Epipen Junior 150 micrograms solution for injection in pre-filled pen
*Company:
Mylan IRE Healthcare LtdStatus:
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
File name
EpiPen® Healthcare Professional Letter- Aug 2023.pdf
Reasons for updating
- Add New Doc
File name
EpiPen® Healthcare Professional Letter.pdf
Reasons for updating
- Add New Doc
Updated on 03 July 2023
File name
ie-pl-se1287-EpiPenJnr-MAHT-clean.pdf
Reasons for updating
- Change to section 6 - marketing authorisation holder
Updated on 03 July 2023
File name
ie-spc-se1287-EpiPenJnr-MAHT-clean.pdf
Reasons for updating
- Change to section 7 - Marketing authorisation holder
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 03 December 2021
File name
ie-pl-se1287-jnr-v029-clean.pdf
Reasons for updating
- Change to section 3 - use in children/adolescents
Updated on 03 December 2021
File name
ie-spc-se1287-jnr-v029-clean.pdf
Reasons for updating
- Change to section 6.6 - Special precautions for disposal and other handling
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 07 December 2020
File name
ie-pl-se1287-jnr-v021-clean.pdf
Reasons for updating
- Change to section 2 - interactions with other medicines, food or drink
- Change to section 3 - how to take/use
- Change to section 4 - possible side effects
- Change to section 4 - how to report a side effect
- Change to section 6 - date of revision
Updated on 07 December 2020
File name
ie-spc-se1287-jnr-v021-clean.pdf
Reasons for updating
- Change to section 4.8 - Undesirable effects
- Change to section 6.5 - Nature and contents of container
- Change to section 6.6 - Special precautions for disposal and other handling
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 06 December 2019
File name
ie-spc-se1287-jnr-v016-clean.pdf
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- 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 be renewed (B)
Updated on 06 December 2019
File name
ie-pl-se1287-jnr-v016-clean.pdf
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 6 - date of revision
Updated on 19 March 2019
File name
ie-pl-se1287-jnr-mahtransfer-clean.pdf
Reasons for updating
- New PIL for new product
Updated on 19 March 2019
File name
ie-spc-se1287-jnr-mahtransfer-clean.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
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 01 February 2018
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 01 February 2018
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.8 - Undesirable effects
- Change to section 5.2 - Pharmacokinetic properties
- Change to section 6.6 - Special precautions for disposal and other handling
- 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
Updated on 01 February 2018
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.8 - Undesirable effects
- Change to section 5.2 - Pharmacokinetic properties
- Change to section 6.6 - Special precautions for disposal and other handling
- Change to section 10 - Date of revision of the text
Free text change information supplied by the pharmaceutical company
Updated on 06 September 2016
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 6.4 - Special precautions for storage
- Change to section 6.5 - Nature and contents of container
- Change to section 6.6 - Special precautions for disposal and other handling
- 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
In section 4.2: Slight text amendment. Recommendation to carry two pens added.
In section 4.4: New special a=warning and precaution added with regards to patients to be thoroughly instructed to understand the indications for the use and the correct method of administration. And to advise to educate the patient’s immediate associates (e.g. parents, caregivers, teachers) for the correct usage of the Epipen Junior in case support is needed in the emergency situation.
In section 6.5: information regarding the exposed and protected needle length added
In section 6.6: the text ‘viewing’ to point No 5
In section 10: Date of revision changed.
Updated on 06 September 2016
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 6.4 - Special precautions for storage
- Change to section 6.5 - Nature and contents of container
- Change to section 6.6 - Special precautions for disposal and other handling
- Change to section 10 - Date of revision of the text
Free text change information supplied by the pharmaceutical company
In section 4.2: Slight text amendment. Recommendation to carry two pens added.
In section 4.4: New special a=warning and precaution added with regards to patients to be thoroughly instructed to understand the indications for the use and the correct method of administration. And to advise to educate the patient’s immediate associates (e.g. parents, caregivers, teachers) for the correct usage of the Epipen Junior in case support is needed in the emergency situation.
In section 6.5: information regarding the exposed and protected needle length added
In section 6.6: the text ‘viewing’ to point No 5
In section 10: Date of revision changed.
Updated on 17 December 2015
Reasons for updating
- Change to section 4.1 - Therapeutic indications
- Change to section 4.2 - Posology and method of administration
- 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
In section 4.1: The therapeutic indications has changed
In section 4.2: Information regarding the posology and method of administration has changed
In In section 10: The date of revision has been changed.
Updated on 17 December 2015
Reasons for updating
- Change to section 4.1 - Therapeutic indications
- Change to section 4.2 - Posology and method of administration
- Change to section 10 - Date of revision of the text
Free text change information supplied by the pharmaceutical company
In section 4.1: The therapeutic indications has changed
In section 4.2: Information regarding the posology and method of administration has changed
In In section 10: The date of revision has been changed.
Updated on 11 November 2014
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 4.8 – Undesirable effects - how to report a side effect
- Change to section 6.6 - Special precautions for disposal and other handling
- 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
In section 4.2: Additional instructions has been added outlining what patients should do following the use of Epipen
In section 4.4: The patient/carer is informed about the possibility of biphasic anaphylaxis, the risk associated with concomitant asthma and warned in relation to related allergens to be investigated.
In section 4.8: the reporting of adverse reports has been reworded
In section 6.6: A reference to 4.2 is added for instructions to be conveyed to patient/carer regarding actions to be taken following use of Epipen
In section 10: the date of revision has changed
Updated on 11 November 2014
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 4.8 – Undesirable effects - how to report a side effect
- Change to section 6.6 - Special precautions for disposal and other handling
- Change to section 10 - Date of revision of the text
Free text change information supplied by the pharmaceutical company
In section 4.2: Additional instructions has been added outlining what patients should do following the use of Epipen
In section 4.4: The patient/carer is informed about the possibility of biphasic anaphylaxis, the risk associated with concomitant asthma and warned in relation to related allergens to be investigated.
In section 4.8: the reporting of adverse reports has been reworded
In section 6.6: A reference to 4.2 is added for instructions to be conveyed to patient/carer regarding actions to be taken following use of Epipen
In section 10: the date of revision has changed
Updated on 25 February 2014
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Updated on 25 February 2014
Reasons for updating
- New SPC for new product