Pulmicort Respules definition

Pulmicort Respules means that formulation of inhaled Nebulized Budesonide marketed under the Trademark ‘Pulmicort Respules’ by AstraZeneca and its Affiliates in the United States and any other branded versions of such product outside the United States.

Examples of Pulmicort Respules in a sentence

  • Pulmicort Respules (budesonide inhalation suspension)Patent proceedings in the USOn 1 April 2013, the US District Court for the District of New Jersey ruled that AstraZeneca’s US Patent No. 6,598,603 is invalid and that the generic defendants involved in the litigation do not infringe a second patent, US Patent No. 7,524,834.

  • Pulmicort Respules (budesonide inhalation suspension)Patent proceedings in the USAs previously disclosed, in December 2013, the US District Court for the District of New Jersey granted AstraZeneca’s motion and temporarily enjoined the generic defendants from entering the market until resolution of AstraZeneca’s motion for a preliminary injunction.

  • For the single doses of BDA MDI and Pulmicort Respules, no safety issues are expected.

  • For Pulmicort Respules, a single dose of the highest recommended dose of 1 mg will be studied (7).

  • The test product (BDA MDI) will be supplied by The reference product (Pulmicort Respules) will be supplied by Both products will be labelled with a study-specific label.

  • Pulmicort Respules is a sterile suspension for inhalation via jet nebulizer and contains the active ingredient budesonide (micronized) and the inactive ingredients disodium edetate, sodium chloride, sodium citrate, citric acid, polysorbate 80, and water for injection.

  • In the United States (US) development program for BDA MDI, Pulmicort Respules will be used as a reference product for the BDA MDI marketing application for children ages 4 and 5 years.

  • III.2 Discussion on the non-clinical aspectsThis product is a hybrid formulation of Pulmicort Respules, which is available on the European market.

  • REDACTED COPYThe exact date and start time of BDA MDI and Pulmicort Respules will be recorded in the eCRF in addition to the exact date and time of PK sampling.

  • The children will be provided with detailed instructions on the use of the placebo MDI device and Pulmicort Respules nebulization.

Related to Pulmicort Respules

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