Ovitrelle 250 micrograms/0.5 ml pre-filled pen
*Company:
MerckStatus:
No Recent UpdateLegal Category:
Product subject to medical prescription which may not be renewed (A)Active Ingredient(s):
*Additional information is available within the SPC or upon request to the company
File name
Ovitrelle-IFU-IE.pdf
Reasons for updating
- Replace File
Free text change information supplied by the pharmaceutical company
Replace File.
Internal reference number: TW 3822268
Updated on 24 November 2021
File name
Ovitrelle PEN PIL IENI - Brexit and Needle - Current V9 - Nov 2021.pdf
Reasons for updating
- Change to section 4 - how to report a side effect
- Change to section 6 - what the product looks like and pack contents
- Change to section 6 - date of revision
Free text change information supplied by the pharmaceutical company
In section 6 - addition of second needle (Our reference: TW 2668182 )
In section 4 - update of United Kingdom to United Kingdom (Northern Ireland)
Updated on 24 November 2021
File name
Ovitrelle PEN IENI - Brexit and Needle - Current V9 - Oct 2021.pdf
Reasons for updating
- Change to Section 4.8 – Undesirable effects - how to report a side effect
- Change to section 6.5 - Nature and contents of container
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
In section 6.5 - addition of second needle (Our reference: TW 2668182 )
In section 4.8 - update of United Kingdom to United Kingdom (Northern Ireland)
File name
IFU Pen_ TW2385848 v8.0 Clean.pdf
Reasons for updating
- Replace File
Updated on 16 November 2020
File name
PIL Pen_ TW2385848 v8.0 Clean.pdf
Reasons for updating
- Change to Section 1 - what the product is
- 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 2 - driving and using machines
- Change to section 3 - how to take/use
- Change to section 4 - possible side effects
- Change to section 6 - date of revision
Updated on 16 November 2020
File name
SPC Pen_ TW2385848 v8.0 Clean.pdf
Reasons for updating
- Change to section 4.1 - Therapeutic indications
- Change to section 4.2 - Posology and method of administration
- Change to section 4.3 - Contraindications
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.6 - Pregnancy and lactation
- Change to section 4.7 - Effects on ability to drive and use machines
- Change to Section 4.8 – Undesirable effects - how to report a side effect
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 5.2 - Pharmacokinetic properties
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may not be renewed (A)
File name
Instructions For Use (emc).pdf
Reasons for updating
- Replace File
Free text change information supplied by the pharmaceutical company
Images have been updated.
Date revised to October 2018.
Updated on 01 November 2018
File name
Leaflet (MA Transfer + Safety combined).pdf
Reasons for updating
- Change to section 2 - excipient warnings
- Change to section 4 - possible side effects
- Change to section 6 - date of revision
Updated on 26 October 2018
File name
Ovitrelle_PEN_UK_ROI_TW1696603_current_V7.0.pdf
Reasons for updating
- 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 not be renewed (A)
Updated on 02 October 2018
File name
Ovitrelle_PEN_UK_ROI_TW1735675_current_V6.0.pdf
Reasons for updating
- Change to section 4.8 - Undesirable effects
- 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 not be renewed (A)
Updated on 27 May 2018
File name
33266.docx
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 15 May 2018
Reasons for updating
- Other
Legal category:Product subject to medical prescription which may not be renewed (A)
File name
Ovitrelle 250micrograms-0.5ml pre-filled pen -IFU.pdf
Reasons for updating
- Add New Doc
Updated on 20 February 2017
File name
PIL_15323_744.pdf
Reasons for updating
- New PIL for new product
Updated on 20 February 2017
Reasons for updating
- Change to section 4 - how to report a side effect
- Change to other sources of information section
Updated on 26 January 2017
Reasons for updating
- Change to section 2 - pregnancy, breast feeding and fertility
- Change to section 3 - how to take/use
- Change to section 6 - manufacturer
Updated on 19 December 2016
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 19 December 2016
Reasons for updating
- Change to Section 4.8 – Undesirable effects - how to report a side effect
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Section 4.8 Undesirable effects - how to report a side effect - was updated with the addition of Malta. Internal Ref: TW1230178.
Updated on 02 August 2016
Reasons for updating
- Change to further information section
Updated on 07 July 2015
Reasons for updating
- Addition of information on reporting a side effect.
Updated on 29 May 2015
Reasons for updating
- Change to section 4.8 - Undesirable effects
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Ireland
HPRA Pharmacovigilance
Earlsfort Terrace
IRL - Dublin 2
Tel: +353 1 6764971
Fax: +353 1 6762517
Website: www.hpra.ie
e-mail: medsafety@hpra.ie
Updated on 17 June 2014
Reasons for updating
- Addition of information on reporting a side effect.
Updated on 13 May 2014
Reasons for updating
- Change to Section 4.8 – Undesirable effects - how to report a side effect
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Updated on 31 March 2014
Reasons for updating
- Change of distributor details
Updated on 19 March 2013
Reasons for updating
- Change of inactive ingredient
- Change of distributor details
Updated on 14 January 2013
Reasons for updating
- 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 not be renewed (A)
Free text change information supplied by the pharmaceutical company
6. PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Mannitol
Methionine
Disodium phosphate dihydrate
Sodium dihydrogen phosphate monohydrate
Poloxamer 188
Phosphoric acid (for pH adjustment)
Sodium hydroxide (for pH adjustment)
Water for injections
10. DATE OF REVISION OF THE TEXT
12/2012
Updated on 10 April 2012
Reasons for updating
- New PIL for medicines.ie
Updated on 13 January 2012
Reasons for updating
- Addition of separate SPCs covering individual presentations
Legal category:Product subject to medical prescription which may not be renewed (A)