MAT - MECHANICAL ADVANCED TOURNIQUET

Informazioni principali

  • Nome commerciale:
  • MAT - MECHANICAL ADVANCED TOURNIQUET
  • Utilizzare per:
  • Esseri umani
  • Tipo di medicina:
  • Dispositivo medico

Documenti

  • per il pubblico:
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  • per i professionisti:
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Localizzazione

  • Disponibile in:
  • MAT - MECHANICAL ADVANCED TOURNIQUET
    Italia
  • Lingua:
  • italiano

Informazioni terapeutiche

  • Gruppo terapeutico:
  • SISTEMI PER EMOSTASI MECCANICI (COMPRESI I TOURNIQUET MONOUSO)

Altre informazioni

Status

  • Fonte:
  • Ministero della Salute - Italia
  • Stato dell'autorizzazione:
  • S
  • Data dell'autorizzazione:
  • 23-03-2010
  • Ultimo aggiornamento:
  • 09-08-2016
  • Il foglio illustrativo per questo prodotto non è al momento disponibile, é possibile inviare una richiesta al nostro Servizio Clienti ed essere avvisati nel momento in cui è disponibile sulla nostra piattaforma.

    Richiedi il foglio illustrativo per il pubblico.

19-1-2019

Data sources on animal diseases: Country Card of Poland

Data sources on animal diseases: Country Card of Poland

Published on: Fri, 18 Jan 2019 Mapping the ‘data sources’ on animal diseases in each European Union (EU) Member State is one of the activities of EFSA's SIGMA1,2 project. The aim of this activity is to identify the central competent authorities responsible for managing the data on animal diseases and animal populations in each Member State. Initially EFSA is focusing on three diseases (on which EFSA is currently working): African swine fever, avian influenza and lumpy skin disease; and on the correspond...

Europe - EFSA - European Food Safety Authority EFSA Journal

19-1-2019

Data sources on animal diseases: Country Card of Belgium

Data sources on animal diseases: Country Card of Belgium

Published on: Fri, 18 Jan 2019 Mapping ‘data sources’ on animal diseases in each European Union (EU) Member State is one of the activities of EFSA's SIGMA1,2 project. The aim of this activity is to identify the central competent authorities responsible for managing the data on animal diseases and animal populations in each Member State. Initially EFSA is focusing on three diseases (on which EFSA is currently working): African swine fever, avian influenza and lumpy skin disease; and on the corresponding ...

Europe - EFSA - European Food Safety Authority EFSA Journal

19-1-2019

Data sources on animal diseases: Country Card of Portugal

Data sources on animal diseases: Country Card of Portugal

Published on: Thu, 17 Jan 2019 Mapping the ‘data sources’ on animal diseases in each European Union (EU) Member State is one of the activities of EFSA's SIGMA1,2 project. The aim of this activity is to identify the central competent authorities responsible for managing the data on animal diseases and animal populations in each Member State. Initially EFSA is focusing on three diseases (on which EFSA is currently working): African swine fever, avian influenza and lumpy skin disease; and on the correspond...

Europe - EFSA - European Food Safety Authority EFSA Journal

19-1-2019

Data sources on animal diseases: Country Card of Lithuania

Data sources on animal diseases: Country Card of Lithuania

Published on: Thu, 17 Jan 2019 Mapping ‘data sources’ on animal diseases in each European Union (EU) Member State is one of the activities of EFSA's SIGMA1,2 project. The aim of this activity is to identify the central competent authorities responsible for managing the data on animal diseases and animal populations in each Member State. Initially EFSA is focusing on three diseases (on which EFSA is currently working): African swine fever, avian influenza and lumpy skin disease; and on the corresponding ...

Europe - EFSA - European Food Safety Authority EFSA Journal

19-1-2019

Data sources on animal diseases: Country Card of Spain

Data sources on animal diseases: Country Card of Spain

Published on: Thu, 17 Jan 2019 Mapping the ‘data sources’ on animal diseases in each European Union (EU) Member State is one of the activities of EFSA's SIGMA1,2 project. The aim of this activity is to identify the central competent authorities responsible for managing the data on animal diseases and animal populations in each Member State. Initially EFSA is focusing on three diseases (on which EFSA is currently working): African swine fever, avian influenza and lumpy skin disease; and on the correspond...

