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ConceptId

Term

Status

Action / Plan

Discussion

1

840651000

 Conventional release chewable capsule (dose form) Not Referenced

2

421873001

 Conventional release oral cream (dose form) Not Referenced

3

783749008

 Conventional release oral ointment (dose form) Not Referenced

4

1231841006

 Porous impregnated material for conventional release vapor inhalation (dose form) ReferencedPending

Mapped to EDQM: 50033100    Inhalation vapour, impregnated plug

Historical associations to active concepts:

  • 1269278009 |Porous impregnated material for conventional release pulmonary vapor inhalation (dose form)|
  • 1269279001 |Porous impregnated material for conventional release oromucosal vapor inhalation (dose form)|

Christopher Jarvis Inhalation implies pulmonary, favors replacing by 1269278009 |Porous impregnated material for conventional release pulmonary vapor inhalation (dose form)| EDQM Interested in understanding the product with more detail.

Ian Spiers The source materials defined that there was oromucosal use in nicotine cartridges. Original request from Sweden. https://www.medicines.org.uk/emc/product/4707/smpc#gref "Nicorette 15mg Inhalator: inhalation cartridge for oromucosal use"

Nicola Ingram Request was from Ireland SPC http://www.hpra.ie/img/uploaded/swedocuments/Licence_PA0330-037-010_31072023145601.pdf  page 3 "The patient may find deep drawing or short sucks on the mouthpiece most effective – patients soon find a favoured technique. Nicotine vapour passing through the mouth is absorbed by the buccal mucosa: little reaches the lungs." Problem was that inhalation was pulmonary dose form. Inactivation reason for  Porous impregnated material for conventional release vapor inhalation (dose form) may be incorrect (did not add clinical drug as failed release validation check at the time)

Julie M. James respiratory track does not include oromucosal.

Guillermo Reynoso why is the inactivation reason Outdated? Maybe an option is to maintain the more general concept and add the new ones as children

5

784575004

 Conventional release oral spray (dose form) Not Referenced

6

784576003

 Prolonged-release intrauterine drug delivery system (dose form) Not Referenced

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