BAYER BREEZE

Glavna informacija

  • Trgovački naziv:
  • BAYER BREEZE
  • Razred:
  • In vitro dijagnostika - dodatak II, lista B
  • Koristi za:
  • Ljudi
  • Vrsta lijekova:
  • Medicinski uređaj
  • Proizveden od:
  • Bayer Consumer Care AG, Švicarska

Dokument

  • za javnost:
  • Informativni letak za ovaj proizvod trenutno nije dostupan, možete poslati zahtjev na našu službu za korisnike, a mi ćemo vas obavijestiti čim smo u mogućnosti da ga dobiju.


    Zatražite informativni letak za javnost.

Lokalizacija

  • Na raspolaganju u:
  • BAYER BREEZE
    Hrvatska
  • Jezik:
  • hrvatski

Terapeutski informacija

  • Terapijska grupa:
  • uređaj za kontrolu razine šećera u perifernoj krvi

Druge informacije

Status

  • Izvor:
  • HALMED Agencija za lijekove i medicinske proizvode - Agency for medicinal products and medical devices of Croatia
  • Broj odobrenja:
  • 381-09-25309
  • Datum autorizacije:
  • 28-10-2009
  • Zadnje ažuriranje:
  • 05-06-2018
  • Informativni letak za ovaj proizvod trenutno nije dostupan, možete poslati zahtjev na našu službu za korisnike, a mi ćemo vas obavijestiti čim smo u mogućnosti da ga dobiju.

    Zatražite informativni letak za javnost.

15-11-2018

Assessment of genetically modified LLCotton25 for renewal of authorisation under Regulation (EC) No 1829/2003 (application EFSA‐GMO‐RX‐010)

Assessment of genetically modified LLCotton25 for renewal of authorisation under Regulation (EC) No 1829/2003 (application EFSA‐GMO‐RX‐010)

Published on: Wed, 14 Nov 2018 Following the submission of application EFSA‐GMO‐RX‐010 under Regulation (EC) No 1829/2003 from Bayer, the Panel on Genetically Modified Organisms of the European Food Safety Authority (GMO Panel) was asked to deliver a scientific risk assessment on the data submitted in the context of the renewal of authorisation application for the herbicide‐tolerant genetically modified LLCotton25, for food and feed uses, import and processing, excluding cultivation within the EU. The d...

Europe - EFSA - European Food Safety Authority Publications

21-9-2018

Modification of the existing maximum residue level for clothianidin in potatoes

Modification of the existing maximum residue level for clothianidin in potatoes

Published on: Thu, 20 Sep 2018 00:00:00 +0200 In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant Bayer CropScience AG submitted a request to the competent national authority in Germany to modify the existing maximum residue level (MRL) for the active substance clothianidin to accommodate the use on potatoes imported from Canada. The data submitted in support of the request were found to be sufficient to derive a MRL proposal. Adequate analytical methods for enforcement are availa...

Europe - EFSA - European Food Safety Authority Publications

17-8-2018

Seabreeze International Corp. recalls certain Smart ThermafloTM Heaters

Seabreeze International Corp. recalls certain Smart ThermafloTM Heaters

In the event of a fault, the safety cut-offs may not operate and allow the heater to rapidly overheat, posing a fire hazard.

Health Canada

3-8-2018

HP Hood LLC Recalls Select Units of Half-Gallon Refrigerated Vanilla Almond Breeze Almond Milk due to Possible Milk Allergen

HP Hood LLC Recalls Select Units of Half-Gallon Refrigerated Vanilla Almond Breeze Almond Milk due to Possible Milk Allergen

HP Hood LLC is voluntarily recalling a limited number of half-gallon (1.89 L) cartons of refrigerated Vanilla Almond Breeze almond milk because the product may contain milk, an allergen not listed on the label. People who have an allergy or severe sensitivity to milk run the risk of serious or life-threatening allergic reaction if they consume these products. The product is safe to consume unless you have a milk allergy or sensitivity. To date, there has been one report of an allergic reaction. Medical ...

FDA - U.S. Food and Drug Administration

28-8-2018

EU/3/18/2064 (Bayer AG)

EU/3/18/2064 (Bayer AG)

EU/3/18/2064 (Active substance: Copanlisib) - Orphan designation - Commission Decision (2018)5734 of Tue, 28 Aug 2018 European Medicines Agency (EMA) procedure number: EMA/OD/071/18

Europe -DG Health and Food Safety

23-8-2018

EU/3/18/1979 (Bayer AG)

EU/3/18/1979 (Bayer AG)

EU/3/18/1979 (Active substance: Human monoclonal IgG2 antibody against tissue factor pathway inhibitor) - Corrigendum - Commission Decision (2018)1246 of Thu, 23 Aug 2018

Europe -DG Health and Food Safety

1-8-2018

Eylea (Bayer AG)

Eylea (Bayer AG)

Eylea (Active substance: aflibercept) - Centralised - 2-Monthly update - Commission Decision (2018)5222 of Wed, 01 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2392/II/45

