ENSURE PLUS ADVANCE JAHODOVÁ PŘÍCHUŤ

Základní informace

  • Název přípravku:
  • ENSURE PLUS ADVANCE JAHODOVÁ PŘÍCHUŤ Perorální roztok
  • Léková forma:
  • Perorální roztok
  • Podání:
  • Perorální podání
  • Jednotky v balení:
  • 4X220ML Lahev
  • Použij pro:
  • Lidé
  • Léčitelství typu:
  • alopatický drog

Dokumenty

Lokalizace

  • K dispozici v:
  • ENSURE PLUS ADVANCE JAHODOVÁ PŘÍCHUŤ Perorální roztok
    Česká republika
  • Jazyk:
  • čeština

Terapeutická informace

  • Terapeutické oblasti:
  • POTRAVINY PRO ZVLÁŠTNÍ LÉKAŘSKÉ ÚČELY (PZLÚ)
  • Přehled produktů:
  • ENSURE PLUS ADVANCE JAHODOVÁ PŘÍCHUŤ

Další informace

Stav

  • Zdroj:
  • SUKL - Státní ústav pro kontrolu léčiv
  • Poslední aktualizace:
  • 22-06-2017

Příbalovou informaci pro pacienta

165-041-000

S757

Abbott2016

ENSURE PLUS ADVANCE

Jahodová příchuť

Potravina pro zvláštní lékařské účely

1,5 kcal/ml

1,5g CaHMB

330kcal

20g bílkovin

13mcg vitamínu D

Ve 220ml

Kompletní vyvážená výživa, speciálně připravená tak, aby splňovala požadavky na výživu

starších dospělých jedinců. Dietní potravina pro zvláštní lékařské účely.

e4x220ml

Určeno k dietnímu postupu u dospělých s podvýživou a/nebo při ztrátou svalové hmoty, síly

a funkčnosti.

Ensure Plus Advance je vysoce kalorická, kompletní a vyvážená perorální výživa bohatá na

bílkoviny a vitamín D s obsahem FOS* a CaHMB**. Návod k použití: Připraveno k použití.

Před otevřením dobře protřepejte. Po otevření výrobek uzavřete, uchovávejte v chladničce a

spotřebujte do 24hodin. Neotevřenou výživu uchovávejte při pokojové teplotě.

Důležité upozornění: Ensure Plus Advance je doplňkový zdroj výživy. Používejte na základě

doporučení lékaře nebo osoby kvalifikované v oblasti výživy lidí, farmacie nebo péče o matku

a dítě. Není určeno pro děti, pokud to nedoporučí lékař nebo osoba kvalifikovaná v oblasti

výživy. Neužívat při galaktosémii. Není určeno k parenterálnímu použití. Bez lepku.

Doporučené dávkování: 2 balení denně.

Složení: voda, hydrolyzovaný kukuřičný škrob, mléčné bílkoviny, sacharóza, rostlinný olej

(řepkový,

kukuřičný),

izolovaná

sójová

bílkovina,

FOS*,

minerály

(citronan

draselný,

fosforečnan vápenatý, citronan sodný, uhličitan hořečnatý, chlorid draselný, síran železnatý,

síran zinečnatý, síran manganatý, síran měďnatý, molybdenan sodný, jodid draselný, chlorid

chromitý, selenan sodný), CaHMB**, aroma, emulgátor: sójový lecitin, stabilizátory (E460,

E466,

E418),

cholin-chlorid,

regulátor

kyselosti:

E525,

vitamíny

nikotinamid,

pantothenan vápenatý, beta-karoten, B

, vit. A palmitát, kyselina listová, K

biotin, B

), L-karnitin, barvivo: E120.

*Fruktooligosacharidy.

**Monohydrát beta-hydroxy-beta-metylbutyrátu vápenatého.

Minimální trvanlivost do konce:

Balené v ochranné atmosféře.

Vyrobeno v EU.

