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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

COM 04/11/22
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

COM 19/10/22
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

COM 19/10/22
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

COM 19/10/22
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

COM 19/10/22
Janssen Sciences Ireland Topamax Sprinkle 15mg
No Recent Update

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

COM 19/10/22
Janssen Sciences Ireland Topamax Sprinkle 25mg
No Recent Update

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

COM 19/10/22
Janssen Sciences Ireland Zolgensma 2 × 1013 vector genomes/mL solution for infusion
Updated

Zolgensma (onasemnogene abeparvovec): Important Safety Information COM

COM 20/02/23
Novartis Ireland Limited