Tenkasi 400 mg powder for concentrate for solution for infusion
*Company:
A. Menarini Pharmaceuticals Ireland LtdStatus:
No Recent UpdateLegal Category:
Product subject to medical prescription which may not be renewed (A)Active Ingredient(s):
*Additional information is available within the SPC or upon request to the company
Updated on 03 July 2024
File name
uk-ie-PIL Tenkasi 400mg Clean Approved May 24.pdf
Reasons for updating
- Change to section 6 - manufacturer
Free text change information supplied by the pharmaceutical company
New manufacturer Falorni
Updated on 12 October 2023
File name
SmPC Ireland Tenkasi 400mg clean approved September 23.pdf
Reasons for updating
- Other
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Regulatory approval for Tenkasi 1200mg IV resulted in changes to this SmpC.
Updated on 12 October 2023
File name
uk-ie-PIL Tenkasi 400mg clean approved September 23.pdf
Reasons for updating
- Introduction of new strength
Free text change information supplied by the pharmaceutical company
Introduction of a 1200mg IV resulted in changes to this leaflet.
Updated on 22 May 2023
File name
SmPC Ireland Tenkasi Pead Indication clean approved May 23.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 6.6 - Special precautions for disposal and other handling
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Extension of indication to the paediatric population - all sections have been updated with the relevant information
Updated on 22 May 2023
File name
uk-ie-PIL Tenkasi Pead Indication clean approved May 23.pdf
Reasons for updating
- Change to section 1 - what the product is used for
- Change to section 2 - use in children and adolescents
- Change to section 3 - dose and frequency
- Change to section 4 - possible side effects
- Change to section 6 - date of revision
Free text change information supplied by the pharmaceutical company
Section 1 - Use in Paediatric population approved - new details added
Section 2 - Use in Paediatric population approved - new details added
Section 3 - Use in Paediatric population approved - new details added
Section 4 - Red man syndrome removed as an AE
Section 6 - Date of revision updated
Updated on 22 August 2022
File name
ie-smpc - Orbactiv - Tenkasi name change clean July 2021.pdf
Reasons for updating
- Correction of spelling/typing errors
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 25 April 2022
File name
ie-smpc - Orbactiv - Tenkasi name change clean July 2021.pdf
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
new upload
Updated on 25 April 2022
File name
uk-ie-pl orbactiv - Tenkasi name change Clean July 2021.pdf
Reasons for updating
- New PIL for new product
Free text change information supplied by the pharmaceutical company
New upload
A. Menarini Pharmaceuticals Ireland Ltd
Address:
Castlecourt, Monkstown Farm, Monsktown, Glenageary, Co. Dublin, IrelandMedical Information E-mail:
medinfo@menarini.ieTelephone:
+353 1 284 6744Fax:
+353 1 284 6769Medical Information Direct Line:
1800 283 045