SCREW-LOG

Informazioni principali

  • Nome commerciale:
  • SCREW-LOG
  • Utilizzare per:
  • Esseri umani
  • Tipo di medicina:
  • Dispositivo medico

Documenti

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Localizzazione

  • Disponibile in:
  • SCREW-LOG
    Italia
  • Lingua:
  • italiano

Informazioni terapeutiche

  • Gruppo terapeutico:
  • VITI CANNULATE

Altre informazioni

Status

  • Fonte:
  • Ministero della Salute - Italia
  • Stato dell'autorizzazione:
  • S
  • Data dell'autorizzazione:
  • 04-03-2010
  • 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.

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6-12-2018

Statement from FDA Commissioner Scott Gottlieb, M.D., on the FDA’s new effort for developing and class labeling of in vitro companion diagnostics for classes of oncology therapeutic products

Statement from FDA Commissioner Scott Gottlieb, M.D., on the FDA’s new effort for developing and class labeling of in vitro companion diagnostics for classes of oncology therapeutic products

Statement from FDA Commissioner Scott Gottlieb, M.D., on the FDA’s new effort for developing and class labeling of vitro companion diagnostics for classes of oncology therapeutic products

FDA - U.S. Food and Drug Administration

26-11-2018

FDA approves an oncology drug that targets a key genetic driver of cancer, rather than a specific type of tumor

FDA approves an oncology drug that targets a key genetic driver of cancer, rather than a specific type of tumor

The FDA granted accelerated approval to Vitrakvi (larotrectinib), a treatment for adult and pediatric patients whose cancers have a specific genetic feature (biomarker).

FDA - U.S. Food and Drug Administration

18-10-2018

Ryerson Canada and Vista Railings Systems Inc. recall Various ProBuilt Aluminum Deck Railing Posts

Ryerson Canada and Vista Railings Systems Inc. recall Various ProBuilt Aluminum Deck Railing Posts

Certain ProBuilt Aluminum Posts have an issue with the screws that affix the base plate to the post which may cause the post to separate from the base plate when forces over 334 pounds are applied horizontally to the top side of the post. As a result, the posts do not fully comply with local building code requirements and may pose a fall hazard.

Health Canada

10-10-2018

Spiraledge Inc. recalls Backless Yoga Chair

Spiraledge Inc. recalls Backless Yoga Chair

The chairs may have missing screws or washers, loose screws or inadequate spot welding, resulting in potential collapse of the chair and injury to the user.

Health Canada

13-9-2018

October 10, 2018: Meeting of the Oncologic Drugs Advisory Committee

October 10, 2018: Meeting of the Oncologic Drugs Advisory Committee

October 10, 2018: Meeting of the Oncologic Drugs Advisory Committee Meeting Announcement

FDA - U.S. Food and Drug Administration

26-7-2018

Opinion/decision on a Paediatric investigation plan (PIP):    Ninlaro, Ixazomib, Therapeutic area: Oncology

Opinion/decision on a Paediatric investigation plan (PIP): Ninlaro, Ixazomib, Therapeutic area: Oncology

Europe - EFSA - European Food Safety Authority EFSA Journal

25-7-2018

Opinion/decision on a Paediatric investigation plan (PIP):    -, Enfortumab vedotin, Therapeutic area: Oncology

Opinion/decision on a Paediatric investigation plan (PIP): -, Enfortumab vedotin, Therapeutic area: Oncology

Europe - EFSA - European Food Safety Authority EFSA Journal

25-7-2018

Opinion/decision on a Paediatric investigation plan (PIP):    -, Ponesimod, Therapeutic area: Neurology

Opinion/decision on a Paediatric investigation plan (PIP): -, Ponesimod, Therapeutic area: Neurology

Europe - EFSA - European Food Safety Authority EFSA Journal

25-7-2018

Opinion/decision on a Paediatric investigation plan (PIP):    Spinraza, Nusinersen, Therapeutic area: Neurology

Opinion/decision on a Paediatric investigation plan (PIP): Spinraza, Nusinersen, Therapeutic area: Neurology

Europe - EFSA - European Food Safety Authority EFSA Journal

18-7-2018

FDA approves first cancer drug through new oncology review pilot that enables greater development efficiency

FDA approves first cancer drug through new oncology review pilot that enables greater development efficiency

FDA approves first cancer drug through new oncology review pilot that enables greater development efficiency

FDA - U.S. Food and Drug Administration

12-7-2018

Oncologic Drugs Advisory Committee Roster

Oncologic Drugs Advisory Committee Roster

This page contains the ODAC roster, which lists the current members and the current number of vacancies for the committee.

