Tyvense 20mg, 40mg & 60mg Capsules, hard

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Tyvense 20mg, 40mg & 60mg Capsules, hard

Name:
Tyvense 20mg, 40mg & 60mg Capsules, hard
Company:
Shire Pharmaceuticals Ireland Limited
Active Ingredients:
Lisdexamfetamine dimesylate
Legal Category:
Product subject to medical prescription which may not be renewed (A)

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 06/11/18

Summary of Product Characteristics last updated on medicines.ie: 5/11/2018

This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions. See section 4.8 for how to report adverse reactions.

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Medicine Name Tyvense 20mg, 40mg & 60mg Capsules, hard	Active Ingredients Lisdexamfetamine dimesylate
Medicine Name Tyvense 30mg, 50mg & 70mg Capsules, hard	Active Ingredients Lisdexamfetamine dimesylate
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When a pharmaceutical company changes any document, a new version is published on medicines.ie. For each version, we show the dates it was published on medicines.ie and the reasons for change.

Updated on 6 November 2018 PIL

Reasons for updating

Change to section 6 - marketing authorisation holder
Company name change or merger

Updated on 5 November 2018 SmPC

Reasons for updating

Change to section 7 - Marketing authorisation holder
Change to section 8 - Marketing authorisation number(s)
Company name change or merger

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

Section 7 (Marketing Authorisation Holder): MAH transfer of MAH name and address - from Shire Pharmaceutical Contracts Limited, One Kingdom Street, W2 6BD, London, United Kingdom to Shire Pharmaceuticals Ireland Limited, Block 2 & 3 Miesian Plaza, 50-58 Baggot Street Lower, Dublin 2, Ireland

Section 8 (Marketing Authroisation numbers): New numbers due to the MAH transfer

Updated on 23 July 2018 PIL

Reasons for updating

Change to section 6 - date of revision

Updated on 20 July 2018 PIL

Reasons for updating

Change to section 6 - date of revision

Updated on 16 July 2018 SmPC

Reasons for updating

New SmPC for new product

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

The Summary of Product Characteristics has been updated to include all licensed strengths (20, 30, 40, 50, 60 and 70mg capsule), consequently sections 1, 2, 3, 6.1, 8 and 10 have been updated.

Updated on 16 July 2018 PIL

Reasons for updating

New PIL for new product