Focuzine mono

Hauptinformation

  • Handelsname:
  • Focuzine mono Filmtablette
  • Darreichungsform:
  • Filmtablette
  • Verwenden für:
  • Menschen
  • Art der Medizin:
  • allopathic Droge

Dokumenten

  • Information für medizinisches Fachpersonal:
  • Das Informationsblatt für dieses Produkt ist derzeit nicht verfügbar, können Sie eine Anfrage an unseren Kundendienst zu senden und wir werden Sie benachrichtigen, sobald wir in der Lage, um es zu erhalten.


    Fordern Sie die Packungsbeilage für medizinisches Fachpersonal.

Lokalisierung

  • Erhältlich in:
  • Focuzine mono Filmtablette
    Belgien
  • Sprache:
  • Deutsch

Therapeutische Informationen

  • Therapiegruppe:
  • Nervensystem

Weitere Informationen

Status

  • Quelle:
  • AFMPS - Agence Fédérale des Médicaments et des Produits de Santé - Belgium
  • Zulassungsnummer:
  • BE466213
  • Letzte Änderung:
  • 12-04-2018

Packungsbeilage

Focuzine mono, Filmtabletten

GEBRAUCHSINFORMATION: INFORMATION FÜR ANWENDER

Focuzine mono, Filmtabletten

Trockenextrakt aus Ginkgo biloba L. Blättern (35-67:1)

EGb 761®).

Auszugsmittel: Aceton 60% (m/m)

Lesen Sie die gesamte Packungsbeilage sorgfältig durch, bevor Sie mit

der Einnahme dieses Arzneimittels beginnen, denn sie enthält wichtige

Informationen.

Nehmen Sie dieses Arzneimittel immer genau wie in dieser Packungsbeilage beschrieben

bzw. genau nach Anweisung Ihres Arztes oder Apothekers ein.

Heben Sie die Packungsbeilage auf. Vielleicht möchten Sie diese später nochmals

lesen.

Wenn Sie weitere Fragen haben, wenden Sie sich an Ihren Arzt oder Apotheker.

Wenn Sie sich nach 8 Wochen (56 Tagen) nicht besser oder gar schlechter

fühlen, wenden Sie sich an Ihren Arzt.

Wenn Sie Nebenwirkungen bemerken, wenden Sie sich an Ihren Arzt oder Apotheker.

Dies gilt auch für Nebenwirkungen, die nicht in dieser Packungsbeilage angegeben sind.

Siehe Abschnitt 4.

Was in dieser Packungsbeilage steht

Was ist Focuzine mono und wofür wird es angewendet?

Was sollten Sie vor der Einnahme von Focuzine mono beachten?

Wie ist Focuzine mono einzunehmen?

Welche Nebenwirkungen sind möglich?

Wie ist Focuzine mono aufzubewahren?

Inhalt der Packung und weitere Informationen

1.

Was ist Focuzine mono und wofür wird es angewendet?

Focuzine mono enthält als Wirkstoff EGb 761®, einen Trockenextrakt aus den Blättern von

Ginkgo biloba L. (35-67:1) (EGb 761®), Auszugsmittel: Aceton 60% (m/m)

Symptomatische

Behandlung

Gedächtnis-,

Aufmerksamkeits-

Konzentrationsstörungen (wie sie im Laufe des natürlichen Alterungsprozesses vorkommen

können).

Vor Beginn der Behandlung mit Focuzine mono Filmtabletten ist vom behandelnden Arzt

auszuschließen, dass die Beschwerden Folgen einer Erkrankung sind, die auf andere Weise

spezifisch zu behandeln ist.

Wenden Sie sich an Ihren Arzt, wenn Sie sich nach 8 Wochen (56 Tagen) nicht besser oder

gar schlechter fühlen.

Leaflet (DE)

Focuzine mono, Filmtabletten

2.

Was sollten Sie vor der Einnahme von Focuzine mono beachten?

Focuzine mono darf nicht eingenommen werden,

wenn Sie allergisch gegen Ginkgo biloba L. Trockenextrakt oder einen der in Abschnitt 6.

genannten sonstigen Bestandteile dieses Arzneimittels sind.

Warnhinweise und Vorsichtsmaßnahmen

Bitte sprechen Sie mit Ihrem Arzt oder Apotheker, bevor Sie Focuzine mono

einnehmen.

