ČEP ZA KATETER

Glavna informacija

  • Trgovački naziv:
  • ČEP ZA KATETER, PRIKLJUČAK ZA ASPIRACIJSKI KATETER, PRIKLJUČAK ZA KLIZMU I PRIKLJUČAK IZMEĐU KATETERA I URINSKE VREĆICE
  • Razred:
  • IIa
  • Koristi za:
  • Ljudi
  • Vrsta lijekova:
  • Medicinski uređaj
  • Proizveden od:
  • TIK d.o.o., Slovenija

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.


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Lokalizacija

  • Na raspolaganju u:
  • ČEP ZA KATETER, PRIKLJUČAK ZA ASPIRACIJSKI KATETER, PRIKLJUČAK ZA KLIZMU I PRIKLJUČAK IZMEĐU KATETERA I URINSKE VREĆICE
    Hrvatska
  • Jezik:
  • hrvatski

Terapeutski informacija

  • Terapijska grupa:
  • potrepštine za katetere

Druge informacije

Status

  • Izvor:
  • HALMED Agencija za lijekove i medicinske proizvode - Agency for medicinal products and medical devices of Croatia
  • Broj odobrenja:
  • 381-13/86-11-01
  • Datum autorizacije:
  • 14-01-2011
  • 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.

9-11-2018

Safety assessment of the active substance polyacrylic acid, sodium salt, cross‐linked, for use in active food contact materials

Safety assessment of the active substance polyacrylic acid, sodium salt, cross‐linked, for use in active food contact materials

Published on: Thu, 08 Nov 2018 00:00:00 +0100 The EFSA Panel on Food Contact Materials, Enzymes and Processing Aids (CEP) assessed the safety of polyacrylic acid, sodium salt, cross‐linked, FCM substance No 1015, which is intended to be used as a liquid absorber in the packaging of fresh or frozen foods such as meat, poultry and seafood as well as fresh fruits and vegetables. Specific migration tests were not performed due to the high absorption of liquids by the substance. The Panel noted that if polya...

Europe - EFSA - European Food Safety Authority Publications

9-11-2018

Safety assessment of the substance Ln 1,4‐benzene dicarboxylic acid (with Ln = La, Eu, Gd, Tb) for use in food contact materials

Safety assessment of the substance Ln 1,4‐benzene dicarboxylic acid (with Ln = La, Eu, Gd, Tb) for use in food contact materials

Published on: Wed, 07 Nov 2018 00:00:00 +0100 The EFSA Panel on Food Contact Materials, Enzymes and Processing Aids (CEP Panel) assessed the safety of the additive Ln 1,4‐benzene dicarboxylic acid (with Ln = La, Eu, Gd, Tb) for use in food contact materials. It is a family of mixtures combining the four lanthanides lanthanum (La), europium (Eu), gadolinium (Gd) and/or terbium (Tb) in different proportions as their 1,4‐benzene dicarboxylate complexes, used as a taggant in plastics for authentication and ...

Europe - EFSA - European Food Safety Authority Publications

23-10-2018

Evaluation of confirmatory data following the Article 12 MRL review for pendimethalin

Evaluation of confirmatory data following the Article 12 MRL review for pendimethalin

Published on: Mon, 22 Oct 2018 00:00:00 +0200 The applicant BASF Agro BV submitted a request to the competent national authority in the Netherlands to evaluate the confirmatory data that were identified in the framework of the maximum residue level (MRL) review under Article 12 of Regulation (EC) No 396/2005 as not available. To address the data gaps, residue trials on strawberries, onions, garlic, tomatoes, peppers, cucumbers, artichokes, leeks and rape seeds were submitted. The data gaps are considere...

Europe - EFSA - European Food Safety Authority Publications

20-10-2018

Scientific Opinion of Flavouring Group Evaluation 411 (FGE.411): 2‐(4‐methylphenoxy)‐N‐(1H‐pyrazol‐3‐yl)‐N‐(thiophen‐2‐ylmethyl)acetamide from chemical group 30 (miscellaneous substances)

Scientific Opinion of Flavouring Group Evaluation 411 (FGE.411): 2‐(4‐methylphenoxy)‐N‐(1H‐pyrazol‐3‐yl)‐N‐(thiophen‐2‐ylmethyl)acetamide from chemical group 30 (miscellaneous substances)

Published on: Fri, 19 Oct 2018 00:00:00 +0200 EFSA was requested to deliver a scientific opinion on the implications for human health of the flavouring substance 2‐(4‐methylphenoxy)‐N‐(1H‐pyrazol‐3‐yl)‐N‐(thiophen‐2‐ylmethyl)acetamide [FL‐no: 16.133], in the Flavouring Group Evaluation 411 (FGE.411), according to Regulation (EC) No 1331/2008 of the European Parliament and of the Council. The substance has not been reported to occur in natural source materials of botanical or animal origin. It is intende...

Europe - EFSA - European Food Safety Authority Publications

22-9-2018

Risk assessment of new sequencing information on genetically modified carnation FLO‐40689‐6

Risk assessment of new sequencing information on genetically modified carnation FLO‐40689‐6

Published on: Fri, 21 Sep 2018 00:00:00 +0200 The GMO Panel has previously assessed genetically modified (GM) carnation FLO‐40689‐6 and concluded that there is no scientific reason to consider that the import, distribution and retailing in the EU of carnation FLO‐40689‐6 cut flowers for ornamental use will cause any adverse effects on human health or the environment. On 27 October 2017, the European Commission requested EFSA to analyse new nucleic acid sequencing data and updated bioinformatics data for...

