Periodic safety update reports (PSURs) | European Medicines Agency

Periodic safety update reports (PSURs) | European Medicines Agency

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Periodic safety update reports (PSURs) | European Medicines Agency

The list does not include substances assessed at national level, although their PSURs must nonetheless be submitted via the PSUR repository. For these active ...

Fees for Periodic Safety Update Reports submission of Veterinary ...

If it is not credited the correct amount. (rounding - up or down - are not acceptable), the submission will be invalidated. NATIONAL PROCEDURE: - Fee for ...

European Medicines Agency (EMA) - europa.eu

The United Kingdom (UK) withdrew from the European Union (EU) on 31 January 2020 and is no longer an EU Member State. EMA is in the process of making ...

European Medicines Agency - Europa.eu

The United Kingdom (UK) withdrew from the European Union (EU) on 31 January 2020 and is no longer an EU Member State. EMA is in the process of making ...

Variations | European Medicines Agency

EMA is in the process of making appropriate changes to this website. If the site still contains content that does not yet reflect the withdrawal of the UK from the EU, ...

Picato | European Medicines Agency

30 Apr 2020 ... The review looked at results of a study comparing Picato with imiquimod (another medicine for actinic keratosis). After 3 years, 6.3% of patients ...

Periodic reports - H2020 Online Manual - European Commission

... of the periodic report and download the reporting template for previewing the ... Exceptionally, the Commission may approve costs related to subcontracts not ...

Duloxetine Zentiva | European Medicines Agency

20 Aug 2015 ... It explains how the Agency assessed the medicine to recommend its authorisation in the EU and its conditions of use. It is not intended to provide ...

apomorphine hydrochloride - European Medicines Agency

16 Feb 2006 ... for the treatment of off-periods in Parkinson's disease not responding to oral treatment ... E-mail: [email protected]. Lega Italiana ...

Entresto, INN-sacubitril/valsartan - European Medicines Agency

Down-titration should be considered in patients who develop a clinically significant decrease in renal function. Hyperkalaemia. Treatment should not be initiated ...

PhVWP Monthly Report Sep 2010 - European Medicines Agency

30 Sep 2010 ... not be administered orally and adverse reactions arising from the ... adverse reaction of unknown frequency in section 4.8 and also listed in the PL, reflecting the available ... Recreational abuse with benzydamine hydrochloride (tantum rosa). ... Tamoxifen is extensively broken down in the body through the ...

Notifying a change of marketing status | European Medicines Agency

... from the market and withdrawal of a marketing authorisation, in the context of the implementation of Directive 2012/26/EU and Regulation (EU) No 1027/2012 ...

Leflunomide medac, INN-leflunomide - European Medicines Agency

30 May 2013 ... Leflunomide medac 15 mg film-coated tablets only differ ... Annex(es) ... 847/2000, the applicant did not submit a critical report addressing the possible ... to down-titrate to the 10 mg (the lowest dose available) strength (SmPC ...

National registers of authorised medicines | European Medicines ...

Please note that the information in these national registers may not be available in English. ... Netherlands. https://www.geneesmiddeleninformatiebank.nl/en.

Home - EMSA - European Maritime Safety Agency

Based in Lisbon, EMSA provid ... ... EMSA Videos. watch more videos ... Your browser does not currently recognize any of the video formats available. Click here ...

European Aviation Safety Agency Certification Specifications for ...

3 May 2020 ... training where a complete flight deck/cockpit environment is not necessary. (g) 'Flight ... For FNPT use in multi-crew cooperation (MCC) training the general technical ... capable of meeting the standards laid down in Parts (b).

IAEA Safety Standards Periodic Safety Review for ... - Publications

Periodic safety review for nuclear power plants : specific safety guide. — Vienna : ... The requirements established in the IAEA safety standards might not be fully ... The basis document should identify the scope, major milestones, including cut-off dates. (beyond ... Email: [email protected] • Web site: http://www.suweco.cz.

Supplementary report to the fifth and sixth periodic reports ... - ECPAT

to matters that do not fall under the competence of the Federal Government ... Its main functions, as laid down in article 46, are inter alia to design and carry out ... 2018, http://www.laprensa.com.ar/460403-Explotacion-sexual-el-8-de-los- ...

The Medicines for Malaria Venture (MMV) - European Commission

There is now real international will to bear down on malaria, reduce the burden so that no-one dies for want of health interventions, and ultimately wipe the disease ...

Federal agency for medicines and health products - AFMPS

down in Directives 2004/23/EC and 2006/17/EC10, and the traceability system as required by Regulation (EC) No 1394/2007 should be considered.

Medicines & Healthcare products Regulatory Agency - Home ...

Laxatives do not help you lose weight. Overuse of laxatives can cause dehydration and problems with your digestive system. Always read the patient information ...

The Turkish Medicines and Medical Devices Agency: Comparison of ...

25 Jan 2018 ... Either your web browser doesn't support Javascript or it is currently turned off. ... Pricing data are not required by the TITCK at the time of submission; however, ... To ease the pressure of government spending, Turkey instituted a reference ... Available online at: http://www.titck.gov.tr/Ilac/IlactaFiyatlandirma ...

The Importance of Periodic Equipment Cleaning - Food Safety ...