CZ: Abbott Laboratories, s.r.o., Hadovka Office Park, Evropská 2591/33d, 160 00 Praha 6,

Česká republika

165-041-000

S757

Abbott2016

Informace o výživové hodnotě

Jednotka

ve 100 ml

ve 220 ml

Energetická hodnota

kcal

631/150

1388/330

Tuky

4,80

10,56

Nasycené mastné kyseliny

0,45

0,99

Sacharidy

16,80

36,96

Cukry

15,0

Vláknina (FOS*)

0,75

1,65

Bílkoviny

9,10

20,02

Sůl

0,38

0,83

0,55

1,21

Karnitin

Cholin

Vitamín A (palmitát)

mcg RE

Vitamín A (beta-karoten)

mcg RE

Vitamín D

12,5

Vitamín E

mg α-TE

Vitamín K

Vitamín C

Kyselina listová

Vitamín B

0,26

0,57

Vitamín B

0,32

0,70

Vitamín B

0,30

0,66

Vitamín B

0,65

1,43

Niacin

mg NE

Kyselina pantothenová

Biotin

13,2

Sodík

Draslík

Chlór

Vápník

Fosfor

Hořčík

Železo

Zinek

1,75

3,85

Mangan

0,45

0,99

Měď

Jód

Selen

19,8

Chrom

18,7

Molybden

Osmolarita

557 mOsm/l

EAN 8710428008046

165-041-000

S757

Abbott2016

ENSURE PLUS ADVANCE

Jahodová příchuť

1 lahvička 220ml

samostatně neprodejné

1,5 kcal/ml

1,5g CaHMB

330kcal

20g bílkovin

13mcg vitamínu D

Ve 220ml

Kompletní vyvážená strava, speciálně připravená tak, aby splňovala požadavky na výživu

starších dospělých jedinců.

Dietní potravina pro zvláštní lékařské účely. Určeno k dietnímu postupu u dospělých s

podvýživou a/nebo při ztrátou svalové hmoty, síly a funkčnosti.

Ensure Plus Advance je vysoce kalorická, kompletní a vyvážená perorální výživa bohatá na

bílkoviny a vitamín D s obsahem FOS* a CaHMB**.

Další informace naleznete na vnějším obalu. Samostatně neprodejné. Obsahuje mléko a sóju.

EAN 8710428008039

12-10-2018

FDA advances investigation into whether more than 40 e-cigarette products are being illegally marketed and outside agency's compliance policy

FDA advances investigation into whether more than 40 e-cigarette products are being illegally marketed and outside agency's compliance policy

FDA advances investigation into whether more than 40 e-cigarette products are being illegally marketed and outside agency's compliance policy

FDA - U.S. Food and Drug Administration

9-10-2018

Statement from FDA Commissioner Scott Gottlieb, M.D., on new efforts to advance the development of generic copies of complex drugs to improve patient access to medicines

Statement from FDA Commissioner Scott Gottlieb, M.D., on new efforts to advance the development of generic copies of complex drugs to improve patient access to medicines

FDA issued a new series of guidance documents that will advance the development of generic transdermal and topical delivery systems

FDA - U.S. Food and Drug Administration

28-9-2018

FDA approves first treatment for advanced form of the second most common skin cancer

FDA approves first treatment for advanced form of the second most common skin cancer

FDA approves Libtayo (cemiplimab-rwlc) for the treatment of patients with metastatic cutaneous squamous cell carcinoma (CSCC) or locally advanced CSCC who are not candidates for curative surgery or curative radiation. This is the first FDA approval of a drug specifically for advanced CSCC.

FDA - U.S. Food and Drug Administration

25-9-2018

Daiso Holdings Ltd. recalls Daiso Brand Consumer Chemical Products

Daiso Holdings Ltd. recalls Daiso Brand Consumer Chemical Products

The recalled products have not been properly classified according to the Consumer Chemicals and Containers Regulations, 2001, in order to ensure appropriate hazard labelling. These regulations are empowered by the Canada Consumer Product Safety Act. Improper labelling could result in unintentional exposure to these products and lead to serious illness, injury or death.

Health Canada

24-9-2018

FDA awards 12 grants to fund new clinical trials to advance the development of medical products for the treatment of rare diseases

FDA awards 12 grants to fund new clinical trials to advance the development of medical products for the treatment of rare diseases

FDA has awarded 12 new clinical trial research grants to enhance the development of medical products for patients with rare diseases

FDA - U.S. Food and Drug Administration

12-9-2018

FDA awards five grants to advance the development of pediatric medical devices

FDA awards five grants to advance the development of pediatric medical devices

FDA has awarded grants to five Pediatric Device Consortia that will provide advice to innovators of children's medical devices

FDA - U.S. Food and Drug Administration

11-9-2018

Assessment of occupational and dietary exposure to pesticide residues

Assessment of occupational and dietary exposure to pesticide residues

Published on: Mon, 27 Aug 2018 00:00:00 +0200 Plant protection products (PPPs) are pesticides containing at least one active substance that drives specific actions against pests (diseases). PPPs are regulated in the EU and cannot be placed on the market or used without prior authorisation. EFSA assesses the possible risks of the use of active substances to humans and environment. Member States decide whether or not to approve their use at EU level. Furthermore, Member States decide at national level on ...

