Summary of the Product Characteristics definition

Summary of the Product Characteristics means expert information on a drug product approved in an authorisation procedure and intended for physicians, dental medicine doctors and pharmacists. Also used as a source of information for drawing up package leaflets for end users, labelling of medicinal products, and for verification of advertising,
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Summary of the Product Characteristics means a summary of expert information on a medicinal product which has been approved through the marketing authorisation procedure and which is intended for healthcare professionals,
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Examples of Summary of the Product Characteristics in a sentence

  • For that reason any claim must be in conformity with the approved Summary of the Product Characteristics (SPC).

  • A Summary of the Product Characteristics (SPC) shall mean a written summary of information about a medicinal product which forms part of the marketing authorisation of the medicinal product and contains information essential for the proper use of the product.

  • An intrinsic part of the authorisation is the Summary of the Product Characteristics (SPC), which shall stipulate the terms and conditions relating to the making available on the market and use of the in situ biocidal product.

  • The rate includes items such as room and board, medical supplies and equipment, personal needs items, social services, and over-the-counter drugs.

  • The MAH has submitted the following documents in scope of the renewal of the Marketing Authorisation:- PSUR data- Clinical Expert statement, dated 18-Dec-2009.- GMP certificates.- QP declarations.- An addendum to the Quality Overall Summary, including a quality expert statement, dated 16 December 2009.- Approved Summary of the Product Characteristics, Package Leaflet and Labelling.

  • Required documents:➢ A copy of valid Summary of the Product Characteristics (SPC) authorised by the regulatory authority of the state from whose market the comparator shall be obtained for the purposes of the clinical trial.

  • The Apifarma’s Code of Ethics further provides that comparisons between medicines (i) should be based on relevant and comparable aspects, (ii) should not be misleading or defamatory, and (iii) should only be performed by reference to the elements included in the Summary of the Product Characteristics (“SmPC”) or on credible clinical data.

  • The team’s findings were outlined with regard to the organisational strengths and challenges of SLRCS.

  • The rapid amelioration of suicidal ideation by ketamine is particularly important since current antidepressants are slow to act and have been reported to potentially worsen suicidal ideation in the short-term (see Summary of the Product Characteristics for individual drugs).

  • Then, together with the pharmaceutical company concerned, it draws up the EPAR (European Public Assessment Report, which summarises the product’s characteristics and the methods with which its approval was decided), the SPC (Summary of the Product Characteristics, a technical file aimed at the prescribing doctor), and the instructions that are placed inside the packaging to inform the patients (2).

Related to Summary of the Product Characteristics

  • Product Description means the description of each Hospitality Package, or series of Hospitality Packages which are the subject of any Confirmation of Purchase.

  • MSAA Indicator Technical Specifications document means, as the context requires, either or both of the document entitled “Multi-Sector Service Accountability Agreement (MSAA) 2019-20 Indicator Technical Specifications November 5, 2018 Version 1.3” and the document entitled “Multi-Sector Service Accountability Agreement (MSAA) 2019-20 Target and Corridor-Setting Guidelines” as they may be amended or replaced from time to time;

  • Monitoring Indicator means a measure of HSP performance that may be monitored against provincial results or provincial targets, but for which no Performance Target is set;

  • Existing Product means any formulation of the same product category and form sold, supplied, manufactured, or offered for sale in California prior to the following dates, or any subsequently introduced identical formulation:

  • Product Schedule means PTC’s standard order form entitled “PTC Product Schedule” (including all schedules, attachments and other document(s) specifically referenced therein) or such alternative order form as may be submitted by Customer and accepted by PTC, in each case that specifies (i) the Licensed Products and/or Services ordered; and (ii) for Licensed Products, the installation address (including the Designated Country) and the Licence Term.

  • Program Parameter means, in respect of a program, the provincial standards (such as operational, financial or service standards and policies, operating manuals and program eligibility), directives, guidelines and expectations and requirements for that program;

  • Existing Products Tangible Products and intangible licensed Products which exist prior to the commencement of work under the Contract. Contractor retains the burden of proving that a particular product was existing before commencement of the Project. .

  • Product Backlog means a list of those Stories that do not form part of the current Sprint Plan at that time and which are to form the subject of a future Sprint, either in the current Release at that time or a subsequent Release;

  • labelling means any words, particulars, trade marks, brand name, pictorial matter or symbol relating to a food and placed on any packaging, document, notice, label, ring or collar accompanying or referring to such food;

  • Filtering facepiece (dust mask) means a negative pressure particulate respirator with a filter as an integral part of the facepiece or with the entire facepiece composed of the filtering medium, not equipped with elastomeric sealing surfaces and adjustable straps.

  • Program Materials means the documents and information provided by the Program Administrator specifying the qualifying EEMs, technology requirements, costs and other Program requirements, which include, without limitation, program guidelines and requirements, application forms and approval letters.

