Summary product characteristics








Summary of Product Characteristics - Wikipedia, the free encyclopedia

12/21/2014
03:13 | Author: Steven Lewis

Summary product characteristics
Summary of Product Characteristics - Wikipedia, the free encyclopedia

The Summary of Product Characteristics is a specific document required within the European Commission before any medicinal product or biocidal product is.

The document is thus an intrinsic part of the authorization and can only be changed after approval by means of an approved Variation. The Summary must be completed and submitted as an application to the European Medicines Agency, the European Chemicals Agency or one of the national competent authorities of the Member States before marketing is authorized.

and the clinical use or industrial use to which it can put. Depending on which Regulation this document is required under the fields contained in the summary may vary.

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Actilyse - Summary of Product Characteristics (SPC) - (eMC)

10/20/2014
01:34 | Author: Allison King

Summary product characteristics
Actilyse - Summary of Product Characteristics (SPC) - (eMC)

Actilyse - Summary of Product Characteristics (SPC) by Boehringer Ingelheim Limited.

Pharmacological properties 5.1 Pharmacodynamic properties Pharmacotherapeutic group: antithrombotic agent, ATC code: B 01 A D 02 The active ingredient of Actilyse is alteplase, a recombinant human tissue-type plasminogen activator, a glycoprotein, which activates plasminogen directly to plasmin. In a study including more than 40,000 patients with an acute myocardial infarction (GUSTO) the administration of 100 mg alteplase over 90 minutes, with concomitant intravenous heparin infusion, led to a lower mortality after 30 days (6.3 %) as compared to the administration of streptokinase, 1.5 million U over 60 minutes, with subcutaneous or intravenous heparin (7.3 %).

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How to prepare and review a summary of product characteristics

8/19/2014
01:01 | Author: Steven Lewis

Summary product characteristics
How to prepare and review a summary of product characteristics

This page includes guidance for pharmaceutical companies on how to prepare and review summaries of product characteristics (SmPCs) for human medicines.

+44 (0)20 3660 5555. +44 (0)20 3660 6000. 30 Churchill Place, Canary Wharf, London E14 5EU, United Kingdom.

SmPCs are also the basis for the preparation of package leaflets, so are important documents in enabling information on medicines to reach patients. Back to top Back to top EMA.

This page includes guidance for pharmaceutical companies on how to prepare and review summaries of product characteristics (SmPCs) for human medicines.

It also aims to raise awareness of the information provided in SmPCs among healthcare professionals. It is intended to enable companies to make sure that the information in SmPCs is of high quality when they submit them to the Agency as part of applications for new marketing authorisations or updates to existing marketing authorisations.

The guidance, prepared by the Agency's SmPC Advisory Group, outlines the principles in the European Commission's guideline on SmPC.

An agency of the European Union Search document library.

SmPCs are a key part of the marketing authorisation of all medicines authorised in the European Union and the basis of information for healthcare professionals on how to use a medicine safely and effectively. They are kept updated throughout the lifecycle of a medicine as new efficacy or safety data emerge.

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GWPharma - Summary of Product Characteristics

6/18/2014
03:12 | Author: Jeremy Rodriguez

Summary product characteristics
GWPharma - Summary of Product Characteristics

Please click on the link below to download a copy of the Sativex Summary of Product Characteristics (SPC): Sativex.

The SPC is not intended to give general advice about treatment of a condition but does state how the product is to be used for a specific treatment. The package leaflet (previously known as the patient information leaflet) supplied with the product contains information that would be of interest to the patient prescribed the medicine. It forms the basis of information for health professionals to know how to use the product safely and effectively.

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Xarelto SPC

4/17/2014
05:05 | Author: Molly Young

Panic Attack Symptoms
Xarelto SPC

See the full Xarelto Summary of Product Characteristics (SPC) as approved by the European This medicinal product is subject to additional monitoring.

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