Patentex oval - Schaumovula

Hauptinformation

  • Handelsname:
  • Patentex oval - Schaumovula
  • Einheiten im Paket:
  • 6 Stück, Laufzeit: 30 Monate,12 Stück, Laufzeit: 30 Monate,24 Stück, Laufzeit: 30 Monate
  • Verschreibungstyp:
  • Arzneimittel zur Abgabe ohne aerztliche Verschreibung
  • Verwenden für:
  • Menschen
  • Art der Medizin:
  • allopathic Droge

Dokumenten

Lokalisierung

  • Erhältlich in:
  • Patentex oval - Schaumovula
    Österreich
  • Sprache:
  • Deutsch

Therapeutische Informationen

  • Therapiebereich:
  • Intravaginal contraceptiv
  • Produktbesonderheiten:
  • Abgabe durch Drogerien oder durch Gewerbetreibende gemäß Gewerbeordnung 1994 mit entsprechender Berechtigung

Weitere Informationen

Status

  • Quelle:
  • AGES
  • Zulassungsnummer:
  • 15906
  • Berechtigungsdatum:
  • 02-08-1976
  • Letzte Änderung:
  • 10-08-2017

Packungsbeilage

Patentex   oval Schaum-Ovula Gebrauchsinformation

Gebrauchsinformation: Information für Anwender

Patentex  oval Schaum-Ovula

Nonoxinol-9

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.

Fragen  Sie  Ihren  Apotheker,  wenn  Sie  weitere  Informationen  oder  einen  Rat 

benötigen.

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:

1. Was sind Patentex   oval Schaum-Ovula und wofür werden sie angewendet?

2. Was sollten Sie vor der Anwendung von Patentex   oval Schaum-Ovula beachten?

3. Wie sind Patentex   oval Schaum-Ovula anzuwenden?

4. Welche Nebenwirkungen sind möglich?

5. Wie sind Patentex   oval Schaum-Ovula aufzubewahren?

6. Inhalt der Packung und weitere Informationen

1. WAS SIND PATENTEX  OVAL SCHAUM-OVULA UND WOFÜR WERDEN SIE 

ANGEWENDET?

Patentex   oval ist ein Verhütungsmittel, das in die Scheide eingeführt wird. Es 

schmilzt bei Körpertemperatur und entwickelt einen feinen, dichten Schaum, in dem 

der Wirkstoff fein verteilt ist. Der Schaum mit dem Wirkstoff hemmt die Bewegung 

der Samenfäden, zusätzlich wird eine Schaumbarriere aufgebaut, die das Eindringen 

des Samens in die Gebärmutter verhindert. Der Empfängnisschutz tritt etwa 10 

Minuten nach der Anwendung ein und hält rund eine Stunde an.

Anwendungsgebiet:

Empfängnisverhütung für Frauen.

2. WAS SOLLTEN SIE VOR DER ANWENDUNG VON PATENTEX  OVAL 

SCHAUM-OVULA BEACHTEN?

Patentex  oval Schaum-Ovula dürfen nicht angewendet werden,

wenn Sie bei früheren Anwendungen das Präparat schlecht vertragen haben 

oder wenn Sie überempfindlich gegen den Wirkstoff Nonoxinol-9 oder einen der 

in Abschnitt 6. genannten sonstigen Bestandteile sind,

bei Entzündungen im Bereich der Scheide oder des Gebärmutterhalses,

bei vaginalen Blutungen ungeklärter Ursache,

Patentex   oval Schaum-Ovula Gebrauchsinformation

bei vermehrtem Sekret-Ausfluss aus der Scheide,

während der Schwangerschaft und Stillzeit sowie

während des Wochenbettes (Wundsekretion nach der Geburt)

Warnhinweise und Vorsichtsmaßnahmen 

Bitte sprechen Sie mit Ihrem Arzt oder Apotheker, bevor Sie Patentex   oval 

anwenden:

- bei Jugendlichen unter 14 Jahren

Patentex   oval wird nicht empfohlen für die Anwendung bei Jugendlichen unter 14 

Jahren aufgrund nicht ausreichender Daten zur Unbedenklichkeit und Wirksamkeit.