  • Manufacturing Facility means buildings and structures, including machinery and equipment, the primary purpose of which is or will be the manufacture of tangible goods or materials or the processing of such goods or materials by physical or chemical change.

  • Manufacturing site means the facilities where a Compound is Manufactured by or on behalf of a Party, as such Manufacturing Site may change from time to time in accordance with Section 8.7.

  • Functional Specifications means the descriptions of features and functions of the Application as expressly set forth in Quote.

  • Sample means urine, blood, breath, saliva, or hair.

  • Detailed manufacturing or process data means technical data that describe the steps, sequences, and conditions of manufacturing, processing or assembly used by the manufacturer to produce an item or component or to perform a process.

  • complex product means a product which is composed of multiple components which can be replaced permitting disassembly and re-assembly of the product.

  • Protocol Number 1002-048 Protocol Title: A Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Multicenter Study to Evaluate the Efficacy and Safety of Bempedoic Acid (ETC-1002) 180 mg/day as Add-on to Ezetimibe Therapy in Patients with Elevated LDL-C Protocol Date: 18 January 2017 Sponsor: Esperion Therapeutics, Inc. Country where Institution is Conducting Study Czech Republic Location where the study will be conducted: Kardiologická ambulance, which is a division/part of the Institution Key Enrollment Date: 100 Calendar Days after Site Initiation Visit (being the date by which Site must enrol at least one (1) subject as more specifically set out in section 1.7 “Key Enrollment Date” below) ECMT / EC / RA ECMT: Ethics Committee Fakultni nemocnice v Motole V Uvalu 84 150 06 Xxxxx 0 Xxxxx Xxxxxxxx; Mgr. xxxxxxxxxxxxx Etická komise Nemocnice Havlíčkův Brod Husova 2624 580 22 Havlíčkův Brod RA: State Institute for Drug Control, Xxxxxxxxx 00, 000 00 Xxxxx 00 Xxxxx Xxxxxxxx Investigator name, (the “Investigator”) xxxxxxxxxxxxx Číslo Protokolu: 1002-048 Název Protokolu: Randomizované, dvojitě zaslepené, placebem kontrolované multicentrické klinické hodnocení, s paralelními skupinami, posuzující účinnost a bezpečnost kyseliny bempedové (ETC 1002) 180 mg denně jako doplňku k léčbě ezetimibem u pacientů se zvýšenou hladinou LDL-C Datum Protokolu: 18. 1. 2017 Zadavatel: Esperion Therapeutics, Inc. Stát, ve kterém má sídlo Zdravotnické zařízení, které provádí Studii Česká republika Místo, kde bude prováděna Studie: Kardiologická ambulance, která je součástí/oddělením Zdravotnického zařízení Klíčové datum zařazení: 100 kalendářních dnů po Iniciační návštěvě Místa provádění klinického hodnocení (a to jakožto den, ke kterému je Místo provádění klinického hodnocení povinno zařadit minimálně jeden (1) subjekt, jak je dále podrobněji rozvedeno níže v odstavci 1.7 “Klíčové datum zařazení”) MEK / EK / SÚKL MEK: Etická komise Fakultní nemocnice v Motole V Úvalu 84 150 06 Xxxxx 0 Xxxxx xxxxxxxxx; xxxxxxxxxxxxx Etická komise Nemocnice Havlíčkův Brod Husova 2624 580 22 Havlíčkův Brod SÚKL: Státní ústav pro kontrolu léčiv, Šrobárova 48, 100 41 Xxxxx 00 Xxxxx xxxxxxxxx Jméno zkoušejícího, ( “Zkoušející”) xxxxxxxxxxxxx The following additional definitions shall apply to this Agreement: Ve Smlouvě jsou použity následující smluvní definice:

  • Filter profile means a graphical representation of individual filter performance, based on continuous turbidity measurements or total particle counts versus time for an entire filter run, from startup to backwash inclusively, that includes an assessment of filter performance while another filter is being backwashed.

  • Manufacturing Facilities means facilities engaged in the mechanical or chemical transformation of materials or substances into new products and shall include:

  • Peer support specialist means an individual who has experienced a severe and persistent mental illness and who has successfully completed standardized training to provide peer support services through the medical assistance program or the Iowa Behavioral Health Care Plan.

  • Manufacturing Cost means ***

  • Custom Local Area Signaling Service Features (CLASS Features) means certain Common Channel Signaling based features available to End Users, including: Automatic Call Back; Call Trace; Distinctive Ringing/Call Waiting; Selective Call Forward; and Selective Call Rejection.

  • Brand Name Specification means a specification limited to one or more items by manufacturers’ names or catalogue number.

  • Core Curriculum Content Standards means the New Jersey Student Learning Standards.

  • Fully Burdened Manufacturing Cost means, with respect to any Licensed Product supplied by or on behalf of NVCR to Zai hereunder if such Licensed Product (or any precursor or intermediate thereof) is manufactured by a Third Party manufacturer [***].