№ lp_1_2_20764
File format: docx Character count: 13474 File size: 62 KB
Category 4 submission detailing the requested PBS listing of Tiotropium Lupin for use with the LupinHaler device as an equivalent generic to Spiriva for the treatment of COPD.
Year: 2023
Region / city: Australia
Type of document: Pharmaceutical submission / Public Summary Document
Regulatory authority: Therapeutic Goods Administration (TGA)
Submitted by: Generic Health Pty Ltd
Product: Tiotropium Lupin 18 microgram powder for inhalation, LupinHaler device
Indication: Chronic obstructive pulmonary disease (COPD)
Previous PBS listing: Spiriva 18 microgram powder for inhalation, HandiHaler device
Submission type: Category 4 (cost-minimisation comparison)
PBS item code: 8626BMP,NP
Maximum quantity: 1 pack, 30 units
Prescriber type: Nurse Practitioners, Medical Practitioners
Restriction type: Restricted benefit
Administrative advice: Not to be used in combination with LAMA/LABA or SAMA; adherence to current inhaler technique to be reviewed at each clinical visit; diagnosis requires spirometry confirmation
Price: 8 / 10 USD
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The product description is provided for reference. Actual content and formatting may differ slightly.
ESTRADIOL Transdermal gel (pump pack) 750 microgram (as hemihydrate) per 1.25 g dose, 64 doses, Estrogel®
Year: 2019
Region / City: Australia
Topic: Hormone Replacement Therapy (HRT)
Document Type: Regulatory Submission
Organization / Institution: Besins Healthcare Australia Pty Ltd
Author: Not specified
Target Audience: Health professionals and regulatory authorities
Period of Effectiveness: Not specified
Approval Date: 8 May 2019
Modification Date: Not specified
Registration Status: TGA Registered
Indications: Estrogen deficiency, prevention of osteoporosis, menstrual irregularities, hormone replacement therapy
Purpose: Request for listing of medications in General Schedule
Product Names: Estrogel®, Prometrium®, Estrogel Pro
Safety Data: Includes safety outcomes such as breast pain, tenderness, breakthrough bleeding, and breast cancer risk
Comparator Products: Sandrena®, MPA (medroxyprogesterone acetate)
Clinical Claims: Efficacy and safety comparison of Estrogel and MP to Sandrena and MPA
Source: Tables 1.2, pp23-24
Topics: Tiotropium Lupin microgram