Somatuline LA 30mg
- Name:
Somatuline LA 30mg
- Company:
Ipsen Pharmaceuticals Ltd
- Active Ingredients:
- 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
(Click to Download) Summary of Product Characteristics last updated on medicines.ie: 1/11/2019
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Ipsen Pharmaceuticals Ltd
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| 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 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 |
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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
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
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
Reasons for updating
- Change to section 4.8 - Undesirable effects
- Change to section 10 - Date of revision of the text
Free text change information supplied by the pharmaceutical company
Update to SPC section 4.8 to add new ADRs.
Updated on 4 July 2018
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
Reasons for updating
- New SmPC 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.
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.
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