Spontaneous reporting from post marketing

side effects reports on the marketed product (from spontaneous reporting)

Side effects reports on the marketed product (from spontaneous reporting)

Adverse drug reactions deriving from post marketing experience are described separately.

Admittance to Member State markets, however, remains at the discretion of the individual Member States.

Hypersensitivity reactions (anaphylaxis and angioedema) have been reported in post marketing experience with valdecoxib and parecoxib (see section 4.8).

Acute renal failure has been reported through post marketing surveillance in patients receiving parecoxib (see section 4.8).

No cases with fatal outcome were reported in GIST and MRCC registrational studies.

This proposal represents a major streamlining of the current rules on safety evaluation and marketing authorisations for feed additives.

For all the ADRs reported from post marketing experience and laboratory findings, it is not possible to apply any ADR frequency and therefore they are mentioned with a not known frequency.

Additionally, serious skin reactions, some of them fatal, including toxic epidermal necrolysis, have been reported through postmarketing surveillance in patients receiving valdecoxib (the active metabolite of parecoxib) and cannot be ruled out for parecoxib (see section 4.8).

35 The ADRs reported from clinical studies, post marketing experience and laboratory findings are listed below according to system organ class.

There have also been post marketing reports of severe depression, death by suicide, delusions and psychosis like behaviour.

Serious skin reactions, including erythema multiforme, exfoliative dermatitis and Stevens Johnson syndrome have been reported through post marketing surveillance in patients receiving parecoxib.

Amendments 51, 52 and 53 on the public s access to information on the marketing authorisation, the assessment report and the scientific reasons

6 Assessment of adverse reactions is based on experience from post marketing surveillance and from three pivotal clinical studies in patients with chronic hepatitis B

Mucocutaneous reaction, including Stevens Johnson Syndrome with fatal outcome, has been rarely reported in post marketing experience.

13 Hepatic injury including elevated serum hepatic enzyme levels, hepatitis, autoimmune hepatitis and hepatic failure has been reported with interferon beta in post marketing (see section 4.8).

The following side effects listing is based on reports from clinical trials with Betaferon (table 1) and from side effects reported on the marketed product (table 2).

The following side effects listing is based on reports from clinical trials with Extavia (List 1) and from side effects reported on the marketed product (List 2).

The company that makes Volibris will set up a study in the European Union (EU) looking at how the medicine is used once it is on the market.

the replacement without delay of any used quantity of antigen by antigens of the same specification (serotype, topotype, Seed Master Strain) and at least the same quality (purification, potency etc.) and origin (manufacturer, marketing authorisation).

Hepatic injury including elevated serum hepatic enzyme levels, hepatitis, autoimmune hepatitis and hepatic failure has been reported with interferon beta in post marketing (see section 4.8).

Additionally, serious skin reactions, some of them fatal, including toxic epidermal necrolysis, have been reported through postmarketing surveillance in patients receiving valdecoxib (the active metabolite of parecoxib) and cannot be ruled out for parecoxib (see section 4.8).

As a result, Japanese companies would seek market shares overseas, and Europe as a potential location has so far been

Medically important adverse reactions reported at an incidence greater than placebo in controlled clinical studies and medically important adverse reactions reported through post marketing surveillance

(Annex VIII to the Agreement referred to in Article 120 of the Agreement)

Applications for marketing authorisations for veterinary medicinal products submitted in accordance with Regulation (EC) No 726 2004 before the date of application of this Regulation shall be examined in accordance with Regulation (EC) No 726 2004.

Where these combination products are classified as medicines, currently they are not covered by the present UK regime for unlicensed herbal medicines and therefore require a marketing authorisation.

IT Centralised deposit, custody and administration services can be provided only by entities duly authorised and supervised by the Consob in agreement with the Bank of Italy.

Opinion of the Scientific Panel on Dietetic Products, Nutrition and Allergies on a request from the Commission related to an application to market Enova oil as a novel food in the EU of 2.12.2004.

The MAH must ensure that the system of pharmacovigilance, as described in version 1.1 presented in Module 1.8.1. of the Marketing Authorisation, is in place and functioning before and whilst the product is on the market.

Mortgage loan services may be provided only by Czech established banks.

Firstly, there is the principle enshrined in Amendment No 8 to allow testing for the sole purpose of receiving market authorisation after the expiry of the patent the so called Bowler exception.

Pfizer Ltd commits to performing the studies and additional pharmacovigilance activities detailed in version 1 of the Risk Management Plan (RMP) presented in the Marketing Authorisation and any subsequent updates of the RMP agreed by the CVMP.

The admission to the market of new financial services or products may be subject to the existence of, and consistency with, a regulatory framework aimed at achieving the objectives indicated in Article 19 of Decision No 2 2001.

Frequencies are defined as very common ( 1 10), common ( 1 100, 1 10) or not known (identified through post marketing safety surveillance and the frequency cannot be estimated from the available data).

The admission to the market of new financial services and instruments may be subject to the existence of, and consistency with the domestic regulatory framework aimed at achieving the objectives indicated in Article 19 of Decision No 2 2001.

The European Food Safety Authority (EFSA), in its opinion on an application from ADM for approval of diacylglycerol oil (EnovaTM oil) of 2 December 2004 2 , came to the conclusion that the oil is safe for human consumption.

The first abuse involved misuses of a Council Regulation 3 (hereinafter SPC Regulation ) under which the basic patent protection for pharmaceutical products can be extended. The second abuse concerned misuses of procedures relating to the authorisation of marketing of pharmaceutical products.

We had the feeling, when addressing the pharmaceutical industry dossier and pharmaceutical legislation at the same time, that it was actually the European Parliament that was defending consumers, through far reaching amendments, in particular on marketing authorisations, on centralised procedure and on consumer protection.

These have included initiatives on paediatric medicines, support for the regulation of TSE in pharmaceuticals, and the development of a strategy for risk assessment, risk management and risk communication in the post licensing period when medicines are widely marketed in the European Union.

The Committee on the Environment, Public Health and Consumer Policy voted in favour of the request for the authorisation of the placing on the market of the two new sweeteners, but it also voted in favour of the adoption of an amendment requiring a re evaluation of these two substances three years after the entry into force of the revised directive.

The admission to the market of new financial services or products may be subject to the existence of, and consistency with, a regulatory framework aimed at achieving the objectives indicated in Article 19 of Decision No 2 2001 of the EU Mexico Joint Council.

The admission to the market of new financial services and instruments may be subject to the existence of, and consistency with the domestic regulatory framework aimed at achieving the objectives indicated in Article 19 of Decision No 2 2001 of the EU Mexico Joint Council.