Summary of Product Characteristics
last updated on the eMC:
09/05/2011
When a pharmaceutical company changes an SPC or PIL, a new version is published on the eMC. For each version, we show the dates it was published on the eMC and the reasons for change.
Updated on 09/05/2011 and displayed until Current
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Reasons for adding or updating:
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Change to section 1 -Name of the Medicinal product
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Change to section 2 - Qualitative and quantitative composition
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Change to section 3 - Pharmaceutical form
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Change to section 4.3 - Contraindications
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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 4.8 - Undesirable Effects
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Change to section 4.9 - Overdose
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| Date of revision of text on the SPC: 24-Mar-2011 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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The following updates were made to the UK Meptid SmPCs :
· section 1 for the tablet updated to include the full pharmaceutical form
· section 2 updated in line with QRD
· section 3 for the injection updated to align with the description parameter as detailed in the finished product specification
· section 4.3 updated to strengthen the safety statements already under sections 4.4 and 4.5 namely contraindicating use during an asthma attacks and for patients on MAOIs and for 14 days after stopping MAOIs
· section 4.4 updated by deleting the cautionary statement regarding MAOIs as this is now under section 4.3
· section 4.5 updated with minor rewording
· section 4.8 updated by ranking undesirable events under headings of frequency using the following convention: very common (≥ 1/10); common (≥1/100 to ≤1/10); uncommon (≥1/1,000 to ≤1/100); rare (≥1/10,000 to ≤1/1,000); very rare (≤1/10,000); not known (cannot be estimated from the available data). This was purely a formatting request by the IMB; where within section 4.8, it was written that these were the "most commonly reported adverse reactions", these AEs were slotted under the tabular heading very common and those detailed as uncommon were slotted under the uncommon tabular heading under the relevant system organ class; "occassional reports" were re-classified as very rare reports.
· section 4.9 for the injection updated with minor rewording
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Updated on 15/03/2011 and displayed until 09/05/2011
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Reasons for adding or updating:
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Change to section 7 - Marketing Authorisation Holder
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| Date of revision of text on the SPC: 26-Mar-2010 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Section 7 updated to change name of MAH from "Laboratorios Almirall SA" to Almirall SA.
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Updated on 25/06/2009 and displayed until 15/03/2011
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Reasons for adding or updating:
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Change to section 10 date of revision of the text
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| Date of revision of text on the SPC: 28-Jan-2009 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| Addition of date of revision (28th January 2009) to the SPC
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Updated on 18/02/2009 and displayed until 25/06/2009
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Reasons for adding or updating:
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Change to section 8 - MARKETING AUTHORISATION NUMBER(S)
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| Date of revision of text on the SPC: 01-Oct-2005 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Change of Ownership / Renewal of the product in UK.
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Updated on 26/09/2008 and displayed until 18/02/2009
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Reasons for adding or updating:
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New SPC for eMC ie an SPC for an existing product, but one that is new for the eMC
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| Date of revision of text on the SPC: |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| None provided |
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