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1-6-2018

SunMed Holdings, LLC Issues a Nationwide Recall of STAT-Check and Medline Manual Resuscitator Bags

SunMed Holdings, LLC Issues a Nationwide Recall of STAT-Check and Medline Manual Resuscitator Bags

On May 29, 2018, SunMed Holdings, LLC initiated a nationwide recall of 18,808 units of STAT-Check and Medline resuscitator bags which were distributed between February 1, 2018 to May 13, 2018. The patient port retaining ring of the affected bags may not fully seat which may allow the patient port to detach during use. If this takes place, the resuscitator bags may not deliver air to the patient and result in a delay in treatment and life-threatening health consequences. There have been no reported injuri...

FDA - U.S. Food and Drug Administration

25-5-2018

Orphan designation:  Treprostinil sodium,  for the: Treatment of chronic thromboembolic pulmonary hypertension

Orphan designation: Treprostinil sodium, for the: Treatment of chronic thromboembolic pulmonary hypertension

On 8 February 2013, orphan designation (EU/3/13/1103) was granted by the European Commission to SciPharm S.a.r.L, Luxembourg, for treprostinil sodium for the treatment of chronic thromboembolic pulmonary hypertension.

Europe - EMA - European Medicines Agency

20-3-2018

Medicines Safety Update, Volume 9, Number 1, February-March 2018

Medicines Safety Update, Volume 9, Number 1, February-March 2018

First-generation oral sedating antihistamines – use in children, Suvorexant (Belsomra) – next day effects, Desvenlafaxine (Pristiq) recommended dose, Miconazole and potential interaction with warfarin

Therapeutic Goods Administration - Australia

1-3-2018

All marketing authorisation letters are now sent electronically to Danish companies

All marketing authorisation letters are now sent electronically to Danish companies

On 20 February 2018, the Danish Medicines Agency extended its use of digital post and now sends all letters, and not just decisions, about marketing authorisations electronically to Danish companies.

Danish Medicines Agency

28-2-2018

Enforcement Report for the Week of February 28, 2018

Enforcement Report for the Week of February 28, 2018

FDA - U.S. Food and Drug Administration

21-2-2018

Enforcement Report for the Week of February 21, 2018

Enforcement Report for the Week of February 21, 2018

FDA - U.S. Food and Drug Administration

14-2-2018

Enforcement Report for the Week of February 14, 2018

Enforcement Report for the Week of February 14, 2018

FDA - U.S. Food and Drug Administration

7-2-2018

Enforcement Report for the Week of February 07, 2018

Enforcement Report for the Week of February 07, 2018

FDA - U.S. Food and Drug Administration

6-3-2017

Danish Pharmacovigilance Update, February 2017

Danish Pharmacovigilance Update, February 2017

The February issue of Danish Pharmacovigilance Update.

Danish Medicines Agency

22-2-2017

Enforcement Report for the Week of February 22, 2017

Enforcement Report for the Week of February 22, 2017

FDA - U.S. Food and Drug Administration

15-2-2017

Enforcement Report for the Week of February 15, 2017

Enforcement Report for the Week of February 15, 2017

FDA - U.S. Food and Drug Administration

8-2-2017

Enforcement Report for the Week of February 08, 2017

Enforcement Report for the Week of February 08, 2017

FDA - U.S. Food and Drug Administration

1-2-2017

Enforcement Report for the Week of February 01, 2017

Enforcement Report for the Week of February 01, 2017

FDA - U.S. Food and Drug Administration

31-1-2017

We are extending our opening hours

We are extending our opening hours

From Wednesday 1 February 2017, we are extending our opening hours. This means that the reception will be open Monday to Friday from 8.30am to 3.30pm. You can also call us on our main telephone number during these hours.

Danish Medicines Agency

9-3-2016

Danish Pharmacovigilance Update, February 2016

Danish Pharmacovigilance Update, February 2016

The February issue of Danish Pharmacovigilance Update with news from the EU, the DKMA and short news.

Danish Medicines Agency

24-2-2016

Enforcement Report for the Week of February 24, 2016

Enforcement Report for the Week of February 24, 2016

FDA - U.S. Food and Drug Administration

17-2-2016

Enforcement Report for the Week of February 17, 2016

Enforcement Report for the Week of February 17, 2016

FDA - U.S. Food and Drug Administration

10-2-2016

Enforcement Report for the Week of February 10, 2016

Enforcement Report for the Week of February 10, 2016

FDA - U.S. Food and Drug Administration

3-2-2016

Enforcement Report for the Week of February 03, 2016

Enforcement Report for the Week of February 03, 2016

FDA - U.S. Food and Drug Administration

16-3-2015

Danish Pharmacovigilance Update, February 2015

Danish Pharmacovigilance Update, February 2015

The February issue of Danish Pharmacovigilance Update with news from the EU, the DHMA and short news.

Danish Medicines Agency

25-2-2015

Enforcement Report for the Week of February 25, 2015

Enforcement Report for the Week of February 25, 2015

FDA - U.S. Food and Drug Administration

18-2-2015

Enforcement Report for the Week of February 18, 2015

Enforcement Report for the Week of February 18, 2015

FDA - U.S. Food and Drug Administration

11-2-2015

Enforcement Report for the Week of February 11, 2015

Enforcement Report for the Week of February 11, 2015

FDA - U.S. Food and Drug Administration

4-2-2015

Enforcement Report for the Week of February 04, 2015

Enforcement Report for the Week of February 04, 2015

FDA - U.S. Food and Drug Administration

3-2-2015

New director at the DHMA

New director at the DHMA

On 1 February 2015, Anne-Marie Vangsted, Acting Head of Division, took up the position as Director with responsibility for supervision at the Danish Health and Medicines Authority. The new position as director was created as part of our action plan aimed at modernising the supervisory function, in which Anne-Marie Vangsted has played a key role since we presented the plan on 15 September 2014.

