De-ursil RR Mite

Hauptinformation

  • Handelsname:
  • De-ursil RR Mite Kapseln
  • Darreichungsform:
  • Kapseln
  • Zusammensetzung:
  • Säure ursodeoxycholicum 225 mg, dibutylis phthalas, conserv.: E 218, excipiens für die Kapsel.
  • Verwenden für:
  • Menschen
  • Art der Medizin:
  • Biologische Medizin

Dokumenten

Lokalisierung

  • Erhältlich in:
  • De-ursil RR Mite Kapseln
    Schweiz
  • Sprache:
  • Deutsch

Therapeutische Informationen

  • Therapiegruppe:
  • Synthetika
  • Therapiebereich:
  • Behandlung von Gallensteinen

Weitere Informationen

Status

  • Quelle:
  • Swissmedic - Swiss Agency for Therapeutic Products
  • Zulassungsnummer:
  • 44619
  • Berechtigungsdatum:
  • 28-06-1983
  • Letzte Änderung:
  • 24-10-2018

Packungsbeilage

Patienteninformation

Diverse (CCDS)

Information für Patientinnen und Patienten

Lesen Sie diese Packungsbeilage sorgfältig, bevor Sie das Arzneimittel einnehmen bzw. anwenden.

Dieses Arzneimittel ist Ihnen persönlich verschrieben worden und Sie dürfen es nicht an andere

Personen weitergeben. Auch wenn diese die gleichen Krankheitssymptome haben wie Sie, könnte

ihnen das Arzneimittel schaden.

Bewahren Sie die Packungsbeilage auf, Sie wollen sie vielleicht später nochmals lesen.

De-ursil, De-Ursil RR, De-ursil RR mite

Was sind De-ursil und De-ursil RR/mite und wann werden sie angewendet?

De-ursil und De-ursil RR/mite enthalten Ursodeoxycholsäure, eine auch in der menschlichen Galle

vorkommende natürliche Gallensäure.

De-ursil und De-ursil RR/mite werden zur Auflösung von Cholesterinkristallen und

Cholesterinsteinen in der funktionstüchtigen Gallenblase und als Vor- und Nachbehandlung bei der

Gallensteinzertrümmerung eingesetzt. De-ursil und De-ursil RR/mite werden auch zur Behandlung

bei chronisch fortschreitendem Leberleiden mit Gallenstauung (primiär biliäre Cholangitis,

sklerosierende Cholangitis) angewendet.

De-ursil und De-ursil RR/mite normalisieren die Zusammensetzung der Galle. Sie beseitigen

schmerzhafte, gallenbedingte Verdauungsbeschwerden einschliesslich einer allfälligen

gallenbedingten Magenschleimhautentzündung (Gastritis), Fettunverträglichkeit und

Darmblähungen.

Bei Lebererkrankungen mit Gallenstauung verringert die mit Ursodeoxycholsäure angereicherte

Galle die lebergewebeschädigenden Eigenschaften der anderen Gallensäuren und verbessert das

Allgemeinbefinden des Patienten.

De-ursil und De-ursil RR/mite sind nur auf Verschreibung des Arztes und unter stetiger Kontrolle

durch den behandelnden Arzt zu verwenden.

Wann dürfen De-ursil und De-ursil RR/mite nicht angewendet werden?

Das Präparat darf bei Patienten mit einer Ursodeoxycholsäure-Unverträglichkeit, häufigen

Gallenkoliken, akuten Leberentzündungen, akuten Entzündungen der Gallenblase und der

Gallenwege, bei Aufnahmestörungen der Gallensäuren (z.B. Entzündungen des Dünn- und

Dickdarms wie Morbus Crohn), Verschluss der Gallenwege, Magen- oder Darmgeschwüren im

aktiven Stadium, bei bestimmten Gallensteinen sowie einer eingeschränkten Funktion der

Gallenblase oder einer Überempfindlichkeit gegen einen Hilfsstoff nicht angewendet werden.

Wann ist bei der Einnahme von De-ursil und De-ursil RR/mite Vorsicht geboten?

De-ursil RR und De-ursil RR mite enthalten 2,84 mg bzw. 1,41 mg Sorbitol pro 450 mg oder 225 mg

Kapsel. Falls Sie an der seltenen angeborenen Fruktose-Intoleranz leiden, sollten Sie De-ursil RR

und De-Ursil RR mite nicht einnehmen.

