Cresemba 100mg Hard Capsules
- Name:
Cresemba 100mg Hard Capsules
- Company:
Pfizer Healthcare Ireland
- 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: 27/08/20
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Pfizer Healthcare Ireland
Company Products
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 28 August 2020 SPC
Reasons for updating
- Change to section 4.2 - Posology and method of administration
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
- 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 6.1 - List of excipients
- Change to section 6.3 - Shelf life
- Change to section 6.6 - Special precautions for disposal and other handling
- Removal of Black Inverted Triangle
Legal category: Product subject to medical prescription which may not be renewed (A)
Updated on 27 August 2020 SPC
Reasons for updating
- Change to section 4.2 - Posology and method of administration
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
- 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 6.1 - List of excipients
- Change to section 6.3 - Shelf life
- 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 27 August 2020 PIL
Reasons for updating
- Change to section 2 - interactions with other medicines, food or drink
- Change to section 2 - driving and using machines
- Change to section 3 - dose and frequency
- Change to section 4 - possible side effects
- Change to section 6 - date of revision
- Removal of Black Inverted Triangle
Updated on 10 January 2020 PIL
Reasons for updating
- Change to section 6 - date of revision
Updated on 30 September 2019 SPC
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)
Updated on 30 September 2019 PIL
Reasons for updating
- Change to section 5 - how to store or dispose
- Change to section 6 - date of revision
Updated on 8 April 2019 PIL
Reasons for updating
- Change to section 6 - manufacturer
Updated on 14 March 2019 PIL
Reasons for updating
- Change to section 6 - marketing authorisation holder
Updated on 14 March 2019 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
The SPC has been updated as follows:
Section 7 - MARKETING AUTHORISATION HOLDER
Basilea Pharmaceutica Deutschland GmbH
Marie-Curie-Strasse 8
79539 Lörrach
Germany
Updated on 17 December 2018 PIL
Reasons for updating
- Change to section 6 - date of revision
- Change of distributor details
Updated on 17 December 2018 SPC
Reasons for updating
- Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
- 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
The SPC has been updated as follows:
Section 4.5: typos in Table 1
Updated on 26 November 2018 PIL
Reasons for updating
- Change to section 4 - possible side effects
- Change to section 6 - date of revision
Updated on 26 November 2018 SPC
Reasons for updating
- 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
The SPC has been updated as follows:
4.4 Special warnings and precautions for use
Subheading; Elevated liver transaminases or hepatitis updated to include reports of hepatitis.
4.8 Side-effects
Hepatitis added as Uncommon side effect
Updated on 31 August 2018 SPC
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
The SPC has been updated as follows:
6.3 Shelf life
Update to shelf life from 24 months to 48 months for vial presentation only
Updated on 28 August 2018 SPC
Reasons for updating
- Change to improve clarity and readability
Legal category: Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
The MAH, Basilea do not have an account with medicines.ie, however they have agreed for Pfizer to update the website under Pfizer banner and Pfizer med info contact details. Basilea will be added as the MA Holder of Cresemba.
Updated on 18 May 2018 PIL
Reasons for updating
- New PIL for new product
Updated on 18 May 2018 SPC
Reasons for updating
- New SPC for new product
Legal category: Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Update Date of Revision