Danish Medicines Agency

21-1-2015

Consultation on transparency in clinical trials

Consultation on transparency in clinical trials

The European Medicines Agency (EMA) has launched a public consultation on how to implement the transparency requirements of the new EU Clinical Trials Regulation. Deadline on 18 February.

Danish Medicines Agency

1-4-2014

Danish Pharmacovigilance Update 27 February 2014

Danish Pharmacovigilance Update 27 February 2014

In this issue of Danish Pharmacovigilance Update: Further restrictions on the use of osteoporosis medicine strontium ranelate (Protelos®), Anticoagulant therapy to be stopped before initiating treatment with the new oral anticoagulants (NOACs).

Danish Medicines Agency

26-2-2014

Enforcement Report for the Week of February 26, 2014

Enforcement Report for the Week of February 26, 2014

FDA - U.S. Food and Drug Administration

19-2-2014

Enforcement Report for the Week of February 19, 2014

Enforcement Report for the Week of February 19, 2014

FDA - U.S. Food and Drug Administration

12-2-2014

Enforcement Report for the Week of February 12, 2014

Enforcement Report for the Week of February 12, 2014

FDA - U.S. Food and Drug Administration

5-2-2014

Enforcement Report for the Week of February 05, 2014

Enforcement Report for the Week of February 05, 2014

FDA - U.S. Food and Drug Administration

25-4-2013

Danish Pharmacovigilance Update, 21 February 2013

Danish Pharmacovigilance Update, 21 February 2013

In this issue of Danish Pharmacovigilance Update: Cardiovascular monitoring when initiating and re-initiating treatment with fingolimod (Gilenya®).

Danish Medicines Agency

27-2-2013

Enforcement Report for the Week of February 27, 2013

Enforcement Report for the Week of February 27, 2013

FDA - U.S. Food and Drug Administration

20-2-2013

Enforcement Report for the Week of February 20, 2013

Enforcement Report for the Week of February 20, 2013

FDA - U.S. Food and Drug Administration

13-2-2013

Enforcement Report for the Week of February 13, 2013

Enforcement Report for the Week of February 13, 2013

FDA - U.S. Food and Drug Administration

6-2-2013

Enforcement Report for the Week of February 06, 2013

Enforcement Report for the Week of February 06, 2013

FDA - U.S. Food and Drug Administration

5-3-2012

Danish Pharmacovigilance Update, 16 February 2012

Danish Pharmacovigilance Update, 16 February 2012

Among the topics covered in this issue of Danish Pharmacovigilance Update are: Risk of overdose with methotrexate in the treatment of rheumatoid arthritis as well as intensified monitoring of heart rate and blood pressure in connection with treatment with Gilenya.

Danish Medicines Agency

1-3-2012

Enforcement Report for the Week of February 29 2012

Enforcement Report for the Week of February 29 2012

FDA - U.S. Food and Drug Administration

23-2-2012

Enforcement Report for the Week of February 22, 2012

Enforcement Report for the Week of February 22, 2012

FDA - U.S. Food and Drug Administration

15-2-2012

Enforcement Report for the Week of February 15, 2012

Enforcement Report for the Week of February 15, 2012

FDA - U.S. Food and Drug Administration

9-2-2012

Enforcement Report for the Week of February 8, 2012

Enforcement Report for the Week of February 8, 2012

FDA - U.S. Food and Drug Administration

11-3-2010

Strengthened warning against Alscreme 'Creme  nr. 2' from www.eminescu.dk

Strengthened warning against Alscreme 'Creme nr. 2' from www.eminescu.dk

On 12 February 2010, the Danish Medicines Agency warned strongly against using the product Alscreme 'Creme nr. 2' sold via www.eminescu.dk, as the product is an unlicensed medicinal product that contains active substance clobetasol.

Danish Medicines Agency

25-5-2018

ACV meeting statement, Meeting 6, 7 February 2018

ACV meeting statement, Meeting 6, 7 February 2018

Advisory Committee on Vaccines meeting statement

Therapeutic Goods Administration - Australia

16-5-2018

 Minutes - PDCO minutes of the 20-23 February 2018 meeting

Minutes - PDCO minutes of the 20-23 February 2018 meeting

Europe - EMA - European Medicines Agency

15-5-2018

 Minutes of the COMP meeting of 13-15 February 2018

Minutes of the COMP meeting of 13-15 February 2018

Europe - EMA - European Medicines Agency

2-5-2018

 Minutes of the CAT meeting 15-16 February 2018

Minutes of the CAT meeting 15-16 February 2018

Europe - EMA - European Medicines Agency

8-2-2018

Human medicines highlights - February 2018

Human medicines highlights - February 2018

This newsletter is addressed primarily to organisations representing patients, consumers and healthcare professionals. It provides a summary of key information relating to medicines for human use published during the previous month by the European Medicines Agency.

Europe - EMA - European Medicines Agency