Europe - EFSA - European Food Safety Authority EFSA Journal

19-1-2019

Data sources on animal diseases: Country Card of Latvia

Data sources on animal diseases: Country Card of Latvia

Published on: Thu, 17 Jan 2019 Mapping ‘data sources’ on animal diseases in each European Union (EU) Member State is one of the activities of EFSA's SIGMA1,2 project. The aim of this activity is to identify the central competent authorities responsible for managing the data on animal diseases and animal populations in each Member State. Initially EFSA is focusing on three diseases (on which EFSA is currently working): African swine fever, avian influenza and lumpy skin disease; and on the corresponding ...

Europe - EFSA - European Food Safety Authority EFSA Journal

19-1-2019

Safety for the environment of vitamin D3 for salmonids

Safety for the environment of vitamin D3 for salmonids

Published on: Thu, 17 Jan 2019 The Panel on Additives and Products or Substances used in Animal Feed (FEEDAP Panel) of EFSA assessed the safety for the target species and the consumer of the use of a maximum total level of 1.5 mg vitamin D3/kg feed in fish nutrition (2017). The assessment was based on data that had been provided by the Norwegian Food Safety Authority (NFSA). Since the data set provided by the NFSA did not include any new information concerning the safety for the user and the environment...

Europe - EFSA - European Food Safety Authority EFSA Journal

18-1-2019

Publication of scientific data from EU-coordinated monitoring programmes and surveys

Publication of scientific data from EU-coordinated monitoring programmes and surveys

Published on: Thu, 17 Jan 2019 Open government data are about wide and free availability of public information created or collected by public entities. The International Open Data Charter and Findable, Accessible, Interoperable And Reusable Data (FAIR) data principles were selected as the guiding principles for the development of this report. A review of open data maturity reports indicated that most of the EU28+ are making significant progress in open government data, however there are different levels...

Europe - EFSA - European Food Safety Authority EFSA Journal

18-1-2019

Data sources on animal diseases: Country Card of Greece

Data sources on animal diseases: Country Card of Greece

Published on: Wed, 16 Jan 2019 Mapping ‘data sources’ on animal diseases in each European Union (EU) Member State is one of the activities of EFSA's SIGMA1,2 project. The aim of this activity is to identify the central competent authorities responsible for managing the data on animal diseases and animal populations in each Member State. Initially EFSA is focusing on three diseases (on which EFSA is currently working): African swine fever, avian influenza and lumpy skin disease; and on the corresponding ...

Europe - EFSA - European Food Safety Authority EFSA Journal

18-1-2019

Data sources on animal diseases: Country Card of Austria

Data sources on animal diseases: Country Card of Austria

Published on: Wed, 16 Jan 2019 Mapping the ‘data sources’ on animal diseases, in each European Union (EU) Member State, is one of the activities of EFSA 's SIGMA1,2 project. The aim of this activity is to identify the central competent authorities responsible for managing the data on animal diseases and animal populations in each Member State. Initially EFSA is focusing on three diseases (on which EFSA is currently working): African swine fever, avian influenza and lumpy skin disease; and on the corresp...

Europe - EFSA - European Food Safety Authority EFSA Journal

18-1-2019

Data sources on animal diseases: Country Card of Cyprus

Data sources on animal diseases: Country Card of Cyprus

Published on: Wed, 16 Jan 2019 Mapping the ‘data sources’ on animal diseases in each European Union (EU) Member State is one of the activities of EFSA's SIGMA1,2 project. The aim of this activity is to identify the central competent authorities responsible for managing the data on animal diseases and animal populations in each Member State. Initially EFSA is focusing on three diseases (on which EFSA is currently working): African swine fever, avian influenza and lumpy skin disease; and on the correspond...

Europe - EFSA - European Food Safety Authority EFSA Journal

18-1-2019

Data sources on animal diseases: Country Card of Bulgaria

Data sources on animal diseases: Country Card of Bulgaria

Published on: Wed, 16 Jan 2019 Mapping the ‘data sources’ on animal diseases in each European Union (EU) Member State, is one of the activities of EFSA 's SIGMA1,2 project. The aim of this activity is to identify the central competent authorities responsible for managing the data on animal diseases and animal populations in each Member State. Initially EFSA is focusing on three diseases (on which EFSA is currently working): African swine fever, avian influenza and lumpy skin disease; and on the correspo...

Europe - EFSA - European Food Safety Authority EFSA Journal

17-1-2019

Safety of cassia gum as a feed additive for cats and dogs based on a dossier submitted by Glycomer GmbH

Safety of cassia gum as a feed additive for cats and dogs based on a dossier submitted by Glycomer GmbH

Published on: Wed, 16 Jan 2019 The additive cassia gum consists mainly of high-molecular weight polysaccharides composed primarily of a linear chain of 1,4-b-D-mannopyranose units with 1,6-linked a-D-galactopyranose units. In 2014, the Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) delivered an opinion on the safety and efficacy of cassia gum in cats and dogs. The Panel concluded, based on positive findings observed in a bacterial reverse mutation test with a semi-refined cassia...

