ZOSTAVAX

  • Name:

    ZOSTAVAX

  • Company:
    info
  • Active Ingredients:

    Varicella-zoster virus (live)

  • Legal Category:

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

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 27/02/19

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Summary of Product Characteristics last updated on medicines.ie: 25/1/2019

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MSD Ireland (Human Health) Limited

MSD Ireland (Human Health) Limited

Company Products

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Medicine Name HBVAXPRO 40mcg Active Ingredients Hepatitis B vaccine (rDNA)
Medicine Name HBVAXPRO 5mcg Active Ingredients Hepatitis B vaccine (rDNA)
Medicine Name Implanon NXT Active Ingredients Etonogestrel
Medicine Name INEGY Tablets Active Ingredients ezetimibe, Simvastatin
Medicine Name INNOVACE TABLETS Active Ingredients Enalapril Maleate
Medicine Name INVANZ Active Ingredients Ertapenem
Medicine Name Isentress 25 mg /100 mg chewable tablets Active Ingredients Raltegravir potassium
Medicine Name Isentress 400 mg tablets Active Ingredients Raltegravir potassium
Medicine Name Isentress 600 mg tablets Active Ingredients Raltegravir potassium
Medicine Name IVEMEND 150 mg powder for solution for infusion Active Ingredients Fosaprepitant dimeglumine
Medicine Name Janumet 50 mg/1000 mg film-coated tablets Active Ingredients Metformin Hydrochloride, sitagliptin phosphate monohydrate
Medicine Name Janumet 50 mg/850 mg film-coated tablets Active Ingredients Metformin Hydrochloride, sitagliptin phosphate monohydrate
Medicine Name Januvia 100mg film-coated tablets Active Ingredients sitagliptin phosphate monohydrate
Medicine Name Januvia 25mg film-coated tablets Active Ingredients sitagliptin phosphate monohydrate
Medicine Name Januvia 50mg film-coated tablets Active Ingredients sitagliptin phosphate monohydrate
Medicine Name KEYTRUDA 25 mg/mL concentrate for solution for infusion Active Ingredients Pembrolizumab
Medicine Name Livial Active Ingredients Tibolone
Medicine Name Marviol Active Ingredients Desogestrel, Ethinylestradiol
Medicine Name Mercilon Active Ingredients Desogestrel, Ethinylestradiol
Medicine Name MMRvaxpro Active Ingredients Measles, mumps and rubella vaccine (live)
Medicine Name Nasonex 50 micrograms/actuation Nasal Spray, Suspension Active Ingredients Mometasone furoate monohydrate
Medicine Name Neoclarityn 0.5mg/ml Oral Solution Active Ingredients Desloratadine
26 - 50 of 84 items.Total: 4 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 27 February 2019 PIL

Reasons for updating

  • Change to further information section

Updated on 25 January 2019 PIL

Reasons for updating

  • Change to section 2 - interactions with other medicines, food or drink
  • Change to section 6 - date of revision

Updated on 25 January 2019 SmPC

Reasons for updating

  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • 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

Update on concomitant use of ZOSTAVAX and a 23-valent pneumococcal polysaccharide

Updated on 3 September 2018 PIL

Reasons for updating

  • Change to section 6 - date of revision

Updated on 14 August 2018 PIL

Reasons for updating

  • Change to section 4 - how to report a side effect
  • Change to other sources of information section

Updated on 17 January 2018 SmPC

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 9 - Date of first authorisation/renewal of the 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

Section 4.4 updated to reinforce warning in Immunocompromised patients.
Section 9: updated renewal date

Updated on 17 January 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 30 August 2017 SmPC

Reasons for updating

  • Change to section 5.1 - Pharmacodynamic properties
  • 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

Addition of the heading “Long-term effectiveness study in individuals 50 years of age or older” in section 5.1

Updated on 3 March 2017 SmPC

Reasons for updating

  • Change to section 7 - Marketing authorisation holder
  • 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

Marketing Authorisation Holder name change to MSD VACCINES

Updated on 2 March 2017 PIL

Reasons for updating

  • New PIL for new product

Updated on 2 March 2017 PIL

Reasons for updating

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

Updated on 17 January 2017 PIL

Reasons for updating

  • Change to MA holder contact details

Updated on 25 February 2016 PIL

Reasons for updating

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

Updated on 25 February 2016 SmPC

Reasons for updating

  • 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 4.8 - Undesirable effects
  • Change to section 9 - Date of renewal of authorisation
  • Change to section 10 - Date of revision of the text
  • 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

Section 4.4:  Included 'ZOSTAVAX is a live, attenuated varicella-zoster vaccine and administration may result in disseminated disease in individuals who are immunosuppressed or immunodeficient. Patients who previously received immune suppressive therapy should be carefully evaluated for the reconstitution of the immune system prior to receiving Zostavax (see section 4.3)'.

