STELARA 90 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 90 mg 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 90 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 90 mg 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 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 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
Updated on 02 October 2023
File name
Stelara 90mg 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
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