01 7F. Hoffmann-La Roche
02 5Genentech
01 2CAP
02 2CAPSULE
03 4CAPSULE;ORAL
04 2Kaps
05 1PELLETS;ORAL
06 1Blank
01 2Originator
02 2Prescription
03 3RX
04 5Blank
01 7ROZLYTREK
02 3Rozlytrek
03 1Rozlytrek 100mg
04 1Rozlytrek 200mg
01 1Australia
02 2Canada
03 2South Africa
04 2Switzerland
05 5USA
Regulatory Info :
Registration Country : Switzerland
Brand Name : Rozlytrek
Dosage Form : Kaps
Dosage Strength : 100mg
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Switzerland
Regulatory Info :
Registration Country : Switzerland
Brand Name : Rozlytrek
Dosage Form : Kaps
Dosage Strength : 200mg
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Switzerland
Regulatory Info : Prescription
Registration Country : Canada
Brand Name : ROZLYTREK
Dosage Form : CAPSULE
Dosage Strength : 200MG
Packaging :
Approval Date :
Application Number : 2495015
Regulatory Info : Prescription
Registration Country : Canada
Regulatory Info : Prescription
Registration Country : Canada
Brand Name : ROZLYTREK
Dosage Form : CAPSULE
Dosage Strength : 100MG
Packaging :
Approval Date :
Application Number : 2495007
Regulatory Info : Prescription
Registration Country : Canada
Regulatory Info : Originator
Registration Country : South Africa
Brand Name : Rozlytrek 100mg
Dosage Form : CAP
Dosage Strength : 100MG
Packaging : 1X30MG
Approval Date :
Application Number :
Regulatory Info : Originator
Registration Country : South Africa
Regulatory Info : Originator
Registration Country : South Africa
Brand Name : Rozlytrek 200mg
Dosage Form : CAP
Dosage Strength : 200MG
Packaging : 1X90MG
Approval Date :
Application Number :
Regulatory Info : Originator
Registration Country : South Africa
Regulatory Info :
Registration Country : Australia
Brand Name : Rozlytrek
Dosage Form :
Dosage Strength :
Packaging : 90
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Australia
Regulatory Info : RX
Registration Country : USA
Brand Name : ROZLYTREK
Dosage Form : CAPSULE;ORAL
Dosage Strength : 100MG
Packaging :
Approval Date : 2019-08-15
Application Number : 212725
Regulatory Info : RX
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
Brand Name : ROZLYTREK
Dosage Form : CAPSULE;ORAL
Dosage Strength : 200MG
Packaging :
Approval Date : 2019-08-15
Application Number : 212725
Regulatory Info : RX
Registration Country : USA
Regulatory Info :
Registration Country : USA
Brand Name : ROZLYTREK
Dosage Form : CAPSULE;ORAL
Dosage Strength : 100MG
Packaging :
Approval Date :
Application Number : 212726
Regulatory Info :
Registration Country : USA
Regulatory Info :
Registration Country : USA
Brand Name : ROZLYTREK
Dosage Form : CAPSULE;ORAL
Dosage Strength : 200MG
Packaging :
Approval Date :
Application Number : 212726
Regulatory Info :
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
Brand Name : ROZLYTREK
Dosage Form : PELLETS;ORAL
Dosage Strength : 50MG/PACKET
Packaging :
Approval Date : 2023-10-20
Application Number : 218550
Regulatory Info : RX
Registration Country : USA
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