'The safety and efficacy of ZOSTAVAX have not been established in adults who are known to be infected with HIV with or without evidence of immunosuppression (see section 4.3) however, a phase II safety and immunogenicity study in HIV-infected adults with conserved immune function (CD 4+T cell count ≥ 200 cells/µL) has been completed (see sections 4.8 and 5.1)'.

Section 4.5: Addition of sentence 'Therefore, administration of the two vaccines should be considered to be separated by at least 4 weeks'.

Section 4.8: Addition of 'Eye disorders Necrotizing retinitis (patients on immunosuppressive therapy) – Very rare'.

Section 9: Date of first authorisation and Renewal amended

Section 10: date revised to 02/2016

Updated on 7 January 2016 SmPC

Reasons for updating

  • Change to section 1 - Name of medicinal product
  • Change to section 2 - Qualitative and quantitative composition
  • 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 5.1 - Pharmacodynamic properties
  • Change to section 6.1 - List of excipients
  • 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

Section 1:  reflects both combinations

Section 2: QRD formatted

Section 4.2: QRD + addition of IM use and the statement "The vaccine should be administered subcutaneously in patients with severe thrombocytopenia or any coagulation disorder (see section 4.4)". Also added the statement "The vaccine should under no circumstances be injected intravascularly".

Section 4.4: addition of IM use + statement "This vaccine should be given subcutaneously to individuals with severe thrombocytopenia or any coagulation disorder, because these individuals may bleed following intramuscular injections". Also added "Immunisation should be postponed in individuals suffering from moderate to severe acute febrile illness or infection".

Section 4.6: aligned with the QRD format

Section 4.8: QRD format + frequency changes from not known to rare

Section 5.1: Clinical Efficacy and Data updated, addition of statement "The European Medicines Agency has waived the obligation to submit the results of studies with ZOSTAVAX in all the subsets of paediatric population (see section 4.2 for information on paediatric use)".

Section 6.1: updated 2 excipients to read:

Monosodium L-glutamate monohydrate

Disodium phosphate

Section 6.5 + 6.6: Updated to be combined vial + pre-filled syringe

Section 10:

Date revised to 12/2015

Updated on 7 January 2016 PIL

Reasons for updating

  • Change to, or new use for medicine
  • Change to warnings or special precautions for use
  • Change to side-effects
  • Change to further information section
  • Change to date of revision

Updated on 11 May 2015 SmPC

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.8 - Undesirable effects
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • Change to section 5.1 - Pharmacodynamic properties
  • 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



In section 4.2 amended text to read 'The need for a booster dose is not known'
In section 4.8
add P029 study results (booster dose), include adverse reaction reporting information
In section 5.1 add P029 study results (
Immunogenicity in Subjects Receiving a Booster Dose)
In section 10, date of revision 04/2015

Updated on 8 December 2014 SmPC

Reasons for updating

  • Change to section 4.8 - Undesirable effects
  • Change to section 5.1 - Pharmacodynamic properties
  • 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 4.8 addition of HIV-infected adults with conserved immune function data

Section 5.1 addition of Immunogenicity in HIV-infected adults with conserved immune function

Section 10 date of last revision updated from 10/2014 to 11/2014

Updated on 18 November 2014 PIL

Reasons for updating

  • Change to side-effects
  • Change to further information section
  • Change to date of revision

Updated on 18 November 2014 SmPC

Reasons for updating

  • Change to section 4.8 - Undesirable effects
  • 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

In section 4.8, herpes zoster has been added. Information contacts on reporting of suspected adverse reactions have also been added.
In section 6.6, reconstitution part has been re-worded.
In section 10, revision date has been updated to 10/2014.

Updated on 31 March 2014 SmPC

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 31 March 2014 PIL

Reasons for updating

  • New PIL for medicines.ie