Europe - EFSA - European Food Safety Authority EFSA Journal

16-1-2019

Review of the existing maximum residue levels for dazomet according to Article 12 of Regulation (EC) No 396/2005

Review of the existing maximum residue levels for dazomet according to Article 12 of Regulation (EC) No 396/2005

Published on: Tue, 15 Jan 2019 According to Article 12 of Regulation (EC) No 396/2005, EFSA has reviewed the maximum residue levels (MRLs) currently established at European level for the pesticide active substance dazomet. To assess the occurrence of dazomet residues in plants, processed commodities, rotational crops and livestock, EFSA considered the conclusions derived in the framework of Directive 91/414/EEC as well as the European authorisations reported by Member States (including the supporting re...

Europe - EFSA - European Food Safety Authority EFSA Journal

15-1-2019


Committee for Advanced Therapies (CAT): 7-9 November 2018, European Medicines Agency, London, UK, from 07/11/2018 to 08/11/2018

Committee for Advanced Therapies (CAT): 7-9 November 2018, European Medicines Agency, London, UK, from 07/11/2018 to 08/11/2018

Committee for Advanced Therapies (CAT): 7-9 November 2018, European Medicines Agency, London, UK, from 07/11/2018 to 08/11/2018

Europe - EMA - European Medicines Agency

15-1-2019

Review of the existing maximum residue levels for metam according to Article 12 of Regulation (EC) No 396/2005

Review of the existing maximum residue levels for metam according to Article 12 of Regulation (EC) No 396/2005

Published on: Mon, 14 Jan 2019 According to Article 12 of Regulation (EC) No 396/2005, EFSA has reviewed the maximum residue levels (MRLs) currently established at European level for the pesticide active substance metam. To assess the occurrence of metam residues in plants, processed commodities, rotational crops and livestock, EFSA considered the conclusions derived in the framework of Commission Regulation (EC) No 33/2008C as well as the European authorisations reported by Member States (including the...

Europe - EFSA - European Food Safety Authority EFSA Journal

15-1-2019

EFSA's activities on emerging risks in 2017

EFSA's activities on emerging risks in 2017

Published on: Mon, 14 Jan 2019 The main objectives of EFSA's activities on emerging risks are: (i) to carry out activities to identify emerging risks in the areas within the remit of EFSA; and (ii) to develop and improve emerging risk identification methodologies and approaches. The current technical report summarises the activities of all groups involved in the emerging risk identification procedure, the issues identified in the course of 2017, a description of methodologies being developed and collabo...

Europe - EFSA - European Food Safety Authority EFSA Journal

15-1-2019

Review of the existing maximum residue levels for fluometuron according to Article 12 of Regulation (EC) No 396/2005

Review of the existing maximum residue levels for fluometuron according to Article 12 of Regulation (EC) No 396/2005

Published on: Mon, 14 Jan 2019 According to Article 12 of Regulation (EC) No 396/2005, EFSA has reviewed the maximum residue levels (MRLs) currently established at European level for the pesticide active substance fluometuron. To assess the occurrence of fluometuron residues in plants, processed commodities, rotational crops and livestock, EFSA considered the conclusions derived in the framework of Commission Regulation (EC) No 33/2008 as well as the European authorisations reported by Member States (in...

Europe - EFSA - European Food Safety Authority EFSA Journal

12-1-2019

Pest categorisation of Pseudopityophthorus minutissimus and P. pruinosus

Pest categorisation of Pseudopityophthorus minutissimus and P. pruinosus

Published on: Fri, 11 Jan 2019 The Panel on Plant Health performed a pest categorisation of Pseudopityophthorus minutissimus and Pseudopityophthorus pruinosus, two well‐defined insect species in the family Curculionidae, subfamily Scolytinae (Insecta: Coleoptera). They can be identified using taxonomic keys. P. minutissimus is present in parts of Canada and the USA, and P. pruinosus is present in parts of the USA, Guatemala, Honduras and Mexico. The main host plants of the two species are Quercus spp., ...

