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18-12-2017

News on dose dispensing of medicinal products

News on dose dispensing of medicinal products

The Danish executive order on dose dispensing of medicinal products has been updated. Based on the update, the storage period is among other thing extended from 4 to 6 weeks for medicinal products approved for dose dispensing.

Danish Medicines Agency

27-10-2017

Keep up with the latest updates on our website

Keep up with the latest updates on our website

Now you can keep up with all updates on the Danish Medicines Agency's website and not only our news items. You can filter the overview by category and month, and the overview is structured in chronological order with the latest update first. You can find a shortcut to the overview on our home page.

Danish Medicines Agency

3-6-2016

Danish Pharmacovigilance Update, May 2016

Danish Pharmacovigilance Update, May 2016

The May issue of Danish Pharmacovigilance Update with news from the EU.

Danish Medicines Agency

10-5-2016

Danish Pharmacovigilance Update, April 2016

Danish Pharmacovigilance Update, April 2016

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

Danish Medicines Agency

25-4-2016

Danish Pharmacovigilance Update, March 2016

Danish Pharmacovigilance Update, March 2016

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

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

10-2-2016

Danish Pharmacovigilance Update, January 2016

Danish Pharmacovigilance Update, January 2016

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

Danish Medicines Agency

8-1-2016

Danish Pharmacovigilance Update, December 2015

Danish Pharmacovigilance Update, December 2015

The December issue of Danish Pharmacovigilance Update with news from the EU, the Danish Medicines Agency and short news.

Danish Medicines Agency

4-1-2016

The Danish Medicines Agency has a new website

The Danish Medicines Agency has a new website

Today, the Danish Medicines Agency launched its new website – laegemiddelstyrelsen.dk/en – where you can read about and subscribe to news about licensing and supervision of medicines, side effects, reimbursement, pharmacies and medical devices.

Danish Medicines Agency

8-12-2015

Danish Pharmacovigilance Update, November 2015

Danish Pharmacovigilance Update, November 2015

The November issue of Danish Pharmacovigilance Update with news from the EU, the Danish Medicines Agency and short news.

Danish Medicines Agency

12-11-2015

Danish Pharmacovigilance Update, October 2015

Danish Pharmacovigilance Update, October 2015

The October issue of Danish Pharmacovigilance Update with news from the EU, the Danish Medicines Agency and short news.

Danish Medicines Agency

7-10-2015

Danish Pharmacovigilance Update, September 2015

Danish Pharmacovigilance Update, September 2015

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

Danish Medicines Agency

15-9-2015

Danish Pharmacovigilance Update, August 2015

Danish Pharmacovigilance Update, August 2015

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

Danish Medicines Agency

14-7-2015

Danish Pharmacovigilance Update, June 2015

Danish Pharmacovigilance Update, June 2015

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

Danish Medicines Agency

9-6-2015

Danish Pharmacovigilance Update, May 2015

Danish Pharmacovigilance Update, May 2015

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

Danish Medicines Agency

8-5-2015

Danish Pharmacovigilance Update, April 2015

Danish Pharmacovigilance Update, April 2015

The April issue of Danish Pharmacovigilance Update with news from the EU, the DHMA and short news:

Danish Medicines Agency

10-4-2015

Danish Pharmacovigilance Update, March 2015

Danish Pharmacovigilance Update, March 2015

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

Danish Medicines Agency

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

10-2-2015

Danish Pharmacovigilance Update, January 2015

Danish Pharmacovigilance Update, January 2015

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

Danish Medicines Agency

12-1-2015

Danish Pharmacovigilance Update, December 2014

Danish Pharmacovigilance Update, December 2014

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

Danish Medicines Agency

2-12-2014

Danish Pharmacovigilance Update, November 2014

Danish Pharmacovigilance Update, November 2014

Five years ago, we issued Danish Pharmacovigilance Update for the first time. We are delighted to celebrate the newsletter's fifth anniversary with more than 3,000 subscribers to the Danish and the English version, and we hope the interest in Danish Pharmacovigilance Update will continue to grow. You can sign up for the newsletter on our website under News. Among the articles in this issue, you can read about how we have developed the pharmacovigilance activities in the recent years.

Danish Medicines Agency

9-5-2014

Updated guidelines on requirements for the QP in a pharmaceutical company

Updated guidelines on requirements for the QP in a pharmaceutical company

The Danish Health and Medicines Authority has updated the guidelines on requirements and expectations for the qualified person (QP) in a pharmaceutical company. The requirements for the QP have not been changed compared to the previous guidelines. The new guidelines have mainly been updated to include the requirements for the duration of the QP's education as specified in the applicable directives. In addition, a number of other updates and specifications have been made that you can read more about in th...

