Pharmaceutically equivalent definition

Pharmaceutically equivalent means drug products that have identical amounts of the same active chemical ingredients in the same dosage form and that meet the identical compendia or other applicable standards of strength, quality, and purity according to the United States Pharmacopoeia or another nationally recognized compendium.
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Pharmaceutically equivalent means drug products that contain identical amounts of the identical active ingredient, in identical dosage forms, but not necessarily containing the same inactive ingredients.
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Pharmaceutically equivalent means drugs that have
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Examples of Pharmaceutically equivalent in a sentence

  • In 1999 (WT/BFA/44), the Committee on Budget Finance and Administration decided to reduce the burden of the costs associated with a Ministerial Conference by spreading the costs over two years with a budgetary appropriation in each year of the regular budget of the WTO of CHF 400,000.

  • Pharmaceutically equivalent drug products, sometimes called chemical equivalents, are formulated to contain the same amount of active ingredient to meet the same or comparable standards (i.e., identity, strength, purity, and quality), but they may differ in characteristics such as color, taste, shape, packaging, preservatives, expiration time, and, within certain limits, labeling.

  • Pharmaceutically equivalent to another contraceptive drug, device, or product in that it contains an identical amount of the same active drug ingredient in the same dosage form and route of administration and meets compendial or other applicable standards of strength, quality, purity, and identity.

  • Pharmaceutically equivalent products containing these ingredients in oral dosage forms are coded BP until adequate in vivo bioequivalence data are submitted, such products are coded AB.

  • Pharmaceutically equivalent gases are considered to be equivalent without the need for further documentation.

  • Consult the World Health Organization (WHO) Technical Report Series, No 937, 2006 Annex 7 Multisource (generic) pharmaceutical products: Guidelines on registration requirements to establish interchangeability to answer this question.• Pharmaceutically equivalent products – these are pharmaceutical products that contain the same molar amount of the same APIs in the same dosage form, if they meet comparable standards and if they are intended to be administered by the same route.

  • Multiple Source Drug – CMS finalized the definition of a multiple source drug as a COD for which there is at least one other drug product which is--• Rated as therapeutically equivalent as reported in FDA's most recent publication of “Approved Drug Products with Therapeutic Equivalence Evaluations”;• Pharmaceutically equivalent and bioequivalent, as determined by FDA; and• Sold or marketed in the United States during the rebate period.

  • Pharmaceutically equivalent licensed product temporarily unavailable* .………………………………………….....................................................................................................................

  • An overall rehabilitation and development scheme for the property has been prepared by Dialog Architects.

  • Master formula A document or a set of documents specifying the starting materials with their quantities and the packaging materials, together with a description of the procedures and precautions required to produce a specified quantity of a finished product as well as the processing instructions, including in-process controls Multisource (generic) pharmaceutical products Pharmaceutically equivalent or pharmaceutically alternative products that may or may not be therapeutically equivalent.


More Definitions of Pharmaceutically equivalent

Pharmaceutically equivalent means containing an active substance in the same proportions, in the same dosage form and concentration (in the case of a liquid dose) and meeting the same or comparable standards in relation to the clinical needs of a patient at the time of use.
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Pharmaceutically equivalent means drug products that have identical amounts of the
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Pharmaceutically equivalent means drug products that have identical amounts of the sameactive chemical ingredients in the same dosage form and that meet the identical compendia or otherapplicable standards of strength, quality, and purity according to the United States Pharmacopoeia oranother nationally recognized compendium.
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Pharmaceutically equivalent means the two drugs share the same active ingredients, strength and dosage. See 21
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Pharmaceutically equivalent means a drug product that, in comparison with another drug, contains identical amounts of the identical medicinal ingredients, in comparable dosage forms, but that does not necessarily contain the same non-medicinal ingredients.
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Related to Pharmaceutically equivalent

  • Therapeutically equivalent means a drug product with the same efficacy and toxicity when administered to an individual as the originally prescribed drug as provided for in Section 39‑24‑40.

  • Therapeutically equivalent drug products means drug products that contain the same active ingredients and are identical in strength or concentration, dosage form, and route of administration and that are classified as being therapeutically equivalent by the U.S. Food and Drug Administration pursuant to the definition of "therapeutically equivalent drug products" set forth in the most recent edition of the Approved Drug Products with Therapeutic Equivalence Evaluations, otherwise known as the "Orange Book."

  • Therapeutic Equivalent means that a Covered Drug can be expected to produce essentially the same therapeutic outcome and toxicity.

