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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

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
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 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 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 Sprinkle 15mg
No Recent Update

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

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

Janssen Sciences Ireland
Zolgensma 2 × 1013 vector genomes/mL solution for infusion
Updated

Zolgensma (onasemnogene abeparvovec): Important Safety Information COM

Novartis Ireland Limited