Treten Kopfschmerzen auf, ist nach 2 Tagen ein Arzt zu Rate zu ziehen.

bei gleichzeitiger Einnahme von Arzneimitteln, welche die Blutgerinnung beeinflussen.

bei krankhaft erhöhter Blutungsneigung wie Hämophilie (Bluterkrankheit)

falls Sie sich eines chirurgischen Eingriffes unterziehen müssen. Es wurde berichtet,

dass möglicherweise Ginkgo-haltige Präparate die Blutungsbereitschaft erhöhen

könnten. Daher ist es ratsam, dieses Arzneimittel vorübergehend vor jeglicher

Operation abzusetzen.

falls Sie an Epilepsie leiden.

Kinder und Jugendliche unter 18 Jahren

Es ist nicht angeraten, Focuzine mono bei Kindern und Jugendlichen unter 18 Jahren

anzuwenden, da keine ausreichenden Daten zur Sicherheit und Wirksamkeit vorliegen.

Es gibt keine relevante Anwendung von Focuzine mono bei Kindern und Jugendlichen unter

18 Jahren.

Einnahme von Focuzine mono zusammen mit anderen Arzneimitteln

Bei gleichzeitiger Einnahme von Focuzine mono mit Antikoagulantien oder Antiaggregantien

(blutgerinnungshemmenden Arzneimitteln) ist es möglich, dass deren Wirkung verstärkt wird.

Wechselwirkungsstudien hinsichtlich der Hemmung oder Induktion von CYP2B6 oder

CYP2C8 sind nicht durchgeführt worden. Eine Wechselwirkungsstudie bezüglich der

Auswirkung auf die Hemmung oder Induktion von CYP3A4 oder CYP2D6 hat ergeben, dass

eine entsprechende Auswirkung von Ginkgo biloba in den empfohlenen Dosen wenig

wahrscheinlich ist.

Informieren Sie Ihren Arzt oder Apotheker, wenn Sie andere Arzneimittel einnehmen, kürzlich

andere Arzneimittel

eingenommen

haben

oder

beabsichtigen,

andere Arzneimittel

einzunehmen.

Einnahme von Focuzine mono zusammen mit Nahrungsmitteln und

Getränken und Alkohol

Focuzine

mono

kann mit einer Mahlzeit oder Getränken eingenommen werden.

Schwangerschaft, Stillzeit und Zeugungs-/Gebärfähigkeit

Wenn Sie schwanger sind oder stillen, oder wenn Sie vermuten, schwanger zu sein

oder beabsichtigen, schwanger zu werden, fragen Sie vor der Einnahme dieses

Arzneimittels Ihren Arzt oder Apotheker um Rat.

Schwangerschaft

Bisher liegen keine oder nur sehr begrenzte Erfahrungen mit der Anwendung von Focuzine

mono bei Schwangeren vor.

liegen

keine

ausreichenden

tierexperimentellen

Studien

Bezug

eine

Reproduktionstoxizität vor.

Vorsichtsgründen

soll

eine Anwendung

Focuzine

mono

während

Schwangerschaft vermieden werden.

Leaflet (DE)

Focuzine mono, Filmtabletten

Stillzeit

Es ist nicht bekannt, ob die Ginkgo biloba Extrakt / Metabolite in die Muttermilch übergehen.

Ein Risiko für das Neugeborene / Kind kann nicht ausgeschlossen werden.

Es muss eine Entscheidung darüber getroffen werden, ob das Stillen zu unterbrechen ist

oder ob auf die Behandlung mit Focuzine mono verzichtet werden soll / die Behandlung mit

Focuzine zu unterbrechen ist. Dabei ist sowohl der Nutzen des Stillens für das Kind als auch

der Nutzen der Therapie für die Frau zu berücksichtigen.

Zeugungs-/Gebärfähigkeit

Tierexperimentelle Studien deuten nicht auf eine potentielle Auswirkung auf die

Zeugungs-/Gebärfähigkeit hin. In diesen Studien wurde das 3,5 - Fache der Maximaldosis

beim Menschen angewandt. Es wurden keine klinischen Studien bezüglich der

Zeugungs-/Gebärfähigkeit beim Menschen und bei Frauen im gebärfähigen Alter, die nicht

verhüten, durchgeführt.

