Somavert 10mg, 15mg, 20mg, 25mg and 30mg Powder and Solvent for Solution for Injection

  • Name:

    Somavert 10mg, 15mg, 20mg, 25mg and 30mg Powder and Solvent for Solution for Injection

  • Company:
    info
  • Active Ingredients:

    Pegvisomant

  • Legal Category:

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

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

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Summary of Product Characteristics last updated on medicines.ie: 8/3/2019

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Pfizer Healthcare Ireland

Pfizer Healthcare Ireland

Company Products

Medicine NameActive Ingredients
Medicine Name Accupro 10 mg Film - Coated tablets Active Ingredients Quinapril hydrochloride
Medicine Name Accupro 20 mg Film - Coated tablets Active Ingredients Quinapril hydrochloride
Medicine Name Accupro 40 mg Film - Coated tablets Active Ingredients Quinapril hydrochloride
Medicine Name Accupro 5 mg Film - Coated tablets Active Ingredients Quinapril hydrochloride
Medicine Name Accuretic 20 mg/12.5 mg Tablets Active Ingredients Hydrochlorothiazide, Quinapril hydrochloride
Medicine Name Aciclovir 25 mg/ml Concentrate for Solution for Infusion. Active Ingredients Aciclovir sodium
Medicine Name Aldactone 100mg film coated tablets Active Ingredients Spironolactone
Medicine Name Aldactone 25mg film-coated tablets Active Ingredients Spironolactone
Medicine Name Aldactone 50 mg Film-coated tablets. Active Ingredients Spironolactone
Medicine Name Amlodipine Pfizer 10 mg Tablets Active Ingredients Amlodipine besilate
Medicine Name Amlodipine Pfizer 5 mg Tablets Active Ingredients Amlodipine besilate
Medicine Name Anugesic HC Cream Active Ingredients Balsam Peru, Benzyl Benzoate, Bismuth Oxide, Hydrocortisone Acetate, Pramocaine Hydrochloride, Zinc Oxide
Medicine Name ARICEPT 10 mg film coated tablets Active Ingredients Donepezil Hydrochloride
Medicine Name ARICEPT 5 mg film coated tablets Active Ingredients Donepezil Hydrochloride
Medicine Name Aromasin 25 mg coated tablets Active Ingredients Exemestane
Medicine Name Arthrotec 50 Active Ingredients Diclofenac Sodium, Misoprostol
Medicine Name Arthrotec 75 modified-release tablets Active Ingredients Diclofenac Sodium, Misoprostol
Medicine Name Ativan 1mg Tablets Active Ingredients Lorazepam
Medicine Name ATIVAN INJECTION Active Ingredients Lorazepam
Medicine Name BeneFIX Active Ingredients nonacog alfa
Medicine Name BESPONSA 1 mg powder for concentrate for solution for infusion Active Ingredients Inotuzumab ozogamicin
Medicine Name Bosulif 100 mg, 400 mg & 500 mg film-coated tablets Active Ingredients Bosutinib monohydrate
Medicine Name Cabaser 1mg Tablet Active Ingredients Cabergoline
Medicine Name Cabaser 2mg Tablet Active Ingredients Cabergoline
Medicine Name CAMPTO 20 mg/ml, concentrate for solution for infusion Active Ingredients Irinotecan hydrochloride trihydrate
1 - 0 of 227 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 November 2019 PIL

Reasons for updating

  • Change to section 6 - date of revision

Updated on 8 March 2019 SmPC

Reasons for updating

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

The SPC has been updated as follows: Section 4.4 of the SmPC to enable differentiation between two situations of elevated liver enzymes that may arise for a patient and Update to section 10 of the SmPC to align with the QRD template (v.10).

