Fycompa 0.5 mg/ml oral suspension

  • Name:

    Fycompa 0.5 mg/ml oral suspension

  • Company:
    info
  • Active Ingredients:

    Perampanel

  • Legal Category:

    Product subject to medical prescription which may be renewed (B)

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 09/07/20

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XPIL

Summary of Product Characteristics last updated on medicines.ie: 9/7/2020

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Eisai Ltd

Eisai Ltd

Company Products

Medicine NameActive Ingredients
Medicine Name Fycompa 0.5 mg/ml oral suspension Active Ingredients Perampanel
Medicine Name Fycompa tablets Active Ingredients Perampanel
Medicine Name Gliadel Active Ingredients Carmustine
Medicine Name Halaven 0.44 mg/ml solution for injection Active Ingredients Eribulin mesylate
Medicine Name Inovelon Oral Suspension Active Ingredients Rufinamide
Medicine Name Inovelon Tablets Active Ingredients Rufinamide
Medicine Name Lenvima (lenvatinib) Active Ingredients Lenvatinib mesilate
Medicine Name Targretin Capsules Active Ingredients Bexarotene
Medicine Name Zebinix 200mg tablets Active Ingredients eslicarbazepine acetate
Medicine Name Zebinix 50 mg/ml Oral Suspension Active Ingredients eslicarbazepine acetate
Medicine Name Zebinix 800mg tablets Active Ingredients eslicarbazepine acetate
Medicine Name Zonegran 100 mg hard capsules Active Ingredients Zonisamide
Medicine Name Zonegran 25 mg hard capsules Active Ingredients Zonisamide
Medicine Name Zonegran 50 mg hard capsules Active Ingredients Zonisamide
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When a pharmaceutical company changes any document, a new version is published on medicines.ie. For each version, we show the dates it was published on medicines.ie and the reasons for change.

Updated on 9 July 2020 SmPC

Reasons for updating

  • Change to section 7 - Marketing authorisation holder

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Change to address of MAH

Updated on 9 July 2020 PIL

Reasons for updating

  • Change to section 6 - marketing authorisation holder
  • Change to section 6 - manufacturer

Free text change information supplied by the pharmaceutical company

Address change for MAH and manufacturer

Updated on 5 May 2020 PIL

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 2 - interactions with other medicines, food or drink
  • Change to section 4 - possible side effects

Free text change information supplied by the pharmaceutical company

Section 2: Raised liver enzymes added; Stevens-Johnson syndrome added as potential serious skin reaction; “oral” contraceptives – changed to “hormonal” contraceptives

Section 4: Stevens-Johnson syndrome added as potential serious skin reaction

Updated on 5 May 2020 SmPC

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.6 - Pregnancy and lactation
  • Change to Section 4.8 – Undesirable effects - how to report a side effect

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Section 4.4: Addition of hepatotoxicity warning; Amendment of “oral” contraceptive to “hormonal” contraceptive; Addition of Stevens-Johnson syndrome as potential severe cutaneous adverse reaction.

Section 4.5: Amendment of “oral” contraceptive to “hormonal” contraceptive (interactions section)

Section 4.6: Amendment of “oral” contraceptive to “hormonal” contraceptive (section on women of childbearing potential and contraception)

Section 4.8: Addition of Stevens-Johnson syndrome as skin adverse reaction (frequency = not known)

Updated on 20 March 2019 PIL

Reasons for updating

  • New PIL for new product

Updated on 20 March 2019 SmPC

Reasons for updating

  • New SmPC for new product

Legal category: Product subject to medical prescription which may be renewed (B)