Wenn Sie schwanger sind oder stillen, oder wenn Sie vermuten, schwanger zu sein oder

beabsichtigen, schwanger zu werden, fragen Sie vor der Einnahme dieses Arzneimittels

Ihren Arzt oder Apotheker um Rat.

Verkehrstüchtigkeit und Fähigkeit zum Bedienen von Maschinen

Gegenstandslos.

Focuzine mono enthält Lactose

Bitte nehmen Sie Focuzine mono - Filmtabletten erst nach Rücksprache mit Ihrem Arzt ein,

wenn Ihnen bekannt ist, dass Sie unter einer Zuckerunverträglichkeit leiden.

3.

Wie ist Focuzine mono einzunehmen?

Nehmen Sie dieses Arzneimittel immer genau nach Absprache mit Ihrem Arzt ein. Fragen Sie

bei Ihrem Arzt oder Apotheker nach, wenn Sie sich nicht sicher sind.

Die empfohlene Dosis beträgt eine Tablette einmal täglich.

Nehmen Sie die Tabletten unzerkaut mit ein wenig Wasser ein, ohne sie zu zerkauen. Die

Einnahme kann unabhängig von den Mahlzeiten erfolgen.

Anwendung bei Kindern und Jugendlichen unter 18 Jahren

Die Anwendung von Focuzine mono bei Kindern und Jugendlichen wird nicht empfohlen.

Wenn Sie eine größere Menge von Focuzine mono eingenommen haben,

als Sie sollten

Wenn Sie zu viel Focuzine mono eingenommen haben, nehmen Sie bitte unverzüglich

Kontakt mit Ihrem Arzt, Ihrem Apotheker oder mit dem Anti-Gift-Zentrum (Telefon

070 245 245) auf.

Überdosierungserscheinungen sind bisher nicht bekannt. Möglicherweise treten die

Nebenwirkungen (siehe Kapitel „Welche Nebenwirkungen sind möglich?“) verstärkt auf,

wenn Sie eine höhere Dosis als verordnet eingenommen haben. Bitte benachrichtigen Sie

Ihren Arzt. Dieser kann über gegebenenfalls erforderliche Maßnahmen entscheiden.

Leaflet (DE)

Focuzine mono, Filmtabletten

Wenn Sie die Einnahme von Focuzine mono vergessen haben

Nehmen Sie nicht die doppelte Menge ein, wenn Sie die vorherige Einnahme vergessen

haben, sondern fahren Sie mit der Einnahme, wie von Ihrem Arzt verordnet oder in dieser

Gebrauchsinformation beschrieben, fort.

Wenn Sie die Einnahme von Focuzine mono abbrechen

Wenn Sie weitere Fragen zur Einnahme dieses Arzneimittels haben, wenden Sie sich an

Ihren Arzt oder Apotheker.

4.

Welche Nebenwirkungen sind möglich?

Wie alle Arzneimittel kann auch dieses Arzneimittel Nebenwirkungen haben, die aber nicht

bei jedem auftreten müssen.

Folgende Nebenwirkungen wurden berichtet: Kopfschmerzen, Blutungen aus einzelnen

Organen, leichte Magen-Darm-Beschwerden und allergische Hautreaktionen (Rötung,

Schwellung, Juckreiz).

Treten Kopfschmerzen auf, ist nach 2 Tagen ein Arzt zu Rate zu ziehen.

Meldung von Nebenwirkungen

Wenn Sie Nebenwirkungen bemerken, wenden Sie sich an Ihren Arzt oder Apotheker. Dies

gilt auch für Nebenwirkungen, die nicht in dieser Packungsbeilage angegeben sind.

Sie können Nebenwirkungen auch direkt über das nationale Meldesystem:Agence Fédérale

des Médicaments et des Produits de Santé

Département Vigilance

EUROSTATION II

Place Victor Horta, 40/40

B-1060 Bruxelles

Site Web : www.fagg.be

E-mail : patientinfo@fagg-afmps.be

anzeigen. Indem Sie Nebenwirkungen melden, können Sie dazu beitragen, dass mehr

Informationen über die Sicherheit dieses Arzneimittels zur Verfügung gestellt werden.

5.

Wie ist Focuzine mono aufzubewahren?