FDA - U.S. Food and Drug Administration

4-7-2018

New guidance on nanotechnologies in food and feed

New guidance on nanotechnologies in food and feed

New guidance on nanotechnologies in food and feed

Europe - EFSA - European Food Safety Authority Press Releases & News Stories

19-6-2018

Opinion/decision on a Paediatric investigation plan (PIP):    -, Pevonedistat, Therapeutic area: Oncology

Opinion/decision on a Paediatric investigation plan (PIP): -, Pevonedistat, Therapeutic area: Oncology

Europe - EFSA - European Food Safety Authority EFSA Journal

19-6-2018

Opinion/decision on a Paediatric investigation plan (PIP):    -, Niraparib, Therapeutic area: Oncology

Opinion/decision on a Paediatric investigation plan (PIP): -, Niraparib, Therapeutic area: Oncology

Europe - EFSA - European Food Safety Authority EFSA Journal

19-6-2018

Opinion/decision on a Paediatric investigation plan (PIP):    -, Durvalumab, Therapeutic area: Oncology

Opinion/decision on a Paediatric investigation plan (PIP): -, Durvalumab, Therapeutic area: Oncology

Europe - EFSA - European Food Safety Authority EFSA Journal

19-6-2018

Opinion/decision on a Paediatric investigation plan (PIP):    -, Tremelimumab, Therapeutic area: Oncology

Opinion/decision on a Paediatric investigation plan (PIP): -, Tremelimumab, Therapeutic area: Oncology

Europe - EFSA - European Food Safety Authority EFSA Journal

19-6-2018

Opinion/decision on a Paediatric investigation plan (PIP):    -, Veliparib, Therapeutic area: Oncology

Opinion/decision on a Paediatric investigation plan (PIP): -, Veliparib, Therapeutic area: Oncology

Europe - EFSA - European Food Safety Authority EFSA Journal

6-6-2018

Opinion/decision on a Paediatric investigation plan (PIP):    -, Quizartinib, Therapeutic area: Oncology

Opinion/decision on a Paediatric investigation plan (PIP): -, Quizartinib, Therapeutic area: Oncology

Europe - EFSA - European Food Safety Authority EFSA Journal

6-6-2018

Opinion/decision on a Paediatric investigation plan (PIP):    -, Binimetinib, Therapeutic area: Oncology

Opinion/decision on a Paediatric investigation plan (PIP): -, Binimetinib, Therapeutic area: Oncology

Europe - EFSA - European Food Safety Authority EFSA Journal

6-6-2018

Opinion/decision on a Paediatric investigation plan (PIP):    -, Encorafenib, Therapeutic area: Oncology

Opinion/decision on a Paediatric investigation plan (PIP): -, Encorafenib, Therapeutic area: Oncology

Europe - EFSA - European Food Safety Authority EFSA Journal

6-6-2018

Opinion/decision on a Paediatric investigation plan (PIP):    -, Erenumab, Therapeutic area: Neurology

Opinion/decision on a Paediatric investigation plan (PIP): -, Erenumab, Therapeutic area: Neurology

Europe - EFSA - European Food Safety Authority EFSA Journal

6-6-2018

Opinion/decision on a Paediatric investigation plan (PIP):    Rydapt, Midostaurin, Therapeutic area: Oncology

Opinion/decision on a Paediatric investigation plan (PIP): Rydapt, Midostaurin, Therapeutic area: Oncology

Europe - EFSA - European Food Safety Authority EFSA Journal

6-6-2018

Opinion/decision on a Paediatric investigation plan (PIP):    -, Selumetinib, Therapeutic area: Oncology

Opinion/decision on a Paediatric investigation plan (PIP): -, Selumetinib, Therapeutic area: Oncology

Europe - EFSA - European Food Safety Authority EFSA Journal

22-5-2018

May 21, 2018: Oncologist and Office Manager Sentenced in Connection with Administering Unapproved, Foreign Drugs

