Rybrevant 1600 mg, 2240 mg, 2400 mg and 3520 mg solution for injection
*Company:
Janssen Sciences Ireland (a Johnson & Johnson Company)Status:
NewLegal 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 26 May 2026
File name
EN_IE-Rybrevant SC_SmPC_20260220_X_0000268898_Q3W+Q4W_Clean-Approved (1).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
EMA/X/0000268898: Grouped Line Extension: Introduction of additional DP presentations of amivantamab subcutaneous formulation: 2400 mg (15 mL vial) and 3520 mg (22 mL vial), new dose regimens and related indications, grouped with other related quality variations.
Updated on 26 May 2026
File name
EN_IE-Rybrevant SC_PIL_20260220_X_0000268898_Q3W+Q4W_Clean-Approved.pdf
Reasons for updating
- New PIL for new product
Free text change information supplied by the pharmaceutical company
EMA/X/0000268898: Grouped Line Extension: Introduction of additional DP presentations of amivantamab subcutaneous formulation: 2400 mg (15 mL vial) and 3520 mg (22 mL vial), new dose regimens and related indications, grouped with other related quality variations.
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