Europe - EFSA - European Food Safety Authority Publications

7-9-2018

Statement from FDA Commissioner Scott Gottlieb, M.D., on new steps to help ensure the quality of and preserve access to compounded drugs by pursuing closer collaboration with states

Statement from FDA Commissioner Scott Gottlieb, M.D., on new steps to help ensure the quality of and preserve access to compounded drugs by pursuing closer collaboration with states

FDA announces revised draft memorandum of understanding between FDA and the states to help ensure the quality of and preserve access to compounded drugs

FDA - U.S. Food and Drug Administration

5-9-2018

Statement from FDA Commissioner Scott Gottlieb, M.D., on the agency’s global efforts to help assure product quality and transparency at foreign drug manufacturing facilities

Statement from FDA Commissioner Scott Gottlieb, M.D., on the agency’s global efforts to help assure product quality and transparency at foreign drug manufacturing facilities

FDA is publishing its internal policy for how manufacturing facilities are prioritized and scheduled for surveillance inspections in an effort to ensure the quality and safety of globally produced products.

FDA - U.S. Food and Drug Administration

30-8-2018

Grant agreement for piloting the Framework Partnership Agreement between the National data provider organisations in Cyprus and EFSA – Final report

Grant agreement for piloting the Framework Partnership Agreement between the National data provider organisations in Cyprus and EFSA – Final report

Published on: Tue, 07 Aug 2018 00:00:00 +0200 Cyprus alongside with another 4 countries has participated successfully in the Grant Agreement GP/EFSA/DATA/2016/01‐GA 02, entitled: “Strategic Partnership with Cyprus on Data Quality”. The project was co‐financed by EFSA, aiming to help both EFSA and data providers from Member States to possess data of high quality in a quantitatively manageable way. The main objective of the grant agreement was the establishment of the data governance, coordination and imp...

Europe - EFSA - European Food Safety Authority Publications

30-8-2018

Grant agreement for piloting the Framework Partnership Agreement between the National data provider organisations in Denmark and EFSA – Final report

Grant agreement for piloting the Framework Partnership Agreement between the National data provider organisations in Denmark and EFSA – Final report

Published on: Tue, 07 Aug 2018 00:00:00 +0200 During the project seven standard operating procedures (SOP) were developed for the four data domains (zoonoses, chemical contaminant, pesticide residues and veterinary medical products residues). The SOPs describe 1) How the national governance of risk assessment data is organised, 2) how data are collected and validated before delivering to EFSA covering all four domains, 3) How data is transferred to EFSA, 4) how to respond to EFSA request for clarificati...

Europe - EFSA - European Food Safety Authority Publications

29-8-2018

Safety assessment of the process ‘General Plastic’, based on Starlinger Decon technology, used to recycle post‐consumer PET into food contact materials

Safety assessment of the process ‘General Plastic’, based on Starlinger Decon technology, used to recycle post‐consumer PET into food contact materials

Published on: Fri, 10 Aug 2018 00:00:00 +0200 This scientific opinion of the EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF Panel) deals with the safety evaluation of the recycling process General Plastic (EU register No RECYC153), which is based on the Starlinger Decon technology. The decontamination efficiency of the process was demonstrated by a challenge test. The input of this process is hot caustic washed and dried poly(ethylene terephthalate) (PET) flakes orig...

Europe - EFSA - European Food Safety Authority Publications

22-8-2018

Statement by FDA Commissioner Scott Gottlieb, M.D., on new steps to advance the development of evidence-based, indication-specific guidelines to help guide appropriate prescribing of opioid analgesics

Statement by FDA Commissioner Scott Gottlieb, M.D., on new steps to advance the development of evidence-based, indication-specific guidelines to help guide appropriate prescribing of opioid analgesics

FDA awarded a contract to the National Academies of Sciences, Engineering, and Medicine to advance the development of evidence-based, indication-specific guidelines to help guide appropriate opioid prescribing.

