AMS SUSTAVI

Glavna informacija

  • Trgovački naziv:
  • AMS SUSTAVI ZA OPERATIVNO LIJEČENJE STRESNE ILI STATIČKE URINARNE INKONTINENCIJE KOD ŽENA
  • Razred:
  • IIb
  • Koristi za:
  • Ljudi
  • Vrsta lijekova:
  • Medicinski uređaj
  • Proizveden od:
  • American Medical Systems Inc., SAD

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:
  • AMS SUSTAVI ZA OPERATIVNO LIJEČENJE STRESNE ILI STATIČKE URINARNE INKONTINENCIJE KOD ŽENA
    Hrvatska
  • Jezik:
  • hrvatski

Terapeutski informacija

  • Terapijska grupa:
  • sustavi za operativno liječenje stresne ili statičke urinarne inkontinencije kod žena

Druge informacije

Status

  • Izvor:
  • HALMED Agencija za lijekove i medicinske proizvode - Agency for medicinal products and medical devices of Croatia
  • Broj odobrenja:
  • 381-13/86-10-02
  • Datum autorizacije:
  • 29-10-2010
  • 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.

10-10-2018

Bazzini LLC Recalls Certain Pistachio Products Because of Possible Health Risk

Bazzini LLC Recalls Certain Pistachio Products Because of Possible Health Risk

BazziniI LLC of Allentown, PA out of an abundance of caution, is recalling 4,000 pounds of Roasted and Salted Colossal Natural, Super Colossal Natural and Rams Head Natural in Shell Pistachios received from one of its suppliers because it has the potential to be contaminated with Salmonella. NO OTHER BAZZINI PISTACHIOS OR BAZZINI PRODUCTS ARE IMPACTED OR PART OF THIS RECALL. The recall is being initiated voluntarily and no illnesses have been reported to date.

FDA - U.S. Food and Drug Administration

17-8-2018

Animal Drug Under Fee Amendments Reauthorized Through September 2023 to Allow for FDA’s Continued Timely Review of Animal Drug Applications

Animal Drug Under Fee Amendments Reauthorized Through September 2023 to Allow for FDA’s Continued Timely Review of Animal Drug Applications

On 8/14/18, the Animal Drug and Animal Generic Drug User Fee Amendments of 2018 was signed into law to reauthorize ADUFA and AGDUFA. These programs help FDA maintain a predictable and timely animal drug review process, foster innovation, and expedite access to new therapies for animals.

FDA - U.S. Food and Drug Administration

19-6-2018

Statement from Douglas Throckmorton, M.D., deputy center director for regulatory programs in FDA’s Center for Drug Evaluation and Research, on the agency’s response to ongoing drug shortages for critical products

Statement from Douglas Throckmorton, M.D., deputy center director for regulatory programs in FDA’s Center for Drug Evaluation and Research, on the agency’s response to ongoing drug shortages for critical products

Statement from Douglas Throckmorton, M.D., deputy center director for regulatory programs in FDA’s Center for Drug Evaluation and Research, on the agency’s response to ongoing drug shortages for critical products

FDA - U.S. Food and Drug Administration

31-5-2018

Statement from FDA Commissioner Scott Gottlieb, M.D., on new policies to reduce the ability of brand drug makers to use REMS programs as a way to block timely generic drug entry, helping promote competition and access

Statement from FDA Commissioner Scott Gottlieb, M.D., on new policies to reduce the ability of brand drug makers to use REMS programs as a way to block timely generic drug entry, helping promote competition and access

FDA Commissioner on new policies to reduce ability of brand drug makers to use REMS programs to block timely generic drug entry

FDA - U.S. Food and Drug Administration

6-4-2017

More batches of EpiPen® are withdrawn

More batches of EpiPen® are withdrawn

MEDA has decided to withdraw four more batches of EpiPen®. The withdrawal concerns two batches of EpiPen® 300 micrograms/dose and two batches of EpiPen® Jr 150 micrograms/dose. The latter is used for acute hypersensitivity reactions in children. The reason for the withdrawal is that there is a risk that the auto-injector does not work.

Danish Medicines Agency

17-3-2017

Withdrawal of a batch of EpiPen® 300 micrograms

Withdrawal of a batch of EpiPen® 300 micrograms

MEDA recalls a batch of the adrenaline product EpiPen® 300 micrograms/dose, which is used for sudden allergic reactions. There is a risk that the auto-injector does not work. The withdrawal concerns product number 578818 with batch number: 5FA665B and expiry date 03/2017.

Danish Medicines Agency

6-11-2018

Samsca (Otsuka Pharmaceutical Netherlands B.V.)

Samsca (Otsuka Pharmaceutical Netherlands B.V.)

Samsca (Active substance: tolvaptan) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)7419 of Tue, 06 Nov 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/980/T/36

Europe -DG Health and Food Safety

31-10-2018

Imraldi (Samsung Bioepis NL B.V.)

Imraldi (Samsung Bioepis NL B.V.)