Bewahren Sie dieses Arzneimittel für Kinder unzugänglich auf.

In der Originalverpackung aufbewahren.

Sie dürfen Focuzine mono nach dem auf dem Umkarton und der Blisterpackung nach „Exp.:“

angegebenen Verfalldatum nicht mehr verwenden. Das Verfalldatum bezieht sich auf den

letzten Tag des angegebenen Monats.

Entsorgen Sie Arzneimittel nicht im Abwasser oder Haushaltsabfall.

Fragen Sie Ihren

Apotheker, wie das Arzneimittel zu entsorgen ist, wenn Sie es nicht mehr verwenden. Sie

tragen damit zum Schutz der Umwelt bei.

6.

Inhalt der Packung und weitere Informationen

Was Focuzine mono enthält

Der Wirkstoff ist

:

120 mg Trockenextrakt aus Ginkgo biloba

L. Blättern (35 - 67:1) (EGb 761®),

quantifiziert

auf 26,4 – 32,4 mg Ginkgoflavonglykoside und 6,48 – 7,92 mg Terpenlaktone

(Ginkgolide, Bilobalide) (EGb 761®).

Auszugsmittel Aceton 60% (m/m).

Leaflet (DE)

Focuzine mono, Filmtabletten

Die sonstigen Bestandteile sind

:

Lactose

Siliciumdioxid

mikrokristalline Cellulose

Maisstärke

Croscarmellose Natrium

Magnesiumstearat

Methylhydroxypropylcellulose

Macrogol 1500

Titandioxid (E171)

Eisenoxid (E172)

Antischaumemulsion SE2

Talkum

Wie Focuzine mono aussieht und Inhalt der Packung

Gelbe, ovale Filmtabletten.

Focuzine mono steht in Packungen mit 10/20/30/40/50/60 Filmtabletten in Durchdrückfolien

zur Verfügung.

Zulassungsinhaber

PharmaLex GmbH

Harrlachweg 6

68163 Mannheim

Deutschland

Hersteller

VSM Geneesmiddelen bv

Berenkoog 35

1822 BH Alkmaar

Niederlande

Für zusätzliche Informationen bezüglich dieses Medikamentes kontaktieren Sie bitte den

lokalen Vertreter des Zulassungsinhabers:

VSM Belgium bvba/ sprl

Prins Boudewijnlaan 24C

B-2550 KONTICH

Zulassungssnummer: BE466213

Verkaufsabgrenzung: Ohne ärztliche Verschreibung erhältlich.

Diese Packungsbeilage wurde zuletzt überarbeitet im 11/2014.

Leaflet (DE)

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Pest categorisation of Acrobasis pirivorella

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Middel tegen ziekte van Kahler in basispakket na succesvolle prijsonderhandelingen

Middel tegen ziekte van Kahler in basispakket na succesvolle prijsonderhandelingen

Minister Bruno Bruins (Medische Zorg) heeft met succes onderhandeld over de prijs van het middel daratumumab in twee verschillende combinatietherapieën voor de vervolgbehandeling van de ziekte van Kahler (multipel myeloom). Bij deze ziekte is er sprake van kwaadaardige woekering van plasmacellen in het beenmerg. Daratumumab was al beschikbaar als zogenaamde monotherapie voor patiënten die al eerder zijn behandeld. Door de prijsafspraken wordt het middel vanaf 1 september voor deze patiënten ook vergoed u...

Netherlands - Ministerie van Volksgezondheid, Welzijn en Sport

14-8-2018

Scientific guideline:  Procedure for the review and revision of European Union herbal monographs and European Union list entries - Revision 2, adopted

Scientific guideline: Procedure for the review and revision of European Union herbal monographs and European Union list entries - Revision 2, adopted

The purpose of this procedure is to enable a consistent and proportionate process in reviewing and revising all European Union herbal monographs and European Union list entries adopted by the HMPC. The aim of this document is to describe how to identify the criteria/reasons that trigger the revision of European Union herbal monographs and list entries and the associated procedure and timelines for both the review and the revision.

