Rekambys
*Company:
Janssen Sciences IrelandStatus:
No Recent UpdateLegal 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 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