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Medicine Status DHPC Document Name Additional Communications Company IMBRUVICA 140 mg, 280 mg, 420 mg and 560 mg film-coated tablets
No Recent Update

IMBRUVICA® (ibrutinib): New risk minimisation measures, including dose modification recommendations, due to the increased risk for serious cardiac events

COM 04/11/22
Janssen Sciences Ireland Zolgensma 2 × 1013 vector genomes/mL solution for infusion
Updated

Zolgensma (onasemnogene abeparvovec): Important Safety Information

COM 20/02/23
Novartis Ireland Limited Quinsair 240 mg nebuliser solution
No Recent Update

Fluoroquinolones DHPC_HPRA_FINAL vs2 30-05-23

COM 14/06/23
Chiesi Limited Gavreto 100 mg hard capsules
No Recent Update

Gavreto DHPC dated 16 Jun 2023

COM 19/06/23
Roche Registration GmbH Dzuveo 30 micrograms sublingual tablet
Updated

Dzuveo DHCP letter

Dzuveo cover letter

COM 14/07/23 COM 14/07/23
Aguettant Ltd Epipen 300 micrograms solution for injection in pre-filled pen
No Recent Update

EpiPen® Healthcare Professional Letter

EpiPen® Healthcare Professional Letter

EpiPen® Healthcare Professional Letter

COM 19/07/23 COM 31/07/23 COM 15/08/23
Mylan IRE Healthcare Ltd Epipen Junior 150 micrograms solution for injection in pre-filled pen
No Recent Update

EpiPen® Healthcare Professional Letter

EpiPen® Healthcare Professional Letter

COM 19/07/23 COM 15/08/23
Mylan IRE Healthcare Ltd Topamax 100mg film-coated tablets
Updated

Topiramate: New restrictions to prevent exposure during pregnancy

Topiramate: New restrictions to prevent exposure during pregnancy

COM 02/11/23 COM 02/11/23
Janssen Sciences Ireland Topamax 200mg film-coated tablets
Updated

Topiramate: New restrictions to prevent exposure during pregnancy

COM 02/11/23
Janssen Sciences Ireland Topamax 25mg film-coated tablet
Updated

Topiramate: New restrictions to prevent exposure during pregnancy

COM 02/11/23
Janssen Sciences Ireland Topamax 50mg film-coated tablets
Updated

Topiramate: New restrictions to prevent exposure during pregnancy

COM 02/11/23
Janssen Sciences Ireland Topamax Sprinkle 25 mg hard capsules
Updated

Topiramate: New restrictions to prevent exposure during pregnancy

Topiramate: New restrictions to prevent exposure during pregnancy

COM 02/11/23 COM 02/11/23
Janssen Sciences Ireland Topamax Sprinkle 15 mg hard capsules
Updated

Topiramate: New restrictions to prevent exposure during pregnancy

COM 02/11/23
Janssen Sciences Ireland