Europe - EFSA - European Food Safety Authority EFSA Journal

6-8-2018

G & C Raw, LLC Recalls Pat's Cat Turkey, and Ground Lamb Pet Food, because of Possible Listeria Monocytogenes Health Risk

G & C Raw, LLC Recalls Pat's Cat Turkey, and Ground Lamb Pet Food, because of Possible Listeria Monocytogenes Health Risk

G & C Raw, of Versailles, OH is recalling 30 1-lb containers of Pat's Cat Turkey Cat Food and 40 2-lb containers of Ground Lamb Dog Food because it has the potential to be contaminated with Listeria monocytogenes. Listeria monocytogenes can cause serious and sometimes fatal infections in animals eating the products.

FDA - U.S. Food and Drug Administration

28-7-2018

Lipari Foods Issues Voluntary Recall of Premo Brand & Fresh Grab Turkey & Swiss Submarine Sandwiches Due to Potential Contamination of Listeria Monocytogenes

Lipari Foods Issues Voluntary Recall of Premo Brand & Fresh Grab Turkey & Swiss Submarine Sandwiches Due to Potential Contamination of Listeria Monocytogenes

Lipari Foods, LLC has issued a voluntary recall of Premo Brand and Fresh Grab turkey and Swiss submarine sandwiches produced and packaged by sister company JLM due to potential contamination of Listeria monocytogenes. Listeria monocytogenes is an organism, which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Although healthy individuals may suffer only short-term symptoms such as high fever, severe headache, stiffness,...

FDA - U.S. Food and Drug Administration

20-7-2018

Liste der aktuell gültigen Monografien für Standardzulassungen – Humanarzneimittel: Stand 18.07.2018

Liste der aktuell gültigen Monografien für Standardzulassungen – Humanarzneimittel: Stand 18.07.2018

In diesem Dokument wurde bei Argininhydrochlorid-Lösung, 1M-L-Form die Menge an Wasser für Injektionszwecke von "zu 100,0 ml" zu "zu 1000,0 ml" geändert.

Deutschland - BfArM - Bundesinstitut für Arzneimittel und Medizinprodukte

19-7-2018

Radagast Pet Food Inc. recalls Rad Cat Raw Diet Free-Range Pet Food

Radagast Pet Food Inc. recalls Rad Cat Raw Diet Free-Range Pet Food

The pet food may be contaminated with Listeria monocytogenes and there is risk of cross contamination and illness after handling the pet food.

Health Canada

19-7-2018

K9 Natural Ltd recalls K9 Natural Frozen Chicken Feast Raw Pet Food 11lb bags

K9 Natural Ltd recalls K9 Natural Frozen Chicken Feast Raw Pet Food 11lb bags

K9 Natural Ltd is voluntarily recalling K9 Natural Frozen Chicken Feast 11lb bags, batch number #150517, that were imported into the Canadian market in July 2017 because they have the potential to be contaminated with Listeria monocytogenes. No other K9 Natural products are affected in Canada.

Health Canada

6-7-2018

Radagast Pet Food, Inc. Voluntarily Recalls Three Lots of Rad Cat Raw Diet Free-Range Chicken Recipe and One Lot of Pasture-Raised Venison Recipe Because of Possible Health Risk

Radagast Pet Food, Inc. Voluntarily Recalls Three Lots of Rad Cat Raw Diet Free-Range Chicken Recipe and One Lot of Pasture-Raised Venison Recipe Because of Possible Health Risk

Radagast Pet Food, Inc. of Portland, OR is recalling three lots of Rad Cat Raw Diet Free-Range Chicken Recipe because testing results indicate they have the potential to be contaminated with Listeria monocytogenes. The Company is also recalling one lot of Rad Cat Raw Diet Pasture-Raised Venison Recipe because testing results indicate it has the potential to be contaminated with Shiga Toxin producing E. coli O121. This recall is being conducted out of an abundance of caution. Due to Radagast Pet Food’s ...

FDA - U.S. Food and Drug Administration

3-7-2018

Listeria monocytogenes: update on foodborne outbreak

Listeria monocytogenes: update on foodborne outbreak

Listeria monocytogenes: update on foodborne outbreak

Europe - EFSA - European Food Safety Authority Press Releases & News Stories

26-5-2018

Giant/Martin’s Voluntarily Recalls Private Brand Frozen Broccoli Cuts

Giant/Martin’s Voluntarily Recalls Private Brand Frozen Broccoli Cuts

GIANT Food Stores, LLC is voluntarily recalling Private Brand Frozen Broccoli Cuts (16 oz.) with sell by date of Mar 15, 2020 and UPC code 68826700926 out of an abundance of caution following a supplier notification that the product may have Listeria monocytogenes.

