№ files_lp_3_process_7_090991
File format: docx Character count: 76720 File size: 293 KB
The document is a submission requesting the inclusion of a new formulation of rivaroxaban for the prevention of recurrent cardiovascular events in patients with stable coronary and peripheral artery disease, outlining clinical evidence and proposed listing conditions.
Year: 2023
Region / City: Australia
Topic: Pharmaceutical application for drug listing
Document Type: Submission for PBS listing
Organization / Institution: PBAC
Author: Bayer Australia Limited
Target Audience: Medical professionals and healthcare authorities
Period of Validity: Not specified
Approval Date: Not specified
Amendment Date: Not specified
Price: 8 / 10 USD
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Canberra Health Services Guideline Apixaban and Rivaroxaban Use in Adults with Severe Kidney Disease
Year: 2021
Region / City: Canberra, Australia
Topic: Pharmacology / Kidney Disease
Document Type: Clinical Guideline
Institution: Canberra Health Services
Author: Not specified
Target Audience: Medical staff and pharmacists
Period of Validity: Not specified
Approval Date: Not specified
Modification Date: Not specified
Rivaroxaban 15 mg film-coated tablets, Rivaroxaban 20 mg film-coated tablets
Active ingredient: Rivaroxaban
Form: Film-coated tablet
Dosage: 15 mg, 20 mg
Indication: Treatment and prevention of deep vein thrombosis and pulmonary embolism
Pharmaceutical form: Film-coated tablet
Therapeutic indications: Treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE), prevention of recurrent DVT and PE
Dosage instructions: 15 mg twice daily for the first three weeks, followed by 20 mg once daily
Special populations: Renal impairment
Side effects: See section 4.8 for adverse reactions
Contraindications: See section 4.3 for contraindications
Storage conditions: Store below 30°C
Review of an application for authorisation of genetically modified maize (Zea mays) with OECD unique identifier MON-87411-9 for direct use as food, feed or for processing in Ghana submitted by Bayer West-Central Africa S.A.
Tracking No: 2023-229-BWCA-002-F
Date: January 26, 2024
Applicant: Bayer West-Central Africa S.A.
Organism: Maize (Zea mays)
Trait: Resistance to Coleoptera, Tolerance to Glyphosate
Genes: cp4 epsps, cry3Bb1, DvSnf7
Food and Feed Safety: Compositional considerations for Maize
Approval History: Argentina, Australia-New Zealand, Brazil, Canada, Colombia, European Union, Japan, Mexico, Paraguay, Philippines, Republic of Korea, USA, Vietnam
Date of First Approval: August 06, 2015 (Australia-New Zealand)
Assessment Summary: Safety and nutritional assessments confirm the event is as safe as its conventional counterpart.
Recommended Terms and Conditions: Limited to food, feed, and processing use; not for cultivation; compliance with biosafety regulations required.
Review of an application for authorisation of genetically modified maize (Zea mays) with OECD unique identifier MON-ØØ81Ø-6 for direct use as food, feed or for processing in Ghana submitted by Bayer West-Central Africa S.A.
Year: 2024
Region / City: Ghana
Theme: Genetically Modified Organisms, Food Safety
Document Type: Risk Assessment Report
Organization: Technical Advisory Committee (TAC)
Author: Not specified
Target Audience: National Biosafety Authority, Regulatory Authorities
Period of Validity: 3 years
Approval Date: January 26, 2024
Date of Amendments: None
Review of an application for authorisation of genetically modified soybean (Glycine max) with OECD unique identifier MON-877Ø5-6 for direct use as food, feed or for processing in Ghana submitted by Bayer West-Central Africa S.A.
Year: 2024
Region / city: Ghana
Topic: Genetically Modified Organisms, Soybean
Document Type: Risk Assessment Recommendation
Organisation: Technical Advisory Committee (TAC)
Author: Technical Advisory Committee (TAC)
Target Audience: National Biosafety Authority (NBA), Regulatory Authorities
Validity Period: 3 years, renewable
Approval Date: January 26, 2024
Date of Changes: N/A
Topics: XARELTO Rivaroxaban Bayer