FDA - U.S. Food and Drug Administration

31-7-2018

Statement from FDA Commissioner Scott Gottlieb, M.D., on FDA’s new efforts to advance antimicrobial stewardship in veterinary settings

Statement from FDA Commissioner Scott Gottlieb, M.D., on FDA’s new efforts to advance antimicrobial stewardship in veterinary settings

Statement from FDA Commissioner Scott Gottlieb, M.D., on FDA’s new efforts to advance antimicrobial stewardship in veterinary settings

FDA - U.S. Food and Drug Administration

23-7-2018

FDA continues taking key actions on bulk drug substances used for compounding to advance the regulatory framework governing compounded drugs and to protect patients

FDA continues taking key actions on bulk drug substances used for compounding to advance the regulatory framework governing compounded drugs and to protect patients

FDA continues making progress on bulk drug substances for compounding

FDA - U.S. Food and Drug Administration

17-7-2018

ALDI Voluntarily Recalls AnnaSea Wasabi Ahi Poke Hawaiian Poke Kits and Limu Ahi Poke Hawaiian Poke Kits Due to Storage at Incorrect Temperature in Area Store

ALDI Voluntarily Recalls AnnaSea Wasabi Ahi Poke Hawaiian Poke Kits and Limu Ahi Poke Hawaiian Poke Kits Due to Storage at Incorrect Temperature in Area Store

Batavia, Ill. Uuly 14, 2018) -ALDI has voluntarily recalled AnnaSea Wasabi Ahi Poke Hawaiian Poke Kits and Limu Ahi Poke Hawaiian Poke Kits sold at one retail store location in North Carolina. While the products are required to remain at frozen temperatures to ensure safety, this store location displayed and sold the products from the cooler section. Because storing the products at temperatures above freezing prior to consumption can render the products unsafe for consumption, ALDI is recalling these items.

FDA - U.S. Food and Drug Administration

12-7-2018

Statement by FDA Commissioner Scott Gottlieb, M.D., on formation of a new drug shortages task force and FDA’s efforts to advance long-term solutions to prevent shortages

Statement by FDA Commissioner Scott Gottlieb, M.D., on formation of a new drug shortages task force and FDA’s efforts to advance long-term solutions to prevent shortages

FDA Commissioner Scott Gottlieb, M.D., on new drug shortages task force and work towards long-term solutions to prevent shortages

FDA - U.S. Food and Drug Administration

12-7-2018

FDA expands its support for states to advance implementation of produce safety activities

FDA expands its support for states to advance implementation of produce safety activities

FDA expands its support for states to advance implementation of produce safety activities

FDA - U.S. Food and Drug Administration

11-7-2018

Statement from FDA Commissioner Scott Gottlieb, M.D. on agency’s efforts to advance development of gene therapies

Statement from FDA Commissioner Scott Gottlieb, M.D. on agency’s efforts to advance development of gene therapies

Statement from FDA Commissioner Scott Gottlieb, M.D. on agency’s efforts to advance development of gene therapies, including three disease specific draft guidances

FDA - U.S. Food and Drug Administration

28-6-2018

Statement from FDA Commissioner Scott Gottlieb, M.D., on developments in the romaine outbreak investigation, recent outbreaks and the use of modern tools to advance food safety

Statement from FDA Commissioner Scott Gottlieb, M.D., on developments in the romaine outbreak investigation, recent outbreaks and the use of modern tools to advance food safety

Being able to identify outbreaks is key to being able to take quick action to prevent additional illnesses and find the source of the contamination. In recent years, the FDA and the Centers for Disease Control and Prevention (CDC) have advanced new tools that make it easier and faster to identify outbreaks of human illness and to link them back to the food source that is the culprit responsible for the illnesses. But our improved ability to spot outbreaks has also caused some to question whether we are e...

FDA - U.S. Food and Drug Administration

28-6-2018

Ambient air quality: ANSES recommends the surveillance of 1,3-butadiene and the enhanced monitoring of ultrafine particles (UFPs) and carbon black

Ambient air quality: ANSES recommends the surveillance of 1,3-butadiene and the enhanced monitoring of ultrafine particles (UFPs) and carbon black

The European monitoring strategy for air quality relies heavily on quality standards for a number of pollutants. Advances in knowledge on the toxicity of substances and their emissions in the atmosphere have shown that certain pollutants that may have an impact on human health are not currently taken into account in regulatory monitoring. ANSES therefore received a formal request from the Ministries of Ecology and Health to propose a list of new priority pollutants for this air quality monitoring to supp...

