METOPIRONE 250 mg
- Name:
METOPIRONE 250 mg
- Company:
HRA Pharma UK and Ireland Limited
- Active Ingredients:
- Legal Category:
Product subject to medical prescription which may be renewed (B)
Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 02/06/20
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HRA Pharma UK and Ireland Limited
Company Products
| Medicine Name | Active Ingredients |
|---|---|
| Medicine Name ellaOne 30 mg | Active Ingredients Ulipristal acetate |
| Medicine Name ellaOne 30 mg film-coated tablet | Active Ingredients Ulipristal acetate |
| Medicine Name Ketoconazole HRA (ketoconazole, 200mg tablets) | Active Ingredients Ketoconazole |
| Medicine Name Lysodren 500 mg tablets | Active Ingredients Mitotane |
| Medicine Name METOPIRONE 250 mg | Active Ingredients Metyrapone |
| Medicine Name Norlevo 1.5mg tablet | Active Ingredients Levonorgestrel |
When a pharmaceutical company changes any document, a new version is published on medicines.ie. For each version, we show the dates it was published on medicines.ie and the reasons for change.
Updated on 2 June 2020 PIL
Reasons for updating
- Change to section 6 - marketing authorisation holder
- Change to section 6 - marketing authorisation number
Updated on 2 June 2020 PIL
Reasons for updating
- Change to section 6 - marketing authorisation holder
- Change to marketing authorisation holder
Updated on 2 June 2020 SmPC
Reasons for updating
- Change to section 7 - Marketing authorisation holder
- Change to section 8 - Marketing authorisation number(s)
- Change to section 10 - Date of revision of the text
- Change to MA holder contact details
Legal category: Product subject to medical prescription which may be renewed (B)
Updated on 29 April 2019 PIL
Reasons for updating
- Change to section 6 - marketing authorisation holder
- Change to section 6 - date of revision
Updated on 26 April 2019 SmPC
Reasons for updating
- Change to section 7 - Marketing authorisation holder
- Change to section 10 - Date of revision of the text
Legal category: Product subject to medical prescription which may be renewed (B)
Updated on 13 February 2017 SmPC
Reasons for updating
- Change to section 6.3 - Shelf life
- Change to section 10 - Date of revision of the text
Legal category: Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
6.3 Shelf life:
Addition of:
“After opening: 2 months”.
10. Date of (partial) revision of text:
Updated as 06 January 2017.
Updated on 13 February 2017 SmPC
Reasons for updating
- New SmPC for new product
Legal category: Product subject to medical prescription which may be renewed (B)
Updated on 1 February 2017 PIL
Reasons for updating
- New PIL for new product
Updated on 1 February 2017 PIL
Reasons for updating
- Change to section 5 - how to store or dispose
- Change to section 6 - manufacturer
- Change to section 6 - date of revision
Updated on 17 April 2015 SmPC
Reasons for updating
- Change to section 4.8 - Undesirable effects
Legal category: Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Updated on 13 April 2015 SmPC
Reasons for updating
- Change due to harmonisation of SPC
Legal category: Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Updated on 8 April 2015 PIL
Reasons for updating
- Change due to harmonisation of PIL
Updated on 29 April 2013 SmPC
Reasons for updating
- Change to section 2 - Qualitative and quantitative composition
- Change to section 3 - Pharmaceutical form
- Change to section 6.1 - List of excipients
- Change to section 10 - Date of revision of the text
Legal category: Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Excipients with known effects :
Each capsule contains 0.71 mg of sodium ethyl parahydroxybenzoate and 0.35 mg sodium propyl parahydroxybenzoate. The printing ink used to mark the capsule contains trace amounts of soya lecithin
.
Section 3 - Pharmaceutical Form
A white to yellowish-white, oblong, soft gelatin capsule printed with words "Ciba HRA" and "LN" in brown in red ink and having faintly yellowish viscous to jellyy-like contents
Section 6.1 List of Excipients
Sodium ethyl parahydroxybenzoate (E214 E215)
Printing ink (Opacode brown Red) :
Carminic acid (E120)
Aluminium chloride hexahydrate
Sodium hydroxide
Hypromellose
Propylene glycol
Isopropyl alcohol
Purified water Shellac glaze Section 10 - Date of Revision of the Text
Iron oxide red (E172)
Iron oxide yellow (E172)
Iron oxide black (E172)
Industrial methylated spirit
Purified water
2-ethoxyethanol
Lecithin (soya, E322)
Titanium dioxide (E171)
Antifoam DC 1510 (Food grade)
February 2013
Updated on 26 April 2013 PIL
Reasons for updating
- Change of inactive ingredient
- Change of manufacturer
- Change to date of revision
- Change to appearance of the medicine
Updated on 5 March 2012 PIL
Reasons for updating
- New PIL for medicines.ie
Updated on 16 February 2012 SmPC
Reasons for updating
- New SPC for medicines.ie
Legal category: Product subject to medical prescription which may be renewed (B)