Nitrolingual Pumpspray 400 micrograms per metered dose, sublingual spray

  • Name:

    Nitrolingual Pumpspray 400 micrograms per metered dose, sublingual spray

  • Company:
    info
  • Active Ingredients:

    Glyceryl Trinitrate

  • Legal Category:

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

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 08/07/20

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Summary of Product Characteristics last updated on medicines.ie: 8/7/2020

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Intrapharm Laboratories Limited

Intrapharm Laboratories Limited

Company Products

Medicine NameActive Ingredients
Medicine Name Lactulose 10 g / 15 ml Oral Solution Sachets Active Ingredients Lactulose
Medicine Name Mydrilate 0.5% w/v Eye Drops Active Ingredients Cyclopentolate Hydrochloride
Medicine Name Mydrilate 1.0% w/v Eye Drops Active Ingredients Cyclopentolate Hydrochloride
Medicine Name Nitrolingual Pumpspray 400 micrograms per metered dose, sublingual spray Active Ingredients Glyceryl Trinitrate
Medicine Name Prialt solution for infusion Active Ingredients Ziconotide acetate
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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 8 July 2020 PIL

Reasons for updating

  • Change to section 4 - possible side effects
  • Change to section 4 - how to report a side effect
  • Change to section 6 - what the product contains
  • Change to section 6 - what the product looks like and pack contents
  • Change to section 6 - date of revision

Free text change information supplied by the pharmaceutical company

PIL updated in-line with HPRA approval for:

Case Reference Number: CRN0099FH

National Variation Type II

Approved: 17/06/2020

Updated on 8 July 2020 SmPC

Reasons for updating

  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • Change to section 6.1 - List of excipients
  • Change to section 6.5 - Nature and contents of container
  • Change to section 10 - Date of revision of the text

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

Free text change information supplied by the pharmaceutical company

SmPC entry updated in-line with:

HPRA Case Reference Number: CRN0099FH

National Variation Type II

Approved: 17/06/2020

Updated on 21 October 2019 SmPC

Reasons for updating

  • File format updated to PDF

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

Free text change information supplied by the pharmaceutical company

(Internal change: file format updated to PDF.)

Updated on 15 May 2018 SmPC

Reasons for updating

  • New SmPC for new product

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

Updated on 8 May 2018 PIL

Reasons for updating

  • New PIL for new product