Pradaxa® 20 mg, 30 mg, 40 mg, 50 mg, 110 mg, 150 mg coated granules
*Company:
Boehringer Ingelheim LimitedStatus:
No Recent UpdateLegal Category:
Product subject to medical prescription which may be renewed (B)Active Ingredient(s):
*Additional information is available within the SPC or upon request to the company
File name
NP-IE-100713 Cardiovascular PRADAXA Pradaxa Pediatrics RMM - Prescriber Guide - IE.pdf
Reasons for updating
- Replace File
File name
NP-IE-100713 Cardiovascular PRADAXA Pradaxa Pediatrics RMM - Prescriber Guide - IE.pdf
Reasons for updating
- Replace File
File name
PAC text -pradaxa-granules-II-147-G.pdf
Reasons for updating
- Replace File
Updated on 02 January 2024
File name
IE-MT-NI - PIL text - coated granules – Var-II-147-G.pdf
Reasons for updating
- Change to section 2 - interactions with other medicines, food or drink
- Change to section 3 - how to take/use
- Change to section 4 - how to report a side effect
- Change to section 6 - date of revision
- Change to other sources of information section
Updated on 02 January 2024
File name
P1b;All-EU-SPC-2.pdf
Reasons for updating
- Change to section 2 - Qualitative and quantitative composition
- Change to section 4.1 - Therapeutic indications
- Change to section 4.2 - Posology and method of administration
- 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 4.8 - Undesirable effects
- Change to Section 4.8 – Undesirable effects - how to report a side effect
- Change to section 4.9 - Overdose
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 5.2 - Pharmacokinetic properties
- Change to section 9 - Date of first authorisation/renewal of the authorisation
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
- Section 4.1: Update to the indication for paediatric patients as follows:
‘Treatment of venous thromboembolic events (VTE) and prevention of recurrent VTE in paediatric patients from birth the time the child is able to swallow soft food to less than 18 years of age.’
- Section 4.2: Deletion of the statement ‘
Pradaxa powder and solvent for oral solution should only be used in children aged less than 1 year.’ - Section 4.2 : The reference to package leaflet’s section ‘Instructions for use’ has been updated to ‘Instructions for administration’.
- Section 5.2: Update to the renal insufficiency/CrCL information in the ‘Special populations’ section
- Sections 2, 4.1, 4.2, 4.3, 4.4, 4.5, 4.6, 4.8, 4.9, 5.1, 5.2, 9: Editorial/format updates
- Section 10: The date of revision has been updated to 11 December 2023
- Editorial/format updates in line with the QRD template have also been made throughout the SmPCs.
File name
NP-IE-100605 Cardiovascular PRADAXA Paediatric Prescriber Guide - IE.pdf
Reasons for updating
- Add New Doc
File name
PAC - 361830 - 09.11.2021 - PCP054034-001 - AMT 108977 - CROPPED.pdf
Reasons for updating
- Add New Doc
Updated on 08 December 2022
File name
IE-MT-NI – PIL text coated granules – Var 133.pdf
Reasons for updating
- New PIL for new product
Free text change information supplied by the pharmaceutical company
Launch PIL for Pradaxa® coated granules (paediatric formulation)
Updated on 08 December 2022
File name
P1b;All-EU-SPC-1 - For medicines.ie.pdf
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Launch SmPC for Pradaxa® coated granules (paediatric formulation)