| Pharmaton Capsules SPC changes
Section 1 – Name of the Medicinal Product
The words “Name of the medicinal product” in the header of this section have been changed to uppercase letters.
Section 2 – Qualitative and Quantitative Composition
The words “Qualitative and quantitative composition” in the header of this section have been changed to uppercase letters.
Section 3 – Pharmaceutical Form
The words “Pharmaceutical form” in the header of this section have been changed to uppercase letters.
Section 4 – Clinical Particulars
The words “4. Clinical particulars” have been removed as a header.
Section 4.9 – Overdose
The words “… symptoms, emergency procedures and antidotes” have been removed from the header of this section.
Under the “Treatment” section, the four paragraphs have had their bullet points removed and the text has been left aligned.
Section 5 – Pharmacological Properties
The words “5. Pharmacological properties” have been removed as a header.
Section 5.3 – Pre-clinical Safety Data
A hyphen has been added to separate the word “Preclinical” i.e. to become “Pre-clinical” in the header of this section.
Section 6 – Pharmaceutical Particulars
The words “Pharmaceutical particulars” in the header of this section have been changed to uppercase letters.
Section 6.2 – Incompatibilities
The word “Major” has been deleted from the header of this section i.e. to become “Incompatibilities” as opposed to “Major incompatibilities”.
Section 6.3 – Shelf-life
A hyphen has been added between the words “Shelf” and “life” in the header of this section.
Section 6.4 – Special Precautions for Storage
The text of this section has been aligned so that it all fits on the one line i.e. “Do not store above 25°C. Keep the container tightly closed”.
Section 6.5 – Nature and Content of Container
The letter “s” has been deleted from the word “contents” in the header of this section.
The text “Registered packs” has been deleted from this section.
In the current marketed packs paragraph, the letter “m” has replaced the text “III” regarding the hydrolytical class).
Section 6.6 – Instructions for Use, Handling and Disposal
The text of this header, “Special precautions for disposal” has been replaced with “Instructions for use, handling and disposal”.
Section 7 – Marketing Authorisation Holder
The words “7. Marketing authorisation holder” in the header of this section have been changed to uppercase letters.
The word “Ltd.,” has been replaced with “Limited”.
The words “Self Medication Division” have been bracketed and moved to after “Limited”. The hyphen between “Self” and “Medication” has been removed.
The text “Trading as Pharmaton Natural Health Products” has been moved to become the second line of this section.
All commas and full stops have been removed from the address text.
Section 8 – Marketing Authorisation Number(s)
The words “8. Marketing authorisation number(s)” in the header of this section have been changed to uppercase letters. A letter “s” has also been added to the end of “number”.
Section 9 – Date of First Authorisation/Renewal of the Authorisation
The words “9. Date of first authorisation” in the header of this section have been changed to uppercase letters.
The word “or” has been deleted from the header of this section.
The words “Renewal of the authorisation” in uppercase letters have been added to the header of this section.
The date in this section has been changed from “1st January 1999” to “03/12/2008”.
Section 10 – Marketing Authorisation Holder
The words “10. Date of revision of the text” in the header of this section have been changed to uppercase letters.
The word “the” has been added to the header of this section.
The date in this section has been changed from “November 2007” to “03/12/2008”.
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