| Oramorph Oral Solution SPC changes
Section 4.3 Contraindications
The words opiods and phaeochromatoma in the third paragraph of this section have been replaced with the correctly spelt versions i.e. opioids and phaeochromocytoma.
Section 4.5 Interaction with Other Medicinal Products and Other Forms of Interaction
The word medicaments has been replaced with the words medicinal products in the header of this section.
New fifth and sixth paragraphs have been added. Paragraph 5 begins with the words Interactions have been reported … and paragraph 6 begins with the words In a study involving healthy volunteers …
Section 5 Pharmacological Properties
The words have been put in upper case to align with the rest of the document’s main section headings.
Section 6 Pharmaceutical Particulars
The words have been put in upper case to align with the rest of the document’s main section headings.
Section 6.6 Special Precautions for Disposal
The words Instructions for Use/Handling have been replaced with the words Special Precautions for Disposal in the header of this section.
Administrative Data
The words Administrative Data have been deleted as a header between sections 6.6 and 7.
Section 7 Marketing Authorisation Holder
The words have been put in upper case to align with the rest of the document’s main section headings.
Section 8 Marketing Authorisation Number
The words have been put in upper case to align with the rest of the document’s main section headings.
Section 9 Date of First Authorisation/Renewal of the Authorisation
The words have been put in upper case to align with the rest of the document’s main section headings.
This section’s text now reads:
Date of first authorisation: 8th March 1988
Date of last renewal: 8th March 1993
as opposed to:
Date of first authorisation/renewal of the authorisation
08.03.88 / 08.03.93
Section 10 Date of Revision of the Text
The section header wording has been changed from Date of (partial) revision of the text to Date of revision of the text and put into upper case letters.
The date of revision has been updated from August 2008 to November 2008.
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