Gilenya 0.5 mg hard capsules
*Company:
Novartis Ireland LimitedStatus:
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 18 May 2023
File name
Gilenya_REG SPC_PF23-0087_05. 2023_clean.pdf
Reasons for updating
- Change to section 6.5 - Nature and contents of container
- Change to section 8 - Marketing authorisation number(s)
Legal category:Product subject to medical prescription which may not be renewed (A)
File name
12404_Gilenya_RMPReminderCard_JUN22_LR9.pdf
Reasons for updating
- Add New Doc
File name
12404_Gilenya_PregnancyReminderCard_JUN22_LR5.pdf
Reasons for updating
- Add New Doc
File name
11781_Gilenya_PrescribersChecklist_JUN22_LR9.pdf
Reasons for updating
- Add New Doc
Updated on 14 December 2022
File name
Gilenya-REGSPC_PF22-0237 _12.2022_Clean.pdf
Reasons for updating
- Change to section 6.5 - Nature and contents of container
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 29 March 2022
File name
Gilenya_REG SPC_PF22-0069_22.03.2022_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)
Updated on 04 August 2021
File name
Gilenya_REG PIL_PF21-0185_08.07.2021_clean.pdf
Reasons for updating
- Removal of Black Inverted Triangle
Updated on 04 August 2021
File name
Gilenya_REG SPC_PF21-0185_08.07.2021_clean.pdf
Reasons for updating
- Removal of Black Inverted Triangle
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 21 December 2020
File name
Gilenya_REG SPC_PF20-0290_14.12.2020_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 21 December 2020
File name
Gilenya_REG PIL_PF20-0290_14.12.2020_clean.pdf
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 4 - possible side effects
Updated on 20 December 2019
File name
Gilenya PIL PF 19-0223 December 2019_Clean.pdf
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 4 - possible side effects
Updated on 20 December 2019
File name
Gilenya REGSPC PF19-0223 December 2019_Clean.pdf
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)
Updated on 05 September 2019
File name
Gilenya PIL Sep 2019_Clean.pdf
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 3 - duration of treatment
- Change to section 4 - possible side effects
Updated on 05 September 2019
File name
Gilenya REGSPC PF19-0193 September 2019_Clean.pdf
Reasons for updating
- Change to section 4.3 - Contraindications
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.6 - Pregnancy and lactation
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 08 February 2019
File name
Gilenya 2219697_R91_p4_LFT_X-4 RA approved 06.02.2019 TBI by 24.05.2019_IPHA.pdf
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
Updated on 22 January 2019
File name
Gilenya REGPIL 2215563_R91_p1_LFT_X-4 RA approved 18.09.2018 IPHA.pdf
Reasons for updating
- Change to section 6 - marketing authorisation holder
Updated on 17 January 2019
File name
Gilenya_0.25mg_0.5mg_HdCap REGSPC-Jan-19_Clean.pdf
Reasons for updating
- Change to section 4.2 - Posology and method of administration
- Change to section 4.3 - Contraindications
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.8 - Undesirable effects
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 5.3 - Preclinical safety data
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 12 December 2018
File name
Gilenya_0.25mg_0.5mg_HdCap_REGSPC Dec 2018_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 4.3 - Contraindications
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.8 - Undesirable effects
- Change to section 4.9 - Overdose
- 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 6.3 - Shelf life
- Change to section 6.5 - Nature and contents of container
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 21 May 2018
File name
Gilenya 0.5mg Hard Caps REGSPC May 2018 _Clean.docx
Reasons for updating
- Change to MA holder contact details
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Address change-BREXIT
Updated on 26 April 2018
File name
Gilenya 0.5 mg 2210167_R91_p1_LFT_X-4 RA approved 11.04.2018 IPHA TBI by 08.06.2018.pdf
Reasons for updating
- Change to section 3 - dose and frequency
Updated on 17 January 2018
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 17 January 2018
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
Updated on 02 January 2018
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.8 - Undesirable effects
- Change to section 4.3 - Contraindications
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Different heart problems have been added under contraindications
4.4 Special warnings and precautions for use
Information on the Immunosuppressive effects of Gilenya has been added
Information on Cutaneous neoplasms has been added
4.8 Undesirable effects
Kaposi’s sarcoma has been changed from a “Not known” to a “very rare” side effect
Updated on 24 May 2017
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 4.6 - Pregnancy and lactation
- 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
Update to Section 4.4 Special warnings and precautions for use, typographical changes (ivabradine no longer listed as a calcium channel blocker)
Update to Section 4.5 Interaction with other medicinal products and other forms of interaction (ivabradine no longer listed as a calcium channel blocker)
Update to Section 4.6 Fertility, pregnancy and lactation update concerning information for use of Gilenya during pregnancy
Update to Section 5.3 Preclinical safety data update concerning information for use of Gilenya during pregnancy
Updated on 21 February 2017
File name
PIL_15126_562.pdf
Reasons for updating
- New PIL for new product
Updated on 21 February 2017
Reasons for updating
- Change to section 4 - possible side effects
Updated on 31 January 2017
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
Section 4.4 Special warnings and precautions for use
Additional information has been added on cryptococcal meningitis and PML
Section 4.8 Undesirable effects
Description of cryptococcal meningitis has been changed from an isolated case to cases
Updated on 14 December 2016
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
|
Kaposi’s sarcoma |
|
Thrombocytopenia |
Updated on 19 May 2016
Reasons for updating
- Change to warnings or special precautions for use
Updated on 01 February 2016
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.8 - Undesirable effects
- Change to section 9 - Date of renewal of authorisation
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
In Section 4.4 Special warnings and precautions for use information on Progressive multifocal leukoencephalopathy (PML) has been added
In Section 4.8 Undesirable effects PML has been added as an adverse reactions with frequency “not known”
In Section 9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION the renewal date has been added.
