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NutropinAq

  • Name:

    NutropinAq

  • Company:
    info
  • Active Ingredients:

    Somatropin

  • Legal Category:

    Product subject to medical prescription which may not be renewed (A)

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 19/02/20

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Summary of Product Characteristics last updated on medicines.ie: 19/2/2020

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Ipsen Pharmaceuticals Ltd

Ipsen Pharmaceuticals Ltd

Company Products

Medicine NameActive Ingredients
Medicine Name Cabometyx Tablets Active Ingredients Cabozantinib
Medicine Name Decapeptyl (triptorelin) 3-month Active Ingredients triptorelin pamoate
Medicine Name Decapeptyl (triptorelin) SR Active Ingredients triptorelin acetate
Medicine Name Decapeptyl 6 Month 22.5mg Active Ingredients triptorelin pamoate
Medicine Name Dysport Active Ingredients Clostridium botulinum type A toxin-haemagglutinin complex
Medicine Name Hexvix 85 mg powder and solvent for solution for intravesical use Active Ingredients Hexaminolevulinate Hydrochloride
Medicine Name INCRELEX Active Ingredients Mecasermin
Medicine Name Mucodyne 375mg Capsules- Discontinued Active Ingredients Carbocisteine
Medicine Name NutropinAq Active Ingredients Somatropin
Medicine Name Somatuline Autogel 60 mg, 90 mg and 120 mg solution for injection in a pre-filled syringe Active Ingredients Lanreotide acetate
Medicine Name Somatuline LA 30mg Active Ingredients Lanreotide acetate
Medicine Name Xermelo 250 mg film-coated tablets Active Ingredients Telotristat ethyl
1 - 0 of 12 items.Total: Infinity pages

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 19 February 2020 PIL

Reasons for updating

  • Change of distributor details
  • Correction of spelling/typing errors
  • Change to date of revision

Free text change information supplied by the pharmaceutical company

Update to local representatives, update of reporting details in section 6

Updated on 19 February 2020 SmPC

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects
  • Correction of spelling/typing errors

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

Update to local representatives on PIL and update of SmPC as per QRD template v10.1

Updated on 10 January 2019 PIL

Reasons for updating

  • Change to section 6 - what the product contains

Updated on 14 September 2018 PIL

Reasons for updating

  • Change to other sources of information section
  • Improved presentation of PIL

Updated on 14 September 2018 SmPC

Reasons for updating

  • Improved presentation of SmPC

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

Update to SmPC in line with QRD version 10-formatting changes only.

Updated on 11 May 2018 SmPC

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • 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 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

Section 4.2: addition of wording relating to women on oestrogen therapy and growth therapy interactions

Section 4.4: addition of warning relating to women on oestrogen therapy

Section 4.5: addition of wording relating to interaction of oestrogen therapy and growth hormones

Updated on 4 May 2018 PIL

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions

Updated on 8 April 2016 PIL

Reasons for updating

  • New PIL for new product

Updated on 8 April 2016 PIL

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to date of revision

Updated on 28 May 2014 PIL

Reasons for updating

  • Correction of spelling/typing errors

Updated on 4 June 2013 SmPC

Reasons for updating

  • New SmPC for new product

Legal category: Product subject to medical prescription which may not be renewed (A)

Updated on 4 June 2013 SmPC

Reasons for updating

  • Change to section 4.8 - Undesirable effects

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

$0The changes are quite extensive, although the majority are to bring the text into line with the latest EU regulatory product information templates (QRD templates) and EU SmPC Guideline.$0$0There has also been one new post-marketing AE added (adenoidal hypertrophy).$0

Updated on 31 May 2013 PIL

Reasons for updating

  • Change to side-effects

Updated on 26 January 2012 SmPC

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • 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
  • Change to section 6.2 - Incompatibilities
  • Change to section 7 - Marketing authorisation holder

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

$0Minor changes are required to section:       4.2, 4.6 (heading), 6.2 (typo).$0$0Major changes are required to sections      4.4, 4.5, 4.8,  7$0

Updated on 26 January 2012 PIL

Reasons for updating

  • Change due to user-testing of patient information

Updated on 27 May 2010 PIL

Reasons for updating

  • Improved electronic presentation

Updated on 28 August 2008 PIL

Reasons for updating

  • Change to date of revision

Updated on 27 August 2008 SmPC

Reasons for updating

  • New SPC for medicines.ie

Legal category: Product subject to medical prescription which may not be renewed (A)

Updated on 18 October 2007 PIL

Reasons for updating

  • New PIL for new product