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Medicine Status DHPC Document Name Additional Communications Company Kymriah 1.2 x 106 – 6 x 108 cells dispersion for infusion
Updated

DHPC - Risk of secondary malignancy of T-cell origin in CD19- or BCMA-directed CAR T-cell therapies

COM 18/07/24
Novartis Ireland Limited Xtandi 40 mg film-coated tablets
Updated

DHPC enzalutamide test interference leading to falsely elevated digoxin plasma levels

COM 01/10/25
Astellas Pharma Co. Ltd Evrysdi 0.75 mg/mL powder for oral solution
Updated

Direct healthcare professional communication (DHPC) - Evrysdi 0.75 mg/mL powder for oral solution (risdiplam)

COM 21/08/25
Roche Registration GmbH Dzuveo 30 micrograms sublingual tablet
No Recent Update

Dzuveo cover letter

Dzuveo DHCP letter

COM 14/07/23 COM 14/07/23
Aguettant Ltd Epipen Junior 150 micrograms solution for injection in pre-filled pen
No Recent Update

EpiPen® Healthcare Professional Letter

COM 15/08/23
Mylan IRE Healthcare Ltd Epipen 300 micrograms solution for injection in pre-filled pen
No Recent Update

EpiPen® Healthcare Professional Letter

COM 15/08/23
Mylan IRE Healthcare Ltd PROSCAR 5 mg Tablets
Updated

Finasteride, dutasteride – New measures to minimise the risk of suicidal ideation

COM 17/09/25
Organon Pharma (Ireland) Limited Quinsair 240 mg nebuliser solution
No Recent Update

Fluoroquinolones DHPC_HPRA_FINAL vs2 30-05-23

COM 14/06/23
Chiesi Limited Adcortyl Intra-articular / Intradermal Injection 10mg/ml Suspension for Injection, 5ml
Discontinued

IE Adcortyl Discontinuation Letter June 2025

COM 04/07/25
Bristol-Myers Squibb Pharmaceuticals uc Infanrix Hexa, Powder and suspension for suspension for injection
No Recent Update

Infanrix Hexa - DHPC

COM 10/10/24
GlaxoSmithKline (Ireland) Ltd Mubucho 111mg film-coated tablets
New

Mubucho HCP cover letter

COM 30/09/25
Zentiva Pharma UK Limited Mubucho 79mg film-coated tablets
New

Mubucho HCP Cover Letter

COM 30/09/25
Zentiva Pharma UK Limited Mubucho 63mg film-coated tablets
New

Mubucho HCP Cover Letter

COM 30/09/25
Zentiva Pharma UK Limited Mubucho 55mg film-coated tablets
Updated

Mubucho HCP Cover letter

COM 30/09/25
Zentiva Pharma UK Limited Mubucho 16 mg film-coated tablets
New

Mubucho HCP cover letter

COM 30/09/25
Zentiva Pharma UK Limited Mubucho 40mg film-coated tablets
Updated

Mubucho HCP letter

COM 30/09/25
Zentiva Pharma UK Limited RISPERDAL 1 mg/ml oral solution
No Recent Update

Risperidone 1mg per ml OS-Risk of medication errors leading to accidental overdoses in children and adolescents

COM 28/02/25
Janssen Sciences Ireland (a Johnson & Johnson Company) Topamax Sprinkle 25 mg hard capsules
Updated

Topiramate: New restrictions to prevent exposure during pregnancy

COM 02/11/23
Janssen Sciences Ireland (a Johnson & Johnson Company) Topamax Sprinkle 15 mg hard capsules
Updated

Topiramate: New restrictions to prevent exposure during pregnancy

COM 02/11/23
Janssen Sciences Ireland (a Johnson & Johnson Company) Topamax 50mg film-coated tablets
Updated

Topiramate: New restrictions to prevent exposure during pregnancy

COM 02/11/23
Janssen Sciences Ireland (a Johnson & Johnson Company) Topamax 25mg film-coated tablets
Updated

Topiramate: New restrictions to prevent exposure during pregnancy

COM 02/11/23
Janssen Sciences Ireland (a Johnson & Johnson Company) Topamax 200mg film-coated tablets
Updated

Topiramate: New restrictions to prevent exposure during pregnancy

COM 02/11/23
Janssen Sciences Ireland (a Johnson & Johnson Company) Topamax 100mg film-coated tablets
Updated

Topiramate: New restrictions to prevent exposure during pregnancy

COM 02/11/23
Janssen Sciences Ireland (a Johnson & Johnson Company) Veoza 45 mg film-coated tablets
No Recent Update

Veoza - 45mg film-coated tablets_DHPC January 2025

COM 14/01/25
Astellas Pharma Co. Ltd