Europe - EFSA - European Food Safety Authority EFSA Journal

9-1-2019

Review of the existing maximum residue levels for triazoxide according to Article 12 of Regulation (EC) No 396/2005

Review of the existing maximum residue levels for triazoxide according to Article 12 of Regulation (EC) No 396/2005

Published on: Tue, 08 Jan 2019 According to Article 12 of Regulation (EC) No 396/2005, EFSA has reviewed the maximum residue levels (MRLs) currently established at European level for the pesticide active substance triazoxide. To assess the occurrence of triazoxide residues in plants, processed commodities, rotational crops and livestock, EFSA considered the conclusions derived in the framework of Commission Regulation (EC) No 33/2008, as well as the European authorisations reported by Member States. Bas...

Europe - EFSA - European Food Safety Authority EFSA Journal

9-1-2019

Review of the existing maximum residue levels for chromafenozide according to Article 12 Regulation (EC) No 396/2005

Review of the existing maximum residue levels for chromafenozide according to Article 12 Regulation (EC) No 396/2005

Published on: Tue, 08 Jan 2019 According to Article 12 of Regulation (EC) No 396/2005, EFSA has reviewed the maximum residue levels (MRLs) currently established at European level for the pesticide active substance chromafenozide. Considering the information provided by Member States, neither EU uses nor import tolerances are currently authorised for chromafenozide within the EU. Furthermore, no MRLs are established by the Codex Alimentarius Commission (codex maximum residue limits) for this active subst...

Europe - EFSA - European Food Safety Authority EFSA Journal

8-1-2019

Sun Pharmaceutical Industries, Inc. Issues Voluntary Nationwide Recall of Vecuronium Bromide for Injection Due to the Presence of Particulate Matter Identified as Glass

Sun Pharmaceutical Industries, Inc. Issues Voluntary Nationwide Recall of Vecuronium Bromide for Injection Due to the Presence of Particulate Matter Identified as Glass

Sun Pharmaceutical Industries, Inc. (SPII), a wholly owned subsidiary of Sun Pharmaceutical Industries, Ltd. is voluntarily recalling three lots of Vecuronium Bromide for Injection, 10 mg (lyophilized powder), and one lot of Vecuronium Bromide for Injection, 20 mg (lyophilized powder) to the hospital level. The Vecuronium Bromide for Injection has been found to contain particulate matter identified as glass.

FDA - U.S. Food and Drug Administration

6-1-2019

Lupin Pharmaceuticals, Inc. Issues Voluntary Recall of Ceftriaxone for Injection USP, 250mg, 500mg, 1g and 2g

Lupin Pharmaceuticals, Inc. Issues Voluntary Recall of Ceftriaxone for Injection USP, 250mg, 500mg, 1g and 2g

Lupin Pharmaceuticals, Inc. is voluntarily recalling 5 lots of Ceftriaxone for Injection, USP, 250mg, 10 lots of Ceftriaxone for Injection, USP, 500mg, 24 lots of Ceftriaxone for Injection, USP, 1g and 3 lots of Ceftriaxone for Injection, USP 2g, to the hospital/physician level. The products have been found to contain visual grey particulate matter in reconstituted vials.

FDA - U.S. Food and Drug Administration

21-12-2018

Peer review of the pesticide risk assessment of the active substance propanil

Peer review of the pesticide risk assessment of the active substance propanil

Published on: Thu, 20 Dec 2018 The conclusions of EFSA following the peer review of the initial risk assessments carried out by the competent authority of the rapporteur Member State Italy for the pesticide active substance propanil and the assessment of applications for maximum residue levels (MRLs) are reported. The context of the peer review was that required by Regulation (EC) No 1107/2009 of the European Parliament and of the Council. The conclusions were reached on the basis of the evaluation of t...

Europe - EFSA - European Food Safety Authority EFSA Journal

20-12-2018

Scientific assistance to assess the detoxification process for dioxins and PCBs in sunflower cake by hexane extraction

Scientific assistance to assess the detoxification process for dioxins and PCBs in sunflower cake by hexane extraction

Published on: Wed, 19 Dec 2018 EFSA was requested to provide scientific assistance to the European Commission on a detoxification process for dioxins and PCBs from sunflower cake by hexane extraction in an emergency situation, as specified in Article 7 of Commission Regulation (EU) 2015/786. The process entails hexane extraction of sunflower oil from the cake to remove dioxins (PCDDs and PCDFs) as well as DL- and NDL-PCBs. The data provided by the applicant were assessed with respect to the efficacy of ...

