REKOVELLE
*Company:
Ferring Ireland LimitedStatus:
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
Updated on 11 October 2023
File name
Rekovelle all strengths- clean SPC- II-37-G -approved 20230720.pdf
Reasons for updating
- Change to section 4.1 - Therapeutic indications
- Change to section 4.2 - Posology and method of administration
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.8 - Undesirable effects
- Change to section 5.1 - Pharmacodynamic properties
- 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 11 October 2023
File name
Rekovelle 72 mcg-clean PIL-II-37-G -approved 20230720.pdf
Reasons for updating
- Change to section 4 - possible side effects
- Change to section 6 - date of revision
Updated on 11 October 2023
File name
Rekovelle 36 mcg- clean PIL II-37-G -approved 20230720.pdf
Reasons for updating
- Change to section 4 - possible side effects
- Change to section 6 - date of revision
Updated on 11 October 2023
File name
Rekovelle 12 mcg- clean PIL-II-37-G -approved 20230720.pdf
Reasons for updating
- Change to section 4 - possible side effects
- Change to section 6 - date of revision
Updated on 19 January 2023
File name
PIL REKOVELLE 72 micrograms_2.16 mL solution for injection in a pre-filled pen.pdf
Reasons for updating
- New PIL for new product
Free text change information supplied by the pharmaceutical company
First Version Upload
Updated on 19 January 2023
File name
PIL REKOVELLE 36 micrograms_1.08 mL solution for injection in a pre-filled pen.pdf
Reasons for updating
- New PIL for new product
Free text change information supplied by the pharmaceutical company
First Version Upload
Updated on 19 January 2023
File name
PIL REKOVELLE 12 micrograms_0.36 mL solution for injection in a pre-filled pen.pdf
Reasons for updating
- New PIL for new product
Free text change information supplied by the pharmaceutical company
First Version Upload
Updated on 29 March 2022
File name
Rekovelle all strengths_in line with license dated 25 03 2022_clean.pdf
Reasons for updating
- Change to section 7 - Marketing authorisation holder
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Change of marketing authorisation holder address
Updated on 17 February 2022
File name
Rekovelle 12-36-72 mcg prefilled pen_in line with license dated 18 03 2021.pdf
Reasons for updating
- Change to section 5.1 - Pharmacodynamic properties
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Update to Section 5.1 - Addition of dose equivalence factor to follitropin alfa
Updated on 13 April 2021
File name
Rekovelle Pre-filled Pen_SPC_24.02.2021.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
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 04 January 2021
File name
Rekovelle 12-36-72 mcg prefilled pen_in line with licence dated 16 12 2020.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
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
SPC Section 4.8 - Update to HPRA adverse event reporting details, to match current EMA Appendix V
SPC Section 6.5 – Change in number of needles from 6 to 9 for the 36 mcg/1.08 mL pack and from 9 to 15 for the 72 mcg/2.16 mL pack
Updated on 12 July 2019
File name
Rekovelle 12 mcg_ 36 mcg_ 72 mcg prefilled pen_approved May 2017.pdf
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may not be renewed (A)