Updated on 10/01/2012 and displayed until Current
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Reasons for adding or updating:
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Change to section 4.6 - Pregnancy and Lactation
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Change to section 4.8 - Undesirable Effects
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Change to section 6.1 - List of Excipients
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| Date of revision of text on the SPC: 19-Dec-2011 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Section 4.6 has been updated to include an additional section on contraception.
Section 4.8 has been updated to delete the first paragraph on incidence rates of A/Es and to add toxic epidermal necrolysis under the sub heading of 'skin and subcutaneous tissue disorders'.
Section 6.1 - sodium larilsulfate and silica colloidal anhydrous have been deleted from the list of excipients
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Updated on 21/12/2011 and displayed until 10/01/2012
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Reasons for adding or updating:
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Change to section 6. 5 - Nature and Contents of Container
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Change to section 8 - MARKETING AUTHORISATION NUMBER(S)
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Correction of spelling/typing errors
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| Date of revision of text on the SPC: 24-Oct-2011 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Omissions added
SPC: Section 6.5 - additional pack sizes included.
Section 8 - corresponding MA numbers added.
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Updated on 21/11/2011 and displayed until 21/12/2011
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Reasons for adding or updating:
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Change to section 4.6 - Pregnancy and Lactation
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Change to section 4.8 - Undesirable Effects
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| Date of revision of text on the SPC: 24-Oct-2011 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Editorial changes have been made to sections 4.2, 4.4, 4.5, 4.9, 5.1 and 5.2.
Section 4.6 has been updated to include an additional section on fertility.
Section 4.8 has been updated to increase the number of individuals used to create the safety profile from 5300 to 6500 and to change the headings in line with the latest SmPC guidelines
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Updated on 11/02/2010 and displayed until 21/11/2011
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Reasons for adding or updating:
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Change to section 4.8 - Undesirable Effects
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Change to section 5.1 - Pharmacodynamic Properties
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| Date of revision of text on the SPC: 12-Jan-2010 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Update of SPC sections 4.8 and 5.1 based on the safety and efficacy data from a new clinical study (prevention of MEC-induced nausea and vomiting in a patient population with a variety of tumour types who were treated with a range of MEC agents).
Section 4.8
- the patient numbers have increased. The following additional side effects have been added:
Neutrophil count decreased, palpitations, cardiovascular disorder, lethargy, somnolence, abdominal distension, faeces hard, neutropenic colitis, rash pruritic, muscular weakness, malaise, chills, gait disturbance.
Section 5.1 -
details of the
clinical study have been added.
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Updated on 03/09/2009 and displayed until 11/02/2010
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Reasons for adding or updating:
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Change to section 4.4 - Special warnings and precautions for Use
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Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
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| Date of revision of text on the SPC: 31-Jul-2009 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Section 4.4 - Additional examples of relevant medicinal products have been added.
Section 4.5 - Section has been re-structured. Additional information on immunosuppressants has been added as follows.
"
Immunosuppressants:
During the 3 day CINV regimen, a transient moderate increase followed by a mild decrease in exposure of immunosuppressants metabolised by CYP3A4 (e.g. ciclosporin, tacrolimus, everolimus and sirolimus) is expected. Given the short duration of the 3-day regimen and the time-dependent limited changes in exposure, dose reduction of the immunosuppressants is not recommended during the 3 days of co-administration with EMEND."
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Updated on 16/10/2008 and displayed until 03/09/2009
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Reasons for adding or updating:
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Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
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Removal of Black Triangle
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Change to section 4.1 - Therapeutic indications
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Change to section 4.2 - Posology and method of administration
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Change to section 4.8 - Undesirable Effects
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| Date of revision of text on the SPC: 01-Sep-2008 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Section 4.1 : It has been made clearer that the product is only for use in adults.
Section 4.2: Some clarification of the dosing regimen has been made.
Section 4.5: The following statement has been added- "Aprepitant does not seem to interact with P-glycoprotein transporter, as suggested by the lack of interaction of EMEND with digoxin".