Europe - EFSA - European Food Safety Authority EFSA Journal

20-12-2018

Data sources on animal diseases: Methodology on mapping the data sources on animal diseases in European Union Member States

Data sources on animal diseases: Methodology on mapping the data sources on animal diseases in European Union Member States

Published on: Wed, 19 Dec 2018 Mapping the ‘data sources’ on animal diseases, in each European Union (EU) Member State, is one of the activities of EFSA's SIGMA1 project. The aim of this activity is to identify the central competent authorities responsible for managing the data on animal diseases and animal populations in each Member State. Initially EFSA is focusing on three diseases (on which Animal Health and Plant Health Unit is currently working): African swine fever, avian influenza and lumpy skin...

Europe - EFSA - European Food Safety Authority EFSA Journal

20-12-2018

Pest categorisation of Gymnosporangium spp. (non‐EU)

Pest categorisation of Gymnosporangium spp. (non‐EU)

Published on: Wed, 19 Dec 2018 Following a request from the European Commission, the EFSA Panel on Plant Health performed a pest categorisation of Gymnosporangium spp. (non‐EU), a well‐defined and distinguishable group of fungal plant pathogens of the family Pucciniaceae affecting woody species. Many different Gymnosporangium species are recognised, of which at least 14 species are considered not to be native in the European Union. All the non‐EU Gymnosporangium species are not known to be present in th...

Europe - EFSA - European Food Safety Authority EFSA Journal

20-12-2018

Pest categorisation of Cronartium spp. (non‐EU)

Pest categorisation of Cronartium spp. (non‐EU)

Published on: Wed, 19 Dec 2018 Following a request from the European Commission, the EFSA Panel on Plant Health performed a pest categorisation of Cronartium spp. (non‐EU), a well‐defined and distinguishable group of fungal pathogens of the family Cronartiaceae. There are at least 40 species described within the Cronartium genus, of which two are considered native to the EU (C. gentianeum and C. pini) and one has been introduced in the 19th century (C. ribicola) and is now widespread in the EU – these t...

Europe - EFSA - European Food Safety Authority EFSA Journal

19-12-2018

Safety and efficacy of vitamin B2 (riboflavin 5′‐phosphate ester monosodium salt) for all animal species when used in water for drinking

Safety and efficacy of vitamin B2 (riboflavin 5′‐phosphate ester monosodium salt) for all animal species when used in water for drinking

Published on: Tue, 18 Dec 2018 Following a request from the European Commission, the Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) was asked to deliver a scientific opinion on vitamin B2 in the form of riboflavin 5′‐phosphate ester monosodium salt as an additive for all animal species for use in water for drinking. The additive under assessment is obtained from ■■■■■ a source of riboflavin produced by Ashbya gossypii. No information was provided on the identity and character...

Europe - EFSA - European Food Safety Authority EFSA Journal

18-12-2018

Review of the existing maximum residue levels for pencycuron according to Article 12 of Regulation (EC) No 396/2005

Review of the existing maximum residue levels for pencycuron according to Article 12 of Regulation (EC) No 396/2005

Published on: Mon, 17 Dec 2018 According to Article 12 of Regulation (EC) No 396/2005, EFSA has reviewed the maximum residue levels (MRLs) currently established at European level for the pesticide active substance pencycuron. To assess the occurrence of pencycuron residues in plants, processed commodities, rotational crops and livestock, EFSA considered the conclusions derived in the framework of Commission Regulation (EC) No 33/2008 as well as the European authorisations reported by Member States (incl...

Europe - EFSA - European Food Safety Authority Publications

18-12-2018

Pest categorisation of Carposina sasakii

Pest categorisation of Carposina sasakii

Published on: Mon, 17 Dec 2018 The EFSA Panel on Plant Health performed a pest categorisation of the peach fruit moth, Carposina sasakii Matsumura (Lepidoptera: Carposinidae) for the EU. C. sasakii is not currently regulated in the EU although C. niponensis, a valid species of no economic significance that was previously mistakenly synonymised with C. sasakii, is regulated in Annex IIAI of 2000/29 EC. C. sasakii is a well‐defined species that is recognised as a major pest of apples, peaches and pears in...

Europe - EFSA - European Food Safety Authority Publications

15-12-2018

Annual report of the Scientific Network on Microbiological Risk Assessment 2018

Annual report of the Scientific Network on Microbiological Risk Assessment 2018

Published on: Fri, 14 Dec 2018 Among the tasks of EFSA, according to its founding regulation (Regulation (EC) No 178/2002), there is the establishment of a system of Networks of organisations operating in the fields within EFSA's mission, the objective being to facilitate a scientific cooperation framework by the coordination of activities, the exchange of information, the development and implementation of joint projects, the exchange of expertise and best practices. Additionally, the EFSA Science Strat...