May 21, 2018: Oncologist and Office Manager Sentenced in Connection with Administering Unapproved, Foreign Drugs

May 21, 2018: Oncologist and Office Manager Sentenced in Connection with Administering Unapproved, Foreign Drugs

FDA - U.S. Food and Drug Administration

12-6-2015

CUG certificates for login to DKMAnet must be replaced

CUG certificates for login to DKMAnet must be replaced

The Danish Health and Medicines Authority has to replace the system used to issue Closed User Group (CUG) certificates to users of DKMAnet who cannot obtain a NemID employee certificate, i.e. primarily users employed in companies without a Danish CVR registration number. If you are currently using a CUG certificate of the old type to log in to DKMAnet, you must obtain a new certificate before 1 September 2015.

Danish Medicines Agency

14-12-2018

#ICYMI: @SGottliebFDA issued a statement on the #FDA’s new effort for  developing and class labeling of in vitro companion diagnostics for classes of oncology therapeutic products. Read the statement here:  https://go.usa.gov/xE3kk  #MedicalDevice

#ICYMI: @SGottliebFDA issued a statement on the #FDA’s new effort for developing and class labeling of in vitro companion diagnostics for classes of oncology therapeutic products. Read the statement here: https://go.usa.gov/xE3kk  #MedicalDevice

#ICYMI: @SGottliebFDA issued a statement on the #FDA’s new effort for developing and class labeling of in vitro companion diagnostics for classes of oncology therapeutic products. Read the statement here: https://go.usa.gov/xE3kk  #MedicalDevice

FDA - U.S. Food and Drug Administration

11-12-2018

Rubraca (Clovis Oncology Ireland Limited)

Rubraca (Clovis Oncology Ireland Limited)

Rubraca (Active substance: rucaparib) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)8686 of Tue, 11 Dec 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4272/T/5

Europe -DG Health and Food Safety

30-10-2018

EU/3/18/2071 (Loxo Oncology Limited)

EU/3/18/2071 (Loxo Oncology Limited)

EU/3/18/2071 (Active substance: 6-(2-hydroxy-2-methylpropoxy)-4-(6-(6-((6-methoxypyridin-3-yl)methyl)-3,6-diazabicyclo[3.1.1]heptan-3-yl)pyridin-3-yl)pyrazolo[1,5-a]pyridine-3-carbonitrile) - Orphan designation - Commission Decision (2018)7272 of Tue, 30 Oct 2018 European Medicines Agency (EMA) procedure number: EMA/OD/125/18

Europe -DG Health and Food Safety

29-5-2018

Rubraca (Clovis Oncology UK Limited)

Rubraca (Clovis Oncology UK Limited)

Rubraca (Active substance: rucaparib) - Centralised - Authorisation - Commission Decision (2018)3344 of Tue, 29 May 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4272

Europe -DG Health and Food Safety

15-5-2018

Pemetrexed Fresenius Kabi (Fresenius Kabi Oncology Plc.)

Pemetrexed Fresenius Kabi (Fresenius Kabi Oncology Plc.)

Pemetrexed Fresenius Kabi (Active substance: pemetrexed) - Centralised - Yearly update - Commission Decision (2018)3060 of Tue, 15 May 2018

Europe -DG Health and Food Safety

23-3-2018

EU/3/18/1995 (Loxo Oncology Limited)

EU/3/18/1995 (Loxo Oncology Limited)

EU/3/18/1995 (Active substance: Larotrectinib) - Orphan designation - Commission Decision (2018)1884 of Fri, 23 Mar 2018 European Medicines Agency (EMA) procedure number: EMA/OD/213/17

Europe -DG Health and Food Safety

21-3-2018

Accesso alle terapie con farmaci biologici: i fenomeni di sottotrattamento e le opportunità offerte dai biosimilari

Accesso alle terapie con farmaci biologici: i fenomeni di sottotrattamento e le opportunità offerte dai biosimilari

I farmaci biologici costituiscono un’arma importante per superare il problema del sottotrattamento e rendere disponibili terapie a un numero sempre maggiore di pazienti, in particolare nelle aree dell’oncologia, reumatologia, gastroenterologia e dermatologia.

Italia - AIFA - Agenzia Italiana del Farmaco