Methotrexat Teva Onco 5 mg/2 ml

Informazioni principali

  • Nome commerciale:
  • Methotrexat Teva Onco 5 mg/2 ml Lösung zur parenteralen Anwendung
  • Forma farmaceutica:
  • Lösung zur parenteralen Anwendung
  • Composizione:
  • methotrexatum 5 mg, natrii chloridum, aqua ad iniectabilia q s. annuncio solutionem pro 2 ml.
  • Utilizzare per:
  • Esseri umani
  • Tipo di medicina:
  • Farmaco biologico

Documenti

  • per il pubblico:
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Localizzazione

  • Disponibile in:
  • Methotrexat Teva Onco 5 mg/2 ml Lösung zur parenteralen Anwendung
    Svizzera
  • Lingua:
  • italiano

Informazioni terapeutiche

  • Gruppo terapeutico:
  • Synthetika
  • Area terapeutica:
  • Zytostatikum

Altre informazioni

Status

  • Fonte:
  • Swissmedic - Swiss Agency for Therapeutic Products
  • Numero dell'autorizzazione:
  • 47999
  • Data dell'autorizzazione:
  • 23-10-1987
  • Ultimo aggiornamento:
  • 19-10-2018
  • 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.



  • Documenti in altre lingue sono disponibili qui

21-12-2018

One lot of Equate brand Lens Care System and Multi-Purpose Solution voluntarily recalled because of a labelling error

One lot of Equate brand Lens Care System and Multi-Purpose Solution voluntarily recalled because of a labelling error

Teva Canada is voluntarily recalling one lot (Lot 150261) of two products because of a labelling error. While the outer carton of Equate brand Lens Care System is correctly labelled, the bottle within the carton is mislabelled as Equate brand Multi-Purpose Solution. Because of the labelling error, the company is recalling both products labelled with Lot 150261. Bottles labelled as Equate Multi-Purpose Solution should contain a 0.0001% w/v polyhexanide based disinfecting solution for rinsing. The mislabel...

Health Canada

17-12-2018

Teva Canada Product Recall (2018-12-17)

Teva Canada Product Recall (2018-12-17)

Health Canada

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

27-11-2018

Teva Pharmaceuticals USA Issues Voluntary Nationwide Recall of All Amlodipine/Valsartan Combination Tablets and Amlodipine/Valsartan/Hydrochlorothiazide Combination Tablets That Are Within Expiry

Teva Pharmaceuticals USA Issues Voluntary Nationwide Recall of All Amlodipine/Valsartan Combination Tablets and Amlodipine/Valsartan/Hydrochlorothiazide Combination Tablets That Are Within Expiry

Teva Pharmaceuticals has initiated a voluntary recall in the United States, to the patient level, of all lots of Amlodipine / Valsartan combination tablets and Amlodipine / Valsartan / Hydrochlorothiazide combination tablets (see table below) due to an impurity detected above specification limits in an active pharmaceutical ingredient (API) manufactured by Mylan India. The impurity found in Mylan’s valsartan API is known as N-nitroso-diethylamine (NDEA), which has been classified as a probable human carc...

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

23-11-2018

Teva Canada Product Recall (2018-11-23)

Teva Canada Product Recall (2018-11-23)

Health Canada

17-10-2018

Applicability of in silico tools for the prediction of dermal absorption for pesticides

Applicability of in silico tools for the prediction of dermal absorption for pesticides

Published on: Tue, 16 Oct 2018 00:00:00 +0200 Based on the “Human in vitro dermal absorption datasets” published as supporting information to the revised EFSA Guidance on Dermal Absorption, in silico models for prediction of absorption across the skin have been evaluated. For this evaluation, a systematic literature search and review was performed, identifying 288 publications describing mathematical models for prediction of dermal absorption. Eleven models potentially relevant to the regulatory assessm...

Europe - EFSA - European Food Safety Authority Publications

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

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

17-7-2018

Teva Pharmaceuticals USA Issues Voluntary Nationwide Recall of Valsartan and Valsartan Hydrochlorothiazide Tablets

Teva Pharmaceuticals USA Issues Voluntary Nationwide Recall of Valsartan and Valsartan Hydrochlorothiazide Tablets

Teva Pharmaceuticals USA today confirmed a voluntary recall to the consumer / user level of 29 lots of single and 51 lots of combination valsartan medicines distributed under the Actavis label in the U.S. due to the detection of trace amounts of an unexpected impurity found in an active pharmaceutical ingredient (API) manufactured by Zhejiang Huahai Pharmaceutical. The impurity detected in the API is N- nitrosodimethylamine (NDMA), which is a substance that occurs naturally in certain foods, drinking wat...

