Saturday, January 07, 2017 7:29:28 PM
The CHMP (Committee for Medicinal Products for Human Use) adopted the positive opinion on 15th of December and recommended the granting of a marketing authorisation for the medicinal product Truxima, intended for the treatment of non-Hodgkin’s lymphoma (NHL), chronic lymphocytic leukaemia (CLL), rheumatoid arthritis (RA), granulomatosis with polyangiitis (GPA) and microscopic polyangiitis (MPA).
Mabthera, which is known as Rituxan in United States, was approved on 2 June 1998 in EU. Now the biosimilar version, Truxima will have the full indications of Mabthera and will be available as a 500 mg concentrate for solution for infusion.
Detailed recommendations for the use of this product will be described in the summary of product characteristics (SmPC), which will be published in the European public assessment report (EPAR) and made available in all official European Union languages after the marketing authorisation has been granted by the European Commission.
Source: EMA"
Never argue with a fool, for after awhile, it becomes difficult to determine which is the fool.
Recent HALO News
- Form 144 - Report of proposed sale of securities • Edgar (US Regulatory) • 09/24/2024 08:05:31 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 09/18/2024 10:49:57 PM
- Form 144 - Report of proposed sale of securities • Edgar (US Regulatory) • 09/18/2024 08:01:16 PM
- Form 144 - Report of proposed sale of securities • Edgar (US Regulatory) • 09/17/2024 08:03:48 PM
- Halozyme Announces FDA Approval of Roche's Subcutaneous OCREVUS ZUNOVO™ with ENHANZE® for People with Relapsing and Primary Progressive Multiple Sclerosis • PR Newswire (US) • 09/13/2024 05:30:00 PM
- Halozyme Announces FDA Approval of Roche's Tecentriq Hybreza™ With ENHANZE® for Multiple Types of Cancer • PR Newswire (US) • 09/13/2024 12:00:00 AM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 09/12/2024 09:56:59 PM
- Form 144 - Report of proposed sale of securities • Edgar (US Regulatory) • 09/12/2024 08:12:07 PM
- Form 144 - Report of proposed sale of securities • Edgar (US Regulatory) • 09/11/2024 08:05:49 PM
- Form 144 - Report of proposed sale of securities • Edgar (US Regulatory) • 09/10/2024 08:16:18 PM
- Halozyme to Present at Upcoming Investor Conferences • PR Newswire (US) • 08/28/2024 12:30:00 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 08/27/2024 11:49:52 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 08/21/2024 10:03:29 PM
- Form 144 - Report of proposed sale of securities • Edgar (US Regulatory) • 08/21/2024 08:11:18 PM
- Form 144 - Report of proposed sale of securities • Edgar (US Regulatory) • 08/20/2024 08:16:46 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 08/15/2024 08:59:35 PM
- Form 144 - Report of proposed sale of securities • Edgar (US Regulatory) • 08/15/2024 08:31:05 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 08/14/2024 08:57:27 PM
- Form 144 - Report of proposed sale of securities • Edgar (US Regulatory) • 08/14/2024 08:08:38 PM
- Form 144 - Report of proposed sale of securities • Edgar (US Regulatory) • 08/13/2024 08:19:53 PM
- Form 10-Q - Quarterly report [Sections 13 or 15(d)] • Edgar (US Regulatory) • 08/06/2024 08:07:29 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 08/06/2024 08:03:09 PM
- HALOZYME REPORTS SECOND QUARTER 2024 FINANCIAL AND OPERATING RESULTS • PR Newswire (US) • 08/06/2024 08:01:00 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 07/24/2024 09:48:14 PM
North Bay Resources Commences Operations at Bishop Gold Mill, Inyo County, California; Engages Sabean Group Management Consulting • NBRI • Sep 25, 2024 9:15 AM
CEO David B. Dorwart Anticipates a Bright Future at Good Gaming Inc. Through His Most Recent Shareholder Update • GMER • Sep 25, 2024 8:30 AM
Cannabix Technologies and Omega Laboratories Inc. Advance Marijuana Breathalyzer Technology - Dr. Bruce Goldberger to Present at Society of Forensic Toxicologists Conference • BLOZF • Sep 24, 2024 8:50 AM
Integrated Ventures, Inc Announces Strategic Partnership For GLP-1 (Semaglutide) Procurement Through MedWell USA, LLC. • INTV • Sep 24, 2024 8:45 AM
Avant Technologies Accelerates Creation of AI-Powered Platform to Revolutionize Patient Care • AVAI • Sep 24, 2024 8:00 AM
VHAI - Vocodia Partners with Leading Political Super PACs to Revolutionize Fundraising Efforts • VHAI • Sep 19, 2024 11:48 AM