  • Pharmaceutical means any compound or mixture, other than food, used in the prevention, diagnosis, alleviation, treatment, or cure of disease in human and animal.

  • Aluminum equivalent means the thickness of type 1100 aluminum alloy affording the same attenuation, under specified conditions, as the material in question.

  • Radiopharmaceutical means any drug that exhibits spontaneous disintegration of unstable nuclei with the emission of nuclear particles or photons and includes any non-radioactive reagent kit or radionuclide generator that is intended to be used in the preparation of any such substance, but does not include drugs such as carbon-containing compounds or potassium-containing salts that include trace quantities of naturally occurring radionuclides. The term also includes any biological product that is labeled with a radionuclide or intended solely to be labeled with a radionuclide.

  • Generic Equivalent or "generically equivalent" means a drug that has an identical amount of the same active chemical ingredients in the same dosage form, that meets applicable standards of strength, quality and purity according to the United States pharmacopeia or other nationally recognized compendium and that, if administered in the same amounts, will provide comparable therapeutic effects. Generic equivalent or generically equivalent does not include a drug that is listed by the federal food and drug administration as having unresolved bioequivalence concerns according to the administration's most recent publication of approved drug products with therapeutic equivalence evaluations.

  • Actuarially Equivalent or "of equal actuarial value" means a benefit of equal value

  • Morphine equivalent dose means a conversion of various opioids to a morphine equivalent dose by the use of accepted conversion tables.

  • Combination Product means (a) a product containing a Licensed Product together with one or more other active ingredients that have independent biologic or chemical activity when present alone that are sold as a single unit, or (b) a Licensed Product together with one or more products, devices, pieces of equipment or components thereof, that are sold as a single package at a single price.

  • Investment product means a financial instrument (within the meaning of Article 4(1)(15) of MiFID II) or a structured deposit (within the meaning of Article 4(1)(43) of MiFID II).

  • Combination Products means any product containing both a pharmaceutically active agent or ingredient which constitutes a Licensed Product and one or more other pharmaceutically active agents or ingredients which do not constitute Licensed Products.

  • ingredient means any substance, including a food additive used in the manufacture or preparation of food and present in the final product, possibly in a modified form;

  • Spousal equivalent means a cohabitant occupying a relationship generally equivalent to that of a spouse.

  • Therapeutic diet means meals served that are soft, low-fat, low-sodium or controlled calorie.

  • Alternative nicotine product means any vaping product, whether or not it includes nicotine, including electronic smoking devices, that can be ingested into the body by chewing, smoking, absorbing, dissolving, inhaling, or by any other means. ‘Alternative nicotine product’ does not include:

  • Diagnostic Product means In Vitro Diagnostics, In Vivo Diagnostic Agents and any product used for Diagnosis.

  • Aerosol coating product means a pressurized coating product containing pigments or resins that dispenses product ingredients by means of a propellant, and is packaged in a disposable can for hand-held application, or for use in specialized equipment for ground traffic/marking applications.

  • Biosimilar Product means, with respect to a Licensed Product in any country, any biosimilar product sold by a Third Party not authorized by or on behalf of Celgene, its Affiliates or Sublicensees, (a) that is a biosimilar biological product, as defined in 21 USC 379j-51 (or any successor or replacement thereof), a similar biological medicinal product, as defined in Annex I to Directive 2001/83/EC (or any successor or replacement thereof), or any similar biosimilar or generic product under the Laws of any country or jurisdiction, or (b) regarding which Regulatory Approval is obtained by referencing Regulatory Data of such Licensed Product.

  • Marihuana-infused product means a topical formulation, tincture, beverage, edible substance, or similar product containing marihuana and other ingredients and that is intended for human consumption.

  • Therapeutic school means a residential group living facility:

  • Biotechnology means any technological application that uses biological systems, living organisms, or derivatives thereof, to make or modify products or processes for specific use.

  • Active Pharmaceutical Ingredient or “API” shall mean one or more of the following active pharmaceutical ingredients: tenofovir alafenamide (“TAF”), tenofovir disoproxil fumarate (“TDF”), elvitegravir (“EVG”), and cobicistat (“COBI”).

  • Dose equivalent (HT) means the product of the absorbed dose in tissue, quality factor, and all other necessary modifying factors at the location of interest. The units of dose equivalent are the sievert (Sv) and rem.

  • Pharmaceutical Product shall have the meaning ascribed to such term in Section 3.1(hh).

  • Lead equivalent means the thickness of lead affording the same attenuation, under specified conditions, as the material in question.