Danish Medicines Agency

22-6-2018

News Release: #FDA permits marketing of first catheter-based systems used to create vascular access for hemodialysis patients  https://go.usa.gov/xUqu9  #medicaldevice

News Release: #FDA permits marketing of first catheter-based systems used to create vascular access for hemodialysis patients https://go.usa.gov/xUqu9  #medicaldevice

News Release: #FDA permits marketing of first catheter-based systems used to create vascular access for hemodialysis patients https://go.usa.gov/xUqu9  #medicaldevice

FDA - U.S. Food and Drug Administration

22-6-2018

News and press releases:  Committee for Medicinal Products for Veterinary Use (CVMP) meeting of 19–21 June 2018

News and press releases: Committee for Medicinal Products for Veterinary Use (CVMP) meeting of 19–21 June 2018

First stem cell-based veterinary medicine recommended for marketing authorisation

Europe - EMA - European Medicines Agency

22-6-2018

News and press releases:  Reinforced EU/US collaboration on medicines

News and press releases: Reinforced EU/US collaboration on medicines

Update on the European Commission/EMA–FDA bilateral of 18-19 June 2018

Europe - EMA - European Medicines Agency

22-6-2018

News and press releases:  First stem cell-based veterinary medicine recommended for marketing authorisation

News and press releases: First stem cell-based veterinary medicine recommended for marketing authorisation

Arti-Cell Forte is indicated in horses with mild to moderate lameness due to joint inflammation

Europe - EMA - European Medicines Agency

21-6-2018

News and press releases:  Interested in joining the Committee for Advanced Therapies (CAT) to represent patients’ associations or clinicians?

News and press releases: Interested in joining the Committee for Advanced Therapies (CAT) to represent patients’ associations or clinicians?

Call for expressions of interest open until 18 July 2018

Europe - EMA - European Medicines Agency

19-6-2018

News and press releases:  Modernising the orphan designation process

News and press releases: Modernising the orphan designation process

EMA launches new submission portal today

Europe - EMA - European Medicines Agency

19-6-2018

News and press releases:  Guidance for pharmaceutical companies to prepare for UK’s withdrawal from EU

News and press releases: Guidance for pharmaceutical companies to prepare for UK’s withdrawal from EU

Publication of updated Q+As and practical guidance

Europe - EMA - European Medicines Agency

15-6-2018

News and press releases:  Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 11-14 June 2018

News and press releases: Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 11-14 June 2018

PRAC held public hearing on quinolone and fluoroquinolone antibiotics

Europe - EMA - European Medicines Agency

14-6-2018

News and press releases:  IT systems unavailable from 15 to 18 June 2018

News and press releases: IT systems unavailable from 15 to 18 June 2018

EMA website and online applications will be temporarily unavailable

Europe - EMA - European Medicines Agency

7-6-2018

News and press releases:  Highlights of 100th Management Board meeting: June 2018

News and press releases: Highlights of 100th Management Board meeting: June 2018

Positive assessment of 2017 operations - Seat Agreement with the Netherlands signed

Europe - EMA - European Medicines Agency

7-6-2018

News and press releases:  Changes to submission and assessment of maximum residue limits of veterinary medicines in foods

News and press releases: Changes to submission and assessment of maximum residue limits of veterinary medicines in foods

Three new implementing regulations replace current guidance

Europe - EMA - European Medicines Agency

7-6-2018

News and press releases:  Public hearing on quinolones and fluoroquinolones: 23 speakers from 11 EU countries to share experience

News and press releases: Public hearing on quinolones and fluoroquinolones: 23 speakers from 11 EU countries to share experience

Agenda and list of speakers for 13 June hearing available

Europe - EMA - European Medicines Agency

6-6-2018

News and press releases:  Towards improved safety monitoring of veterinary medicines

News and press releases: Towards improved safety monitoring of veterinary medicines

Companies are encouraged to report all suspected side effects in EudraVigilance Veterinary

Europe - EMA - European Medicines Agency

1-6-2018

News and press releases:  Two more EU Member States benefit from EU-US mutual recognition agreement for inspections

News and press releases: Two more EU Member States benefit from EU-US mutual recognition agreement for inspections

Agreement now operational between 14 EU Member States and FDA

Europe - EMA - European Medicines Agency

1-6-2018

News and press releases:  Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 28-31 May 2018

News and press releases: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 28-31 May 2018

Nine medicines recommended for approval, including two orphans

Europe - EMA - European Medicines Agency

1-6-2018

News and press releases:  First monoclonal antibody therapy for prevention of migraine

News and press releases: First monoclonal antibody therapy for prevention of migraine

