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Sandostatin LAR 20mg Powder and Solvent for Suspension for Injection

*
Pharmacy Only: Prescription

  • Company:

    Novartis Ireland Limited

  • Status:

    No Recent Update

  • Legal Category:

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

  • Active Ingredient(s):

    Octreotide Acetate

    *Additional information is available within the SPC or upon request to the company

  • Sandostatin 20-1.png
  • Sandostatin 20-2.png

Updated on 05 January 2024

File name

Sandostatin LAR_REGPIL_PF23-0171_Jan2024_clean.pdf

Reasons for updating

  • Change to section 6 - manufacturer

Updated on 19 July 2022

File name

Sandostatin LAR 20mg_REG SPC_PF22-0082_14.07.2022_clean_IPHA.pdf

Reasons for updating

  • 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)

Updated on 19 July 2022

File name

Sandostatin LAR_REG PIL_PF22_0082_14.07.2022_clean_IPHA.pdf

Reasons for updating

  • Change to information for healthcare professionals

Updated on 11 November 2021

File name

Sandostatin LAR REG PIL _PF 21-0207_clean_Nov 2021.pdf

Reasons for updating

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

Updated on 11 November 2021

File name

Sandostatin 20mg LAR REGSPC PF 21-0207 clean November 2021.pdf

Reasons for updating

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

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

Updated on 14 September 2021

File name

Sandostatin LAR REG PIL _PF 21-0106_clean July 2021.pdf

Reasons for updating

  • Correction of spelling/typing errors

Updated on 21 July 2021

File name

Sandostatin LAR REG PIL _PF 21-0106_clean July 2021.pdf

Reasons for updating

  • Change to section 6 - manufacturer

Updated on 02 June 2021

File name

Sandostatin LAR REGPIL PF 20-0111_Clean Feb 2021.pdf

Reasons for updating

  • Change to section 2 - interactions with other medicines, food or drink

Updated on 01 April 2021

File name

Sandostatin 20mg LAR REGSPC PF 20-0111 Clean March 2021.pdf

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction

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

Updated on 05 February 2021

File name

Sandostatin LAR REGPIL PF20-0099 Jan2021 Clean.pdf

Reasons for updating

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

Updated on 05 February 2021

File name

Sandostatin LAR 20mg REGSPC PF20-0099 Jan 2021 clean.pdf

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.4 - Special warnings and precautions for use

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

Updated on 12 October 2020

File name

Sandostatin LAR_P REGPIL_Art61(3) PF20-0141 Clean.pdf

Reasons for updating

  • Change of manufacturer

Updated on 28 November 2019

File name

Sandostatin LAR REGPIL PF19-0028 February 2019_IPHA.pdf

Reasons for updating

  • Change to improve clarity and readability

Updated on 28 November 2019

File name

Sandostatin LAR REGPIL PF19-0028 February 2019 IPHA.pdf

Reasons for updating

  • Improved presentation of PIL

Updated on 22 March 2019

File name

Sandostatin LAR 2220975_IE_p1_LFT_X-4 RA approved 19.03.2019_IPHA.pdf

Reasons for updating

  • Change to section 4 - how to report a side effect

Updated on 22 January 2019

File name

Sandostatin LAR 2214773_IE_p3_LFT_X-4 RA approved 05.09.2018 IPHA.pdf

Reasons for updating

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

Updated on 24 July 2018

File name

Sandostatin LAR 20mg REGSPC July 2018_clean.pdf

Reasons for updating

  • Change to section 7 - Marketing authorisation holder
  • Change to section 8 - Marketing authorisation number(s)
  • Change to MA holder contact details

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

Updated on 26 April 2018

File name

Sandostatin LAR 2209962_IE_p1_LFT_X-4 RA approved 28.03.2018 IPHA TBI by 17.08.2018.pdf

Reasons for updating

  • Change to section 4 - possible side effects

Updated on 23 February 2018

Reasons for updating

  • New SPC for new product

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

Updated on 23 February 2018

Reasons for updating

  • Change to section 4.3 - Contraindications
  • Change to section 4.4 - Special warnings and precautions for use
  • 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

