Actilyse 50 mg
*Company:
Boehringer Ingelheim LimitedStatus:
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 23 June 2023
File name
Cropped PIL 319881-02 dated 15.12.2022 (TPA-05+155-G).pdf
Reasons for updating
- Change to section 2 - what you need to know - contraindications
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 2 - pregnancy, breast feeding and fertility
Free text change information supplied by the pharmaceutical company
Availability of gentamicin free stock.
Updated on 23 June 2023
File name
A1(50 mg)-E-SPC-23.pdf
Reasons for updating
- Change to section 4.3 - Contraindications
- Change to section 4.4 - Special warnings and precautions for use
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
The following sections of the SmPC have been updated:
Section 4.3 & 4.4: Updated to remove the information referring to gentamicin.
Updated on 06 April 2023
File name
Actilyse-PIL text-155-G.pdf
Reasons for updating
- Change to section 2 - what you need to know - contraindications
- Change to section 2 - pregnancy, breast feeding and fertility
- Change to section 6 - date of revision
Updated on 04 April 2023
File name
A1(50 mg)-E-SPC-24.pdf
Reasons for updating
- Change to section 4.3 - Contraindications
- 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 4.6 - Pregnancy and lactation
- 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
- 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.
Updated on 21 September 2022
File name
Cropped PIL 316354-05 11.10.2021 PIP046192-005.pdf
Reasons for updating
- New PIL for new product
Free text change information supplied by the pharmaceutical company
The following sections have been updated:
- Section 2 & 6: Updated to remove the information mentioning the stopper contains natural rubber (a derivatives of latex)
Updated on 16 September 2022
File name
A1(50 mg)-E-SPC-21.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 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.