Rybrevant 350 mg concentrate for solution for infusion
*Company:
Janssen Sciences Ireland (a Johnson & Johnson Company)Status:
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 17 September 2024
File name
EN-Rybrevant-20240822-IE-PIL-II-011-clean-approved.pdf
Reasons for updating
- Change to section 1 - what the product is used for
- Change to section 2 - excipient warnings
- Change to section 4 - possible side effects
Free text change information supplied by the pharmaceutical company
EMEA/H/C/005454/II/0011: Extension of Indication for Rybrevant (amivantamab) based on the data from the MARIPOSA 2 study.
Updated on 17 September 2024
File name
EN-Rybrevant-20240822-IE-SmPC-II-011-clean-approved.pdf
Reasons for updating
- Change to section 4.1 - Therapeutic indications
- Change to section 4.2 - Posology and method of administration
- Change to section 4.4 - 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
EMEA/H/C/005454/II/0011: Type II variation to add a new indication (MARIPOSA-2). Final indication wording:
RYBREVANT is indicated in combination with carboplatin and pemetrexed for the treatment of adult patients with advanced non-small cell lung cancer (NSCLC) with EGFR Exon 19 deletions or Exon 21 L858R substitution mutations after failure of prior therapy including an EGFR tyrosine kinase inhibitor (TKI).
As a result, following SmPC sections are impacted
4.1 therapeutic indication,
4.2 posology and method of administration,
4.4 special warnings and precautions
4.8 undesirable effects,
5.1 pharmacodynamic properties (Clinical efficacy and safety).
Updated on 02 July 2024
File name
EN-Rybrevant-20240627-IE-SmPC-II-010-clean-approved_EDMS-ERI-207794849_43.0.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 4.9 - Overdose
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 5.2 - Pharmacokinetic properties
- Change to section 6.6 - Special precautions for disposal and other handling
- 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 not be renewed (A)
Free text change information supplied by the pharmaceutical company
PAPILLON Type II Extension of Indication Variation
Updated on 02 July 2024
File name
EN-Rybrevant-20240627-IE-PIL-II-010-clean-approved_EDMS-ERI-207794849_43.0.pdf
Reasons for updating
- Change to section 1 - what the product is used for
- Change to section 3 - dose and frequency
- Change to section 4 - possible side effects
- Change to how the medicine works
- Change to section 7 - Instructions for use
Free text change information supplied by the pharmaceutical company
PAPILLON Type II Extension of Indication Variation
Updated on 13 February 2024
File name
IE SmPC Rybrevant-clean-EDMS-ERI-207794849 V41-20Sep23.pdf
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 13 February 2024
File name
IE PIL Rybrevant-Clean-EDMS-ERI-207794849 V41-20Sep23.pdf
Reasons for updating
- New PIL for new product