Die gleichzeitige Anwendung von Colestyramin, Cholestipol, magnesium- und

aluminiumhydroxidhaltigen Medikamenten gegen Magensäureüberschuss (wie z.B. Alucol,

Andursil, Gaviscon) ist zu vermeiden, da diese Substanzen die Ursodeoxycholsäure binden, so dass

De-ursil und De-ursil RR/mite nicht aufgenommen werden können.

De-ursil und De-ursil RR/mite sollten nicht zusammen mit Arzneimitteln eingenommen werden, die

die Cholesterolausscheidung erhöhen oder Leberschäden hervorrufen können (z.B. Östrogene,

hormonelle Verhütungsmittel und einige Blutfett-senkende Medikamente).

Informieren Sie Ihren Arzt oder Apotheker bzw. Ihre Ärztin oder Apothekerin, wenn Sie

-an anderen Krankheiten leiden,

-Allergien haben oder

-andere Arzneimittel (auch selbst gekaufte!) einnehmen oder äusserlich anwenden!

Dürfen De-ursil und De-ursil RR/mite während einer Schwangerschaft oder in der Stillzeit

eingenommen werden?

In der Schwangerschaft dürfen De-ursil, De-ursil RR und De-ursil RR mite nur auf ausdrückliche

Verschreibung des Arztes resp. der Ärztin eingenommen werden. In der Stillzeit darf De-ursil nur

auf ausdrückliche Verschreibung des Arztes resp. der Ärztin eingenommen werden. In der Stillzeit

darf De-ursil RR und

De-ursil RR mite nicht eingenommen werden. Sprechen Sie mit Ihrem Arzt oder mit Ihrer Ärztin,

wenn Sie schwanger sind, eine Schwangerschaft planen, vermuten schwanger zu sein oder Ihr Kind

stillen.

Wie verwenden Sie De-ursil und De-ursil RR/mite?

Der Arzt legt die individuelle Dosierung und Behandlungsdauer fest. Der Arzt wird vor

Behandlungsbeginn Ihre Leberwerte überprüfen. Die unten angegebenen üblichen Dosierungen

können auf Anweisung des behandelnden Arztes geändert werden. Wenn nicht anders verordnet,

werden De-ursil und De-ursil RR/mite als abendliche Einmaldosis vor dem Schlafengehen

eingenommen. Die Kapseln nehmen Sie ungeöffnet und unzerkaut mit Flüssigkeit ein.

Auflösung von Cholesterinsteinen, Vor- und Nachbehandlung bei der Gallensteinzertrümmerung:

-Bis zu 70 kg Körpergewicht: täglich 1 Kapsel De-ursil RR 450 mg oder 2 Kapseln De-ursil 300 mg.

-Über 70 kg Körpergewicht: täglich 1-2 Kapseln De-ursil RR 450 mg und/oder De-ursil RR mite 225

mg, gemäss Angaben des Arztes.

Schmerzhafte Verdauungsbeschwerden gallenbedingten Ursprungs, gallenbedingte

Magenschleimhautentzündung (Gastritis), Fettunverträglichkeit und Blähungen:

Täglich 2 Kapseln De-ursil 150 mg oder 1 Kapsel De-ursil 300 mg oder 1 Kapsel De-ursil RR mite

225 mg.

Chronisch progressives Leberleiden mit Gallenstauung (Primär biliäre Zirrhose):

Täglich 2 Kapseln De-ursil 300 mg oder gemäss Angaben des Arztes.

Spezielle Dosierungsanweisungen:

Für die Gallensteinauflösung beträgt die Mindestbehandlungsdauer drei Monate. Nach dem durch

Ultraschall- oder Röntgen-Untersuchung festgestellten Verschwinden der Steine ist die Therapie

vorsorglich noch drei Monate lang weiterzuführen, um die in der Untersuchung nicht mehr

feststellbaren kleinsten Steinfragmente aufzulösen.

Bei der Gallensteinzertrümmerung wird De-ursil oder De-ursil RR/mite zwei Wochen vor der

Steinzertrümmerung eingenommen und die Behandlung bis zu drei Monate nach dem Verschwinden

der Steinfragmente fortgesetzt.

Kinder und Jugendliche:

Die Anwendung und Sicherheit von De-ursil und De-ursil RR/mite bei Kindern und Jugendlichen ist

bisher nicht geprüft worden, daher dürfen De-ursil und De-ursil RR/mite nur auf ausdrückliche

ärztliche Verschreibung von Kindern und Jugendlichen eingenommen werden.