France - Agence Nationale du Médicament Vétérinaire

26-6-2018

Statement from FDA Commissioner Scott Gottlieb, M.D., on FDA’s new steps to advance health through improvements in nutrition under the agency’s Nutrition Innovation Strategy

Statement from FDA Commissioner Scott Gottlieb, M.D., on FDA’s new steps to advance health through improvements in nutrition under the agency’s Nutrition Innovation Strategy

Announcement of public meeting to solicit input on plans to modernize food standards and labeling

FDA - U.S. Food and Drug Administration

12-6-2018

Statement from FDA Commissioner Scott Gottlieb, M.D., on new agency efforts to advance the patient voice in medical product development and FDA regulatory decision-making

Statement from FDA Commissioner Scott Gottlieb, M.D., on new agency efforts to advance the patient voice in medical product development and FDA regulatory decision-making

FDA issues draft guidance on collecting patient experiences to inform the development and evaluation of medical products

FDA - U.S. Food and Drug Administration

12-6-2018

Statement from FDA Commissioner Scott Gottlieb, M.D., on new efforts to advance medical product communications to support drug competition and value-based health care

Statement from FDA Commissioner Scott Gottlieb, M.D., on new efforts to advance medical product communications to support drug competition and value-based health care

Statement from FDA Commissioner Scott Gottlieb, M.D., on new efforts to advance medical product communications to support drug competition and value-based health care

FDA - U.S. Food and Drug Administration

5-6-2018

FDA and USDA announce key step to advance collaborative efforts to streamline produce safety requirements for farmers

FDA and USDA announce key step to advance collaborative efforts to streamline produce safety requirements for farmers

FDA and USDA announce key step to advance collaborative efforts to streamline produce safety requirements for farmers by aligning USDA program with FDA’s Produce Safety Rule requirements.

FDA - U.S. Food and Drug Administration

22-5-2018

Statement from FDA Commissioner Scott Gottlieb, M.D., on new FDA actions to keep consumers safe from the harmful effects of sun exposure, and ensure the long-term safety and benefits of sunscreens

Statement from FDA Commissioner Scott Gottlieb, M.D., on new FDA actions to keep consumers safe from the harmful effects of sun exposure, and ensure the long-term safety and benefits of sunscreens

The FDA is announcing three new efforts as part of a comprehensive set of actions to advance the FDA’s framework for sun protection products ahead of this coming summer

FDA - U.S. Food and Drug Administration

17-5-2018

Intent to submit a marketing authorisation application for a veterinary medicinal product using the decentralised procedure with France as a Reference Member State (RMS).

Intent to submit a marketing authorisation application for a veterinary medicinal product using the decentralised procedure with France as a Reference Member State (RMS).

An applicant intending to submit a marketing authorisation application for a veterinary medicinal product using the decentralised procedure with France acting as RMS has to inform the Anses-ANMV at least 2 months in advance.

France - Agence Nationale du Médicament Vétérinaire

15-5-2018

Nonprescription Drugs Advisory Committee

Nonprescription Drugs Advisory Committee

he Nonprescription Drugs Advisory Committee advises the Commissioner or designee in discharging responsibilities as they relate to helping to ensure safe and effective drugs for human use and, as required, any other product for which the Food and Drug Administration has regulatory responsibility.

FDA - U.S. Food and Drug Administration

9-5-2018

SLIM BODY Advanced capsules

SLIM BODY Advanced capsules

Safety advisory

Therapeutic Goods Administration - Australia

2-6-2017

Additional Risk Minimisation Measures (aRMM)

Additional Risk Minimisation Measures (aRMM)

From 1 June 2017 IMA will take seven days to ensure that all relevant documents are enclosed in an application for aRMM evaluation. This is done to facilitate IMAs review of the material.

IMA - Icelandic Medicines Agency

18-12-2006

Reassessment of reimbursement status

Reassessment of reimbursement status

This summer, the Danish Medicines Agency will begin the periodic reassessment of reimbursement status of medicinal products. Over a 5-year period, the reimbursement status of all medicinal products will be reassessed to ensure that the medicinal products having been granted general reimbursement still meet the required criteria and that medicinal products which have not been granted general reimbursement do not meet the criteria.

