• Section 2: Polysorbate 20 listed as an excipient of known effect in line with excipients guideline.
• Section 4.2: deletion of cross-references to section 4.4 and addition of sub-heading “Drugs affecting coagulation/platelet function”.
• Section 4.3: INR limit changed from 1.3 to 1.7. Contraindications such as Prolonged cardiopulmonary resuscitation and seizure at onset of stroke are moved to section 4.4. Deletion of contraindication for symptoms beginning or possibly beginning more than 4.5 hours prior. Additionally, other existing contraindications have been re-worded.
• Section 4.4: INR limit changed from 1.3 to 1.7. Warnings related to body weight < 60 kg and condition associated with increased risk of haemorrhage have been removed. Thrombo-embolism warning added as separate section. Additional warnings related to traumatic cardiopulmonary resuscitation or cardiac massage, seizure at onset of stroke and patients initially presenting with glucose < 50 mg/dL added. Other re-wording throughout section. Warning for polysorbate 20 added in line with excipients guideline.
• Section 4.5: minor re-wording to improve clarity and cross-references to other sections added.
• Section 4.8: ADR reporting website link for Malta updated.
• Section 6.1: addition of E numbers for phosphoric acid and polysorbate 20.
• Section 10: date of revision has been updated to 06/2025. The website link for EMA has also been updated.

• The country list in the title of the SmPC has been revised to remove reference to Northern Ireland
• Section 4.8: Removal of United Kingdom (Northern Ireland) AE reporting details
• Section 10: Date of revision of the SmPC has been updated to April 2025.

New PIL for new product

New SmPC for new product.