medicinal product


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medicinal product

A term which is defined by the UK’s Nursing and Midwifery Council Directive 65/65/EEC as: “Any substance or combination of substances presented for treating or preventing disease in human beings or in animals. Any substance or combination of substances which may be administered to human beings or animals with a view to making a medical diagnosis or to restoring, correcting or modifying physiological functions in human beings or animals is likewise considered a medicinal product.”

Patient discussion about medicinal product

Q. is it ok to use drugs for medical reasons? and who is to decide when is necessary to use drugs when needed?

A. Today the most used "medical" drugs are narcotics- for pain relief, for patients who suffer extreme pain. All sorts of Codaine and Morphine types are used and on a very wide basis, and they are specially perscribed for ones who need them.

Q. How about Psychiatric Drugs for bipolar? One of my friend is suffering from bipolar. Will Psychiatric medications help him to come out of this affect?

A. from what i read- there are certain medication that can help. if the first one doesn't - there is a second and third line of medication. from a personal experience (not mine, a friend of the family) it can even save your friend's life..

Q. What medications are forbidden to take with alcohol? And why is that?

A. I think this web page will give you something to think about:
http://pubs.niaaa.nih.gov/publications/aa27.htm
apparently there are more drugs you shouldn’t mix with alcohol then I could think of…

More discussions about medicinal product
References in periodicals archive ?
It will be developed in stages, priority being given to medicinal products authorised the European Agency for the Evaluation of Medicinal Products, and subsequently be extended to include any medicinal product marketed in the European Union.
In addition to this new obligation, the option is opened more widely for companies to use the centralised system, whenever the medicinal product is a significant innovation from a therapeutic, scientific or technical point of view or is of interest at EU level to patients.Each application for authorisation must take account of the unique, EU nature of the authorisation requested.
- a homeopathic medicinal product lawfully placed on the market in the
Under the Regulation proposed in October 2004, all new requests for authorisation for medicinal products should be accompanied by a "paediatric investigation plan" (specifying conditions for authorisation for use of the medicinal product in the treatment of children).
3) was revised in order to include a reference to the "Guideline on excipients in the label and package leaflet of medicinal products for human use" and to the need to put an appropriate warning on the label in case a herbal medicinal product contains alcohol.
Regarding therapeutic indications for herbal medicinal products with a well-established medicinal use, a standard statement "herbal medicinal product ..." is proposed, followed by a specific statement, e.g.
Apart from the case of substances or combinations of substances intended for the purpose of making a medical diagnosis, a product cannot be regarded as a 'medicinal product' under Article 1(2)(b) of the Directive, where, having regard to its composition (including its content in active substances) and if used as intended, it is incapable of appreciably restoring, correcting or modifying physiological functions by exerting a pharmacological, immunological or metabolic action.
Further, the ECJ rejected the argument of Poland that the importation and the placing on the national market of a medicinal product cheaper than the equivalent medicinal product which has obtained marketing authorisation may be justified by financial considerations inasmuch as they are necessary both in order to ensure the financial stability of the national social security system and to allow patients who have only limited financial means to have access to the treatment which they need.
Schaber, Ph.D., executive vice president and COO of Discovery, stated, "The granting of Orphan Medicinal Product designation together with the United States FDA's acceptance of the Surfaxin NDA, increases our confidence in the potential for Surfaxin to become a new, worldwide standard of care for the prevention and treatment of RDS.
Orphan Medicinal Product designation also allows for protocol assistance free of charge on clinical trials, a reduced Marketing Authorisation Application (MAA) filing fee and the potential for grant funding.