Routine cleaning is typically focused on product contact surfaces, areas adjacent to product contact surfaces that require minimal disassembly and the ...

Monitoring the quality and safety of medicines - Government.nl

The Medicines Act (in Dutch) lays down rules so that medicines are used safely. ... Inspectorate (IGZ) and customs jointly track down suppliers of fake medicines.

1000-5000 - European Commission - European Road Safety Charter

Children do not enjoy studying in the traditional manner. ... These, often small, streets are full with parents dropping their children off in cars, bikes or 'bakfietsen'.

ranking eu progress on road safety - European Transport Safety ...

19 Jun 2019 ... [email protected] · www.etsc.eu/pin ... responsibility of ETSC and do not necessarily ... safety fell down the political priority list in some.

Periodic Table and Periodic Properties - Entrytest.com

The metals can be broken down into several groups. ... Nonmetals lie to the right of the staircase and do not conduct electricity well because they do not have ...

Order Medicines Online: Buy medicines at Best Price - Medlife

If you do not have a prescription, get it instantly by our doctors ... For browser, visit https://www.medlife.com/order or download the Medlife app from Google Play ...

Consumer fire safety: European statistics and potential fire safety ...

potential benefits of measures with respect to products not subject to any regulation ... The Netherlands Institute for Safety (NIFV) has been commissioned by the Consumer. Council ... 1996 – Ontario fire death rate 11.6 – down 62% from 1980.

Reports and Agency Statistics | MultCoPets.org

This method assigns each animal, upon admission to the shelter, a condition status of either “healthy”, “treatable”, or “unhealthy/untreatable”, known as a Pet ...

TV news agency - Rome Reports

“My Brother Chases Dinosaurs:” Inspiring family film about living with Down syndrome @Bosco_Films via @romereports. 2020-08-16 13:45:11. Five years since ...

Availability of Medicines - Heads of Medicines Agencies

The United Kingdom ( UK ) withdrew from the European Union ( EU ) on 31 January 2020 and is no longer an EU Member State. HMA and CMDh/v are in the ...

European Space Agency (ESA)

The European Space Agency portal features the latest news in space exploration, human spaceflight, launchers, telecommunications, navigation, monitoring ...

European GNSS Agency

The European GNSS Agency, or GSA, manages Europe's GNSS programmes ... The GSA is linking the benefits of satellite navigation technology to European citizens, ... Evaluations for the EUSPA Logo Contest are ongoing ... The European GNSS Agency and its crew touched down on the runway of the Vaclav ... No, thanks.

European Space Agency

... Agency portal features the latest news in space exploration, human spaceflight, launchers, telecommunications, navigation, monitoring and space science.

European Defence Agency (EDA)

Follow us. Search. Menu. EDA B2B Platform. Find out how it works! The EDA magazine is out! ... When seven EDA Member States established a Working Group in 2013 to improve collaboration and information-sharing in . ... The European Defence Agency (EDA) supports its 26 Member States in ... Download PDF · See All ...

Frontex | European Union Agency

Frontex promotes, coordinates and develops European border management in line with the EU fundamental rights charter applying the concept of Integrated ...

Automating Reports Helped This Agency Scale ... - Reportgarden

3 Apr 2020 ... These free tools keep costs down and work well for getting the job done ... That's three hours where he's not focused on marketing strategy or ...

E-OBS gridded dataset — European Environment Agency

22 Oct 2011 ... E-OBS gridded version of the ECA dataset (netCDF) with daily ... The data that underpin EEA indicators and figures is not directly ... Register as user in order to download data or contact the organisation for further clarification.

European Union Agency for Cybersecurity - Wikipedia

EU Regulation No 2019/881. Website, enisa.europa.eu. The European Union Agency for Cybersecurity – self-designation ENISA from the abbreviation ... In 2016, the Committee on Budgets backed ENISA's bid to shut down the Heraklion office ...

Blue Flags — European Environment Agency

26 May 2017 ... Awarded sites with Blue flag, which are the result of intense work from ... Dataset URL: http://www.blueflag.global/all-bf-sites/; information.png ...

DECISION n° 173 - European Railway Agency - Europa.eu

120 Rue Marc Lefrancq | BP 20392 | FR-59307 Valenciennes Cedex ... Railways laying down rules on the secondment to the Agency of ... sector or is an independent university or research organisation that does not seek to make profits for.

Being Trans in the EU - European Union Agency for Fundamental ...

FRA responded by including trans persons in its EU-wide LGBT survey, which for the first time provided ... change not only their gender but also their civil status.

Guide for the application of the INF TSI - European Railway Agency

14 Dec 2015 ... F-59307 Valenciennes Cedex. France. Document ... Guidance is not provided for sections where the original INF TSI requires no further explanation. ... Specific requirements for the relevant track gauge system (chapter 4) will be ... the possibility to apply any other traffic code for Off TEN Lines. P1520 and ...

Coronavirus pandemic in the EU - European Union Agency for ...

4 May 2020 ... information and views contained in the document do not necessarily reflect the ... (fjernundervisning) while schools have been physically shut down.13 ... https://stps.dk/da/nyheder/2020/vigtig-information-om-begraensning-af- ...

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