Imraldi (Active substance: adalimumab) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)7344 of Wed, 31 Oct 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4279/T/15

Europe -DG Health and Food Safety

30-10-2018

#DYK: Mammograms are still the best tool for breast cancer screening.  Check out @US_FDA’s information on the importance of choosing a certified mammography facility:  https://go.usa.gov/xPPpT  #MedicalDevice #BreastCancerAwarenessMonthpic.twitter.com/YaG

#DYK: Mammograms are still the best tool for breast cancer screening. Check out @US_FDA’s information on the importance of choosing a certified mammography facility: https://go.usa.gov/xPPpT  #MedicalDevice #BreastCancerAwarenessMonthpic.twitter.com/YaG

#DYK: Mammograms are still the best tool for breast cancer screening. Check out @US_FDA’s information on the importance of choosing a certified mammography facility: https://go.usa.gov/xPPpT  #MedicalDevice #BreastCancerAwarenessMonth pic.twitter.com/YaGqeGgrTH

FDA - U.S. Food and Drug Administration

24-10-2018

It’s #BreastCancerAwarenessMonth and the @US_FDA is reminding patients and caregivers that thermography is not a substitute for mammograms.pic.twitter.com/XGJFHvut4x

It’s #BreastCancerAwarenessMonth and the @US_FDA is reminding patients and caregivers that thermography is not a substitute for mammograms.pic.twitter.com/XGJFHvut4x

It’s #BreastCancerAwarenessMonth and the @US_FDA is reminding patients and caregivers that thermography is not a substitute for mammograms. pic.twitter.com/XGJFHvut4x

FDA - U.S. Food and Drug Administration

21-10-2018

It’s concerning that many women who qualify for a mammogram don’t go for regular screening, in part due to common myths like mammograms “are painful” or “cause cancer.”  During this Breast Cancer Awareness month, I urge women to check the facts  https://g

It’s concerning that many women who qualify for a mammogram don’t go for regular screening, in part due to common myths like mammograms “are painful” or “cause cancer.” During this Breast Cancer Awareness month, I urge women to check the facts https://g

It’s concerning that many women who qualify for a mammogram don’t go for regular screening, in part due to common myths like mammograms “are painful” or “cause cancer.” During this Breast Cancer Awareness month, I urge women to check the facts https://go.usa.gov/xPnyD . pic.twitter.com/DGz5Xvquky

FDA - U.S. Food and Drug Administration

17-10-2018

Mark Your Calendars: October 21 is Pink Ribbon Sunday! Wear pink to raise awareness about breast cancer and the value of mammograms:   http://go.usa.gov/xPkDE pic.twitter.com/IdHFDQ7dAW

Mark Your Calendars: October 21 is Pink Ribbon Sunday! Wear pink to raise awareness about breast cancer and the value of mammograms: http://go.usa.gov/xPkDE pic.twitter.com/IdHFDQ7dAW

Mark Your Calendars: October 21 is Pink Ribbon Sunday! Wear pink to raise awareness about breast cancer and the value of mammograms: http://go.usa.gov/xPkDE  pic.twitter.com/IdHFDQ7dAW

FDA - U.S. Food and Drug Administration

9-10-2018

Mammograms: Get the Facts.  http://go.usa.gov/xNGH8  #BCAMpic.twitter.com/dBRwahv5RW

Mammograms: Get the Facts. http://go.usa.gov/xNGH8  #BCAMpic.twitter.com/dBRwahv5RW

Mammograms: Get the Facts. http://go.usa.gov/xNGH8  #BCAM pic.twitter.com/dBRwahv5RW

FDA - U.S. Food and Drug Administration

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

13-8-2018

Today is Day 1 of the Pediatric Medical Device Development Public Meeting. Today we will discuss the programs, policies, and procedures at the #FDA intended to streamline evidence generation.  https://go.usa.gov/xU6rg 
#devices4kids #Pediatricspic.twitter

Today is Day 1 of the Pediatric Medical Device Development Public Meeting. Today we will discuss the programs, policies, and procedures at the #FDA intended to streamline evidence generation. https://go.usa.gov/xU6rg  #devices4kids #Pediatricspic.twitter

Today is Day 1 of the Pediatric Medical Device Development Public Meeting. Today we will discuss the programs, policies, and procedures at the #FDA intended to streamline evidence generation. https://go.usa.gov/xU6rg  #devices4kids #Pediatrics pic.twitter.com/3tXTgwPJPo

FDA - U.S. Food and Drug Administration

3-7-2018

Samsca (Otsuka Pharmaceutical Europe Ltd)

Samsca (Otsuka Pharmaceutical Europe Ltd)

Samsca (Active substance: tolvaptan) - Centralised - 2-Monthly update - Commission Decision (2018) 4250 of Tue, 03 Jul 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/980/II/31

Europe -DG Health and Food Safety

15-5-2018

Flixabi (Samsung Bioepis UK Limited)

Flixabi (Samsung Bioepis UK Limited)

Flixabi (Active substance: infliximab) - Centralised - Yearly update - Commission Decision (2018)3056 of Tue, 15 May 2018

Europe -DG Health and Food Safety