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Drug Approvals
17
TGA:17
Drug Approvals
KALYDECO ivacaftor 13.4 mg granules sachet (449865)
- Product Name
- KALYDECO ivacaftor 13.4 mg granules sachet
- Approval Date
- Feb 6, 2025
TGA
TRIKAFTA 80/40/60 GRANULES elexacaftor 80 mg/tezacaftor 40 mg/ivacaftor 60 mg granules and ivacaftor 59.5 mg granules sachet composite pack (402132)
- Product Name
- TRIKAFTA 80/40/60 GRANULES elexacaftor 80 mg/tezacaftor 40 mg/ivacaftor 60 mg granules and ivacaftor 59.5 mg granules sachet composite pack
- Approval Date
- Feb 7, 2024
TGA
TRIKAFTA 100/50/75 GRANULES elexacaftor 100 mg/tezacaftor 50 mg/ivacaftor 75 mg granules and ivacaftor 75 mg granules sachet composite pack (402133)
- Product Name
- TRIKAFTA 100/50/75 GRANULES elexacaftor 100 mg/tezacaftor 50 mg/ivacaftor 75 mg granules and ivacaftor 75 mg granules sachet composite pack
- Approval Date
- Feb 7, 2024
TGA
ORKAMBI 75/94 lumacaftor/ivacaftor 75mg/94mg granules sachet (389450)
- Product Name
- ORKAMBI 75/94 lumacaftor/ivacaftor 75mg/94mg granules sachet
- Approval Date
- May 16, 2023
TGA
TRIKAFTA 50/25/37.5 elexacaftor 50mg/tezacaftor 25mg/ivacaftor 37.5mg film-coated tablet and ivacaftor 75mg film-coated tablet blister composite pack (372334)
- Product Name
- TRIKAFTA 50/25/37.5 elexacaftor 50 mg/tezacaftor 25 mg/ivacaftor 37.5 mg film-coated tablet and ivacaftor 75 mg film-coated tablet blister pack composite pack
- Approval Date
- Nov 1, 2022
TGA
KALYDECO ivacaftor 25 mg granules sachet (342815)
- Product Name
- KALYDECO ivacaftor 25 mg granules sachet
- Approval Date
- Sep 24, 2021
TGA
SYMDEKO 50/75 tezacaftor 50 mg/ivacaftor 75 mg film-coated tablet and ivacaftor 75 mg film-coated tablet composite pack (337367)
- Product Name
- SYMDEKO 50/75 tezacaftor 50 mg/ivacaftor 75 mg film-coated tablet and ivacaftor 75 mg film-coated tablet composite pack
- Approval Date
- Apr 29, 2021
TGA
TRIKAFTA 100/50/75 elexacaftor 100mg/tezacaftor 50mg/ivacaftor 75mg film-coated tablet and ivacaftor 150mg film-coated tablet blister composite pack (330423)
- Product Name
- TRIKAFTA 100/50/75 elexacaftor 100 mg / tezacaftor 50 mg / ivacaftor 75 mg film-coated tablet and ivacaftor 150 mg film-coated tablet blister composite pack
- Approval Date
- Mar 24, 2021
TGA
ORKAMBI 100/125 lumacaftor/ivacaftor 100mg/125mg granules sachet (305011)
- Product Name
- ORKAMBI 100/125 lumacaftor/ivacaftor 100mg/125mg granules sachet
- Approval Date
- Jun 21, 2019
TGA
ORKAMBI 150/188 lumacaftor/ivacaftor 150mg/188mg granules sachet (305012)
- Product Name
- ORKAMBI 150/188 lumacaftor/ivacaftor 150mg/188mg granules sachet
- Approval Date
- Jun 21, 2019
TGA
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