Updated on 12 January 2016
Reasons for updating
- Change to warnings or special precautions for use
- Change to side-effects
Updated on 26 November 2015
Reasons for updating
- Change to section 4.1 - Therapeutic indications
- Change to section 4.3 - Contraindications
- 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
In Section 4.1 Therapeutic indications, Active disease indication has been added
In Section 4.3 Contraindications, “except for patients with cutaneous basal cell carcinoma” has been removed
In Section 4.4 Special warnings and precautions for use, information has been added on the following
Very rare cases of T-wave inversion have been reported in patients treated with fingolimod
opportunistic infections
Basal cell carcinoma
In Section 4.8 Undesirable effects, the following side effects have been added with given frequencies:
Common: Basal cell carcinoma
Rare: Lymphoma
Not known: Peripheral oedema
|
Not known***: |
Hypersensitivity reactions, including rash, urticaria and angioedema upon treatment initiation |
|
Very rare***: |
T-wave inversion |
|
Uncommon***: |
Nausea |
In the post-marketing setting, cases of infections with opportunistic pathogens, such as viral (e.g. varicella zoster virus [VZV], John Cunningham virus [JCV] causing Progressive Multifocal Leukoencephalopathy, herpes simplex virus [HSV]), fungal (e.g. cryptococci including cryptococcal meningitis) or bacterial (e.g. atypical mycobacterium), have been reported (see section 4.4).
Updated on 03 September 2015
Reasons for updating
- Change to warnings or special precautions for use
Updated on 18 June 2015
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
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
In Section 4.4 Special warnings and precautions for use
The following information has been added: Isolated cases of cryptococcal meningitis (a fungal infection) have been reported in the post-marketing setting
In Section 4.5 Interaction with other medicinal products and other forms of interaction
Teriflunomide has been added to this Section. Caution should be taken when switching from this product to Gilenya.
In section 4.8 Undesirable effects
Cryptococcal infections has been added as a side effect with unknown frequency
Updated on 08 June 2015
Reasons for updating
- Addition of information on reporting a side effect.
Updated on 10 March 2015
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
7. MARKETING AUTHORISATION HOLDER address has been changed.
Updated on 25 September 2014
Reasons for updating
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 5.2 - Pharmacokinetic properties
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Updated on 22 September 2014
Reasons for updating
- Change to, or new use for medicine
- Change to date of revision
Updated on 08 July 2014
Reasons for updating
- Change to section 4.1 - Therapeutic indications
- 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
Change to Section 4.8 to include "hypersensitivity " and "rash" as unknown side effects
Updated on 11 June 2014
Reasons for updating
- Change of active ingredient
- Change to warnings or special precautions for use
Updated on 03 June 2014
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 - how to report a side effect
- Change to section 6.5 - Nature and contents of container
- 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 Infection: VZV and concomittant use of corticosteroids, upgrade of PRES from ADR to warnings and precautions.Changes in frequencies of ADR in line with update of Section 4.8
Section 4.5 Interaction with other medicinal products and other forms of Interaction - concomitant use with corticosteroids (connected to VZV)
Section 4.8 Revised ADR profile (table and related text) based on pooled analysis from D2301/D2309
Section 5.2- to amend the information related to the enzymes involved in the metabolic pathway of fingolimod
Section 6.5 - to include the new pack size of 98 capsules
Section 10- Date of revision of the text
Updated on 13 March 2014
Reasons for updating
- Addition of information on reporting a side effect.
- Addition of black triangle
Updated on 12 March 2014
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 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
Updated on 17 February 2014
Reasons for updating
- Change to drug interactions
Updated on 08 January 2014
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
Updated on 15 November 2013
Reasons for updating
- Addition of black triangle
- 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
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 4.8 to specify the periodicity of CBC assessments ; at month 3 and atleast yearly thereafter.
Update of Section 10 to state October 2013 for Date of Revision.
Updated on 23 July 2013
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- 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
Updated on 24 April 2013
Reasons for updating
- Change to side-effects
- Change to dosage and administration
- Change to warnings or special precautions for use
- Change to date of revision
Updated on 12 March 2013
Reasons for updating
- Change to section 2 - Qualitative and quantitative composition
- Change to section 4.2 - Posology and method of administration
- Change to section 4.3 - Contraindications
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.8 - Undesirable effects
- 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
Posology in Section 4.2 has been updated in relation to first dose monitoring......
Section 4.4 has been updated to include information on treatment discontinuation and first dose monitoring....
Section 5.1 has been updated
Updated on 16 January 2013
Reasons for updating
- Change to section 4.8 - Undesirable effects
- 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
Change to Section 6.4 of the SPC to update the storage conditions from 30 degrees to 25 degrees celsius
Updated on 31 August 2012
Reasons for updating
- Change to warnings or special precautions for use
- Change to side-effects
- Change to drug interactions
Updated on 02 August 2012
Reasons for updating
- Change to warnings or special precautions for use
- Change to side-effects
- Change to date of revision
Updated on 05 July 2012
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 4.9 - Overdose
- 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
Updated on 02 March 2012
Reasons for updating
- 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
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Updated on 28 October 2011
Reasons for updating
- Introduction of new pack/pack size
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Updated on 30 August 2011
Reasons for updating
- New PIL for new product
Updated on 28 July 2011
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may not be renewed (A)