Generelle monografier

Publisert: 27.09.2023

Oppdatert: 17.03.2025

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Generelle monografier

1063	Allergenpreparater	Allergen products
En Beskrivelse: This monograph does not apply to: chemicals that are used solely for diagnosis of contact dermatitis; chemically synthesised products; allergens derived by recombinant DNA technology. It does not necessarily apply to allergen products for veterinary use.
2098	Eteriske oljer	Essential oils
En Beskrivelse: The statements in this monograph are intended to be read in conjunction with general chapter 5.30 Monographs on essential oils (information chapter) and the individual monographs on essential oils in the European Pharmacopoeia. The competent authority may decide to apply the monograph to other essential oils.
2619	Farmasøytiske preparater	Pharmaceutical preparations
En Beskrivelse: This monograph is intended to be a reference source of standards in the European Pharmacopoeia on active substances, excipients and dosage forms, which are to be applied in the manufacture/preparation of pharmaceuticals, but not a guide on how to manufacture as there is specific guidance available covering methods of manufacture and associated controls.
3186	Genterapeutiske legemidler til human bruk	Gene therapy medicinal products for human use
En Beskrivelse: Gene therapy medicinal products (GTMPs) for human use are biological medicinal products that contain or consist of a recombinant nucleic acid used in or administered to human beings with a view to regulating, repairing, replacing, adding or deleting a genetic sequence. Their therapeutic, prophylactic or diagnostic activity is directly linked to the recombinant nucleic acid sequence or to the product expressed from the recombinant nucleic acid sequence.
0030	Immunsera til dyr	Immunosera for veterinary use
En Beskrivelse: Immunosera for veterinary use are preparations containing immunoglobulins, purified immunoglobulins or immunoglobulin fragments obtained from serum or plasma of immunised animals. They may be preparations of crude polyclonal antisera or purified preparations.
0084	Immunsera til humanbruk, animalske	Immunosera for human use, animal
En Beskrivelse: Animal immunosera for human use are liquid or freeze-dried preparations containing purified immunoglobulins or immunoglobulin fragments obtained from serum or plasma of immunised animals of different species.
2902	Kjemiske utgangsstoffer til radioaktive preparater	Chemical precursors for radiopharmaceutical preparations
En Beskrivelse: Chemical precursors for radiopharmaceutical preparations, hereinafter referred to as ‘chemical precursors’, are non-radioactive substances obtained by chemical synthesis for combination with a radionuclide.
3053	Levende bioterapeutiske produkter til humanbruk	Live biotherapeutics products for human use
En Beskrivelse: Live biotherapeutic products (LBP) are medicinal products containing live micro-organisms (bacteria or yeasts) for human use.
2031	Monoklonale antistoffer til humanbruk	Monoclonal antibodies for human use
En Beskrivelse: Monoclonal antibodies for human use are preparations of an immunoglobulin or a fragment of an immunoglobulin, for example, F(ab′)2, with defined specificity, produced by a single clone of cells. They may be conjugated to other substances, including for radiolabelling.
1468	Produkter fremstilt ved fermentering	Products of fermentation
En Beskrivelse: This monograph applies to indirect gene products obtained by fermentation. See list in monograph for which it is applicable. This monograph provides general requirements for the development and manufacture of products of fermentation. These requirements are not necessarily comprehensive in a given case and requirements complementary or additional to those prescribed in this monograph may be imposed in an individual monograph or by the competent authority.

Monografinummer: 1063
Norsk navn: Allergenpreparater
Engelsk navn: Allergen products

Monografinummer: 2098
Norsk navn: Eteriske oljer
Engelsk navn: Essential oils

Monografinummer: 2619
Norsk navn: Farmasøytiske preparater
Engelsk navn: Pharmaceutical preparations

Monografinummer: 3186
Norsk navn: Genterapeutiske legemidler til human bruk
Engelsk navn: Gene therapy medicinal products for human use

Monografinummer: 0030
Norsk navn: Immunsera til dyr
Engelsk navn: Immunosera for veterinary use

Monografinummer: 0084
Norsk navn: Immunsera til humanbruk, animalske
Engelsk navn: Immunosera for human use, animal

Monografinummer: 2902
Norsk navn: Kjemiske utgangsstoffer til radioaktive preparater
Engelsk navn: Chemical precursors for radiopharmaceutical preparations

Monografinummer: 3053
Norsk navn: Levende bioterapeutiske produkter til humanbruk
Engelsk navn: Live biotherapeutics products for human use

Monografinummer: 2031
Norsk navn: Monoklonale antistoffer til humanbruk
Engelsk navn: Monoclonal antibodies for human use

Monografinummer: 1468
Norsk navn: Produkter fremstilt ved fermentering
Engelsk navn: Products of fermentation

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Generelle monografier

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