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Medicine Status DHPC Document Name Additional Communications Company Remsima 40 mg/mL concentrate for solution for infusion (100mg & 350mg vials)
No Recent Update

DHPC - Remsima: new IV formulation contraindicated in HFI

Celltrion Healthcare Ireland Ltd.
Kymriah 1.2 x 106 – 6 x 108 cells dispersion for infusion
No Recent Update

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

Novartis Ireland Limited
Tegretol 100mg/5ml Oral Suspension
No Recent Update

DHPC communication - restriction of use in neonates as concentration of the excipient, propylene glycol, exceeds recommended threshold

Novartis Ireland Limited
Xtandi 40 mg film-coated tablets
No Recent Update

DHPC enzalutamide test interference leading to falsely elevated digoxin plasma levels

Astellas Pharma Co. Ltd
Epipen Junior 150 micrograms solution for injection in pre-filled pen
No Recent Update

EpiPen® Healthcare Professional Letter

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

EpiPen® Healthcare Professional Letter

Mylan IRE Healthcare Ltd
PROSCAR 5 mg Tablets
No Recent Update

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

Organon Pharma (Ireland) Limited
Quinsair 240 mg nebuliser solution
No Recent Update

Fluoroquinolones DHPC_HPRA_FINAL vs2 30-05-23

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

IE Adcortyl Discontinuation Letter June 2025

Bristol-Myers Squibb Pharmaceuticals uc
Infanrix Hexa, Powder and suspension for suspension for injection
No Recent Update

Infanrix Hexa - DHPC

GlaxoSmithKline (Ireland) Ltd
PALMEUX_ Paliperidone palmitate 75mg prolonged-release suspension for injection in PFS
No Recent Update

Product Recall Palmeux - pharmacy letter

ADVANZ Pharma
PALMEUX_ Paliperidone palmitate 50mg prolonged-release suspension for injection in PFS
No Recent Update

Product Recall Palmeux - pharmacy letter

ADVANZ Pharma
PALMEUX_ Paliperidone palmitate 150mg prolonged-release suspension for injection in PFS
No Recent Update

Product Recall Palmeux - pharmacy letter

ADVANZ Pharma
PALMEUX_ Paliperidone palmitate 100mg prolonged-release suspension for injection in PFS
No Recent Update

Product Recall Palmeux- pharmacy letter

ADVANZ Pharma
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

Janssen Sciences Ireland (a Johnson & Johnson Company)
Nuvaring
Updated

Signal assessment on meningioma risk

Organon Pharma (Ireland) Limited
Mercilon 150/20 microgram Tablets
Updated

Signal assessment on meningioma risk

Organon Pharma (Ireland) Limited
Marviol 150/30 microgram Tablets
Updated

Signal assessment on meningioma risk

Organon Pharma (Ireland) Limited
Implanon NXT
Updated

Signal Assessment on meningioma risk

Organon Pharma (Ireland) Limited
Cerazette 75 microgram film-coated tablet
Updated

Signal Assessment on meningioma risk

Organon Pharma (Ireland) Limited
Topamax Sprinkle 25 mg hard capsules
Updated

Topiramate: New restrictions to prevent exposure during pregnancy

Janssen Sciences Ireland (a Johnson & Johnson Company)
Topamax Sprinkle 15 mg hard capsules
Updated

Topiramate: New restrictions to prevent exposure during pregnancy

Janssen Sciences Ireland (a Johnson & Johnson Company)
Topamax 50mg film-coated tablets
Updated

Topiramate: New restrictions to prevent exposure during pregnancy

Janssen Sciences Ireland (a Johnson & Johnson Company)
Topamax 25mg film-coated tablets
Updated

Topiramate: New restrictions to prevent exposure during pregnancy

Janssen Sciences Ireland (a Johnson & Johnson Company)
Topamax 200mg film-coated tablets
Updated

Topiramate: New restrictions to prevent exposure during pregnancy

Janssen Sciences Ireland (a Johnson & Johnson Company)