STELARA 45 mg solution for injection in pre-filled pen
*Company:
Janssen Sciences Ireland (a Johnson & Johnson Company)Status:
UpdatedLegal 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 10 March 2025
File name
EN-Stelara 45mg PFP-20250226-PIL-II-107-clean-approved.pdf
Reasons for updating
- Change to section 2 - excipient warnings
- Change to section 6 - date of revision
Free text change information supplied by the pharmaceutical company
Approval of EMA/H/C/958/II/107 - type II variation:
Section 2: Addition of warning on the polysorbate threshold;
Section 6: Update of revision date to 12/2024.
Updated on 10 March 2025
File name
EN-Stelara 45mg PFP 90mg PFP-20250226-SmPC-II-107-clean-approved.pdf
Reasons for updating
- 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 4.8 - Undesirable effects
- 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 medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Approval of EMA/H/C/958/II/107 - type II variation:
- Section 5.1, 5.2: Drug Interaction Study to Evaluate the Effect of Ustekinumab on Cytochrome P450 Enzyme Activities Following Induction and Maintenance Dosing in Participants with Active Crohn’s Disease or Ulcerative Colitis;
- Section 4.5, 4.8: Addition of patient exposure numbers based on data from study CNTO1275UCO3001;
- Section 4.4: Addition of warning on the polysorbate threshold;
- Section 10: Date of revision of the text.
Updated on 30 September 2024
File name
EN-IE-Stelara 45mg PFP 90mg PFP-20240925-SmPC-PSUSA-3085-202312-clean-approved.pdf
Reasons for updating
- 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
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
EMEA/H/C/PSUSA/00003085/202312: PSUR (01 Jan 2023 to 31 Dec 2023): The EU PI was updated to advise against the use of live vaccines such as the BCG vaccine for a period of 12 months, instead of the previously stated 6 months.
Updated on 30 September 2024
File name
EN-IE-Stelara 45 PFP-20240925-PIL-PSUSA-3085-202312-clean-approved.pdf
Reasons for updating
- Change to section 2 - interactions with other medicines, food or drink
- Change to section 2 - pregnancy, breast feeding and fertility
Free text change information supplied by the pharmaceutical company
EMEA/H/C/PSUSA/00003085/202312: PSUR (01 Jan 2023 to 31 Dec 2023): The EU PI was updated to advise against the use of live vaccines such as the BCG vaccine for a period of 12 months, instead of the previously stated 6 months.
Updated on 24 September 2024
File name
EN-Stelara 45mg PFP 90mg PFP-20240905-SmPC-II-104-clean-approved.pdf
Reasons for updating
- 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
EMEA/H/C/000958/II/0104: Stelara I-CARE Final Report
Section 4.4 Special Warnings and Precautions for Use of the SmPC was updated to remove non-melanoma from the sentence “All patients, in particular those greater than 60 years of age, patients with a medical history of prolonged immunosuppressant therapy or those with a history of PUVA treatment, should be monitored for the appearance of non-melanoma skin cancer.”
Updated on 24 July 2024
File name
EN-Stelara 45 PFP_90mg PFP_0240613-SmPC-II-100-clean-approved.pdf
Reasons for updating
- Change to section 4.6 - Pregnancy and lactation
- Change to section 4.8 - Undesirable effects
- Change to section 6.1 - List of excipients
- Change to section 6.6 - Special precautions for disposal and other handling
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
EMEA/H/C/000958/II/0100: Stelara OTIS Final Report
Updated on 24 July 2024
File name
EN-Stelara 45mg PFP-20240613-PIL-II-100-clean-approved.pdf
Reasons for updating
- Change to section 2 - pregnancy, breast feeding and fertility
- Change to section 5 - how to store or dispose
- Change to section 6 - what the product contains
Free text change information supplied by the pharmaceutical company
EMEA/H/C/000958/II/0100: Stelara OTIS Final Report
Updated on 02 October 2023
File name
Stelara 45mg PFP PIL_19.06.2023.pdf
Reasons for updating
- New PIL for new product
Free text change information supplied by the pharmaceutical company
Initial MA
Updated on 02 October 2023
File name
Stelara 45mg & 90mg PFP SPC_21.06.2023.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
Initial MA
Janssen Sciences Ireland (a Johnson & Johnson Company)
Address:
Janssen Sciences Ireland UC, Barnahely, Ringaskiddy, IRL - Co. Cork P43 FA46Medical Information E-mail:
medinfo@its.jnj.comTelephone:
+353 1 4665200Website:
https://innovativemedicine.jnj.com/ireland/Medical Information Direct Line:
1800 709 122