Rekambys
*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):
This medicinal product is subject to additional monitoring.
*Additional information is available within the SPC or upon request to the company
Updated on 21 January 2025
File name
IE-Rekambys-900mg-20250113-PIL-II-022-clean.pdf
Reasons for updating
- Change to Section 1 - what the product is
- Change to section 1 - what the product is used for
- Change to section 2 - use in children and adolescents
- Change to section 2 - excipient warnings
- Change to section 6 - what the product contains
- Change to section 6 - date of revision
- Change to section 7 - Instructions for use
Free text change information supplied by the pharmaceutical company
EMEA/H/C/005060/II/0022: The indication has been extended to include adolescents (at least 12 years of age and weighing at least 35 kg) based on data from the MOCHA (208580) trial. In addition, editorial edits have been made to align with current QRD template v10.4.
Updated on 21 January 2025
File name
IE_Rekambys-20250113-PI-II-022-clean.pdf
Reasons for updating
- Change to section 4.1 - Therapeutic indications
- Change to section 4.2 - Posology and method of administration
- Change to section 4.8 - Undesirable effects
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 5.2 - Pharmacokinetic properties
- Change to section 6.1 - List of excipients
- 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
EMEA/H/C/005060/II/0022:The indication has been extended to include adolescents (at least 12 years of age and weighing at least 35 kg) based on data from the MOCHA (208580) trial. In addition to the main update, editorial edits have been made to align with current QRD template v10.4.
Updated on 22 May 2024
File name
20240411_Rekambys SPC.pdf
Reasons for updating
- Change to section 4.2 - Posology and method of administration
- 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
TII variation - IFU Vial adaptor update
Updated on 22 May 2024
File name
20240411_Rekambys PIL.pdf
Reasons for updating
- Change to section 6 - date of revision
- Change to information for healthcare professionals
Free text change information supplied by the pharmaceutical company
TII variation - IFU Vial adaptor update
Updated on 12 June 2023
File name
20230607 Rekambys SPC.pdf
Reasons for updating
- Change to section 6.4 - Special precautions for storage
- 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 variation type IB - EMEA/H/C/005060/IB/0017 Update to special precautions for storage + IE local rep + IFU
Updated on 12 June 2023
File name
20230607 Rekambys PIL.pdf
Reasons for updating
- Change to section 2 - interactions with other medicines, food or drink
- Change to section 6 - date of revision
Free text change information supplied by the pharmaceutical company
Approval variation type IB - EMEA/H/C/005060/IB/0017 Update to special precautions for storage + IE local rep + IFU
Updated on 05 December 2022
File name
Rekambys IE SPC - HIV Transmission and Breast-feeding - EMEA_H_C_005060_IB_0014.pdf
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.6 - Pregnancy and lactation
- Change to section 4.8 - Undesirable effects
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
REKAMBYS - EMEA/H/C/005060/IB/G
Grouped IB variations with linguistic review EUPI Update HIV Transmission, Breastfeeding and MedDRA
- Annex I Summary of Product Characteristics
- Section 4.4: Special warnings and precautions for use
- Section 4.6: Fertility, pregnancy and lactation
- Section 4.8: Undesirable effects
Updated on 05 December 2022
File name
REKAMBYS 900mg - PIL - EMEA_H_C_005060_IB_G.pdf
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
Free text change information supplied by the pharmaceutical company
Grouped IB variations with linguistic review EUPI Update HIV Transmission, Breastfeeding and MedDRA
REKAMBYS - EMEA/H/C/005060/IB/G
- Annex III.B Package Leaflet
- Section 2. What you need to know before you use REKAMBYS - Warnings and precautions
Updated on 21 October 2022
File name
EN-Rekambys-20220915-EUPI-II-008-012-clean-approved PIL.pdf
Reasons for updating
- Change to section 4 - possible side effects
Free text change information supplied by the pharmaceutical company
Changes made following EU approval of EMEA/H/C/005060/II/0012
Type II variation for EUPI update of section 4.8 and 5.1 of the SmPC based on data from clinical study 207966 (ALTAS-2M) week 96 and impacting section 4 possible side effects of PIL (editorial)
Updated on 21 October 2022
File name
EN-Rekambys-20220915-EUPI-II-008-012-clean-approved.pdf
Reasons for updating
- Change to section 4.2 - Posology and method of administration
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.8 - Undesirable effects
- Change to section 5.1 - Pharmacodynamic properties
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Change to the SmPC following to EU approvals:
II/008 ATLAS 96+152 weeks - CHMP opinion 1 September 2022
II/012 Alternate oral bridging - CHMP opinion 15 September 2022
These changes have been implemented together
Updated on 27 June 2022
File name
EN-Rekambys-20220113-EUSmPC-II-010.pdf
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 27 June 2022
File name
EN-Rekambys-20220113-PIL-IE-II-010.pdf
Reasons for updating
- New PIL for new product