Europe - EFSA - European Food Safety Authority Publications

15-12-2018

Annual Report of the Scientific Network on BSE‐TSE 2018

Annual Report of the Scientific Network on BSE‐TSE 2018

Published on: Fri, 14 Dec 2018 The EFSA Scientific Network on bovine spongiform encephalopathies and other transmissible spongiform encephalopathies (BSE‐TSE) held its 13th meeting on 15‐16 October 2018 in Parma. The meeting served as an opportunity to exchange scientific information on BSE‐TSE related issues among EU Member States, countries from the European Free Trade Association (EFTA), EFSA, the European Commission and ad hocparticipants. In this occasion, ad hoc representation included the World A...

Europe - EFSA - European Food Safety Authority Publications

14-12-2018

Analysis of hunting statistics collection frameworks for wild boar across Europe and proposals for improving the harmonisation of data collection

Analysis of hunting statistics collection frameworks for wild boar across Europe and proposals for improving the harmonisation of data collection

Published on: Thu, 13 Dec 2018 Heterogeneities in the wild boar data collection frameworks across Europe were analysed using questionnaires to explore comparability of hunting data in the short term and propose a common framework for future collection. Fifty‐seven respondents representing 32 countries covering more than 95% of European territory participated to the questionnaire. The most frequently recorded information in the official statistics included the quantity of animals shot per hunting ground ...

Europe - EFSA - European Food Safety Authority Publications

18-1-2019


Checklist for the submission of Type IA and Type IB (without linguistic review) product information annexes and Annex A (if applicable) - veterinary

Checklist for the submission of Type IA and Type IB (without linguistic review) product information annexes and Annex A (if applicable) - veterinary

Checklist for the submission of Type IA and Type IB (without linguistic review) product information annexes and Annex A (if applicable) - veterinary

Europe - EMA - European Medicines Agency

10-1-2019


BCG vaccine (freeze-dried): CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation  - PSUSA/00000304/201803

BCG vaccine (freeze-dried): CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00000304/201803

BCG vaccine (freeze-dried): CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00000304/201803

Europe - EMA - European Medicines Agency

10-1-2019


Lorazepam: CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00001909/201801

Lorazepam: CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00001909/201801

Lorazepam: CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00001909/201801

Europe - EMA - European Medicines Agency

7-1-2019


Scientific recommendation on classification of advanced therapy medicinal products: In vitro cultured autologous mesenchymal stem cells isolated from bone marrow

Scientific recommendation on classification of advanced therapy medicinal products: In vitro cultured autologous mesenchymal stem cells isolated from bone marrow

Scientific recommendation on classification of advanced therapy medicinal products: In vitro cultured autologous mesenchymal stem cells isolated from bone marrow

Europe - EMA - European Medicines Agency

7-1-2019


Scientific recommendation on classification of advanced therapy medicinal products: Codon-optimized mRNA that will be translated to functional human cystic fibrosis transmembrane conductance regulator protein after cellular uptake

Scientific recommendation on classification of advanced therapy medicinal products: Codon-optimized mRNA that will be translated to functional human cystic fibrosis transmembrane conductance regulator protein after cellular uptake

Scientific recommendation on classification of advanced therapy medicinal products: Codon-optimized mRNA that will be translated to functional human cystic fibrosis transmembrane conductance regulator protein after cellular uptake

Europe - EMA - European Medicines Agency

7-1-2019


Scientific recommendation on classification of advanced therapy medicines: Allogeneic Epstein-Barr Virus specific cytotoxic T lymphocytes

Scientific recommendation on classification of advanced therapy medicines: Allogeneic Epstein-Barr Virus specific cytotoxic T lymphocytes

Scientific recommendation on classification of advanced therapy medicines: Allogeneic Epstein-Barr Virus specific cytotoxic T lymphocytes

Europe - EMA - European Medicines Agency

7-1-2019


Scientific recommendation on classification of advanced therapy medicines: In vitro cultured autologous mesenchymal stem cells isolated from bone marrow

Scientific recommendation on classification of advanced therapy medicines: In vitro cultured autologous mesenchymal stem cells isolated from bone marrow

Scientific recommendation on classification of advanced therapy medicines: In vitro cultured autologous mesenchymal stem cells isolated from bone marrow

Europe - EMA - European Medicines Agency

7-1-2019


Scientific recommendation on classification of advanced therapy medicinal products: Recombinant adeno-associated virus serotype 9 vector encoding the soluble lysosomal enzyme TPP1

Scientific recommendation on classification of advanced therapy medicinal products: Recombinant adeno-associated virus serotype 9 vector encoding the soluble lysosomal enzyme TPP1