- bei Risikokontakten

Patentex   oval schützt Sie nicht vor Infektionskrankheiten, die beim 

Geschlechtsverkehr übertragen werden können, und damit auch nicht vor Gefahren 

wie AIDS. Verwenden Sie daher bei Risikokontakten zusätzlich ein Kondom.

Anwendung von Patentex  oval Schaum-Ovula zusammen mit anderen 

Arzneimitteln

      

Es ist nicht zu empfehlen, dass Patentex   oval gleichzeitig mit anderen Arzneimitteln, 

die in die Scheide eingeführt werden, verwendet wird. Patentex   oval kann 

zusammen mit Latex Kondomen verwendet werden.

Informieren Sie Ihren Arzt oder Apotheker, wenn Sie andere Arzneimittel 

einnehmen/anwenden, kürzlich andere Arzneimittel eingenommen/angewendet 

haben oder beabsichtigen andere Arzneimittel einzunehmen/anzuwenden.

Schwangerschaft und Stillzeit

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

fragen Sie vor der Anwendung dieses Arzneimittels Ihren Arzt oder Apotheker um 

Rat. Es liegen keine Hinweise auf negative Auswirkungen von Patentex   oval vor. Da 

keine ausreichenden Erfahrungen vorliegen, sollte das Präparat während der 

Schwangerschaft und Stillzeit nicht verwendet werden.

Verkehrstüchtigkeit und Fähigkeit zum Bedienen von Maschinen

Patentex   oval Schaum-Ovula haben keinen Einfluss auf die Verkehrstüchtigkeit und 

das Bedienen von Maschinen.

3. WIE SIND PATENTEX  OVAL SCHAUM-OVULA ANZUWENDEN?

Wenden Sie Patentex   oval immer genau wie in dieser Packungsbeilage 

beschrieben bzw. genau nach der mit Ihrem Arzt oder Apotheker getroffenen 

Absprache an. Fragen Sie bei Ihrem Arzt oder Apotheker nach, wenn Sie sich nicht 

sicher sind.

Patentex   oval Schaum-Ovula Gebrauchsinformation

Falls von der Ärztin / vom Arzt nicht anders verordnet, ist die übliche Art der 

Anwendung:

Ein Schaum-Ovulum mindestens 10 Minuten vor dem Geschlechtsverkehr 

fingertief in die Scheide einführen.

Wenn es innerhalb 1 Stunde nach dem Einführen des Ovulums zu keinem 

Samenerguss gekommen ist, empfehlen wir, erneut ein Ovulum einzuführen.

III. Vor Wiederholung des Verkehrs – ganz gleich in welchem Zeitraum – stets ein 

neues Ovulum einführen. Wieder 10 Minuten warten.

Patentex   oval darf nicht öfter als 3mal innerhalb von 24 Stunden angewendet 

werden.

Was ist, wenn Schaum austritt?

Die Vaginagröße ist bei Frauen unterschiedlich. Unabhängig davon soll Patentex   

oval jedoch jede Frau zuverlässig vor Empfängnis schützen. Bei einer kleinen Vagina 

kann daher schon vor dem Verkehr etwas Schaum austreten. Dies beeinträchtigt 

nicht den zuverlässigen Schutz.

Was ist für die Zuverlässigkeit eines Verhütungsmittels von Bedeutung?

Keine Methode bietet einen 100%igen Schutz vor einer ungewollten 

Schwangerschaft. Um jedoch höchstmögliche Zuverlässigkeit zu erreichen, ist die 

korrekte Anwendung der gewünschten Methode von größter Bedeutung. 

Um die Wirksamkeit zu erhöhen wird die zusätzliche Anwendung eines 

mechanischen Verhütungsmittels empfohlen.

Bitte beachten Sie, dass der Schutz durch Patentex   oval nur eine Stunde anhält!

Wenn Sie weitere Fragen zur Anwendung dieses Arzneimittels haben, wenden Sie 

sich an Ihren Arzt oder Apotheker.

Patentex   oval Schaum-Ovula Gebrauchsinformation

4. WELCHE NEBENWIRKUNGEN SIND MÖGLICH?

Wie alle Arzneimittel kann Patentex   oval Nebenwirkungen haben, die aber nicht bei 

jedem auftreten müssen.