Danish Medicines Agency

27-9-2018

Read about how the FDA is seeking more resources in FY2019 to help  advance our #FDAPrecert model for #DigitalHealth-modernizing our regulatory approach to help innovate digital health technologies, while  protecting patients. Click here:  https://go.usa.

Read about how the FDA is seeking more resources in FY2019 to help advance our #FDAPrecert model for #DigitalHealth-modernizing our regulatory approach to help innovate digital health technologies, while protecting patients. Click here: https://go.usa.

Read about how the FDA is seeking more resources in FY2019 to help advance our #FDAPrecert model for #DigitalHealth-modernizing our regulatory approach to help innovate digital health technologies, while protecting patients. Click here: https://go.usa.gov/xPWZ3  #mobilehealth

FDA - U.S. Food and Drug Administration

24-9-2018

News and press releases:  Companies stepping up efforts to ensure medicine supply post Brexit

News and press releases: Companies stepping up efforts to ensure medicine supply post Brexit

Focus is now on 39 centrally authorised medicines, down from 108

Europe - EMA - European Medicines Agency

17-9-2018

 European Medicines Agency (EMA) Human Scientific Committees' Working Party with Healthcare Professionals’ Organisations (HCPWP), European Medicines Agency, London, UK, From: 26-Sep-2018, To: 26-Sep-2018

European Medicines Agency (EMA) Human Scientific Committees' Working Party with Healthcare Professionals’ Organisations (HCPWP), European Medicines Agency, London, UK, From: 26-Sep-2018, To: 26-Sep-2018

This Healthcare Professionals' Working Party (HCPWP) plenary meeting will include discussions on advances in clinical practice and the scientific and regulatory challenges. Members will also be invited to present how they are including regulatory sciences in fellowships and young researchers’ training. Feedback will be given from the representatives of the Scientific Committees.

Europe - EMA - European Medicines Agency

14-9-2018

#FDA awards five grants to advance the development of pediatric medical devices. Click the link to read more about the grants and the FDA's work to advance the development of pediatric #MedicalDevices:  http://go.usa.gov/xPg2A 

#FDA awards five grants to advance the development of pediatric medical devices. Click the link to read more about the grants and the FDA's work to advance the development of pediatric #MedicalDevices: http://go.usa.gov/xPg2A 

#FDA awards five grants to advance the development of pediatric medical devices. Click the link to read more about the grants and the FDA's work to advance the development of pediatric #MedicalDevices: http://go.usa.gov/xPg2A 

FDA - U.S. Food and Drug Administration

22-8-2018

Routine eye exams and visiting your eye doctor will help ensure and maintain healthy eyes for everyone. #OnePairTakeCare #FDA #MedicalDevicepic.twitter.com/SQYFz30oFy

Routine eye exams and visiting your eye doctor will help ensure and maintain healthy eyes for everyone. #OnePairTakeCare #FDA #MedicalDevicepic.twitter.com/SQYFz30oFy

Routine eye exams and visiting your eye doctor will help ensure and maintain healthy eyes for everyone. #OnePairTakeCare #FDA #MedicalDevice pic.twitter.com/SQYFz30oFy

FDA - U.S. Food and Drug Administration

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

20-8-2018

Contact Lens Health Week is here and the FDA and @CDCgov are reminding you of safe measures to ensure proper use of contact lenses. Check out the CDC’s Healthy Habits Mean Healthy Eye video #OnePairTakeCarepic.twitter.com/jxiBHA3CiT

Contact Lens Health Week is here and the FDA and @CDCgov are reminding you of safe measures to ensure proper use of contact lenses. Check out the CDC’s Healthy Habits Mean Healthy Eye video #OnePairTakeCarepic.twitter.com/jxiBHA3CiT

Contact Lens Health Week is here and the FDA and @CDCgov are reminding you of safe measures to ensure proper use of contact lenses. Check out the CDC’s Healthy Habits Mean Healthy Eye video #OnePairTakeCare pic.twitter.com/jxiBHA3CiT

FDA - U.S. Food and Drug Administration

27-7-2018

Scientific guideline:  Reflection paper on dose optimisation of established veterinary antibiotics in the context of summary of product characteristics (SPC) harmonisation, draft: consultation open

Scientific guideline: Reflection paper on dose optimisation of established veterinary antibiotics in the context of summary of product characteristics (SPC) harmonisation, draft: consultation open

Established veterinary antibiotics are not always used at the authorised dose, and the dose may need to be reviewed in order to maintain their effectiveness whilst limiting the risks of antimicrobial resistance. Before a new dose is introduced, the company would typically have to conduct new studies to ensure it does not negatively affect the safety of the target animal, the consumer of animal produce, or the environment. This may reduce product availability, which could have a negative impact on antimic...

