ChondroCelect definition

ChondroCelect or “Product” means a cell-based medicinal product, consisting of characterized viable autologous cartilage cells (initially taken from a healthy region of a Patient’s articular knee cartilage), expanded ex vivo (outside the body) expressing specific [***] Certain information has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to omitted portions. marker proteins, and finally re-implanted during surgery. ChondroCelect was approved by Marketing Authorization no EU/1/09/563/001 dated 5 October 2009;

Related to ChondroCelect

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  • COVID-19 symptoms means fever of 100.4 degrees Fahrenheit or higher, chills, cough, shortness of breath or difficulty breathing, fatigue, muscle or body aches, headache, new loss of taste or smell, sore throat, congestion or runny nose, nausea or vomiting, or diarrhea, unless a licensed health care professional determines the person’s symptoms were caused by a known condition other than COVID-19.

  • HIV means human immunodeficiency virus.

  • Prosthesis means an artificial substitute for a missing body part.

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  • Cardiopulmonary resuscitation or "CPR" means artificial ventilation or external

  • Cannabinoid edible means food or potable liquid into which a cannabinoid concentrate, cannabinoid extract or dried marijuana leaves or flowers have been incorporated.

  • Orthotics means the science and practice of evaluating, measuring, designing, fabricating, assembling, fitting, adjusting, or servicing an orthosis under an order from a licensed physician or podiatrist for the correction or alleviation of neuromuscular or musculoskeletal dysfunction, disease, injury, or deformity.

  • Diagnosis means the definition of the nature of the Client's disorder. When formulating the Diagnosis of Client, CONTRACTOR shall use the diagnostic codes and axes as specified in the most current edition of the DSM published by the American Psychiatric Association. DSM diagnoses will be recorded on all IRIS documents, as appropriate.

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  • Licensed Nurse means an Oregon licensed practical or registered nurse.

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  • Anatomical gift means a donation of all or part of a human body to take effect after the donor's death for the purpose of transplantation, therapy, research, or education.

  • Adult cabaret means a nightclub, bar, restaurant, or similar commercial establishment which regularly features:

  • Psychotherapy or "Therapy" means a goal directed process using generally accepted clinical approaches provided face-to-face by a qualified service provider with consumers in individual, group or family settings to promote positive emotional or behavioral change.

  • Licensed clinical social worker means an individual who meets the licensed clinical social worker requirements established in KRS 335.100.

  • Mobile crisis outreach team means a crisis intervention service for minors or families of minors experiencing behavioral health or psychiatric emergencies.

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  • Active Pharmaceutical Ingredient or “API” means the active pharmaceutical substance of the Drug in bulk form prior to incorporation into the Product.

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  • Medical marijuana product means a product that contains cannabinoids that have been extracted from plant material or the resin therefrom by physical or chemical means and is intended for administration to a licensed patient, including but not limited to concentrates, oils, tinctures, edibles, pills, topical forms, gels, creams, and other derivative forms, except that this term does not include live plant forms.

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  • Collaborative pharmacy practice means a practice of pharmacy whereby one or

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  • Gene Therapy means a product or service for the treatment or prevention of a disease that utilizes ex vivo or in vivo delivery (via viral or nonviral gene transfer methods or systems) of Genetic Material, including any cell incorporating Genetic Material.

  • Objective medical evidence means reports of examinations or treatments; medical