Europe - EFSA - European Food Safety Authority Publications

22-9-2018

Risk assessment of new sequencing information for genetically modified soybean BPS‐CV127‐9

Risk assessment of new sequencing information for genetically modified soybean BPS‐CV127‐9

Published on: Fri, 21 Sep 2018 00:00:00 +0200 The GMO Panel has previously assessed genetically modified (GM) soybean BPS‐CV127‐9. This soybean was found to be as safe and nutritious as its conventional counterpart and commercial soybean varieties with respect to potential effects on human and animal health and the environment in the context of its intended uses. On 16 February 2018, European Commission requested EFSA to analyse new nucleic acid sequencing data and updated bioinformatics data for GM soy...

Europe - EFSA - European Food Safety Authority Publications

29-8-2018

Scientific Opinion about the Guidance of the Chemical Regulation Directorate (UK) on how aged sorption studies for pesticides should be conducted, analysed and used in regulatory assessments

Scientific Opinion about the Guidance of the Chemical Regulation Directorate (UK) on how aged sorption studies for pesticides should be conducted, analysed and used in regulatory assessments

Published on: Mon, 27 Aug 2018 00:00:00 +0200 The EFSA Panel on Plant Protection Products and their Residues reviewed the guidance on how aged sorption studies for pesticides should be conducted, analysed and used in regulatory assessment. The inclusion of aged sorption is a higher tier in the groundwater leaching assessment. The Panel based its review on a test with three substances taken from a data set provided by the European Crop Protection Association. Particular points of attention were the quali...

Europe - EFSA - European Food Safety Authority Publications

29-8-2018

Risk to human and animal health related to the presence of 4,15‐diacetoxyscirpenol in food and feed

Risk to human and animal health related to the presence of 4,15‐diacetoxyscirpenol in food and feed

Published on: Thu, 16 Aug 2018 00:00:00 +0200 4,15‐Diacetoxyscirpenol (DAS) is a mycotoxin primarily produced by Fusarium fungi and occurring predominantly in cereal grains. As requested by the European Commission, the EFSA Panel on Contaminants in the Food Chain (CONTAM) assessed the risk of DAS to human and animal health related to its presence in food and feed. Very limited information was available on toxicity and on toxicokinetics in experimental and farm animals. Due to the limitations in the avai...

Europe - EFSA - European Food Safety Authority Publications

15-5-2018

Orphan designation:  Melatonin,  for the: Treatment of neonatal encephalopathy

Orphan designation: Melatonin, for the: Treatment of neonatal encephalopathy

Europe - EMA - European Medicines Agency

10-6-2014

Falsified cancer medicine not distributed in Denmark

Falsified cancer medicine not distributed in Denmark

Falsified batches of the cancer medicine Herceptin® from Roche have been identified in England, Germany and Finland. None of the affected batches have been distributed in Denmark.

Danish Medicines Agency

28-8-2018

LIFMIOR (Pfizer Europe MA EEIG)

LIFMIOR (Pfizer Europe MA EEIG)

LIFMIOR (Active substance: etanercept) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)5700 of Tue, 28 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4167T/17

Europe -DG Health and Food Safety

7-8-2018

By Aug. 10, all packages and advertisements for “covered” tobacco products (except for cigars and pipe tobacco) and roll-your-own/cigarette tobacco products must have the required nicotine warning statement. https://cards.twitter.com/cards/2m2m96/5xn98 …

By Aug. 10, all packages and advertisements for “covered” tobacco products (except for cigars and pipe tobacco) and roll-your-own/cigarette tobacco products must have the required nicotine warning statement. https://cards.twitter.com/cards/2m2m96/5xn98 …

By Aug. 10, all packages and advertisements for “covered” tobacco products (except for cigars and pipe tobacco) and roll-your-own/cigarette tobacco products must have the required nicotine warning statement. https://cards.twitter.com/cards/2m2m96/5xn98 …

FDA - U.S. Food and Drug Administration

1-8-2018

Enbrel (Pfizer Europe MA EEIG)

Enbrel (Pfizer Europe MA EEIG)

Enbrel (Active substance: Etanercept) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)5195 of Wed, 01 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/262/T/222

Europe -DG Health and Food Safety

13-7-2018

Erelzi (Sandoz GmbH)

Erelzi (Sandoz GmbH)

Erelzi (Active substance: etanercept) - Centralised - Yearly update - Commission Decision (2018)4712 of Fri, 13 Jul 2018

Europe -DG Health and Food Safety

3-7-2018

Granupas (Eurocept International B.V.)

Granupas (Eurocept International B.V.)

Granupas (Active substance: Para-aminosalicylic acid) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018) 4256 of Tue, 03 Jul 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2709/T/25

Europe -DG Health and Food Safety

29-5-2018

EU/3/10/826 (Eurocept International B.V.)

EU/3/10/826 (Eurocept International B.V.)

EU/3/10/826 (Active substance: Para-aminosalicylic acid) - Transfer of orphan designation - Commission Decision (2018)3396 of Tue, 29 May 2018 European Medicines Agency (EMA) procedure number: EMA/OD/072/10/T/02

Europe -DG Health and Food Safety

15-5-2018

LIFMIOR (Pfizer Limited)

LIFMIOR (Pfizer Limited)

LIFMIOR (Active substance: etanercept) - Centralised - Yearly update - Commission Decision (2018)3004 of Tue, 15 May 2018

Europe -DG Health and Food Safety

4-5-2018

Medical devices and IVDs: Cancellations from the ARTG

Medical devices and IVDs: Cancellations from the ARTG

Cancellation of Profile Surgical Forceps, biopsy

Therapeutic Goods Administration - Australia