Datroway 100 mg powder for concentrate for solution for infusion
*Company:
Daiichi Sankyo Ireland LtdStatus:
UpdatedLegal 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 11 August 2026
File name
datroway-pil-ie-v05-2607.pdf
Reasons for updating
- Change to section 1 - what the product is used for
- Change to section 4 - possible side effects
- Change to section 6 - what the product contains
- Change to section 6 - date of revision
Updated on 11 August 2026
File name
datroway-smpc-ie-v04-260729.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 4.6 - Pregnancy and lactation
- Change to Section 4.8 – Undesirable effects - how to report a side effect
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 5.2 - Pharmacokinetic properties
- 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
Update to include new indication in triple negative breast cancer.
Updated on 16 June 2026
File name
datroway-smpc-ie-v03-260123.pdf
Reasons for updating
- New SPC for new product
Legal category:Product subject to restricted prescription (C)
Free text change information supplied by the pharmaceutical company
First SmPC published on medicines.ie
Updated on 16 June 2026
File name
datroway-pil-ie-v04-2601.pdf
Reasons for updating
- New PIL for new product
Free text change information supplied by the pharmaceutical company
First Patient Information Leaflet published on medicines.ie
Daiichi Sankyo Ireland Ltd
Address:
Unit 29, Block 3, Northwood Court, Northwood Avenue, Santry, Dublin 9, IrelandMedical Information E-mail:
medinfo-ie@daiichisankyo.comTelephone:
+353 1 489 3000