MENJUGATE 10 micrograms suspension for injection (PFS)

  • Name:

    MENJUGATE 10 micrograms suspension for injection (PFS)

  • Company:
    info
  • Active Ingredients:

    Meningococcal group C conjugate vaccine

  • Legal Category:

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

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 26/02/19

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Summary of Product Characteristics last updated on medicines.ie: 10/1/2020

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GlaxoSmithKline (Ireland) Ltd

GlaxoSmithKline (Ireland) Ltd

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Medicine Name Augmentin 500mg/125mg Film-coated Tablets Active Ingredients Amoxicillin trihydrate, Potassium clavulanate
Medicine Name Augmentin 875/125mg Film Coated tablets Active Ingredients Amoxicillin trihydrate, Clavulanic Acid
Medicine Name Augmentin Duo Mixed Fruit 400 mg/57 mg /5 ml Powder for Oral Suspension Active Ingredients Amoxicillin trihydrate, Clavulanic Acid
Medicine Name Augmentin DUO Suspension 400/57mg Active Ingredients Amoxicillin trihydrate, Potassium clavulanate
Medicine Name Augmentin Intravenous 1.2g Active Ingredients Amoxicillin sodium, Potassium clavulanate
Medicine Name Augmentin Paediatric 125mg/31.25mg per 5ml Powder for Oral Suspension Active Ingredients Amoxicillin trihydrate, Potassium clavulanate
Medicine Name AVAMYS 27.5 micrograms/spray nasal spray suspension Active Ingredients Fluticasone furoate
Medicine Name Avodart Soft Capsules 0.5mg Active Ingredients Dutasteride
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Medicine Name Bactroban Nasal Ointment Active Ingredients Mupirocin calcium
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Medicine Name Becotide Evohaler 100 Active Ingredients Beclometasone Dipropionate
Medicine Name Becotide Evohaler 250 Active Ingredients Beclometasone Dipropionate
Medicine Name Becotide Evohaler 50 Active Ingredients Beclometasone Dipropionate
Medicine Name Benlysta 120 mg and 400 mg powder for concentrate for solution for infusion Active Ingredients Belimumab
Medicine Name Betnovate C 0.1% / 3% w/w Cream Active Ingredients Betamethasone Valerate, Clioquinol
Medicine Name Betnovate Cream 0.1% w/w Active Ingredients Betamethasone Valerate
Medicine Name Betnovate Ointment 0.1% w/w Active Ingredients Betamethasone Valerate
Medicine Name Betnovate RD Cream Active Ingredients Betamethasone Valerate
Medicine Name Betnovate RD Ointment Active Ingredients Betamethasone Valerate
Medicine Name Betnovate Scalp Application 0.1% w/v Cutaneous Solution Active Ingredients Betamethasone Valerate
Medicine Name Bexsero, suspension for injection in pre-filled syringe Active Ingredients Meningococcal group-B vaccine (rDNA, component, adsorbed)
1 - 0 of 134 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 10 January 2020 SmPC

Reasons for updating

  • 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

Renewal date added to section 9

Updated on 17 April 2019 SmPC

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)

Free text change information supplied by the pharmaceutical company

Section 4.4 corrected from:

Individuals receiving treatment that inhibits terminal complement activation (for example, eculizumab) remain at increased risk of invasive disease caused by Neisseria meningitidis group C even following vaccination with Menjugate.’

 

to:

‘Individuals with familial complement deficiencies (for example, C3 or C5 deficiencies) and individuals receiving treatments that inhibit terminal complement activation (for example, eculizumab) are at increased risk for invasive disease caused by Neisseria meningitidis group C, even if they develop antibodies following vaccination with Menjugate.’

Updated on 26 February 2019 PIL

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 6 - date of revision

Updated on 26 February 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

4.4 Special warnings and precautions for use - ” update to section relative to individuals receiving treatment that inhibits terminal complement activation (for example eculizumab)

Updated on 12 February 2018 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 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects
  • Change to section 10 - Date of revision of the text
  • Change from joint to individual SPCs

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 - formatting and clarity.
4.2 Posology and method of administration - minor update for sentence to read better.
4.4 Special warnings and precautions for use - minor updates to read better.
4.8 Undesirable effects - addition of General disorders and administration site conditions
Very rare: Extensive swelling of the vaccinated limb

Plus change from joint to individual SPCs

Updated on 12 February 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 9 February 2018 PIL

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 4 - possible side effects
  • Change to section 6 - date of revision

Updated on 9 February 2018 PIL

Reasons for updating

  • New PIL for new product

Updated on 21 December 2015 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

Change of name of MAH to GSK

Updated on 18 December 2015 PIL

Reasons for updating

  • Change to date of revision
  • Change to marketing authorisation holder

Updated on 17 August 2015 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 13 August 2015 PIL

Reasons for updating

  • New PIL for medicines.ie