Europe - EMA - European Medicines Agency

22-7-2018

Our aim: ensure that devices not only meet the gold standard for getting to market but continue to meet this standard as we get more data and learn more about their benefit-risk profile in real-world settings. These new approaches will also help advance b

Our aim: ensure that devices not only meet the gold standard for getting to market but continue to meet this standard as we get more data and learn more about their benefit-risk profile in real-world settings. These new approaches will also help advance b

Our aim: ensure that devices not only meet the gold standard for getting to market but continue to meet this standard as we get more data and learn more about their benefit-risk profile in real-world settings. These new approaches will also help advance beneficial innovation

FDA - U.S. Food and Drug Administration

22-7-2018

We will advance medical device cybersecurity to keep pace with emerging threats and vulnerabilities. This includes updating premarket guidance and considering new post-market authority. We'll have an announcement soon on major new policy.pic.twitter.com/t

We will advance medical device cybersecurity to keep pace with emerging threats and vulnerabilities. This includes updating premarket guidance and considering new post-market authority. We'll have an announcement soon on major new policy.pic.twitter.com/t

We will advance medical device cybersecurity to keep pace with emerging threats and vulnerabilities. This includes updating premarket guidance and considering new post-market authority. We'll have an announcement soon on major new policy. pic.twitter.com/tzZKxpQbmx

FDA - U.S. Food and Drug Administration

20-7-2018

Agenda:  Agenda - CAT agenda of the 18-20 July 2018 meeting

Agenda: Agenda - CAT agenda of the 18-20 July 2018 meeting

Committee for Advanced Therapies (CAT) agenda for the meeting on 18-20 July 2018

Europe - EMA - European Medicines Agency

18-7-2018

HSCC announced today a new workstream, conducted under the Task Group, that will discuss and seek input on a software bill of materials (SBOM) for medical devices. SBOMs can ensure that users have better understanding of what software elements are in a me

HSCC announced today a new workstream, conducted under the Task Group, that will discuss and seek input on a software bill of materials (SBOM) for medical devices. SBOMs can ensure that users have better understanding of what software elements are in a me

HSCC announced today a new workstream, conducted under the Task Group, that will discuss and seek input on a software bill of materials (SBOM) for medical devices. SBOMs can ensure that users have better understanding of what software elements are in a medical device.

FDA - U.S. Food and Drug Administration

11-6-2018

SomaKit TOC (Advanced Accelerator Applications)

SomaKit TOC (Advanced Accelerator Applications)

SomaKit TOC (Active substance: edotreotide) - Centralised - Yearly update - Commission Decision (2018)3762 of Mon, 11 Jun 2018

Europe -DG Health and Food Safety

5-6-2018

Advance notice - update to an eCTD file download for version 3.1

Advance notice - update to an eCTD file download for version 3.1

The TGA intends to make a small amendment to the eCTD validation criteria

Therapeutic Goods Administration - Australia

29-5-2018

Ensure that you have optimised your Class I medical device ARTG entries

Ensure that you have optimised your Class I medical device ARTG entries

Information sheet to assist sponsors to optimise their Class I ARTG

Therapeutic Goods Administration - Australia

22-5-2018

Statement from @SGottliebFDA on new FDA actions to keep consumers safe from the harmful effects of sun exposure, and ensure the long-term safety and benefits of sunscreens:  http://go.usa.gov/xQmjP 

Statement from @SGottliebFDA on new FDA actions to keep consumers safe from the harmful effects of sun exposure, and ensure the long-term safety and benefits of sunscreens: http://go.usa.gov/xQmjP 

Statement from @SGottliebFDA on new FDA actions to keep consumers safe from the harmful effects of sun exposure, and ensure the long-term safety and benefits of sunscreens: http://go.usa.gov/xQmjP 

FDA - U.S. Food and Drug Administration