METOPIRONE 250 mg
*Company:
HRA Pharma UK and Ireland LimitedStatus:
No Recent UpdateLegal Category:
Product subject to medical prescription which may be renewed (B)Active Ingredient(s):
*Additional information is available within the SPC or upon request to the company
Updated on 20 April 2022
File name
PIL- Metyrapone- Ireland new update Apr 2022.pdf
Reasons for updating
- Change to section 2 - what you need to know - contraindications
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 2 - pregnancy, breast feeding and fertility
- Change to section 4 - possible side effects
- Change to section 6 - date of revision
Updated on 20 April 2022
File name
SmPC - Metyrapone- Ireland new update Apr 2022.pdf
Reasons for updating
- Change to section 4.2 - Posology and method of administration
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.6 - Pregnancy and lactation
- Change to section 4.8 - Undesirable effects
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 02 June 2020
File name
PIL - Meto - April 2020.pdf
Reasons for updating
- Change to section 6 - marketing authorisation holder
- Change to section 6 - marketing authorisation number
Updated on 02 June 2020
File name
PIL - Meto- Clean- 19.11.2018.pdf
Reasons for updating
- Change to section 6 - marketing authorisation holder
- Change to marketing authorisation holder
Updated on 02 June 2020
File name
SmPC - Meto - 2020.pdf
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
File name
PIL - Meto- Clean- 19.11.2018.pdf
Reasons for updating
- Change to section 6 - marketing authorisation holder
- Change to section 6 - date of revision
Updated on 26 April 2019
File name
SmPC- Meto- Clean- 19.11.2018.pdf
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
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 13 February 2017
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 01 February 2017
File name
PIL_15283_31.pdf
Reasons for updating
- New PIL for new product
Updated on 01 February 2017
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
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
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 08 April 2015
Reasons for updating
- Change due to harmonisation of PIL
Updated on 29 April 2013
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
Reasons for updating
- Change of inactive ingredient
- Change of manufacturer
- Change to date of revision
- Change to appearance of the medicine
Updated on 05 March 2012
Reasons for updating
- New PIL for medicines.ie
Updated on 16 February 2012
Reasons for updating
- New SPC for medicines.ie
Legal category:Product subject to medical prescription which may be renewed (B)