Section 4.8: The percentage rates of the most common A/Es in patients treated with aprepitant have been compared to that of standard therapy.
The A/E categories have been re-ordered.
Additional A/Es in patients treated with the 40mg strength are listed.
The additional side effects of pruritis, rash, urticaria, and hypersensitivity have been added to a section headed " Additional A/Es reported during post-marketing experience.
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Updated on 04/05/2007 and displayed until 16/10/2008
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Reasons for adding or updating:
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Change to section 2 - Qualitative and quantitative composition
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Change to section 4.1 - Therapeutic indications
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Change to section 4.2 - Posology and method of administration
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Change to section 4.4 - Special warnings and precautions for Use
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Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
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Change to section 4.7 - Effects on Ability to Drive and Use Machines
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Change to section 4.8 - Undesirable Effects
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Change to section 6.1 - List of Excipients
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Change to section 6. 4 - Special Precautions for Storage
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| Date of revision of text on the SPC: 02/2007 |
| Legal Category: POM |
| Black Triangle (CHM):
YES |
Free-text change information supplied by the pharmaceutical company
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Section 2 - inclusion of the quantity of sucrose in each strength
Section 4.1: Indication for 40mg strength added with footnote indicating this strength is not marketed
Section 4.2 - children's statement was modified according to standardised wording.
Section 4.5 - Addition of the statement regarding the effect of EMEND on the pharmacokinetics of orally and IV administered CYP3A4 substrates. Rewording of the interactions of EMEND with chemotherapeutic agents which includes information on vinorelbine. Where applicable, the abbreviation 'mcg' was changed to ' ¦Ìg'. Addition of information from a clinical study with midazolam IV
Section 4.7: Rewording of statement on driving and use of machinery.
Section 4.8: Addition of side effects for the 40 mg strength (abdominal pain, bowel sounds, dysarthria, dyspnoea, hypoaethesia, insomnia, miosis, nausea, sensory disturbance, stomach discomfort, visual acuity reduced, wheezing).
Section 4.8: Addition of two serious adverse experiences in PONV clinical studies in patients taking a higher dose of apprepitant - 1 case of constipation and 1 case of sub-ileus.
Section 4.8 - reference to 'events' was deleted in the first paragraph and the statement for frequencies was revised by updating the symbol '>' to '¡Ý'.
Section 6.1: Change to INN name to sodium laurilsulfate for the capsule content. Addition of sodium laurilsulphate and silica colloidal anhydrous to the capsule shell excipient list.
Section 6.4: Change in wording for storage conditions from 'No special precautions for storage' to 'Store in the original packaging to protect from moisture'.
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Updated on 23/01/2006 and displayed until 04/05/2007
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Reasons for adding or updating:
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Change to section 4.4 - Special Warnings and Precautions for Use
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Change to section 4.5 - Interactions with other Medicaments and other forms of Interaction
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Updated on 17/05/2005 and displayed until 23/01/2006
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Reasons for adding or updating:
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Change to section 4.1 - Therapeutic Indications
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Change to section 4.2 - Posology and Method of Administration
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Change to section 4.5 - Interactions with other Medicaments and other forms of Interaction
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Change to section 4.8 - Undesirable Effects
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Change to section 5.1 - Pharmacodynamic Properties
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Change to section 6. 3 - Shelf Life
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Updated on 10/01/2005 and displayed until 17/05/2005
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Reasons for adding or updating:
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Correction of spelling/typing errors
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Updated on 23/12/2004 and displayed until 10/01/2005
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Reasons for adding or updating:
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Change to section 4.5 - Interactions with other Medicaments and other forms of Interaction
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Change to section 5.1 - Pharmacodynamic Properties
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Updated on 05/08/2004 and displayed until 23/12/2004
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Reasons for adding or updating:
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Change to section 6. 3 - Shelf Life
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Updated on 20/01/2004 and displayed until 05/08/2004
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Reasons for adding or updating:
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