Rozlytrek 100 mg and 200 mg hard capsules
*Company:
Roche Registration GmbHStatus:
No Recent UpdateLegal Category:
Product subject to medical prescription which may not be renewed (A)Active Ingredient(s):
This medicinal product is subject to additional monitoring.
*Additional information is available within the SPC or upon request to the company
Updated on 01 April 2025
File name
ROZ _PSUSA_capsules_PIL_24Mar2025.pdf
Reasons for updating
- Change to section 4 - possible side effects
- Change to section 6 - date of revision
- Change to information for healthcare professionals
Updated on 01 April 2025
File name
ROZ_PSUSA_capsules_SmPC_24Mar2025.pdf
Reasons for updating
- Change to section 4.8 - Undesirable effects
- Change to section 9 - Date of first authorisation/renewal of the authorisation
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 03 July 2024
File name
ROZ_II17G_Caps_SmPC_dated 27Jun2024.pdf
Reasons for updating
- Change to section 4.1 - Therapeutic indications
- Change to section 4.2 - Posology and method of administration
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
- Change to section 4.8 - Undesirable effects
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 5.2 - Pharmacokinetic properties
- Change to section 5.3 - Preclinical safety data
- Change to section 6.1 - List of excipients
- Change to section 6.3 - Shelf life
- Change to section 6.4 - Special precautions for storage
- Change to section 6.6 - Special precautions for disposal and other handling
- Change to section 9 - Date of first authorisation/renewal of the authorisation
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 03 July 2024
File name
ROZ_II17G_Caps_PIL_dated 27Jun2024.pdf
Reasons for updating
- Change to Section 1 - what the product is
- Change to section 1 - what the product is used for
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 2 - interactions with other medicines, food or drink
- Change to section 2 - driving and using machines
- Change to section 3 - dose and frequency
- Change to section 3 - use in children/adolescents
- Change to section 3 - how to take/use
- Change to section 4 - possible side effects
- Change to section 5 - how to store or dispose
- Change to section 6 - what the product contains
Updated on 27 May 2024
File name
ROZ_R20_PIL_16May2024.pdf
Reasons for updating
- Change to section 4 - possible side effects
- Change to section 6 - date of revision
Updated on 27 May 2024
File name
ROZ_R20_SmPC_16May2024.pdf
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.8 - Undesirable effects
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 14 July 2023
File name
ENT-EN-R15-220523-Clean-CD_SmPC_1.pdf
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.8 - Undesirable effects
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 14 July 2023
File name
ENT-EN-R15-220523-Clean-CD_PL_1.pdf
Reasons for updating
- Change to section 4 - possible side effects
- Change to date of revision
Updated on 17 March 2023
File name
ENT-EN-VII14-200223-Clean-CD_SmPC_1.pdf
Reasons for updating
- Change to section 4.2 - Posology and method of administration
- Change to section 5.2 - Pharmacokinetic properties
- Change to section 9 - Date of first authorisation/renewal of the authorisation
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 17 March 2023
File name
ENT-EN-VII14-200223-Clean-CD_PL_1.pdf
Reasons for updating
- Change to section 6 - date of revision
Updated on 14 October 2022
File name
Rozlytrek-EN-VII12-101022-Clean-CD_SmPC_1.pdf
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 30 June 2022
File name
ROZ_IB11_SmPC_dated 27Jun2022.pdf
Reasons for updating
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 6.3 - Shelf life
- Change to section 6.4 - Special precautions for storage
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 30 June 2022
File name
ROZ_IB11_SmPC_dated 27Jun2022.pdf
Reasons for updating
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 6.3 - Shelf life
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 30 June 2022
File name
ROZ_IB11_PIL_dated 27Jun2022.pdf
Reasons for updating
- Change to section 5 - how to store or dispose
- Change to section 6 - date of revision
Updated on 07 June 2022
File name
ROZ_R07_SmPC_dated 30 May 2022.pdf
Reasons for updating
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 9 - Date of first authorisation/renewal of the authorisation
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 07 June 2022
File name
ROZ_R07_PIL_dated 30 May 2022.pdf
Reasons for updating
- Change to section 1 - what the product is used for
- Change to date of revision
Updated on 17 August 2021
File name
Rozlytrek_PIL_IB-0005G_clean.pdf
Reasons for updating
- Change to section 4 - how to report a side effect
- Change to section 6 - date of revision
Updated on 17 August 2021
File name
Rozlytrek_SmPC_IB-0005G_clean.pdf
Reasons for updating
- Change to section 4.8 - Undesirable effects
- Change to Section 4.8 – Undesirable effects - how to report a side effect
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 6.3 - Shelf life
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 07 July 2021
File name
Rozlytrek_SmPC_R_21Jun2021_clean.pdf
Reasons for updating
- Change to section 9 - Date of first authorisation/renewal of the authorisation
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 20 October 2020
File name
Rozlytrek_SmPC_IB01_15Oct2020_clean.pdf
Reasons for updating
- Change to section 6.3 - Shelf life
- Change to section 10 - Date of revision of the text
- Correction of spelling/typing errors
- Change to section 5 - Pharmacological properties
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 20 October 2020
File name
Rozlytrek_PIL_IB01_15Oct2020_clean.pdf
Reasons for updating
- Change to section 4 - possible side effects
- Change to section 6 - date of revision
Updated on 10 August 2020
File name
Rozlytrek SmPC_31Jul2020.pdf
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 10 August 2020
File name
Rozlytrek PIL_31Jul2020.pdf
Reasons for updating
- New PIL for new product
Roche Registration GmbH
Address:
3004 Lake Drive, Citywest, Naas Road, Dublin 24Medical Information E-mail:
ireland.druginfo@roche.comTelephone:
+353 1 469 0700Fax:
+353 1 469 0791