USE IN SPECIFIC POPULATIONS Sample Clauses

USE IN SPECIFIC POPULATIONS. ∙Lactation: Advise women not to breastfeed. Please see Full Prescribing Information<hxxxx://xxxxxxx.xxx/xxx/full-prescribing-information.pdf> for additional safety information. About Puma Biotechnology Puma Biotechnology, Inc. is a biopharmaceutical company with a focus on the development and commercialization of innovative products to enhance cancer care. The Company in-licenses the global development and commercialization rights to three drug candidates — PB272 (neratinib, oral), PB272 (neratinib, intravenous) and PB357. Neratinib, oral was approved by the U.S. Food and Drug Administration in July 2017 for the extended adjuvant treatment of adult patients with early stage HER2-overexpressed/amplified breast cancer, following adjuvant trastuzumab-based therapy, and is marketed in the United States as NERLYNX® (neratinib) tablets. NERLYNX was granted marketing authorization by the European Commission in September 2018 for the extended adjuvant treatment of adult patients with early stage hormone receptor-positive HER2-overexpressed/amplified breast cancer and who are less than one year from completion of prior adjuvant trastuzumab-based therapy. NERLYNX is a registered trademark of Puma Biotechnology, Inc. Further information about Puma Biotechnology can be found at wxx.xxxxxxxxxxxxxxxxx.xxx.
Sample 1
AutoNDA by SimpleDocs
USE IN SPECIFIC POPULATIONS. Discontinue IMCIVREE when pregnancy is recognized unless the benefits of therapy outweigh the potential risks to the fetus. ​ Treatment with IMCIVREE is not recommended for use while breastfeeding. ​ To report SUSPECTED ADVERSE REACTIONS, contact Rhythm Pharmaceuticals at +0 (000) 000-0000 or FDA at 1-800-FDA-1088 or xxx.xxx.xxx/xxxxxxxx. ​ See U.S. Full Prescribing Information, EU SmPC and MHRA SmPC for IMCIVREE. ​ Forward-Looking Statements ​ This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements, including without limitation statements regarding activities in connection with the exclusive licensing agreement with RareStone and potential payments thereunder, the potential, safety, efficacy, and regulatory and clinical progress of setmelanotide, including the anticipated timing for initiation of clinical trials and ​ ​ ​
Sample 1
USE IN SPECIFIC POPULATIONS. 8.1 Pregnancy
Sample 1
USE IN SPECIFIC POPULATIONS. Pregnancy: May cause fetal harm (8.1). See 17 for PATIENT COUNSELING INFORMATION. Revised: 02/2018 FULL PRESCRIBING INFORMATION: CONTENTS* WARNING: ADDICTION, ABUSE, AND MISUSE; LIFE-THREATENING RESPIRATORY DEPRESSION; ACCIDENTAL INGESTION; NEONATAL OPIOID WITHDRAWAL SYNDROME; AND HEPATOTOXICITY
Sample 1
USE IN SPECIFIC POPULATIONS. Lactation: Advise women not to breastfeed. [***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions. Confidential Treatment Requested by Puma Biotechnology, Inc.
Sample 1
USE IN SPECIFIC POPULATIONS. Pregnancy There are no data from the use of setmelanotide in pregnant women. Animal studies do not indicate direct harmful effects with respect to reproductive toxicity. However, administration of setmelanotide to pregnant rabbits resulted in decreased maternal food consumption leading to embryo-fetal effects. As a precautionary measure, setmelanotide should not be started during pregnancy or while attempting to get pregnant as weight loss during pregnancy may result in fetal harm. If a patient who is taking setmelanotide has reached a stable weight and becomes pregnant, consideration should be given to maintaining setmelanotide treatment as there was no proof of teratogenicity in the nonclinical data. If a patient who is taking setmelanotide and still losing weight gets pregnant, setmelanotide should either be discontinued, or the dose reduced while monitoring for the recommended weight gain during pregnancy. The treating physician should carefully monitor weight during pregnancy in a patient taking setmelanotide. Breast-feeding It is unknown whether setmelanotide is excreted in human milk. A nonclinical study showed that setmelanotide is excreted in the milk of nursing rats. No quantifiable setmelanotide concentrations were detected in plasma from nursing pups. A risk to the newborn/infant cannot be excluded. A decision must be made whether to discontinue breastfeeding or to discontinue/abstain from setmelanotide therapy taking into account the benefit of breastfeeding for the child and the benefit of therapy for the mother. Fertility No human data on the effect of setmelanotide on fertility are available. Animal studies did not indicate harmful effects with respect to fertility. To report SUSPECTED ADVERSE REACTIONS, contact Rhythm Pharmaceuticals at +0 (000) 000-0000. See Summary of Product Characteristics’ APPENDIX V for a list of European national reporting systems to communicate adverse reactions. Please see the full Prescribing Information for additional Important Safety Information. Forward-Looking Statements
Sample 1