FDA - U.S. Food and Drug Administration

26-5-2018

Stop & Shop Voluntarily Recalls Stop & Shop Frozen Broccoli Cuts

Stop & Shop Voluntarily Recalls Stop & Shop Frozen Broccoli Cuts

Stop & Shop is voluntarily recalling Private Brand Frozen Broccoli Cuts (16 oz.) with sell by date of Mar 15, 2020 and UPC code 68826700926 out of an abundance of caution due to our supplier notifying us the product may have Listeria monocytogenes.

FDA - U.S. Food and Drug Administration

25-5-2018

Giant Food Voluntarily Recalls Giant Food Frozen Broccoli Cuts

Giant Food Voluntarily Recalls Giant Food Frozen Broccoli Cuts

Giant Food, LLC is voluntarily recalling Private Brand Frozen Broccoli Cuts (16 oz.) with sell by date of Mar 15, 2020 and UPC code 68826700926 out of an abundance of caution due to our supplier notifying us the product may have Listeria monocytogenes.

FDA - U.S. Food and Drug Administration

19-5-2018

Hickory Harvest Recalls Certain Island Fruit Mix and Organic Nut Mix Products Because of Possible Health Risk

Hickory Harvest Recalls Certain Island Fruit Mix and Organic Nut Mix Products Because of Possible Health Risk

Hickory Harvest Foods of Akron, Ohio is voluntarily recalling specific lots due to the potential exposure to Listeria monocytogenes. Listeria monocytogenes, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, pregnant women, and others with weakened immune systems. Healthy individuals may experience short-term symptoms such as high fever, severe headache, stiffness, nausea, abdominal pain, and diarrhea. Listeria infection can also cause miscarr...

FDA - U.S. Food and Drug Administration

18-5-2018

Keytruda (pembrolizumab) or Tecentriq (atezolizumab): FDA Alerts Health Care Professionals and Investigators: FDA Statement - Decreased Survival in Some Patients in Clinical Trials Associated with Monotherapy

Keytruda (pembrolizumab) or Tecentriq (atezolizumab): FDA Alerts Health Care Professionals and Investigators: FDA Statement - Decreased Survival in Some Patients in Clinical Trials Associated with Monotherapy

Early reviews found patients in the monotherapy arms of both trials with PD-L1 low status had decreased survival compared to patients who received cisplatin- or carboplatin-based chemotherapy.

FDA - U.S. Food and Drug Administration

7-10-2016

Experts for the European Pharmacopoeia's groups of experts and working parties

Experts for the European Pharmacopoeia's groups of experts and working parties

A very large part of the work related to the drafting of new monographs for the European Pharmacopoeia (EDQM) is carried out by external experts in 75 groups of experts and working parties. Experts for the groups are appointed for a period of three years, and the EDQM is now seeking experts for the period from 2017 to 2019.

Danish Medicines Agency

30-10-2018

EU/3/18/2076 (Orphan Europe S.A.R.L.)

EU/3/18/2076 (Orphan Europe S.A.R.L.)

EU/3/18/2076 (Active substance: Glycine, L-alanine, L-arginine, L-aspartic acid, L-cysteine, L-cystine, L-glutamic acid, L-histidine, L-lysine monohydrate, L-methionine, L-phenylalanine, L-proline, L-serine, L-threonine, L-tryptophan, L-tyrosine, taurine) - Orphan designation - Commission Decision (2018)7277 of Tue, 30 Oct 2018 European Medicines Agency (EMA) procedure number: EMA/OD/100/18

Europe -DG Health and Food Safety

23-10-2018

Dexa Loscon® mono

Rote - Liste

27-9-2018

OXACANT mono

Rote - Liste

23-8-2018

Codicaps® mono 30 mg Weichkapseln

Rote - Liste

17-8-2018

Scientific guideline:  Draft guideline on clinical investigation of medicinal products in the treatment of epileptic disorders - Revision 3, draft: consultation open

Scientific guideline: Draft guideline on clinical investigation of medicinal products in the treatment of epileptic disorders - Revision 3, draft: consultation open

The present document is a third revision of the existing guideline. It should be considered as general guidance on the development of medicinal products for the treatment of epileptic disorders and should be read in conjunction with other EMA and ICH guidelines, which may apply to these conditions and patient populations. The main changes to the existing guideline include incorporation of the new classification / definitions of seizure types and epilepsies, the acceptance of add-on studies in support o...

