№ lp_2_1_02967
File format: docx Character count: 67374 File size: 192 KB
Year: 2023
Region / city: Australia
Subject: Pneumococcal vaccine
Document type: Submission
Organ / institution: Therapeutic Goods Administration (TGA), Pharmaceutical Benefits Advisory Committee (PBAC)
Author: Pfizer Australia Pty Ltd
Target audience: Healthcare professionals, public health policymakers
Period of validity: Ongoing
Approval date: 27 April 2023 (FDA approval)
Amendment date: 20 December 2022 (TGA submission)
Background: This document presents the submission for the 20-valent pneumococcal conjugate vaccine to be listed on the National Immunisation Program in Australia for specific paediatric populations.
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Pneumococcal polysaccharide conjugate vaccine (20-valent, adsorbed) (PCV20) Patient Group Direction (PGD)
Year: 2025
Region / city: England
Topic: Immunization
Document type: Patient Group Direction (PGD)
Authoring body: UK Health Security Agency (UKHSA)
Target audience: Healthcare professionals involved in immunization programs
Period of validity: 17 December 2025 - 17 December 2028
Approval date: 9 December 2025
Review date: 17 July 2028
Expiry date: 17 December 2028
METHOTREXATE, Tablet 2.5 mg (as sodium) Tablet 10 mg (as sodium), Methoblastin®, PFIZER AUSTRALIA PTY LTD
Year: 2023
Region / city: Australia
Theme: Pharmaceutical submission
Document type: Pharmaceutical submission
Organization / institution: Pfizer Australia Pty Ltd
Author: Not specified
Target audience: Medical practitioners, nurse practitioners
Effective period: Not specified
Approval date: Not specified
Amendment date: Not specified
Context: Pharmaceutical submission requesting the inclusion of a new formulation of methotrexate under the General Schedule of the PBS for Australia, with changes in packaging and excipient composition.
Gemtuzumab Ozogamicin, Powder for Injection 5 mg, Mylotarg®, Pfizer Australia Pty Ltd.
Year: 2020
Region / city: Australia
Therapeutic area: Oncology
Document type: Regulatory submission
Institution: Pfizer Australia Pty Ltd.
Author: Pfizer Australia Pty Ltd.
Target audience: Regulatory authorities, medical professionals
Effective period: Ongoing
Approval date: April 9, 2020
Date of last revision: March 2021
TOFACITINIB, Tablet 5 mg, Xeljanz®, Pfizer Australia Pty Ltd.
Year: 2023
Region / city: Australia
Subject: Ankylosing spondylitis treatment
Document type: Pharmaceutical submission
Institution: Pfizer Australia Pty Ltd
Author: Pfizer Australia Pty Ltd
Target audience: Medical professionals
Period of validity: Ongoing
Approval date: 25 January 2023
Date of changes: Not specified
Topics: Prevenar 20-valent PFIZER