Europe -DG Health and Food Safety

22-7-2018

Even when Essure is no longer sold, the #FDA will remain vigilant in protecting patients who’ve already had this device implanted. We’ll continue to monitor adverse events and publicly communicate any new safety findings on this - and any other device. ht

Even when Essure is no longer sold, the #FDA will remain vigilant in protecting patients who’ve already had this device implanted. We’ll continue to monitor adverse events and publicly communicate any new safety findings on this - and any other device. ht

Even when Essure is no longer sold, the #FDA will remain vigilant in protecting patients who’ve already had this device implanted. We’ll continue to monitor adverse events and publicly communicate any new safety findings on this - and any other device. https://www.bloomberg.com/news/articles/2018-07-20/bayer-to-stop-selling-contraceptive-implant-after-threats-by-fda …

FDA - U.S. Food and Drug Administration

22-7-2018

On Friday, Bayer said the permanent birth control device Essure would no longer be sold or distributed in the US for commercial reasons after 12/31/18. This came after FDA’s patient safety action in April restricting sale and distribution of the device an

On Friday, Bayer said the permanent birth control device Essure would no longer be sold or distributed in the US for commercial reasons after 12/31/18. This came after FDA’s patient safety action in April restricting sale and distribution of the device an

On Friday, Bayer said the permanent birth control device Essure would no longer be sold or distributed in the US for commercial reasons after 12/31/18. This came after FDA’s patient safety action in April restricting sale and distribution of the device and earlier agency actions

FDA - U.S. Food and Drug Administration

20-7-2018

Bayer to stop #Essure sales in the U.S.  https://go.usa.gov/xUnaA  #MedicalDevice

Bayer to stop #Essure sales in the U.S. https://go.usa.gov/xUnaA  #MedicalDevice

Bayer to stop #Essure sales in the U.S. https://go.usa.gov/xUnaA  #MedicalDevice

FDA - U.S. Food and Drug Administration

16-7-2018

Procox (Bayer Animal Health GmbH)

Procox (Bayer Animal Health GmbH)

Procox (Active substance: emodepside and toltrazuril) - Centralised - Yearly update - Commission Decision (2018)4753 of Mon, 16 Jul 2018

Europe -DG Health and Food Safety

11-7-2018

Betaferon (Bayer AG)

Betaferon (Bayer AG)

Betaferon (Active substance: Interferon beta-1b) - Centralised - Yearly update - Commission Decision (2018)4527 of Wed, 11 Jul 2018

Europe -DG Health and Food Safety

27-6-2018

EU/3/18/1995 (Bayer AG)

EU/3/18/1995 (Bayer AG)

EU/3/18/1995 (Active substance: Larotrectinib) - Transfer of orphan designation - Commission Decision (2018)4092 of Wed, 27 Jun 2018 European Medicines Agency (EMA) procedure number: EMA/OD/213/17/T/01

Europe -DG Health and Food Safety

27-6-2018

EU/3/15/1606 (Bayer AG)

EU/3/15/1606 (Bayer AG)

EU/3/15/1606 (Active substance: (S)-N-(5-((R)-2-(2,5-difluorophenyl)pyrrolidin-1-yl)pyrazolo[1,5-a]pyrimidin-3-yl)-3-hydroxypyrrolidine-1-carboxamide hydrogen sulfate) - Transfer of orphan designation - Commission Decision (2018)4094 of Wed, 27 Jun 2018 European Medicines Agency (EMA) procedure number: EMA/OD/184/15/T/02

Europe -DG Health and Food Safety

25-6-2018

Xofigo (Bayer AG)

Xofigo (Bayer AG)

Xofigo (Active substance: Radium Ra 223 dichloride) - Centralised - Renewal - Commission Decision (2018)4018 of Mon, 25 Jun 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2653/R/30

Europe -DG Health and Food Safety

13-6-2018

Veraflox (Bayer Animal Health GmbH)

Veraflox (Bayer Animal Health GmbH)

Veraflox (Active substance: Pradofloxacin) - Centralised - Yearly update - Commission Decision (2018)3834 of Wed, 13 Jun 2018

Europe -DG Health and Food Safety

29-5-2018

Profender (Bayer Animal Health GmbH)

Profender (Bayer Animal Health GmbH)

Profender (Active substance: Emodepside / Praziquantel) - Centralised - Yearly update - Commission Decision (2018)3405 of Tue, 29 May 2018

Europe -DG Health and Food Safety

24-5-2018

Stivarga (Bayer AG)

Stivarga (Bayer AG)

Stivarga (Active substance: regorafenib) - Centralised - Renewal - Commission Decision (2018)3266 of Thu, 24 May 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2573/R/25

Europe -DG Health and Food Safety

24-5-2018

Xarelto (Bayer AG)

Xarelto (Bayer AG)

Xarelto (Active substance: rivaroxaban) - Centralised - Renewal - Commission Decision (2018)3264 of Thu, 24 May 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/944/R/60

Europe -DG Health and Food Safety