Study Intervention Administered Sample Clauses

Study Intervention Administered. ‌ Intervention Name ALXN2050 (formerly ACH-0145228) ALXN2050 (formerly ACH-0145228) Type Drug Drug Dose Formulation Capsule Tablet Unit Dose Strength(s) 60 mg 60 mg Dosage Level(s) 120 mg or 180 mg 120 mg or 180 mg Route of Administration Oral twice daily (bid) Oral twice daily (bid) Use Experimental Experimental IMP/NIMP IMP IMP Sourcing Provided by Sponsor Provided by Sponsor Packaging and Labeling Study medication will be provided in bottles. Each bottle will be labeled as required per country requirement. Study medication will be provided in bottles. Each bottle will be labeled as required per country requirement. Abbreviations: IMP = investigational medicinal product; NIMP = non-investigational medicinal product Details on the formulation of the study medication are provided in the Investigators’ Brochure and Pharmacy Manual.
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Study Intervention Administered. Details of ALXN1840 administered in the study are provided in Table 5. Intervention Name ALXN1840 (formerly WTX101) Type Drug Dose Formulation Tablet Unit Dose Strength(s) 15 mg ALXN1840 containing 7.8 mg of tetrathiomolybdic acid Dosage Level(s) Repeat dose 30 mg administered as 2 × 15 mg ALXN1840 tablets for 15 days Route of Administration Oral Use experimental/study intervention IMP and NIMP IMP Sourcing Provided centrally by Xxxxxxx Packaging and Labeling The labeling of study intervention will be in compliance with Good Manufacturing Practice specifications, as described in the Rules Governing Medicinal Products in the European Union, Volume 4, annex 13, Investigational Medicinal Products, and any other or local applicable regulations. Sample labels will be submitted to the UK health authorities according to the submission requirements. Current/Former Name(s) or Xxxxx(es) Bis-choline tetrathiomolybdate Abbreviations: IMP = investigational medicinal product; NIMP = noninvestigational medicinal product.

Related to Study Intervention Administered

  • Tobacco Use Counseling and Intervention This plan covers smoking cessation programs when prescribed by a physician in accordance with R.I. General Law §27-20-53 and ACA guidelines. Smoking cessation programs include, but are not limited to, the following: • Smoking cessation counseling must be provided by a physician or upon his or her • Over-the-counter and FDA approved nicotine replacement therapy and/or smoking cessation prescription drugs, prescribed by a physician, and purchased at a pharmacy. See the Summary of Pharmacy Benefits for details on coverage. This plan covers adult and pediatric preventive vaccinations and immunizations in accordance with current guidelines. Our allowance includes the administration and the vaccine. If a covered immunization is provided as part of an office visit, the office visit copayment and deductible (if any) will apply. Travel immunizations are covered to the extent that such immunizations are recommended for adults and children by the Centers for Disease Control and Prevention (CDC). The recommendations are subject to change by the CDC. This plan covers preventive screenings based on the ACA guidelines noted above. Preventive screenings include but are not limited to: • mammograms; • pap smears; • prostate-specific antigen (PSA) tests; • flexible sigmoidoscopy; • double contrast barium enema; • fecal occult blood tests, screening for gestational diabetes, and human papillomavirus; and • genetic counseling for breast cancer susceptibility gene (BRCA). This plan covers colonoscopies in accordance with R.I. General Laws § 27-18-58. Covered healthcare services include an initial colonoscopy or other medical tests or procedures for colorectal cancer screening and a follow-up colonoscopy if the results of the initial test are abnormal. This plan covers the following contraceptive services: • FDA approved contraceptive drugs and devices requiring a prescription; • barrier method (cervical cap, diaphragm, or implantable) fitted and supplied during an office visit; and • surgical and sterilization services for women with reproductive capacity, including but not limited to tubal ligation. This plan covers lactation (breastfeeding) support and counseling during the pregnancy or postpartum period when provided by a licensed lactation counselor. This plan covers manual, electric, or battery operated breast pumps for a female member in conjunction with each birth event.

  • Regulatory Intervention In the event that there is any change to any applicable statutes, enactments, acts of legislatures or parliament, laws, ordinances, orders, rules, by-laws or regulations of any government or statutory authority in India including but not limited to the Ministry of Information and Broadcasting and The Telecom Regulatory Authority or any final un-appealable order of any competent court or tribunal, etc, which would have a material adverse effect on either of the Parties, then the affected Party may request that the Parties consult as soon as reasonably practicable with a view to negotiating in good faith an amendment to this Agreement including but not limited to the Subscription Fee payable hereunder. Such amendment shall take effect from the date of such change. In the event the Parties are unable to agree on an amendment within thirty (30) days of the date of the request by the affected Party, then either Party may approach TDSAT for appropriate resolution of the dispute.

  • Clinical Management for Behavioral Health Services (CMBHS) System 1. request access to CMBHS via the CMBHS Helpline at (000) 000-0000. 2. use the CMBHS time frames specified by System Agency. 3. use System Agency-specified functionality of the CMBHS in its entirety. 4. submit all bills and reports to System Agency through the CMBHS, unless otherwise instructed.

  • Interventions 1. Door to balloon time 2. Door to needle time 3. No interventions b. Discharge status 1. Home

  • Early Intervention Services (EIS) Coverage provided for members from birth to 36 months. The provider must be certified as an EIS provider by the Rhode Island Department of Human Services. 0% - After deductible The level of coverage is the same as network provider. Asthma management 0% - After deductible 40% - After deductible

  • Orally Administered Anticancer Medication In accordance with RIGL § 27-20-67, prescription drug coverage for orally administered anticancer medications is provided at a level no less favorable than coverage for intravenously administered or injected cancer medications covered under your medical benefit.

  • CENTRAL GRIEVANCE PROCESS The following process pertains exclusively to grievances on central matters that have been referred to the central process. In accordance with the School Boards Collective Bargaining Act central matters may also be grieved locally, in which case local grievance processes will apply.

  • Intervention If the Commission finds deficiencies in the School's performance or legal compliance, the Commission and the School shall follow the Intervention Protocol attached as Exhibit D. Intervention may be initiated when the Commission finds that the School has failed to: (a) Comply with applicable laws, rules, policies, or procedures; (b) Comply with the terms and conditions of this Contract; or (c) Meet performance expectations as set forth in the Performance Frameworks. Failure to invoke the Intervention Protocol shall not be (i) construed as a waiver or relinquishment of any requirement under applicable laws, rules, policies, procedures, contractual terms and conditions, or performance expectations; or (ii) deemed a necessary precedent to non-renewal or revocation.

  • Project Manager, County The County shall appoint a Project Manager to act as liaison between the County and the Subrecipient during the term of this Contract. The County’s Project Manager shall coordinate the activities of the County staff assigned to work with the Subrecipient.

  • Anesthesia Services This plan covers general and local anesthesia services received from an anesthesiologist when the surgical procedure is a covered healthcare service. This plan covers office visits or office consultations with an anesthesiologist when provided prior to a scheduled covered surgical procedure.

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