Europe - EMA - European Medicines Agency

27-7-2018

EU/3/16/1635 (Leadiant GmbH)

EU/3/16/1635 (Leadiant GmbH)

EU/3/16/1635 (Active substance: N-acetyl-D-mannosamine monohydrate) - Transfer of orphan designation - Commission Decision (2018)5053 of Fri, 27 Jul 2018 European Medicines Agency (EMA) procedure number: EMA/OD/228/15/T/01

Europe -DG Health and Food Safety

19-6-2018

Femoston® mono 2 mg Filmtabletten

Rote - Liste

12-6-2018

EU/3/10/811 (Celgene Europe B.V.)

EU/3/10/811 (Celgene Europe B.V.)

EU/3/10/811 (Active substance: N-tert-butyl-3-[(5-methyl-2-{[4-(2-pyrrolidin-1-ylethoxy)phenyl]amino}pyrimidin-4-yl)amino] benzenesulfonamide dihydrochloride monohydrate) - Transfer of orphan designation - Commission Decision (2018)3809 of Tue, 12 Jun 2018 European Medicines Agency (EMA) procedure number: EMA/OD/092/10/T/03

Europe -DG Health and Food Safety

12-6-2018

EU/3/10/810 (Celgene Europe B.V.)

EU/3/10/810 (Celgene Europe B.V.)

EU/3/10/810 (Active substance: N-tert-butyl-3-[(5-methyl-2-{[4-(2-pyrrolidin-1-ylethoxy)phenyl]amino}pyrimidin-4-yl)amino] benzenesulfonamide dihydrochloride monohydrate) - Transfer of orphan designation - Commission Decision (2018)3808 of Tue, 12 Jun 2018 European Medicines Agency (EMA) procedure number: EMA/OD/084/10/T/03

Europe -DG Health and Food Safety

12-6-2018

EU/3/10/794 (Celgene Europe B.V.)

EU/3/10/794 (Celgene Europe B.V.)

EU/3/10/794 (Active substance: N-tert-butyl-3-[(5-methyl-2-{[4-(2-pyrrolidin-1-ylethoxy)phenyl]amino}pyrimidin-4-yl)amino] benzenesulfonamide dihydrochloride monohydrate) - Transfer of orphan designation - Commission Decision (2018)3803 of Tue, 12 Jun 2018 European Medicines Agency (EMA) procedure number: EMA/OD/069/10/T/03

Europe -DG Health and Food Safety

16-5-2018

EU/3/14/1305 (AbbVie Deutschland GmbH and Co. KG)

EU/3/14/1305 (AbbVie Deutschland GmbH and Co. KG)

EU/3/14/1305 (Active substance: Humanised recombinant monoclonal antibody against epidermal growth factor receptor conjugated to maleimidocaproyl monomethylauristatin F) - Transfer of orphan designation - Commission Decision (2018)3022 of Wed, 16 May 2018 European Medicines Agency (EMA) procedure number: EMA/OD/065/14/T/01

Europe -DG Health and Food Safety

21-3-2018

EU/3/11/919 (Monopar Therapeutics SARL)

EU/3/11/919 (Monopar Therapeutics SARL)

EU/3/11/919 (Active substance: Clonidine hydrochloride) - Transfer of orphan designation - Commission Decision (2018)1817 of Wed, 21 Mar 2018 European Medicines Agency (EMA) procedure number: EMA/OD/069/11/T/02

Europe -DG Health and Food Safety

21-3-2018

EU/3/15/1595 (IQVIA RDS Ireland Limited)

EU/3/15/1595 (IQVIA RDS Ireland Limited)

EU/3/15/1595 (Active substance: Live attenuated Listeria monocytogenes bioengineered with a chimeric human epidermal growth factor receptor 2 fused to a truncated form of the Lm protein listeriolysin O) - Transfer of orphan designation - Commission Decision (2018)1819 of Wed, 21 Mar 2018 European Medicines Agency (EMA) procedure number: EMA/OD/162/15/5T/01

Europe -DG Health and Food Safety