Ändern Sie nicht von sich aus die verschriebene Dosierung. Wenn Sie glauben, das Arzneimittel

wirke zu schwach oder zu stark, so sprechen Sie mit Ihrem Arzt oder Apotheker bzw. mit Ihrer

Ärztin oder Apothekerin.

Welche Nebenwirkungen können De-ursil und De-ursil RR/mite haben?

Folgende Nebenwirkungen können bei der Einnahme von De-ursil und De-ursil RR/mite auftreten:

·Häufig können auftreten: Durchfall oder breiförmiger Stuhlgang; sowie Stuhlunregelmässigkeiten,

die bei fortlaufender Therapie wieder verschwinden.

·Sehr selten können auftreten: rechtsseitige Oberbauchschmerzen.

·Verkalkung von Gallensteinen

·bei Behandlung einer primär billiär Cholangitis im fortgeschrittenem Stadium konnte ein

Leberversagen (dekompensierte Leberzirrhose) beobachtet werden, diese klingt nach

Behandlungsabbruch teilweise wieder ab

·Nesselsucht

Wenn Sie Nebenwirkungen bemerken, die hier nicht beschrieben sind, sollten Sie Ihren Arzt oder

Apotheker bzw. Ihre Ärztin oder Apothekerin informieren.

Was ist ferner zu beachten?

Bei Raumtemperatur (15-25°C), vor Feuchtigkeit geschützt und ausser Reichweite von Kindern

aufbewahren. Das Arzneimittel darf nur bis zu dem auf dem Behälter mit «EXP» bezeichneten

Datum verwendet werden. Sollten Sie Kapseln besitzen, deren Verfallzeit abgelaufen ist, so bringen

Sie diese bitte in Ihre Apotheke oder Arztpraxis zur Vernichtung zurück.

Weitere Auskünfte erteilen Ihnen Ihr Arzt oder Apotheker bzw. Ihre Ärztin oder Apothekerin. Diese

Personen verfügen über die ausführliche Fachinformation.

Was ist in De-ursil und De-ursil RR/mite enthalten?

1 Kapsel De-ursil 150 bzw. 300 enthält:

Wirkstoff: Ursodeoxycholsäure 150 mg, bzw. 300 mg

Hilfsstoffe für Kapseln

1 Kapsel De-ursil RR enthält:

Wirkstoff: Ursodeoxycholsäure 450 mg

Hilfsstoffe: Sorbitol, Dibutylphthalat,

Konservierungsmittel: Methylparahydroxybenzoat (E218) und weitere Hilfsstoffe

1 Kapsel De-ursil RR mite enthält:

Wirkstoff: Ursodeoxycholsäure 225 mg

Hilfsstoffe: Sorbitol, Dibutylphthalat,

Konservierungsmittel: Methylparahydroxybenzoat (E218) und weitere Hilfsstoffe

Die Ausgangstoffe, die für die Herstellung des Wirkstoffes verwendet werden, stammen aus Galle

von Rindern oder anderen Tieren.

Zulassungsnummer

41655, 44619 (Swissmedic)

Wo erhalten Sie De-ursil und De-ursil RR/mite? Welche Packungen sind erhältlich?

In Apotheken nur gegen ärztliche Verschreibung.

De-ursil 150 mg: 30 und 100 Kapseln

De-ursil 300 mg: 10, 30 und 100 Kapseln

De-ursil RR 450 mg: 10, 20 und 60 Kapseln

De-ursil RR mite 225 mg: 20 Kapseln

Zulassungsinhaberin

CPS Cito Pharma Services GmbH, 8610 Uster

Diese Packungsbeilage wurde im April 2018 letztmals durch die Arzneimittelbehörde (Swissmedic)

geprüft.