Related to USE IN SPECIFIC POPULATIONS

  • Country-Specific Provisions The Award shall be subject to any special provisions set forth in Exhibit A for your country, if any. If you relocate to one of the countries included in Exhibit A during the life of the Award or while holding Shares acquired upon vesting of the Restricted Share Units, the special provisions for such country shall apply to you, to the extent the Company determines that the application of such provisions is necessary or advisable in order to comply with applicable laws with regard to the acquisition, issuance or sale of the Shares or facilitate the administration of the Plan. Exhibit A constitutes part of this Agreement.

  • State Specific Provisions N/A. ATTACHED EXHIBIT. The Exhibit noted below, if marked with an "X" in the space provided, is attached to this Note: X Exhibit A Modifications to Multifamily Note

  • Country Specific Terms Appendix A contains additional terms and conditions of the Agreement applicable to Participants residing in those countries. In addition, Appendix A also contains information and notices of exchange control and certain other issues of which the Participant should be aware.

  • GEOGRAPHIC AREA AND SECTOR SPECIFIC ALLOWANCES, CONDITIONS AND EXCEPTIONS The following allowances and conditions shall apply where relevant: Where the company does work which falls under the following headings, the company agrees to pay and observe the relevant respective conditions and/or exceptions set out below in each case.

  • Public Posting of Approved Users’ Research Use Statement The PI agrees that information about themselves and the approved research use will be posted publicly on the dbGaP website. The information includes the PI’s name and Requester, project name, Research Use Statement, and a Non-Technical Summary of the Research Use Statement. In addition, and if applicable, this information may include the Cloud Computing Use Statement and name of the CSP or PCS. Citations of publications resulting from the use of controlled-access datasets obtained through this DAR may also be posted on the dbGaP website.

  • Specific Provisions 4.1 Unless the CERT otherwise agrees, based on exceptional circumstance and sufficient justification, Implementing Agreements shall be for an initial term of up to, but no more than, five years.

  • Specific Provision The grievant shall cite on the grievance form the specific article(s) and/or section(s) or combination thereof that the grievant alleges to have been violated. Failure to cite said provision(s) shall relieve the Employer of any obligation to process the grievance.

  • Use of Basement and Service Areas The basement(s) and service areas, if any, as located within the (project name), shall be earmarked for purposes such as parking spaces and services including but not limited to electric sub-station, transformer, DG set rooms, underground water tanks, pump rooms, maintenance and service rooms, fire fighting pumps and equipment's etc. and other permitted uses as per sanctioned plans. The Allottee shall not be permitted to use the services areas and the basements in any manner whatsoever, other than those earmarked as parking spaces, and the same shall be reserved for use by the association of allottees formed by the Allottees for rendering maintenance services.

  • Project Specific Milestones In addition to the milestones stated in Section 212.5 of the Tariff, as applicable, during the term of this ISA, Interconnection Customer shall ensure that it meets each of the following development milestones:

  • CLOUD SPECIFIC TERMS AND CONDITIONS To the extent that Contractor has received an award for Lot 3, Cloud, the following terms and conditions apply to Lot 3, Cloud. For the duration of an Authorized User Agreement, the Cloud Solution shall conform to the Cloud Solution Manufacturer’s specifications, Documentation, performance standards (including applicable license duration, warranties, guarantees, Service Level Agreements, service commitments, and credits). PROTECTION OF DATA, INFRASTRUCTURE AND SOFTWARE Contractor is responsible for providing physical and logical security for all Data, infrastructure (e.g. hardware, networking components, physical devices), and software related to the services the Contractor is providing under the Authorized User Agreement. All Data security provisions agreed to by the Authorized User and Contractor within the Authorized User Agreement may not be diminished for the duration of the Authorized User Agreement without prior written agreement by the parties amending the Authorized User Agreement.

Time is Money Join Law Insider Premium to draft better contracts faster.