Die Häufigkeit des Auftretens von Nebenwirkungen wird wie folgt eingeteilt:

Sehr häufig

betrifft mehr als 1 Behandelten von 10

Häufig:

betrifft 1 bis 10 Behandelte von 100

Gelegentlich:

betrifft 1 bis 10 Behandelte von 1000

Selten:

betrifft 1 bis 10 Behandelte von 10.000

Sehr selten:

betrifft weniger als 1 Behandelten von 10.000

Nicht bekannt:

Häufigkeit auf Grundlage der verfügbaren 

Daten nicht abschätzbar

Allgemeine Erkrankungen und Beschwerden am Verabreichungsort:

Häufig (betrifft 1 bis 10 von 100 Personen): Wärmegefühl und lokale Reizungen, aber 

auch Trockenheit oder Brennen der Scheide, Wundsein, Ausfluss, sowie auch 

Schmerzen beim Wasserlassen traten auf; beide Partner können betroffen sein. 

Informieren Sie bitte Ihren Arzt oder Apotheker, wenn eine der aufgeführten 

Nebenwirkungen Sie erheblich beeinträchtigt, oder Sie eine Nebenwirkung 

bemerken, die nicht in dieser Gebrauchsinformation angegeben ist.

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

Bundesamt für Sicherheit im Gesundheitswesen

Traisengasse 5

1200 Wien

Fax: + 43 (0) 50 555 36207

Website: http://www.basg.gv.at/

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

mehr Informationen über die Sicherheit dieses Arzneimittels zur Verfügung gestellt 

werden.

5. WIE SIND PATENTEX  OVAL SCHAUM-OVULA AUFZUBEWAHREN?

Nicht über 25°C lagern.

Bewahren Sie dieses Arzneimittel für Kinder unzugänglich auf.

Patentex   oval Schaum-Ovula Gebrauchsinformation

Sie dürfen dieses Arzneimittel nach dem auf dem Umkarton angegebenen 

Verfalldatum nicht mehr anwenden. Das Verfalldatum bezieht sich auf den letzten 

Tag des angegebenen Monats.

6. INHALT DER PACKUNG UND WEITERE INFORMATIONEN

Was Patentex  oval Schaum-Ovula enthalten

Ein Schaum-Ovulum enthält 75 mg Nonoxinol-9.

Die sonstigen Bestandteile sind: 

Polyethylenglycol 1500, Polyethylenglycol 1000, Natriumbicarbonat, Natrium  

Dodecylsulfat, Weinsäure.

Wie Patentex  oval Schaum-Ovula aussehen und Inhalt der Packung

Patentex    oval  sind  weiße  Schaum-Ovula.  Die  Ovula  befinden  sich  in  speziell 

geformten und versiegelten Kunststoffstreifen, wobei ein Streifen 6 Ovula enthält. 

Packungsgrößen: 12 und 24 Stück

Pharmazeutischer Unternehmer und Hersteller:

Pharmazeutischer Unternehmer:

Merz Consumer Care Austria GmbH, Guglgasse 17, 1110 Wien, Tel: 01/8658895-0

Hersteller:

Merz Pharma GmbH & Co.KGaA; Eckenheimer Landstraße 100, D-60318 Frankfurt, 

Deutschland

Zulassungsnummer: 15.906

Diese Packungsbeilage wurde zuletzt überarbeitet im September 2014.

Document Outline

18-9-2018

FDA takes important steps to encourage appropriate and rational prescribing of opioids through final approval of new safety measures governing the use of immediate-release opioid analgesic medications

FDA takes important steps to encourage appropriate and rational prescribing of opioids through final approval of new safety measures governing the use of immediate-release opioid analgesic medications

FDA takes important steps to encourage appropriate and rational prescribing of opioids through final approval of new safety measures governing the use of immediate-release opioid analgesic medications.

FDA - U.S. Food and Drug Administration

14-9-2018

Peer review of the pesticide risk assessment of the active substance azadirachtin (Margosa extract)

Peer review of the pesticide risk assessment of the active substance azadirachtin (Margosa extract)

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Europe - EFSA - European Food Safety Authority Publications

11-9-2018

Novel foods: a risk profile for the house cricket (Acheta domesticus)

Novel foods: a risk profile for the house cricket (Acheta domesticus)

Published on: Tue, 28 Aug 2018 00:00:00 +0200 Novel foods could represent a sustainable alternative to traditional farming and conventional foodstuffs. Starting in 2018, Regulation (EU) 2283/2015 entered into force, laying down provisions for the approval of novel foods in Europe, including insects. This Approved Regulation establishes the requirements that enable Food Business Operators to bring new foods into the EU market, while ensuring high levels of food safety for European consumers. The present ...

