Summaries of Product Characteristics SPCs

EU regulations require the submission of a Summary of Product Characteristics (SPC) as part of the product information section. Specific templates and guidance are... 

The requirements for the contents of an application dossier are set out in Annex I of Directive 2001/82/EC. The dossier should be assembled in four parts, as outlined in Figure 7.6. The application form. Summary of Product Characteristics (SPC) and labelling, expert reports and quality sections are quite similar in content to human... 

Significant changes in the Summary of Product Characteristics (SPC) such as, the introduction of new contraindications, the introduction of new warnings, the reduction in the recommended dose, the restriction in the indications, the restriction in the availability of the medicinal product. 

The DRA in Venezuela allows prescription drugs to be advertised in the press on a onetime basis as an announcement that the dmg is now registered in Venezuela. Information presented in the promotion and advertising materials must be based on the product information, as specified in the summary of product characteristics (SPC), approved at the time of registration. In all countries except Australia, patient information leaflets and labels are also subject to approval. In Australia, although approval is not needed, the information must not conflict with the approved product information. 

In our meta-analysis, more than half of the clinical trials submitted to the FDA showed no difference between drug and placebo. Most reviewers of the clinical-trials literature have not had access to unpublished studies and may not even know of their existence. But the FDA and other regulatory agencies around the world knew of these data. Nevertheless, their existence is not even mentioned in the product labels, information leaflets and official Summaries of Product Characteristics (SPC) of most antidepressants. 

The Risk Assessment model comprises (1) prediction of the concentration that will reach the enviromnent (PEC), (2) prediction of the no-effect concentration (PNEC) on a small selection of organisms (3 species), and (3) propose possible minimization measures which will be inserted, in form of standard sentences, in summary of product characteristics (SPC) and/or patient information leaflet of respective Medicinal Product [125]. 

The Summary of Product Characteristics (SPC) for a medicinal product reflects the information in the marketing authorisation of the product. It is prepared by the manufacturer and is intended for health professionals. Updates are necessary to reflect any approved changes by the regulatory body in the marketing authorisation. 

Medicines Control Agency. Guidelines on the Summary of Product Characteristics (SPC) for Human Medicinal Products. Version 3, March 2001. London MHRA,2001. 

This also includes congenital abnormalities/birth defects and serious adverse clinical consequences with use outside the terms of the Summary of Product Characteristics (SPC) including overdoses or abuse. 

Much later. Directive 83/570 required the applicants to produce a draft Summary of Product Characteristics (SPC) as an integral part of the documentation. In September 1995, an order was made (SI 1995/2321) to the effect that, in the United Kingdom, data sheets were no longer required where a product had an approved SPC and also that data sheets no longer had to be sent to all doctors and dentists prior to advertising. 

The BNF Joint Formulary Committee as of May 2005 will publish a Paediatric version annually. It will comprise monographs on safe and effective medicines for use in children, even if usage in children is not included in the summary of product characteristics (SPC). 

In 21 healthy Asian men who took digoxin and exenatide there was no important change in digoxin exposure Cmax fell by 17% and tmax was prolonged by a median of 2.5 hours. No digoxin concentrations increased to more than 2.0 mg/1 (19). The summary of product characteristics (SPC) for exenatide specifies that dosage adjustment is not required for paracetamol or digoxin. 

Although not required for approval, a short-term bioassay, Tg-Hras2 model, was conducted postapproval and is mentioned in the Summary of Product Characteristics (SPC) and the postapproval procedural steps summary. There were no findings suggestive of tumor growth promotion in this study. 

Pharmacokinetics Considers Absorption Distribution Metabolism Elimination A summary of relevant facts which may be incomplete, depending on the data available References 1—6 and Summaries of Product Characteristics (SPC)... 

Sometimes the British National Formulary (BNF) [1] or the Summary of Product Characteristics (SPC) endorses the use of a drug in patients with liver disease. This is often sufficient and no further research is required. Fiowever, ensure that you also check the adverse effects of the drug, as these may preclude its use in some patients, even if there are no explicit contraindications or precautions regarding liver disease in the SPC. 

The Summary of Product Characteristics (SPC) for each product states that all statins are contraindicated in active liver disease and in patients with persistent unexplained elevations of liver enzymes exceeding three times the upper limit of normal (ULN) [1, 2]. This is due to their extensive liver metabolism, their ability to cause raised transaminases and the risk of myopathy or rhabdomyolysis in the presence of reduced synthetic function, or to a drug interaction that reduces their metabolism. 

If the decision is favourable, the drug is granted a marketing authorisation (for 5 years renewable), which allows it to be marketed for specified therapeutic uses. The authority must satisfy itself of the adequacy of the information to be provided to prescribers in a Summary of Product Characteristics (SPC) and also a Patient Information Leaflet (PIL). 

In order to improve the processing, the evaluation of the data and the approval procedures, the summary of product characteristics (SPC) and the user s... 

The Patient Information Leaflet (PIL), different from the Summary of Product Characteristics (SPC), was introduced as early as the mid-1970s in Hungary. A detailed NIP Guideline was issued in 1990,2 years earlier that the corresponding 92/ 27/EEC Directive (Paal 1996c). However, there were only minor differences in their content. In Hungary, for example, label texts should not be repeated on the PIL and not all excipients, only those that may have an adverse effect on certain patients, should be listed, the address of the MA holder were not necessarily to be specified, etc. 

Outcome of the Approval Process Summary of Product Characteristics (SPC)... 

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