FDA - U.S. Food and Drug Administration

16-7-2018

Major Pharmaceuticals Issues Voluntary Nationwide Recall of Valsartan Due to The Potential Presence of a Probable Carcinogen (NDMA)

Major Pharmaceuticals Issues Voluntary Nationwide Recall of Valsartan Due to The Potential Presence of a Probable Carcinogen (NDMA)

As a precautionary measure, the distribution firm, Major Pharmaceuticals, is issuing a nationwide voluntary recall of all lots within expiry of Valsartan which were supplied by Teva Pharmaceuticals and labeled as Major Pharmaceuticals.

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

29-6-2018

Medicines Safety Update, Volume 9, Number 2, June 2018

Medicines Safety Update, Volume 9, Number 2, June 2018

Oral methotrexate dosing, medicines associated with a risk of neuropsychiatric adverse events, and clozapine and gastrointestinal effects

Therapeutic Goods Administration - Australia

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):    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

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

14-12-2018

Desloratadine Teva (Teva B.V.)

Desloratadine Teva (Teva B.V.)

Desloratadine Teva (Active substance: desloratadine) - Centralised - Yearly update - Commission Decision (2018)8912 of Fri, 14 Dec 2018

Europe -DG Health and Food Safety

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

30-11-2018

Pioglitazone Teva (Teva B.V.)

Pioglitazone Teva (Teva B.V.)

Pioglitazone Teva (Active substance: pioglitazone) - Centralised - Yearly update - Commission Decision (2018)8159 of Fri, 30 Nov 2018

Europe -DG Health and Food Safety

30-11-2018

Pioglitazone Teva Pharma (Teva B.V.)

Pioglitazone Teva Pharma (Teva B.V.)

Pioglitazone Teva Pharma (Active substance: pioglitazone) - Centralised - Yearly update - Commission Decision (2018)8158 of Fri, 30 Nov 2018

Europe -DG Health and Food Safety

26-11-2018

Kentera (Teva B.V.)

Kentera (Teva B.V.)

Kentera (Active substance: Oxybutynin) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)7967 of Mon, 26 Nov 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/532/T/49

Europe -DG Health and Food Safety

14-11-2018

Clopidogrel ratiopharm (Teva B.V.)

Clopidogrel ratiopharm (Teva B.V.)

Clopidogrel ratiopharm (Active substance: clopidogrel) - Centralised - Yearly update - Commission Decision (2018)7602 of Wed, 14 Nov 2018

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

22-10-2018

Irbesartan / Hydrochlorothiazide Teva (Teva B.V.)

Irbesartan / Hydrochlorothiazide Teva (Teva B.V.)

Irbesartan / Hydrochlorothiazide Teva (Active substance: irbesartan / hydrochlorothiazide) - Centralised - Yearly update - Commission Decision (2018) 6974 of Mon, 22 Oct 2018

Europe -DG Health and Food Safety

2-10-2018

Lamivudine Teva Pharma B.V. (Teva B.V.)

Lamivudine Teva Pharma B.V. (Teva B.V.)

Lamivudine Teva Pharma B.V. (Active substance: Lamivudine) - Centralised - Yearly update - Commission Decision (2018)6476 of Tue, 02 Oct 2018

Europe -DG Health and Food Safety

2-10-2018

Docetaxel Teva (Teva B.V.)

Docetaxel Teva (Teva B.V.)

Docetaxel Teva (Active substance: Docetaxel) - Centralised - Yearly update - Commission Decision (2018)6463 of Tue, 02 Oct 2018

Europe -DG Health and Food Safety

2-10-2018

Zoledronic acid Teva (Teva B.V.)

Zoledronic acid Teva (Teva B.V.)

Zoledronic acid Teva (Active substance: zoledronic acid) - Centralised - Yearly update - Commission Decision (2018)6466 of Tue, 02 Oct 2018

Europe -DG Health and Food Safety

24-9-2018

Cinqaero (Teva B.V.)

Cinqaero (Teva B.V.)

Cinqaero (Active substance: reslizumab) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)6218 of Mon, 24 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/3912T/18

Europe -DG Health and Food Safety

1-8-2018

Temozolomide Teva (Teva B.V.)

Temozolomide Teva (Teva B.V.)

Temozolomide Teva (Active substance: temozolomide) - Centralised - Yearly update - Commission Decision (2018)5214 of Wed, 01 Aug 2018

Europe -DG Health and Food Safety

30-7-2018

Rasagiline ratiopharm (Teva B.V.)

Rasagiline ratiopharm (Teva B.V.)

Rasagiline ratiopharm (Active substance: rasagiline) - Centralised - Yearly update - Commission Decision (2018)5108 of Mon, 30 Jul 2018

Europe -DG Health and Food Safety

11-7-2018

Concorsi AIFA 2018 - Diario delle prove scritte

Concorsi AIFA 2018 - Diario delle prove scritte

L'Agenzia Italiana del Farmaco comunica il diario delle prove scritte relative ai Concorsi AIFA 2018.

Italia - AIFA - Agenzia Italiana del Farmaco

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