Europe - EFSA - European Food Safety Authority Publications

4-9-2018

Outcome of the consultation with Member States and EFSA on the basic substance application for milk for use in plant protection as fungicide

Outcome of the consultation with Member States and EFSA on the basic substance application for milk for use in plant protection as fungicide

Published on: Mon, 03 Sep 2018 00:00:00 +0200 The European Food Safety Authority (EFSA) was asked by the European Commission to provide scientific assistance with respect to the evaluation of applications received by the European Commission concerning basic substances. In this context, EFSA's scientific views on the specific points raised during the commenting phase conducted with Member States and EFSA on the basic substance application for milk are presented. The context of the evaluation was that req...

Europe - EFSA - European Food Safety Authority Publications

29-8-2018

Explanatory note on the determination of newly expressed protein levels in the context of genetically modified plant applications for EU market authorisation

Explanatory note on the determination of newly expressed protein levels in the context of genetically modified plant applications for EU market authorisation

Published on: Mon, 20 Aug 2018 00:00:00 +0200 Genetically modified organisms are subject to a risk assessment and regulatory approval before entering the European market. According to legislation (Directive 2001/18/EC, Regulation (EC) No 1829/2003 and Regulation (EU) No 503/2013) and the EFSA guidance documents on the risk assessment of food and feed from genetically modified (GM) plants and on the environmental risk assessment of GM plants, applicants need to perform a molecular characterisation of any...

Europe - EFSA - European Food Safety Authority Publications

17-8-2018

Temporary Total Artificial Heart Companion 2 Driver System by SynCardia Systems: Letter to Health Care Providers - Risk of Mortality and Stroke

Temporary Total Artificial Heart Companion 2 Driver System by SynCardia Systems: Letter to Health Care Providers - Risk of Mortality and Stroke

FDA has reviewed the final results from the post-approval study conducted by SynCardia Systems, LLC. for their Temporary Total Artificial Heart (TAH-t) Companion 2 Driver System (C2 Driver System). These final results indicate a higher mortality rate and higher stroke rate for patients initially supported with the C2 Driver System compared to patients initially supported with the previous generation driver, the Circulatory Support System (CSS) Console.

FDA - U.S. Food and Drug Administration

10-8-2018

FDA approves first-of-its kind targeted RNA-based therapy to treat a rare disease

FDA approves first-of-its kind targeted RNA-based therapy to treat a rare disease

FDA approves new drug for treatment of polyneuropathy caused by hereditary transthyretin-mediated amyloidosis (hATTR). This is the first FDA-approved treatment for this rare, debilitating and often fatal genetic disease and the first FDA approval of a new class of drugs called small interfering ribonucleic acid (siRNA) treatment.

FDA - U.S. Food and Drug Administration

7-8-2018

FDA’s Center for Veterinary Medicine Announces Second eSubmitter Webinar in Ongoing Series

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On August 22, 2018, FDA-CVM will host the second of a three-part webinar series on using eSubmitter, CVM’s electronic submission tool for the animal drug approval process. Sponsors must use eSubmitter to submit applications as of October 1, 2018.

FDA - U.S. Food and Drug Administration

3-8-2018

Statement from FDA Commissioner Scott Gottlieb, M.D., on new steps the agency is taking to support the development of novel nicotine replacement drug therapies to help smokers quit cigarettes

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FDA releases the first of two draft guidances aimed at supporting the development of novel, inhaled nicotine replacement therapies that could be submitted for approval as new drugs.

FDA - U.S. Food and Drug Administration

23-7-2018

FDA Awards Grants to Fund Studies for Drugs for Minor Uses/Minor Species

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FDA has awarded five grants totaling $650,000 to provide funding for studies to support the approval or conditional approval of three different products, including a cancer drug for dogs.

FDA - U.S. Food and Drug Administration

10-7-2018

FDA takes action to support American military personnel by granting an authorization for freeze-dried plasma product to enable broader access while the agency works toward approval of the product

FDA takes action to support American military personnel by granting an authorization for freeze-dried plasma product to enable broader access while the agency works toward approval of the product

FDA granted an EUA to DOD to enable the emergency use of Pathogen-Reduced Leukocyte-Depleted Freeze-Dried Plasma (referred to as French FDP).

