CRESEMBA 100 mg hard capsules
*Company:
Pfizer Healthcare Ireland Unlimited CompanyStatus:
No Recent UpdateLegal Category:
Product subject to medical prescription which may not be renewed (A)Active Ingredient(s):
*Additional information is available within the SPC or upon request to the company
Updated on 30 August 2024
File name
Adv SPC CM 15_2 IE (clean).pdf
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 4.1 - Therapeutic indications
- 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 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 6.5 - Nature and contents of container
- Change to section 6.6 - Special precautions for disposal and other handling
- Change to section 8 - Marketing authorisation number(s)
- Change to section 9 - Date of first authorisation/renewal of the authorisation
- Change to section 10 - Date of revision of the text
- Introduction of new pack/pack size
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 30 August 2024
File name
Adv PIL CM 15_1 capsule IE & NI (clean).pdf
Reasons for updating
- Change to section 1 - what the product is used for
- Change to section 2 - use in children and adolescents
- Change to section 2 - driving and using machines
- Change to section 3 - dose and frequency
- Change to section 3 - use in children/adolescents
- Change to section 4 - possible side effects
- Change to section 6 - what the product contains
- Change to section 6 - what the product looks like and pack contents
- Change to section 6 - date of revision
- Change to name of medicinal product
Updated on 24 May 2024
File name
clean Adv SPC CM 14_0 IE.pdf
Reasons for updating
- 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 22 December 2022
File name
AdvSPCCM131IEclean.pdf
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
- Change to section 6.1 - List of excipients
- 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 NI and SPC IE have been updated as follows:
• Section 4.5, Table 1 – typos (superscript of footnotes)
• Section 5.1 – update of pharmacotherapeutic group
• Section 6.1 (capsules only) – deletion of “purified water”
• Section 6.3 (capsules only) – addition of full stop
Updated on 22 December 2022
File name
AdvPILCM142capsuleIENIclean.pdf
Reasons for updating
- Change to section 1 - what the product is used for
- Change to section 6 - what the product contains
- Change to section 6 - manufacturer
- Change to section 6 - date of revision
- Correction of spelling/typing errors
Updated on 23 June 2022
File name
Adv PIL CM 13_1 Capsule IE NI clean.pdf
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 4 - how to report a side effect
- Change to section 6 - date of revision
- Correction of spelling/typing errors
Updated on 23 June 2022
File name
Adv SPC CM 12_1 IE clean.pdf
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)
Updated on 04 November 2021
File name
Adv SPC CM 11_1 IE (clean).pdf
Reasons for updating
- Change to section 5.1 - Pharmacodynamic properties
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 04 November 2021
File name
Adv PIL CM 12_2 Capsule IE & NI (clean).pdf
Reasons for updating
- Change to section 4 - how to report a side effect
- Change to section 6 - marketing authorisation holder
- Change to section 6 - date of revision
- Individual PILs superseded by joint PIL
Updated on 26 May 2021
File name
DEC202135279_Adv SPC CM 10_2 IE (clean).pdf
Reasons for updating
- Change to section 5.3 - Preclinical safety data
- Correction of spelling/typing errors
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 26 May 2021
File name
DEC202135279_Adv PIL CM 11_0 Capsule IE (clean).pdf
Reasons for updating
- Change to section 6 - what the product looks like and pack contents
- Change to section 6 - date of revision
- Correction of spelling/typing errors
Updated on 25 February 2021
File name
DEC202112651_Adv SPC CM 9_0 IE (clean).pdf
Reasons for updating
- 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
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 25 February 2021
File name
DEC202112651_Adv PIL CM 10_0 Capsule IE (clean).pdf
Reasons for updating
- Change to section 2 - interactions with other medicines, food or drink
- Change to section 4 - possible side effects
- Change to section 6 - what the product contains
- Change to section 6 - date of revision
Updated on 28 August 2020
File name
DEC202053490_Adv SPC CM 8_0 IE Clean.pdf
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
File name
DEC202053490_Adv SPC CM 8_0 IE Clean.pdf
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
File name
DEC202053490_Adv PIL CM 9_0 Capsule IE Clean.pdf
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
File name
DEC202001397_Adv PIL CM 7_0 Capsule UK & IE clean.pdf
Reasons for updating
- Change to section 6 - date of revision
Updated on 30 September 2019
File name
DEC201953839_Adv SPC CM 6_0 UK & IE Clean.pdf
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
File name
DEC201953839_Adv PIL CM 6_0 Capsule UK & IE Clean.pdf
Reasons for updating
- Change to section 5 - how to store or dispose
- Change to section 6 - date of revision
Updated on 08 April 2019
File name
DEC201914643_Adv PIL CM 5_0 Capsule UK & IE CLEAN.pdf
Reasons for updating
- Change to section 6 - manufacturer
Updated on 14 March 2019
File name
Adv PIL CM 4_0 Capsule UK & IE clean.pdf
Reasons for updating
- Change to section 6 - marketing authorisation holder
Updated on 14 March 2019
File name
Adv SPC CM 5_0 UK & IE clean.pdf
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
File name
Adv PIL CM 3_0 Capsules UK & IE clean.pdf
Reasons for updating
- Change to section 6 - date of revision
- Change of distributor details
Updated on 17 December 2018
File name
Adv SPC CM 4_0 UK & IE clean.pdf
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
File name
Adv PIL CM 2_0 Capsules UK & IE clean.pdf
Reasons for updating
- Change to section 4 - possible side effects
- Change to section 6 - date of revision
Updated on 26 November 2018
File name
Adv SPC CM 3_0 UK & IE clean.pdf
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
File name
Adv SPC CM 2_0 UK & IE clean.pdf
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
File name
Adv_SPC_CM_1_0_UK_&_IE_clean.pdf
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
File name
Adv PIL CM 1_0 Capsules UK & IE clean.pdf
Reasons for updating
- New PIL for new product
Updated on 18 May 2018
File name
Adv_SPC_CM_1_0_UK_&_IE_clean.docx
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