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Europe -DG Health and Food Safety

2-10-2018

Imraldi (Samsung Bioepis UK Limited)

Imraldi (Samsung Bioepis UK Limited)

Imraldi (Active substance: adalimumab) - Centralised - 2-Monthly update - Commission Decision (2018)6458 of Tue, 02 Oct 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4279/IB/14

Europe -DG Health and Food Safety

2-10-2018

Intuniv (Shire Pharmaceuticals Ireland Limited)

Intuniv (Shire Pharmaceuticals Ireland Limited)

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

Europe -DG Health and Food Safety

2-10-2018

Vimizim (BioMarin International Limited)

Vimizim (BioMarin International Limited)

Vimizim (Active substance: elosulfase alfa) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)6491 of Tue, 02 Oct 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/002779/T/0026

Europe -DG Health and Food Safety

25-9-2018

Slenyto (RAD Neurim Pharmaceuticals EEC Limited)

Slenyto (RAD Neurim Pharmaceuticals EEC Limited)

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

Europe -DG Health and Food Safety

25-9-2018

Pelgraz (Accord Healthcare Limited)

Pelgraz (Accord Healthcare Limited)

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

Europe -DG Health and Food Safety

24-9-2018

Lenalidomide Accord (Accord Healthcare Limited)

Lenalidomide Accord (Accord Healthcare Limited)

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

Europe -DG Health and Food Safety

24-9-2018

Nitisinone MDK (MendeliKABS Europe Limited)

Nitisinone MDK (MendeliKABS Europe Limited)

Nitisinone MDK (Active substance: nitisinone) - Centralised - Yearly update - Commission Decision (2018)6241 of Mon, 24 Sep 2018

Europe -DG Health and Food Safety

24-9-2018

Xerava (Tetraphase Pharmaceuticals Ireland Limited)

Xerava (Tetraphase Pharmaceuticals Ireland Limited)

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

Europe -DG Health and Food Safety

24-9-2018

Cosentyx (Novartis Europharm Limited)

Cosentyx (Novartis Europharm Limited)

Cosentyx (Active substance: secukinumab) - PSUSA - Modification - Commission Decision (2018)6213 of Mon, 24 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/PSUSA/00010341/201712

Europe -DG Health and Food Safety

24-9-2018

Mitem® 20 mg

Rote - Liste

10-9-2018

Alkindi (Diurnal Limited)

Alkindi (Diurnal Limited)

Alkindi (Active substance: hydrocortisone) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)5945 of Mon, 10 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4416/T/03

Europe -DG Health and Food Safety

10-9-2018

Retacrit (Hospira UK Limited)

Retacrit (Hospira UK Limited)

Retacrit (Active substance: epoetin zeta) - Centralised - Yearly update - Commission Decision (2018)5946 of Mon, 10 Sep 2018

Europe -DG Health and Food Safety

4-9-2018

Spinraza (Biogen Idec Limited)

Spinraza (Biogen Idec Limited)

Spinraza (Active substance: nusinersen) - Centralised - 2-Monthly update - Commission Decision (2018)5862 of Tue, 04 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4312/II/4

Europe -DG Health and Food Safety

29-8-2018

Mekinist (Novartis Europharm Limited)

Mekinist (Novartis Europharm Limited)

Mekinist (Active substance: trametinib) - Centralised - 2-Monthly update - Commission Decision (2018)5778 of Wed, 29 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2643/WS/1274

Europe -DG Health and Food Safety

29-8-2018

Nucala (GlaxoSmithKline Trading Services Limited)

Nucala (GlaxoSmithKline Trading Services Limited)

Nucala (Active substance: mepolizumab) - Centralised - 2-Monthly update - Commission Decision (2018)5770 of Wed, 29 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/3860/II/13/G

Europe -DG Health and Food Safety

29-8-2018

Varuby (TESARO U.K. Limited)

Varuby (TESARO U.K. Limited)

Varuby (Active substance: rolapitant) - Centralised - Yearly update - Commission Decision (2018)5765 of Wed, 29 Aug 2018

Europe -DG Health and Food Safety

28-8-2018

Kalydeco (Vertex Pharmaceuticals (Europe) Limited)

Kalydeco (Vertex Pharmaceuticals (Europe) Limited)

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

Europe -DG Health and Food Safety

28-8-2018

EU/3/18/2062 (IQVIA RDS Ireland Limited)

EU/3/18/2062 (IQVIA RDS Ireland Limited)

EU/3/18/2062 (Active substance: Bertilimumab) - Orphan designation - Commission Decision (2018)5740 of Tue, 28 Aug 2018 European Medicines Agency (EMA) procedure number: EMA/OD/098/18

Europe -DG Health and Food Safety

28-8-2018

EU/3/18/2060 (Biogen Idec Limited)

EU/3/18/2060 (Biogen Idec Limited)

EU/3/18/2060 (Active substance: Adeno-associated viral vector serotype hu68 containing the human SMN1 gene) - Orphan designation - Commission Decision (2018)5732 of Tue, 28 Aug 2018 European Medicines Agency (EMA) procedure number: EMA/OD/065/18