FDA - U.S. Food and Drug Administration

30-5-2018

Procleix West Nile Virus (WNV) Assay

Procleix West Nile Virus (WNV) Assay

Product approval information is indicated for the qualitative detection of West Nile Virus (WNV) RNA in plasma specimens from individual human donors, including volunteer donors of whole blood and blood components, and other living donors.

FDA - U.S. Food and Drug Administration

30-5-2018

FDA approves new treatment for moderately to severely active ulcerative colitis

FDA approves new treatment for moderately to severely active ulcerative colitis

FDA today expanded the approval of Xeljanz (tofacitinib) to include adults with moderately to severely active ulcerative colitis.

FDA - U.S. Food and Drug Administration

29-5-2018

Fälschung des Arzneimittels Sovaldi® 400 mg Filmtabletten (Charge VVDXD) auf den deutschen Markt gelangt

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Pressemitteilung Nr. 11/17

Deutschland - BfArM - Bundesinstitut für Arzneimittel und Medizinprodukte

14-5-2018

FDA Approves Mirataz, a New Animal Drug to Manage Undesired Weight Loss in Cats

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FDA has approved Mirataz (mirtazapine transdermal ointment), a new animal drug to manage undesired weight loss in cats. Mirataz is the first transdermal product to receive FDA approval for use in cats. FDA-approved drugs have been demonstrated to be safe and effective for their intended use.

FDA - U.S. Food and Drug Administration

11-5-2018

FDA expands approval of Gilenya to treat multiple sclerosis in pediatric patients

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FDA approves Gilenya (fingolimod) to treat multiple sclerosis MS in children age 10 and older. This is the first FDA approval of a drug to treat MS in pediatric patients

FDA - U.S. Food and Drug Administration

9-5-2018

FDA seeks permanent injunctions against two stem cell clinics

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FDA - U.S. Food and Drug Administration

3-5-2018

CVM eSubmitter Webinar 1 Agenda

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CVM will host the first of a three-part webinar series to provide information on the use of CVM’s electronic submission tool, eSubmitter, in the new animal drug application approval process. These webinars will support the use of eSubmitter as we move to 100% electronic submission.

FDA - U.S. Food and Drug Administration

3-5-2018

FDA Approves Application for AquaBounty Salmon Facility in Indiana

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FDA approved a supplemental New Animal Drug Application submitted by AquaBounty Technologies, Inc. The supplemental NADA requested FDA approval to raise AquAdvantage Salmon at a land-based contained facility near Albany, Indiana.

FDA - U.S. Food and Drug Administration

1-5-2018

Recent Animal Drug Approvals

Recent Animal Drug Approvals

Animal drug approval information including name, species and indications for use from the last six months.

FDA - U.S. Food and Drug Administration

27-6-2011

Danish Pharmacovigilance Update, 16 June 2011

Danish Pharmacovigilance Update, 16 June 2011

Among the articles in this issue of Danish Pharmacovigilance Update, you can read about the removal of contraindication for Velcade® (bortezomib) used for the treatment of multiple myeloma.

Danish Medicines Agency

14-9-2018

#FDA approves device for treatment of acute coronary artery perforations. Read more about the approval here:  https://go.usa.gov/xPgTA  #MedicalDevice

#FDA approves device for treatment of acute coronary artery perforations. Read more about the approval here: https://go.usa.gov/xPgTA  #MedicalDevice

#FDA approves device for treatment of acute coronary artery perforations. Read more about the approval here: https://go.usa.gov/xPgTA  #MedicalDevice

FDA - U.S. Food and Drug Administration

5-9-2018

#FDA announces draft guidance: Consideration of Uncertainty in Making Benefit-Risk Determinations in #MedicalDevice Premarket Approvals. The document is now open for comment for 90 days. Click the link to review the draft guidance and provide comments:  h

#FDA announces draft guidance: Consideration of Uncertainty in Making Benefit-Risk Determinations in #MedicalDevice Premarket Approvals. The document is now open for comment for 90 days. Click the link to review the draft guidance and provide comments: h