Scientific recommendation on classification of advanced therapy medicinal products: Recombinant adeno-associated virus serotype 9 vector encoding the soluble lysosomal enzyme TPP1

Europe - EMA - European Medicines Agency

4-1-2019


New product information wording: extracts from PRAC recommendations on signals adopted at the 26-29 November 2018 PRAC

New product information wording: extracts from PRAC recommendations on signals adopted at the 26-29 November 2018 PRAC

New product information wording: extracts from PRAC recommendations on signals adopted at the 26-29 November 2018 PRAC

Europe - EMA - European Medicines Agency

3-1-2019

Reformatting Product Information: Frequently asked questions

Reformatting Product Information: Frequently asked questions

Updated to include new and revised FAQs

Therapeutic Goods Administration - Australia

2-1-2019

Medicine shortages guidance and resources

Medicine shortages guidance and resources

Medicine Shortages Information Initiative - Critical medicine shortages and other information

Therapeutic Goods Administration - Australia

20-12-2018

.@US_FDA provides an update on new steps to revise #Essure's post-market study to collect long-term safety information following discontinuation of its U.S. sales. Read FDA Commissioner @SGottliebFDA's statement on the new steps here:  https://go.usa.gov/

.@US_FDA provides an update on new steps to revise #Essure's post-market study to collect long-term safety information following discontinuation of its U.S. sales. Read FDA Commissioner @SGottliebFDA's statement on the new steps here: https://go.usa.gov/

. @US_FDA provides an update on new steps to revise #Essure's post-market study to collect long-term safety information following discontinuation of its U.S. sales. Read FDA Commissioner @SGottliebFDA's statement on the new steps here: https://go.usa.gov/xEaNB  #MedicalDevice

FDA - U.S. Food and Drug Administration

19-12-2018

Consultation: Medical device cyber security

Consultation: Medical device cyber security

The TGA is seeking comments from interested parties on the applicability and usefulness of the content contained in the draft regulatory guidance and information materials. Closing date: 14 February 2019

Therapeutic Goods Administration - Australia

18-12-2018


Committee for Advanced Therapies (CAT) work programme 2019

Committee for Advanced Therapies (CAT) work programme 2019

Committee for Advanced Therapies (CAT) work programme 2019

Europe - EMA - European Medicines Agency

18-12-2018


Scientific recommendation on classification of advanced therapy medicinal products: Mesenchymal stem cells isolated from autologous bone marrow

Scientific recommendation on classification of advanced therapy medicinal products: Mesenchymal stem cells isolated from autologous bone marrow

Scientific recommendation on classification of advanced therapy medicinal products: Mesenchymal stem cells isolated from autologous bone marrow

Europe - EMA - European Medicines Agency

18-12-2018


Scientific recommendation on classification of advanced therapy medicinal products: In vitro cultured autologous melanocytes

Scientific recommendation on classification of advanced therapy medicinal products: In vitro cultured autologous melanocytes

Scientific recommendation on classification of advanced therapy medicinal products: In vitro cultured autologous melanocytes

Europe - EMA - European Medicines Agency

18-12-2018


Scientific recommendation on classification of advanced therapy medicinal products: In vitro cultured autologous muscle-derived stem cells

Scientific recommendation on classification of advanced therapy medicinal products: In vitro cultured autologous muscle-derived stem cells

Scientific recommendation on classification of advanced therapy medicinal products: In vitro cultured autologous muscle-derived stem cells

Europe - EMA - European Medicines Agency

18-12-2018


Scientific recommendation on classification of advanced therapy medicinal products: Human autologous keratinocytes

Scientific recommendation on classification of advanced therapy medicinal products: Human autologous keratinocytes

Scientific recommendation on classification of advanced therapy medicinal products: Human autologous keratinocytes

Europe - EMA - European Medicines Agency

18-12-2018


Scientific recommendation on classification of advanced therapy medicinal products: Viable human autologous skin fibroblasts

Scientific recommendation on classification of advanced therapy medicinal products: Viable human autologous skin fibroblasts

Scientific recommendation on classification of advanced therapy medicinal products: Viable human autologous skin fibroblasts

Europe - EMA - European Medicines Agency

18-12-2018


Scientific recommendation on classification of advanced therapy medicinal products: In vitro cultured autologous chondrocytes

Scientific recommendation on classification of advanced therapy medicinal products: In vitro cultured autologous chondrocytes

Scientific recommendation on classification of advanced therapy medicinal products: In vitro cultured autologous chondrocytes

