Norwegian Medical Products Agency

Last updated

The Norwegian Medical Products Agency formerly the Norwegian Medicines Agency (Direktoratet for Medisinske Produkter tidl. Statens legemiddelverk, Legemiddelverket) is the national regulatory authority in Norway for new and existing pharmaceuticals, medical devices and for the supply chain security of these. The Agency is responsible for supervising the production, trials and marketing of medicines. It approves medicines and monitors their use, and ensures cost-efficient, effective and well-documented use of medicines. The Inspectorate also supervises the supply chain and regulates pharmacy prices and trade conditions. [1]

Related Research Articles

Transfusion medicine is the branch of medicine that encompasses all aspects of the transfusion of blood and blood components including aspects related to hemovigilance. It includes issues of blood donation, immunohematology and other laboratory testing for transfusion-transmitted diseases, management and monitoring of clinical transfusion practices, patient blood management, therapeutic apheresis, stem cell collections, cellular therapy, and coagulation. Laboratory management and understanding of state and federal regulations related to blood products are also a large part of the field.

<span class="mw-page-title-main">Good manufacturing practice</span> Manufacturing quality standards

Current good manufacturing practices (cGMP) are those conforming to the guidelines recommended by relevant agencies. Those agencies control the authorization and licensing of the manufacture and sale of food and beverages, cosmetics, pharmaceutical products, dietary supplements, and medical devices. These guidelines provide minimum requirements that a manufacturer must meet to assure that their products are consistently high in quality, from batch to batch, for their intended use.

<span class="mw-page-title-main">Carisoprodol</span> Muscle relaxant medication


Carisoprodol, sold under the brand name Soma among others, is a medication used for musculoskeletal pain. Effects generally begin within half an hour and last for up to six hours. It is taken orally.

<span class="mw-page-title-main">Regulation of therapeutic goods</span> Legal management of drugs and restricted substances

The regulation of therapeutic goods, defined as drugs and therapeutic devices, varies by jurisdiction. In some countries, such as the United States, they are regulated at the national level by a single agency. In other jurisdictions they are regulated at the state level, or at both state and national levels by various bodies, as in Australia.

<span class="mw-page-title-main">European Medicines Agency</span> Agency of the European Union

The European Medicines Agency (EMA) is an agency of the European Union (EU) in charge of the evaluation and supervision of pharmaceutical products. Prior to 2004, it was known as the European Agency for the Evaluation of Medicinal Products or European Medicines Evaluation Agency (EMEA).

The Medicines and Healthcare products Regulatory Agency (MHRA) is an executive agency of the Department of Health and Social Care in the United Kingdom which is responsible for ensuring that medicines and medical devices work and are acceptably safe.

Bevacizumab, sold under the brand name Avastin among others, is a monoclonal antibody medication used to treat a number of types of cancers and a specific eye disease. For cancer, it is given by slow injection into a vein (intravenous) and used for colon cancer, lung cancer, ovarian cancer, glioblastoma, hepatocellular carcinoma, and renal-cell carcinoma. In many of these diseases it is used as a first-line therapy. For age-related macular degeneration it is given by injection into the eye (intravitreal).

<span class="mw-page-title-main">Insulin glargine</span> Long-acting insulin

Insulin glargine sold under the brand name Lantus among others is a long-acting modified form of medical insulin, used in the management of type I and type II diabetes. It is injected just under the skin. Effects generally begin an hour after use.

<span class="mw-page-title-main">Plumpy'nut</span> Peanut-derived food used to treat child malnutrition, particularly during famines

Plumpy'Nut is a peanut-based paste in a plastic wrapper for treatment of severe acute malnutrition manufactured by Nutriset, a French company. Feeding with the 92-gram packets of this paste reduces the need for hospitalization. It can be administered at home, allowing more people to be treated.

<span class="mw-page-title-main">National Medical Products Administration</span>

The National Medical Products Administration is a national bureau responsible for drug supervision under the State Council of China and is managed by the State Administration for Market Regulation.

Ranibizumab, sold under the brand name Lucentis among others, is a monoclonal antibody fragment (Fab) created from the same parent mouse antibody as bevacizumab. It is an anti-angiogenic that is approved to treat the "wet" type of age-related macular degeneration, diabetic retinopathy, and macular edema due to branch retinal vein occlusion or central retinal vein occlusion.

<span class="mw-page-title-main">NHS Supply Chain</span>

NHS Supply Chain supports the National Health Service (NHS) in England, and other healthcare organisations in England and Wales, by providing procurement and logistics services.

Ustekinumab, sold under the brand name Stelara among others, is a monoclonal antibody medication developed by Janssen Pharmaceuticals, for the treatment of Crohn's disease, ulcerative colitis, plaque psoriasis and psoriatic arthritis, targeting both IL-12 and IL-23.

<span class="mw-page-title-main">FDA Center for Devices and Radiological Health</span>

The Center for Devices and Radiological Health (CDRH) is one of six product centers of the U.S. Food and Drug Administration (FDA), an agency that is part of the U.S. Department of Health and Human Services (HHS). CDRH is responsible for ensuring that patients and providers in the U.S. have timely and continued access to safe, effective, and high-quality medical devices and safe radiation-emitting products.

Pharmacy in China involves the activities engaged in the preparation, standardization and dispensing of drugs, and its scope includes the cultivation of plants that are used as drugs, the synthesis of chemical compounds of medicinal value, and the analysis of medicinal agents. Pharmacists in China are responsible for the preparation of the dosage forms of drugs, such as tablets, capsules, and sterile solutions for injection. They compound physicians', dentists', and veterinarians' prescriptions for drugs. Pharmacological activities are also closely related to pharmacy in China.

Aflibercept, sold under the brand names Eylea and Zaltrap among others, is a medication used to treat wet macular degeneration and metastatic colorectal cancer. It was developed by Regeneron Pharmaceuticals.

<span class="mw-page-title-main">H5N1 vaccine</span> Vaccine designed to provide immunity against H5N1 influenza

A H5N1 vaccine is an influenza vaccine intended to provide immunization to influenza A virus subtype H5N1.

<span class="mw-page-title-main">Semaglutide</span> Anti-diabetic and anti-obesity medication

Semaglutide is an antidiabetic medication used for the treatment of type 2 diabetes and an anti-obesity medication used for long-term weight management. It is a peptide similar to the hormone glucagon-like peptide-1 (GLP-1), modified with a side chain. It can be administered by subcutaneous injection or taken orally. It is sold under the brand names Ozempic and Rybelsus for diabetes, and under the brand name Wegovy for weight loss.

The distribution of medications has special drug safety and security considerations. Some drugs require cold chain management in their distribution.

Regdanvimab, sold under the brand name Regkirona, is a human monoclonal antibody used for the treatment of COVID-19. The antibody is directed against the spike protein of SARS-CoV-2. It is developed by Celltrion. The medicine is given by infusion (drip) into a vein.

References

  1. "Our goals and tasks". Norwegian Medical Products Agency. Archived from the original on 2024-12-12. Retrieved 2024-12-13.