#FDA announces draft guidance: Consideration of Uncertainty in Making Benefit-Risk Determinations in #MedicalDevice Premarket Approvals. The document is now open for comment for 90 days. Click the link to review the draft guidance and provide comments: https://go.usa.gov/xPcpT  pic.twitter.com/hAuLWaIYiK

FDA - U.S. Food and Drug Administration

3-9-2018

Webinar: TGA fast track approval of prescription medicines: Information for health professionals

Webinar: TGA fast track approval of prescription medicines: Information for health professionals

To provide health professionals with information on how new pathways will contribute to providing treatment for patients with serious and life threatening conditions

Therapeutic Goods Administration - Australia

21-8-2018

It’s Contact Lens Health Week and the FDA is working to ensure safe and useful devices are available to patients and consumers. Check out our recent contact lens approvals:  https://go.usa.gov/xUz4M  and https://go.usa.gov/xUz4t  #OnePairTakeCarepic.twitt

It’s Contact Lens Health Week and the FDA is working to ensure safe and useful devices are available to patients and consumers. Check out our recent contact lens approvals: https://go.usa.gov/xUz4M  and https://go.usa.gov/xUz4t  #OnePairTakeCarepic.twitt

It’s Contact Lens Health Week and the FDA is working to ensure safe and useful devices are available to patients and consumers. Check out our recent contact lens approvals: https://go.usa.gov/xUz4M  and https://go.usa.gov/xUz4t  #OnePairTakeCare pic.twitter.com/PcxUGHgwoV

FDA - U.S. Food and Drug Administration

17-8-2018

#FDA issues letter to healthcare providers on the final post-approval study results & risks associated with #SynCardia TAH-t: C2 Driver System.  https://go.usa.gov/xUeYd  #MedicalDevices

#FDA issues letter to healthcare providers on the final post-approval study results & risks associated with #SynCardia TAH-t: C2 Driver System. https://go.usa.gov/xUeYd  #MedicalDevices

#FDA issues letter to healthcare providers on the final post-approval study results & risks associated with #SynCardia TAH-t: C2 Driver System. https://go.usa.gov/xUeYd  #MedicalDevices

FDA - U.S. Food and Drug Administration

6-8-2018

Scientific guideline:  Draft guideline on the use of minimal residual disease as a clinical endpoint in multiple myeloma studies, draft: consultation open

Scientific guideline: Draft guideline on the use of minimal residual disease as a clinical endpoint in multiple myeloma studies, draft: consultation open

The guideline aims to address the use of undetectable minimal residual disease (MRD) as an intermediate efficacy endpoint in controlled randomised clinical studies in patients with multiple myeloma (MM), adequately designed to demonstrate efficacy by relevant hard endpoints. MRD as an endpoint in this context would allow earlier approval of new drugs pending final confirmatory data.

Europe - EMA - European Medicines Agency

2-8-2018

Database of section 19A approvals to import and supply medicines to address medicine shortages

Database of section 19A approvals to import and supply medicines to address medicine shortages

The Section 19A database has been updated to include new approvals

Therapeutic Goods Administration - Australia

27-7-2018

News and press releases:  Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 23-26 July 2018

News and press releases: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 23-26 July 2018

Sixteen medicines recommended for approval, including two orphans

Europe - EMA - European Medicines Agency

10-7-2018

Sovaldi (Gilead Sciences Ireland UC)

Sovaldi (Gilead Sciences Ireland UC)

Sovaldi (Active substance: sofosbuvir) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)4482 of Tue, 10 Jul 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2798/T/51

Europe -DG Health and Food Safety

29-6-2018

News and press releases:  Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 25-28 June 2018

News and press releases: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 25-28 June 2018

Nine medicines recommended for approval, including the first two CAR-T cell therapies in the EU

Europe - EMA - European Medicines Agency

29-6-2018

News and press releases:  First two CAR-T cell medicines recommended for approval in the European Union

News and press releases: First two CAR-T cell medicines recommended for approval in the European Union

Development of Kymriah and Yescarta supported through PRIME

Europe - EMA - European Medicines Agency

22-6-2018

FDA expands approval of hybrid closed loop system for monitoring and delivering insulin to pediatric patients as young as 7. #cgm #diabetes #pediatrics #fdaapproval #medicaldevice  http://go.usa.gov/xUqgQ pic.twitter.com/wZdrU6tTzf

