Translarna
*Company:
PTC Therapeutics International LimitedStatus:
No Recent UpdateLegal Category:
Product subject to restricted prescription (C)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 06 June 2023
File name
Translarna-SmPC-13mar2023-II068.pdf
Reasons for updating
- Change to section 5.1 - Pharmacodynamic properties
Legal category:Product subject to restricted prescription (C)
Free text change information supplied by the pharmaceutical company
Addition of information from Study 045 in section 5.1 "Paediatric population"
Updated on 12 September 2022
File name
Traslarna-SmPC-20jun2022-R 067.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 restricted prescription (C)
Free text change information supplied by the pharmaceutical company
Updated date of last renewal, and consequently update of the date of last revision of the text. Only applicable to SmPC
Updated on 23 July 2021
File name
Traslarna-PIL-15apr2021-N062.pdf
Reasons for updating
- Change to section 6 - date of revision
- Change to MA holder contact details
Free text change information supplied by the pharmaceutical company
Details of local representative of the Marketing Authorisation Holder added to the PIL
Updated on 23 July 2021
File name
Traslarna-SmPC-17jun2021-R061.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 restricted prescription (C)
Free text change information supplied by the pharmaceutical company
Section 9
Date of last renewal updated to 17 June 2021
Updated on 28 July 2020
File name
Translarna-SmPC-23jul2020-II 058 & R057.pdf
Reasons for updating
- Change to section 4.1 - Therapeutic indications
- Change to section 9 - Date of first authorisation/renewal of the authorisation
Legal category:Product subject to restricted prescription (C)
Free text change information supplied by the pharmaceutical company
Section 4.1
Removed sentence "Efficacy has not been demonstrated in non-ambulatory patients."
Section 9
Date of last renewal updated to 23 July 2020
Updated on 07 January 2020
File name
Translarna-SmPC-12dec2019-II 053 G.pdf
Reasons for updating
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 5.3 - Preclinical safety data
Legal category:Product subject to restricted prescription (C)
Free text change information supplied by the pharmaceutical company
Correction of typo in section 5.1 Paediatric population (correction of paediatric population aged 6 months to 2 years old)
Addition of last paragraph in Section 5.3
Updated on 13 August 2019
File name
Translarna-SmPC-25jul2019-R 051.pdf
Reasons for updating
- Change to section 9 - Date of first authorisation/renewal of the authorisation
Legal category:Product subject to restricted prescription (C)
Free text change information supplied by the pharmaceutical company
Annual renewal of Conditional MA
Updated on 27 June 2019
File name
Translarna-PIL-06jun2019-II 046.pdf
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
Updated on 27 June 2019
File name
Translarna-SmPC-06jun2019-II 046.pdf
Reasons for updating
- Change to section 4.2 - Posology and method of administration
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 5.2 - Pharmacokinetic properties
Legal category:Product subject to restricted prescription (C)
Free text change information supplied by the pharmaceutical company
Updated to Section 4.2, 4.4 and 5.2 to include new information for patients with renal impairment
Updated on 11 April 2019
File name
Translarna-PIL-29mar2019-II 045 & IAG 052.pdf
Reasons for updating
- Change to section 2 - interactions with other medicines, food or drink
- Change to section 6 - manufacturer
Updated on 10 April 2019
File name
Translarna-SmPC-29mar2019-II 045 & IAG 052.pdf
Reasons for updating
- 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
Legal category:Product subject to restricted prescription (C)
Free text change information supplied by the pharmaceutical company
Update of sections
4.4 - Potential interactions with other medicinal products
Removed reference to OATP1B3 substrates
4.5 - Effect of ataluren on pharmacokinetics of other medicinal products
Added paragraph on potential for ataluren to inhibit OATP1B3 using telmisartan
Updated on 20 August 2018
File name
Translarna-PIL-23jul2018-II037 & R041.pdf
Reasons for updating
- Change to section 1 - what the product is used for
- Change to section 2 - use in children and adolescents
Updated on 20 August 2018
File name
Translarna-SmPC-23jul2018-II037 & R041.pdf
Reasons for updating
- Change to section 4.1 - Therapeutic indications
- Change to section 4.2 - Posology and method of administration
- Change to section 4.8 - Undesirable effects
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 5.2 - Pharmacokinetic properties
- Change to section 9 - Date of first authorisation/renewal of the authorisation
Legal category:Product subject to restricted prescription (C)
Free text change information supplied by the pharmaceutical company
SmPC updated to reflect extension of indication to patients aged 2 to 5 years old.
Date of last renewal date updated.
Updated on 11 June 2018
File name
SmPC_21may2018_IB 043.docx
Reasons for updating
- Change to section 5.1 - Pharmacodynamic properties
Legal category:Product subject to restricted prescription (C)
Free text change information supplied by the pharmaceutical company
Addition of following paragraph in the Paediatric Section:
In the clinical program investigating the efficacy and safety of monotherapy ataluren in patients with nonsense mutation cystic fibrosis, no statistically significant effect was observed in the primary and key secondary clinical outcome measures (ppFEV1 and pulmonary exacerbation rate) in adults and children aged 6 years and older.
Updated on 11 June 2018
File name
Translarna-PIL-21may2018-IB043.pdf
Reasons for updating
- Change to section 5 - how to store or dispose
Updated on 03 May 2018
File name
SmPC_23mar2018_II039.docx
Reasons for updating
- 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 5.2 - Pharmacokinetic properties
Legal category:Product subject to restricted prescription (C)
Free text change information supplied by the pharmaceutical company
Update of information for Hepatic impaired patients:
4.2 - Addition of specific section on Hepatic impairment: "No dosage adjustment is required for patients with mild, moderate or severe hepatic impairment "
4.4 - Removal of close monitoring requirement for hepatically impaired patients
4.5 - Minor amend
5.2 - Addition of specific section on Hepatic impairment
Updated on 26 April 2018
File name
Translarna-PIL-23mar2018-II 039.pdf
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
Updated on 12 January 2018
Reasons for updating
- New SPC for new product
Legal category:Product subject to restricted prescription (C)
Updated on 12 January 2018
File name
PIL_17395_660.pdf
Reasons for updating
- New PIL for new product