Europe -DG Health and Food Safety

28-8-2018

EU/3/18/2058 (IQVIA RDS Ireland Limited)

EU/3/18/2058 (IQVIA RDS Ireland Limited)

EU/3/18/2058 (Active substance: 1-(3-methylbutanoyl)-L-aspartyl-L-threonyl-L-histidyl-L-phenylalanyl-L-prolyl-(L-cystinyl-L-isoleucyl-[(N6-(S)-4-carboxy-4-palmitamidobutanoyl)-L-lysinyl]-L-phenylalanyl-L-glutamyl-L-prolyl-L-arginyl-L-serinyl-L-lysinyl-L-glycinyl-L-cystinyl)-L-lysinamide, disulfide, acetate) - Orphan designation - Commission Decision (2018)5730 of Tue, 28 Aug 2018 European Medicines Agency (EMA) procedure number: EMA/OD/099/18

Europe -DG Health and Food Safety

28-8-2018

EU/3/18/2063 (IQVIA RDS Ireland Limited)

EU/3/18/2063 (IQVIA RDS Ireland Limited)

EU/3/18/2063 (Active substance: CD34+ haematopoietic stem and progenitor cells with CD3+ T-cells) - Orphan designation - Commission Decision (2018)5733 of Tue, 28 Aug 2018 European Medicines Agency (EMA) procedure number: EMA/OD/088/18

Europe -DG Health and Food Safety

28-8-2018

EU/3/18/2057 (Pharm Research Associates (UK) Limited)

EU/3/18/2057 (Pharm Research Associates (UK) Limited)

EU/3/18/2057 (Active substance: 1-(2-hydroxyethyl)-8-{[5-(4-methylpiperazin-1-yl)-2-(trifluoromethoxy) phenyl]amino}-4,5-dihydro-1H-pyrazolo[4,3-h]quinazoline-3-carboxamide fumarate salt) - Orphan designation - Commission Decision (2018)5729 of Tue, 28 Aug 2018 European Medicines Agency (EMA) procedure number: EMA/OD/051/18

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/3/18/2055 (IQVIA RDS Ireland Limited)

EU/3/18/2055 (IQVIA RDS Ireland Limited)

EU/3/18/2055 (Active substance: (3R,3aS,9R,9aS,9bS)-3-((dimethylamino)methyl)-9-hydroxy-6,9-dimethyl-3,3a,4,5,7,8,9,9a-octahydroazuleno[4,5-b]furan-2(9bH)-one fumarate) - Orphan designation - Commission Decision (2018)5727 of Tue, 28 Aug 2018 European Medicines Agency (EMA) procedure number: EMA/OD/060/18

Europe -DG Health and Food Safety

28-8-2018

EU/3/18/2067 (Omeros London Limited)

EU/3/18/2067 (Omeros London Limited)

EU/3/18/2067 (Active substance: Recombinant human monoclonal antibody against mannan-binding lectin-associated serine protease-2) - Orphan designation - Commission Decision (2018)5737 of Tue, 28 Aug 2018 European Medicines Agency (EMA) procedure number: EMA/OD/044/18

Europe -DG Health and Food Safety

28-8-2018

Orkambi (Vertex Pharmaceuticals (Europe) Limited)

Orkambi (Vertex Pharmaceuticals (Europe) Limited)

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

Europe -DG Health and Food Safety

27-8-2018

Firazyr (Shire Pharmaceuticals Ireland Limited)

Firazyr (Shire Pharmaceuticals Ireland Limited)

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

Europe -DG Health and Food Safety

27-8-2018

Kymriah (Novartis Europharm Limited)

Kymriah (Novartis Europharm Limited)

Kymriah (Active substance: tisagenlecleucel) - Centralised - Authorisation - Commission Decision (2018)5717 of Mon, 27 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4090

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

25-8-2018

Xagrid (Shire Pharmaceuticals Ireland Limited)

Xagrid (Shire Pharmaceuticals Ireland Limited)

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

Europe -DG Health and Food Safety

24-8-2018

Progynova® 21 mite

Rote - Liste

22-8-2018

Lenvima (Eisai Europe Limited)

Lenvima (Eisai Europe Limited)

Lenvima (Active substance: lenvatinib) - Centralised - 2-Monthly update - Commission Decision (2018)5627 of Wed, 22 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/3727/II/11/G

Europe -DG Health and Food Safety