FDA expands approval of hybrid closed loop system for monitoring and delivering insulin to pediatric patients as young as 7. #cgm #diabetes #pediatrics #fdaapproval #medicaldevice http://go.usa.gov/xUqgQ pic.twitter.com/wZdrU6tTzf

FDA expands approval of hybrid closed loop system for monitoring and delivering insulin to pediatric patients as young as 7. #cgm #diabetes #pediatrics #fdaapproval #medicaldevice http://go.usa.gov/xUqgQ  pic.twitter.com/wZdrU6tTzf

FDA - U.S. Food and Drug Administration

1-6-2018

News and press releases:  Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 28-31 May 2018

News and press releases: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 28-31 May 2018

Nine medicines recommended for approval, including two orphans

Europe - EMA - European Medicines Agency

29-5-2018

EU/3/18/2026 (Alnylam UK Limited)

EU/3/18/2026 (Alnylam UK Limited)

EU/3/18/2026 (Active substance: Synthetic double-stranded siRNA oligonucleotide targeted against transthyretin mRNA, with six phosphorothioate linkages in the backbone, and nine 2'-fluoro and thirty-five 2'-O-methyl nucleoside residues in the sequence, which is covalently linked via a phosphodiester group to a ligand containing three N-acetylgalactosamine residues) - Orphan designation - Commission Decision (2018)3394 of Tue, 29 May 2018 European Medicines Agency (EMA) procedure number: EMA/OD/019/18

Europe -DG Health and Food Safety

28-5-2018

News and press releases:  Committee for Medicinal Products for Veterinary Use (CVMP) meeting of 23–25 May 2018

News and press releases: Committee for Medicinal Products for Veterinary Use (CVMP) meeting of 23–25 May 2018

New vaccine to reduce the incidence of intramammary infections in cows/heifers recommended for approval

Europe - EMA - European Medicines Agency

25-5-2018

Therapeutic Goods (Medicines-Listing) Approval of Application Forms and Specification of Office to which Application Must be Delivered

Therapeutic Goods (Medicines-Listing) Approval of Application Forms and Specification of Office to which Application Must be Delivered

I, Larry Kelly, Acting Deputy Secretary, Health Products Regulation Group, a delegate of the Secretary of the Department of Health for the purposes of section 23C of the Therapeutic Goods Act 1989, make the following instrument under paragraphs 23C(2)(a...

Therapeutic Goods Administration - Australia

18-5-2018

Ovaleap (Teva B.V.)

Ovaleap (Teva B.V.)

Ovaleap (Active substance: Follitropin alfa) - Centralised - Renewal - Commission Decision (2018)3154 of Fri, 18 May 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2608/R/23

Europe -DG Health and Food Safety

18-5-2018

EU/3/14/1298 (Genzyme Europe B.V.)

EU/3/14/1298 (Genzyme Europe B.V.)

EU/3/14/1298 (Active substance: Synthetic double-stranded siRNA oligonucleotide directed against antithrombin mRNA and covalently linked to a ligand containing three N-acetylgalactosamine residues) - Transfer of orphan designation - Commission Decision (2018)3148 of Fri, 18 May 2018 European Medicines Agency (EMA) procedure number: EMA/OD/041/14/T/01

Europe -DG Health and Food Safety

18-5-2018

EU/3/14/1297 (Genzyme Europe B.V.)

EU/3/14/1297 (Genzyme Europe B.V.)

EU/3/14/1297 (Active substance: Synthetic double-stranded siRNA oligonucleotide directed against antithrombin mRNA and covalently linked to a ligand containing three N-acetylgalactosamine residues) - Transfer of orphan designation - Commission Decision (2018)3147 of Fri, 18 May 2018 European Medicines Agency (EMA) procedure number: EMA/OD/039/14/T/01

Europe -DG Health and Food Safety

16-5-2018

EU/3/16/1667 (AbbVie Deutschland GmbH and Co. KG)

EU/3/16/1667 (AbbVie Deutschland GmbH and Co. KG)

EU/3/16/1667 (Active substance: Rovalpituzumab tesirine) - Transfer of orphan designation - Commission Decision (2018)3025 of Wed, 16 May 2018 European Medicines Agency (EMA) procedure number: EMA/OD/015/16/T02

Europe -DG Health and Food Safety