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 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