Section 2: polysorbate 80 has been listed as an excipient with known effect in line with excipients guideline.

Section 4.1: wording for acute ischaemic stroke indication has been updated.

Section 4.2:

warning statement moved from section 4.4 that Actilyse should be prescribed by physicians experienced with thrombolytics and with facilities to monitor use.

warning box for stoke indication: ‘onset of symptoms’ changed to ‘after last known well and after exclusion of intracranial haemorrhage by appropriate imaging techniques’.

warning box for stroke indication: statement added that treatment effect is time-dependent.

Section 4.3:

‘known history of or suspected intracranial haemorrhage’ moved from contraindication section for all indications to contraindication for stroke.

‘suspected subarachnoid haemorrhage or condition after subarachnoid haemorrhage from aneurysm’ deleted.

‘traumatic external heart massage’ deleted.

‘documented ulcerative gastrointestinal disease during the last 3 months’ changed to ‘active ulcerative gastrointestinal disease’.

for stroke: ‘symptoms of ischaemic attack beginning more than 4.5 hours prior to infusion start or symptoms for which the onset time is unknown and could potentially be more than 4.5 hours ago’ is deleted.

for stroke: ‘seizure at onset of stroke’ is deleted.

for stroke: INR limit changed from INR > 1.3 to INR > 1.7.

Section 4.4:

‘prolonged (> 2 minutes) or traumatic cardiopulmonary resuscitation’ added as condition where benefit/risk should be carefully considered.

for patients receiving oral anticoagulant treatment: the INR limit of 1.7 for stroke added in line with the same change made to section 4.3

section on thromboembolism being moved from under heading for AMI.

for AMI and PE: benefit/risk should be considered in patients with body weight < 50 kg added.

for AMI and PE: advanced age now being stated as 75 years or older.

for stroke: ‘all situations listed in section 4.3 and in general all situations involving a high risk of haemorrhage’ is deleted.

for stroke: ‘seizure at onset of stroke’ added as condition where benefit/risk should be thoroughly considered.

for stroke: patients presenting with blood glucose < 50 mg/dL, thrombolysis may be considered after correction to normal values if diagnosis persists added as a condition where benefit/risk should be thoroughly considered.

warning for polysorbate 80 added in line with excipients guideline.

Section 4.5:

pulmonary embolism and stroke indications included in the statement that no formal interactions studies have been performed.

wording updated for section ‘Drugs affecting coagulation/platelet function’.

Sections 4.8, 5.1: minor formatting changes (e.g. thousand comma separator being deleted).

Section 6.1: addition of E numbers for excipients phosphoric acid and polysorbate 80.

Section 10: date of revision has been updated to 06/2026.

• Section 6.6: Replacement of images in the handling instructions
• Section 10: Date of revision has been updated to September 2024

Availability of gentamicin free stock.

The following sections of the SmPC have been updated:

Section 4.3 & 4.4: Updated to remove the information referring to gentamicin. 

• Section 4.3: Minor editorial change
• Section 4.4: Updated to include information of the concomitant use of other active substances affecting coagulation or platelet function
• Section 4.5: Updated to in order to improve readability
• Section 4.6: Inclusion of a statement to advice on the use of Actilyse during breastfeeding.
• Section 5.2: Updated to complement the information on pharmacokinetics for the active substance
• Section 6.6: Minor editorial changes to provide clearer instructions
• Section 10: Date of revision has been updated to 03/2023.

The following sections have been updated:

• Section 2 & 6: Updated to remove the information mentioning the stopper contains natural rubber (a derivatives of latex)

New individual SmPC

Plus the following sections of the SmPC have been updated:

• Section 4.4 (Hypersensitivity): Updated to remove the information mentioning the stopper contains natural rubber (a derivatives of latex)
• Section 10: Date of revision has been updated to March 2022.