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Somatuline LA 30mg

  • Name:

    Somatuline LA 30mg

  • Company:
    info
  • Active Ingredients:

    Lanreotide acetate

  • Legal Category:

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

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 12/11/19

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Summary of Product Characteristics last updated on medicines.ie: 1/11/2019

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Ipsen Pharmaceuticals Ltd

Ipsen Pharmaceuticals Ltd

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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 12 November 2019 PIL

Reasons for updating

  • Change to Section 1 - what the product is
  • Change to section 2 - what you need to know - contraindications
  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 3 - how to take/use
  • Change to section 4 - possible side effects
  • Change to section 5 - how to store or dispose
  • Change to section 6 - date of revision

Free text change information supplied by the pharmaceutical company

Addition of cholangitis as an ADR to the SmPC and PIL

Updated on 11 November 2019 PIL

Reasons for updating

  • Change to Section 1 - what the product is
  • 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 2 - pregnancy, breast feeding and fertility
  • Change to section 3 - how to take/use
  • Change to section 3 - overdose, missed or forgotten doses
  • Change to section 4 - possible side effects
  • Change to section 6 - date of revision

Updated on 1 November 2019 PIL

Reasons for updating

  • Change to section 1 - what the product is used for
  • 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 3 - how to take/use
  • Change to section 4 - how to report a side effect
  • Change to section 6 - date of revision

Free text change information supplied by the pharmaceutical company

To update SmPC section 4.4 to include ‘complications of cholelithiasis’, to update section 4.8 to add a new ADR ‘cholangitis’ and to make corresponding updates to the PIL

Updated on 1 November 2019 SPC

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects
  • 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

 

To update SmPC section 4.4 to include ‘complications of cholelithiasis’, to update section 4.8 to add a new ADR ‘cholangitis’ and to make corresponding updates to the PIL

Updated on 20 September 2018 PIL

Reasons for updating

  • Change to section 4 - possible side effects
  • Change to section 6 - date of revision

Updated on 19 September 2018 PIL

Reasons for updating

  • Change to section 4 - possible side effects
  • Change to section 6 - date of revision

Updated on 19 September 2018 SPC

Reasons for updating

  • Change to section 4.8 - Undesirable effects
  • 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

Update to SPC section 4.8 to add new ADRs.

Updated on 4 July 2018 SPC

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 3 - Pharmaceutical form

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 to include sodium content, update description of the finished product and to update section headings in line with QRD template

Updated on 4 July 2018 PIL

Reasons for updating

  • Change to section 2 - excipient warnings
  • Change to section 6 - what the product looks like and pack contents

Updated on 13 June 2016 SPC

Reasons for updating

  • New SPC for new product

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

Updated on 13 June 2016 SPC

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects
  • 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 4.4: removal of reference to requirement for checking if patient has obstructive intestinal tumour before prescribing Somatuline LA
Section 4.8: inclusion of reference to AEs for GEP NET patients. Reordering of AE table to include reference to GEP NET AEs in line with CCSI v7.

Updated on 10 June 2016 PIL

Reasons for updating

  • New PIL for new product

Updated on 10 June 2016 PIL

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to side-effects
  • Change to date of revision
  • Change to improve clarity and readability

Updated on 15 December 2014 PIL

Reasons for updating

  • Change to side-effects

Updated on 15 December 2014 SPC

Reasons for updating

  • Change to section 4.8 - Undesirable effects
  • Change to section 5.1 - Pharmacodynamic properties

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

Free text change information supplied by the pharmaceutical company

To include allergic reaction as an adverse event in the post marketing section of the SPC and to add   As a reminder this  was a type II safety information (C.I.4). It was triggered by the Belgian Authorities request in August last year, asking us to update section 4.8 of the Belgian SmPC. PV made a comprehensive search of all allergic reactions cases, and finally the lanreotide CCSI was revised to add this event in the post marketing safety experience section with an unknown frequency.

Paediatric population

The European Medicines Agency has waived the obligation to submit the results of studies with Lanreotide PR 30 mg in all subsets of the paediatric population in acromegaly, pituitary gigantism, gastrointestinal fistulae, metastases to peritoneum and pituitary neoplams (see section 4.2 for information on paediatric use). The European Medicines Agency has listed gastroenteropancreatic neuroendocrine tumours (excluding neuroblastoma, neuroganglioblastoma and phaeochromocytoma) on the list of class waivers.

Updated on 20 August 2014 PIL

Reasons for updating

  • Change to further information section

Updated on 22 July 2014 SPC

Reasons for updating

  • Change to section 5.1 - Pharmacodynamic properties

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

Free text change information supplied by the pharmaceutical company

The addition of randomised, placebo controlled study investigating the effects of Somatuline LA 30 mg administration every 10 days on top of  concomitant treatment regimen including intravenous corticoids, proton-pump inhibitors, antispasmodics, antiemetics and analgesics,  in 80 patients with upper intestinal obstruction of malignant origin due to confirmed peritoneal carcinomatosis in palliative care to section 5.1.

Updated on 9 May 2013 PIL

Reasons for updating

  • Improved electronic presentation

Updated on 8 February 2013 SPC

Reasons for updating

  • 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

IPSEN Change of address to:$0$0$0$0$0Endocrinology Product Manager$0$0Ipsen Pharmaceuticals Ltd$0$0Blanchardstown industrial Park$0$0Blanchardstown $0$0Dublin 15$0$0

Updated on 12 May 2012 SPC

Reasons for updating

  • Change to section 1 - Name of medicinal product
  • Change to section 3 - Pharmaceutical form
  • Change to section 4 - Clinical particulars
  • Change to section 4.3 - Contraindications
  • 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 4.7 - Effects on ability to drive and use machines
  • Change to section 4.8 - Undesirable effects
  • Change to section 4.9 - Overdose
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 5.3 - Preclinical safety data
  • Change to section 6.4 - Special precautions for storage
  • Change to section 6.5 - Nature and contents of container
  • Change to section 6.6 - Special precautions for disposal and other handling

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

Free text change information supplied by the pharmaceutical company

Application Type: 2010 - National Variation Type II (60 day)

Case Description: Somatuline LA 30mg Powder & solvent for suspension for injection -

C.I.Z Update of the product information (sections 1, 3, 4.3, 4.4, 4.5, 4.6, 4.7, 4.8, 4.9, 5.1,5.2, 5.3, 6.4, 6.5 & 6.6)

Updated on 11 May 2012 PIL

Reasons for updating

  • Change to packaging

Updated on 16 April 2012 PIL

Reasons for updating

  • Improved electronic presentation

Updated on 15 June 2010 SPC

Reasons for updating

  • New SPC for medicines.ie

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

Free text change information supplied by the pharmaceutical company

None provided

Updated on 28 May 2010 PIL

Reasons for updating

  • New PIL for medicines.ie