In Section 4.4 Special warnings and precautions for use

Information on Gallbladder and related events has been updated

In Section 4.8     Undesirable effects

thyroid dysfunction has been renamed as thyroid disorder

Blood and lymphatic system disorders –Thrombocytopenia has been added as an Adverse drug reactions derived from spontaneous reports

Information has been added on Gallbladder and related reactions, Hypersensitivity and anaphylactic reactions, Cardiac disorders and Thrombocytopenia

Typographical changes have been made to sections 4.2, 4.3.

Updated on 28 October 2016

File name

PIL_8525_668.pdf

Reasons for updating

  • New PIL for new product

Updated on 28 October 2016

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 3 - how to take/use

Updated on 30 September 2016

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 6.1 - List of excipients
  • Change to section 6.2 - Incompatibilities
  • Change to section 6.3 - Shelf life
  • 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

2  QUALITATIVE AND QUANTITATIVE COMPOSITION

 

Typographical change

4.4 Special warnings and precautions for use

Info provided on Sodium content

6.1 List of excipients

Typographical change

6.2 Incompatibilities

Section updated

6.3 Shelf life

Section updated

6.4 Special precautions for storage

Updated

6.5 Nature and contents of container

Updated

6.6 Special precautions for disposal and other handling

Updated

Updated on 07 January 2016

Reasons for updating

  • Change to Section 4.8 – Undesirable effects - how to report a side effect

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

Free text change information supplied by the pharmaceutical company

In section 4.8 (undesirable effects), information on the reporting of side effects has been added.

Updated on 23 April 2015

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to side-effects
  • Change to dosage and administration
  • Addition of information on reporting a side effect.

Updated on 23 March 2015

Reasons for updating

  • Change to section 4.1 - Therapeutic indications
  • Change to section 4.2 - Posology and method of administration
  • 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 6.1 - List of excipients
  • Change to section 6.2 - Incompatibilities
  • Change to section 6.3 - Shelf life
  • 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
  • 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


Referral approval-update to Sections 4.1, 4.2, 4.3, 4.4, 4.5, 4.6, 4.7, 4.8, 4.9, 5.1, 5.2, 5.3, 6.1, 6.2, 6.3, 6.4, 6.5, 6.6

Updated on 23 April 2014

Reasons for updating

  • Change to packaging
  • Change to, or new use for medicine

Updated on 29 November 2013

Reasons for updating

  • Change to section 3 - Pharmaceutical form
  • Change to section 4.2 - Posology and method of administration
  • Change to section 6.1 - List of excipients
  • 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

In Section 3 Pharmaceutical form, description of Powder and Solvent has changed.

 

In Section 4.2 Posology and method of administration, diagrams have been moved to section 6.6 of SmPC and replaced with new diluent diagrams

 

In Section 6.1 List of Excipients, Poloxamer 188 has been added as an excipient

 

In Section 6.4 Special precautions for storage, typographical changes have been made

 

In Section 6.5 Nature and Contents of Container, Section has been updated to reflect new diluent

 

In Section 6.6 Instructions for Use/Handling, Section has been changed to reflect new diluent

Updated on 27 June 2013

Reasons for updating

  • Change to side-effects

Updated on 29 May 2013

Reasons for updating

  • New individual SPC (was previously included in combined SPC)

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

Free text change information supplied by the pharmaceutical company

In Section 4.1. Therapeutic Indications, new promid indication has been added

In Section 4.2 Posology and method of administration, information has been updated in line with new indication

In Section 5.1. Pharmacodynamic Properties, information has been updated in line with new indication

Updated on 28 February 2013

Reasons for updating

  • PIL re-instated

Updated on 29 August 2006

Reasons for updating

  • Change to date of revision
  • PIL retired pending re-submission

Updated on 17 May 2005

Reasons for updating

  • Change to dosage and administration
  • Change to packaging

Updated on 25 August 2004

Reasons for updating

  • New PIL for medicines.ie