Aimovig recommended for marketing authorisation

Europe - EMA - European Medicines Agency

1-6-2018

News and press releases:  New medicine for hereditary rare disease

News and press releases: New medicine for hereditary rare disease

Tegsedi addresses unmet medical need for treatment of hereditary transthyretin amyloidosis

Europe - EMA - European Medicines Agency

1-6-2018

News and press releases:  Esmya: new measures to minimise risk of rare but serious liver injury

News and press releases: Esmya: new measures to minimise risk of rare but serious liver injury

EMA concludes review of medicine for uterine fibroids

Europe - EMA - European Medicines Agency

1-6-2018

News and press releases:  EMA restricts use of Keytruda and Tecentriq in bladder cancer

News and press releases: EMA restricts use of Keytruda and Tecentriq in bladder cancer

Data show lower survival in some patients with low levels of cancer protein PD-L1

Europe - EMA - European Medicines Agency

29-5-2018

News and press releases:  Construction of new EMA building in Amsterdam on track

News and press releases: Construction of new EMA building in Amsterdam on track

Foundation stone-laying ceremony takes place at Zuidas

Europe - EMA - European Medicines Agency

28-5-2018

News and press releases:  Committee for Medicinal Products for Veterinary Use (CVMP) meeting of 23–25 May 2018

News and press releases: Committee for Medicinal Products for Veterinary Use (CVMP) meeting of 23–25 May 2018

New vaccine to reduce the incidence of intramammary infections in cows/heifers recommended for approval

Europe - EMA - European Medicines Agency

24-5-2018

News and press releases:  Development of antibiotics for children - towards a global approach

News and press releases: Development of antibiotics for children - towards a global approach

Workshop with regulators from EU, Japan and US open for registration

Europe - EMA - European Medicines Agency

22-5-2018

News and press releases:  Working together for people with rare and complex diseases

News and press releases: Working together for people with rare and complex diseases

Live broadcast of workshop with European Reference Networks on 29 May

Europe - EMA - European Medicines Agency

18-5-2018

News and press releases:  Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 14-17 May 2018

News and press releases: Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 14-17 May 2018

PRAC concludes two referrals, maintains recommendation on HES solutions for infusion and issues precautionary advice on HIV medicine

Europe - EMA - European Medicines Agency

18-5-2018

News and press releases:  PRAC recommends new measures to minimise risk of rare but serious liver injury with Esmya for fibroids

News and press releases: PRAC recommends new measures to minimise risk of rare but serious liver injury with Esmya for fibroids

Regular liver function testing required during treatment

Europe - EMA - European Medicines Agency

18-5-2018

News and press releases:  EMA review of Zinbryta confirms medicine’s risks outweigh its benefits

News and press releases: EMA review of Zinbryta confirms medicine’s risks outweigh its benefits

Multiple sclerosis medicine no longer authorised and has been recalled from hospitals and pharmacies

Europe - EMA - European Medicines Agency

18-5-2018

News and press releases:  New study suggests risk of birth defects in babies born to women on HIV medicine dolutegravir

News and press releases: New study suggests risk of birth defects in babies born to women on HIV medicine dolutegravir

While EMA review is ongoing, dolutegravir should not be used in women seeking to become pregnant

Europe - EMA - European Medicines Agency

18-5-2018

News and press releases:  European Medicines Agency closed 21 May 2018

News and press releases: European Medicines Agency closed 21 May 2018

EMA closed from 18:30 on Friday 18 May until 7:30 on Tuesday 22 May 2018

Europe - EMA - European Medicines Agency

7-5-2018

News and press releases:  Two years of PRIME

News and press releases: Two years of PRIME

Driving innovation to where it is most needed

Europe - EMA - European Medicines Agency

7-5-2018

News and press releases:  European Medicines Agency closed 9-11 May 2018

News and press releases: European Medicines Agency closed 9-11 May 2018

EMA closed from 18:30 on Tuesday 8 May until 7:30 on Monday 14 May 2018

Europe - EMA - European Medicines Agency

2-5-2018

News and press releases:  EMA 2017 annual report published

News and press releases: EMA 2017 annual report published

Report highlights major achievements and includes key figures

Europe - EMA - European Medicines Agency

30-4-2018

News and press releases:  Update of EU recommendations for 2018/2019 seasonal flu vaccine composition

News and press releases: Update of EU recommendations for 2018/2019 seasonal flu vaccine composition

Update to recommendations issued in March 2018

Europe - EMA - European Medicines Agency

30-4-2018

News and press releases:  Civil society representatives wanted for EMA's Management Board and Pharmacovigilance Committee

News and press releases: Civil society representatives wanted for EMA's Management Board and Pharmacovigilance Committee

Submission deadline is 8 June 2018

Europe - EMA - European Medicines Agency