Updated on 23 October 2018 PIL

Reasons for updating

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

Updated on 18 October 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

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

Free text change information supplied by the pharmaceutical company

The SPC sections affected are Section 4.2 and 4.4 of SmPC updated to provide prior warning and detailed recommendations on the need for the physician to measure liver enzymes prior to initiation of treatment with SOMAVERT. Corresponding sections of PIL are also updated to align with changes to SmPC.

Updated on 29 August 2018 PIL

Reasons for updating

  • Change to section 6 - marketing authorisation holder
  • Change to section 6 - date of revision

Updated on 29 August 2018 SmPC

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

The SPC has been updated as follows: Section 7 Marketing Authorisation Holder has changed from Pfizer Ltd UK to Pfizer EEIG Belgium

Updated on 12 July 2018 SmPC

Reasons for updating

  • Change to section 6.4 - Special precautions for storage

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

Free text change information supplied by the pharmaceutical company

The SPC has been updated as follows: Section 6.4 is updated to include storage condition for prefilled syringe

Updated on 12 July 2018 PIL

Reasons for updating

  • Change to section 5 - how to store or dispose
  • Change to section 6 - date of revision

Updated on 12 May 2018 SmPC

Reasons for updating

  • New SmPC for new product

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

Updated on 16 January 2017 SmPC

Reasons for updating

  • New SmPC for new product

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

Updated on 16 January 2017 SmPC

Reasons for updating

  • 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

The SPC – only the date of revision has been updated in line with the EMA Product Information Annex update.  There is no content change.

Updated on 13 January 2017 PIL

Reasons for updating

  • New PIL for new product

Updated on 13 January 2017 PIL

Reasons for updating

  • Change to section 6 - date of revision
  • Change to information for healthcare professionals

Updated on 4 November 2016 SmPC

Reasons for updating

  • 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

The SPC – only the date of revision has been updated in line with the EMA Product Information Annex update.  There is no content change.

Updated on 3 November 2016 PIL

Reasons for updating

  • Change to section 6 - date of revision
  • Change to information for healthcare professionals

Updated on 8 August 2016 SmPC

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.2 - Posology and method of administration
  • Change to section 5.1 - Pharmacodynamic properties
  • 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

Updates to Section 2, 4.2 and 5.1: editorial changes

Section 6.5 and 6.6: Implementation of changes to EU PI to incorporate pre-filled syringe container closure system in place of glass vial for diluent used in preparation of dose.

Updated on 5 August 2016 PIL

Reasons for updating

  • Change to storage instructions
  • Change to side-effects
  • Change to information about pregnancy or lactation
  • Change to further information section
  • Change to date of revision
  • Change to dosage and administration

Updated on 26 July 2016 SmPC

Reasons for updating

  • Change to section 1 - Name of medicinal product
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 3 - Pharmaceutical form
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.6 - Pregnancy and lactation
  • Change to section 4.8 - Undesirable effects
  • 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 8 - MA number
  • Change to section 9 - Date of renewal of authorisation
  • 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

The changes to the SPC are as detailed below:

Section 1: editorial changes

Section 2- change of formatting from tabular format to free text

Section 3: addition of (powder for injection) as a shorter version of the pharmaceutical form

Section 4.2, 4.4, 4.6: editorial changes

Section 4.8: update ADR Frequencies and formatting from free text to tabular format

Section 6.5: updated description of pack sizes

Section 6.6: editorial change

Section8: editorial changes

Section 9- editorial changes

Section10: new revision date

Updated on 22 July 2016 PIL

Reasons for updating

  • Change to side-effects
  • Change to drug interactions
  • Change to information about pregnancy or lactation
  • Change to date of revision

Updated on 23 July 2015 SmPC

Reasons for updating

  • Introduction of new strength

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

Free text change information supplied by the pharmaceutical company



·         The SPC has been updated as follows: Line extension 25mg and 30mg strengths and QRD

Updated on 21 July 2015 PIL

Reasons for updating

  • Change to packaging
  • Change to side-effects
  • Change to further information section
  • Change to date of revision
  • Change to MA holder contact details
  • Change to improve clarity and readability
  • Change of special precautions for disposal
  • Introduction of new pack/pack size