Europe - EMA - European Medicines Agency

18-12-2018


Scientific recommendation on classification of advanced therapy medicinal products: Autologous cultured adipose derived mesenchymal stem cells

Scientific recommendation on classification of advanced therapy medicinal products: Autologous cultured adipose derived mesenchymal stem cells

Scientific recommendation on classification of advanced therapy medicinal products: Autologous cultured adipose derived mesenchymal stem cells

Europe - EMA - European Medicines Agency

18-12-2018


Scientific recommendation on classification of advanced therapy medicinal products: Extracellular matrix isolated from adipose tissue

Scientific recommendation on classification of advanced therapy medicinal products: Extracellular matrix isolated from adipose tissue

Scientific recommendation on classification of advanced therapy medicinal products: Extracellular matrix isolated from adipose tissue

Europe - EMA - European Medicines Agency

18-12-2018


Scientific recommendation on classification of advanced therapy medicinal products: Autologous cultured fibroblasts

Scientific recommendation on classification of advanced therapy medicinal products: Autologous cultured fibroblasts

Scientific recommendation on classification of advanced therapy medicinal products: Autologous cultured fibroblasts

Europe - EMA - European Medicines Agency

18-12-2018


Scientific recommendation on classification of advanced therapy medicinal products: Live-attenuated, double-deleted Listeria monocytogenes expressing prostate antigens

Scientific recommendation on classification of advanced therapy medicinal products: Live-attenuated, double-deleted Listeria monocytogenes expressing prostate antigens

Scientific recommendation on classification of advanced therapy medicinal products: Live-attenuated, double-deleted Listeria monocytogenes expressing prostate antigens

Europe - EMA - European Medicines Agency

18-12-2018


Scientific recommendation on classification of advanced therapy medicinal products: Live-attenuated, double-deleted Listeria monocytogenes expressing human mesothelin

Scientific recommendation on classification of advanced therapy medicinal products: Live-attenuated, double-deleted Listeria monocytogenes expressing human mesothelin

Scientific recommendation on classification of advanced therapy medicinal products: Live-attenuated, double-deleted Listeria monocytogenes expressing human mesothelin

Europe - EMA - European Medicines Agency

18-12-2018


Scientific recommendation on classification of advanced therapy medicinal products: Concentrate of autologous bone marrow-derived mononuclear cells (BM-MNC)

Scientific recommendation on classification of advanced therapy medicinal products: Concentrate of autologous bone marrow-derived mononuclear cells (BM-MNC)

Scientific recommendation on classification of advanced therapy medicinal products: Concentrate of autologous bone marrow-derived mononuclear cells (BM-MNC)

Europe - EMA - European Medicines Agency

18-12-2018


Scientific recommendation on classification of advanced therapy medicinal products: Allogenic bone marrow derived mesenchymal stem cells expanded in vitro

Scientific recommendation on classification of advanced therapy medicinal products: Allogenic bone marrow derived mesenchymal stem cells expanded in vitro

Scientific recommendation on classification of advanced therapy medicinal products: Allogenic bone marrow derived mesenchymal stem cells expanded in vitro

Europe - EMA - European Medicines Agency

12-12-2018


Scientific recommendation on classification of advanced therapy medicinal products: Homogenate of antlerogenic stem cells - Tissue engineered product

Scientific recommendation on classification of advanced therapy medicinal products: Homogenate of antlerogenic stem cells - Tissue engineered product

Scientific recommendation on classification of advanced therapy medicinal products: Homogenate of antlerogenic stem cells - Tissue engineered product

Europe - EMA - European Medicines Agency

12-12-2018


Scientific recommendation on classification of advanced therapy medicinal products: Recombinant adeno-associated viral vector capsid containing the human iduronate-2-sulfatase (hIDS) expression cassette

Scientific recommendation on classification of advanced therapy medicinal products: Recombinant adeno-associated viral vector capsid containing the human iduronate-2-sulfatase (hIDS) expression cassette

Scientific recommendation on classification of advanced therapy medicinal products: Recombinant adeno-associated viral vector capsid containing the human iduronate-2-sulfatase (hIDS) expression cassette

Europe - EMA - European Medicines Agency

12-12-2018


Scientific recommendation on classification of advanced therapy medicinal products: Codon-optimized human ornithine transcarbamylase messenger ribonucleic acid

Scientific recommendation on classification of advanced therapy medicinal products: Codon-optimized human ornithine transcarbamylase messenger ribonucleic acid

Scientific recommendation on classification of advanced therapy medicinal products: Codon-optimized human ornithine transcarbamylase messenger ribonucleic acid

Europe - EMA - European Medicines Agency