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Medicine Status DHPC Document Name Additional Communications Company Epipen Junior 150 micrograms solution for injection in pre-filled pen
No Recent Update

EpiPen® Healthcare Professional Letter COM

Mylan IRE Healthcare Ltd
Epipen 300 micrograms solution for injection in pre-filled pen
No Recent Update

EpiPen® Healthcare Professional Letter COM

Mylan IRE Healthcare Ltd
Quinsair 240 mg nebuliser solution
No Recent Update

Fluoroquinolones DHPC_HPRA_FINAL vs2 30-05-23 COM

Chiesi Limited
Gavreto 100 mg hard capsules
No Recent Update

Gavreto DHPC dated 16 Jun 2023 COM

Roche Registration GmbH
IMBRUVICA 140 mg, 280 mg, 420 mg and 560 mg film-coated tablets
Updated

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

Janssen Sciences Ireland
Topamax 200mg film-coated tablets
No Recent Update

Topamax: Ongoing EU review of potential risk of neurodevelopmental disorders in children exposed in utero COM

Janssen Sciences Ireland
Topamax Sprinkle 25 mg hard capsules
Updated

Topamax: Ongoing EU review of potential risk of neurodevelopmental disorders in children exposed in utero COM

Janssen Sciences Ireland
Topamax Sprinkle 15 mg hard capsules
Updated

Topamax: Ongoing EU review of potential risk of neurodevelopmental disorders in children exposed in utero COM

Janssen Sciences Ireland
Topamax 50mg film-coated tablets
No Recent Update

Topamax: Ongoing EU review of potential risk of neurodevelopmental disorders in children exposed in utero COM

Janssen Sciences Ireland
Topamax 25mg film-coated tablet
No Recent Update

Topamax: Ongoing EU review of potential risk of neurodevelopmental disorders in children exposed in utero COM

Janssen Sciences Ireland
Topamax 100mg film-coated tablets
No Recent Update

Topamax: Ongoing EU review of potential risk of neurodevelopmental disorders in children exposed in utero COM

Janssen Sciences Ireland
Zolgensma 2 × 1013 vector genomes/mL solution for infusion
No Recent Update

Zolgensma (onasemnogene abeparvovec): Important Safety Information COM

Novartis Ireland Limited