Updated on 25 June 2015 PIL

Reasons for updating

  • Change to date of revision
  • Change to MA holder contact details

Updated on 19 March 2014 SmPC

Reasons for updating

  • 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 Section 10 – Update to DATE OF REVISION OF THE TEXT

Updated on 10 September 2013 PIL

Reasons for updating

  • Change to date of revision
  • Change to MA holder contact details
  • Addition of marketing authorisation holder

Updated on 4 January 2012 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

To update section 4.8 Undesirable Effects with the addition of systemic hypersensitivity reactions as a listed undesirable effect.

Updated on 4 January 2012 PIL

Reasons for updating

  • Change to side-effects
  • Change to date of revision

Updated on 16 June 2011 SmPC

Reasons for updating

  • Improved electronic presentation

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

Free text change information supplied by the pharmaceutical company

Legal Category has been removed from the SmPC

Updated on 30 November 2010 SmPC

Reasons for updating

  • Change to section 1 - Name of medicinal product

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

Free text change information supplied by the pharmaceutical company

SmPC – The Black Triangle has been removed from Section 1 of the SmPC. Since we maintain a combined Somavert SmPC for UK and Ireland, the labelling for both markets is affected by this change.

Updated on 11 February 2010 SmPC

Reasons for updating

  • Change to section 5.3 - Preclinical safety data

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

Free text change information supplied by the pharmaceutical company

 

5.3 Preclinical safety data (submission of a non-clinical carcinogenicity report and the related updates in section 5.3 of the SmPC)

 

Updated on 27 August 2009 SmPC

Reasons for updating

  • 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

SPC currently on IPHa has a black triangle - have removed the triangle

Updated on 17 June 2008 SmPC

Reasons for updating

  • Change to section 6.3 - Shelf life

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

Free text change information supplied by the pharmaceutical company

Section 6.3 The shelf life of the product has been changed from 2 to 3 years.

Updated on 21 February 2008 PIL

Reasons for updating

  • Correction of spelling/typing errors

Updated on 25 January 2008 PIL

Reasons for updating

  • Change to side-effects
  • Change to further information section
  • Change to date of revision
  • Change to dosage and administration
  • Addition of joint PIL covering all presentations

Updated on 18 January 2008 SmPC

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.8 - Undesirable effects
  • Change to section 6.5 - Nature and contents of container
  • Change to section 9 - Date of renewal of authorisation
  • 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

4.2 – Update to section

4.8 – Update to section and Addition of text

6.5 - Update to Section

9 - Update to Section

10- Update to Section

Updated on 12 October 2007 PIL

Reasons for updating

  • Change to, or new use for medicine
  • Change to warnings or special precautions for use
  • Change to storage instructions
  • Change to side-effects
  • Change to information about pregnancy or lactation
  • Change to information about driving or using machinery
  • Change to further information section
  • Change to date of revision

Updated on 9 October 2007 SmPC

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.8 - Undesirable effects
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 6.2 - Incompatibilities
  • Change to section 6.4 - Special precautions for storage
  • 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 – Update to Section 2

4.2 - addition of “There is no experience in children”

4.5:  revision to interaction studies statement

4.5 – revision of wording under “Use in Lactation”

4.8 – Update Section 4.8 (Undesirable effects)

5.1 - Update to Section 5.1 (Pharmacotherapeutic group)

6.2 - Update to Section 6.2

6.4 – Update to Section 6.4

6.6 - Update to Section 6.4

Updated on 11 January 2006 PIL

Reasons for updating

  • Change to packaging

Updated on 7 April 2005 PIL

Reasons for updating

  • Change to further information section

Updated on 5 April 2005 SmPC

Reasons for updating

  • New SPC for medicines.ie

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

Updated on 20 September 2004 PIL

Reasons for updating

  • New PIL for medicines.ie