: Live gE- tk- double-gene deleted Bovine Herpes Virus type 1 (BoHV-1), strain CEDDEL) - Centralised - Yearly update - Commission Decision (2018)4520 of Wed, 11 Jul 2018

Europe -DG Health and Food Safety

10-7-2018

Ninlaro (Takeda Pharma A/S)

Ninlaro (Takeda Pharma A/S)

Ninlaro (Active substance: ixazomib) - Centralised - Yearly update - Commission Decision (2018)4463 of Tue, 10 Jul 2018

Europe -DG Health and Food Safety

4-7-2018

Prialt (RIEMSER Pharma GmbH)

Prialt (RIEMSER Pharma GmbH)

Prialt (Active substance: ziconotide) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)4334 of Wed, 04 Jul 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/551/T/56

Europe -DG Health and Food Safety

29-6-2018

EU/3/18/2036 (PharmaKrysto Ltd)

EU/3/18/2036 (PharmaKrysto Ltd)

EU/3/18/2036 (Active substance: L-cystine bis(N'-methylpiperazide)) - Orphan designation - Commission Decision (2018)4181 of Fri, 29 Jun 2018 European Medicines Agency (EMA) procedure number: EMA/OD/012/18

Europe -DG Health and Food Safety