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Rybrevant 350 mg concentrate for solution for infusion

*
Pharmacy Only: Prescription

  • Company:

    Janssen Sciences Ireland

  • Status:

    No Recent Update

  • Legal Category:

    Product subject to medical prescription which may not be renewed (A)

  • Active Ingredient(s):

    Amivantamab

    This medicinal product is subject to additional monitoring.

    *Additional information is available within the SPC or upon request to the company

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