A.MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE
Name and address of the manufacturer(s) responsible for batch release
Wasdell Packaging Limited, Units 1, 2, 3, 5, 6, 7 & 8 Euro Way Industrial Estate, Blagrove, Swindon, SN5 8YW, United Kingdom.
B.CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE
Medicinal product subject to restricted medical prescription (See Annex I: Summary of Product Characteristics, section 4.2).
C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION
The holder of this marketing authorisation must inform the European Commission about the marketing plans for the medicinal product authorised by this decision.
Periodic Safety Update Reports
The requirements for submission of periodic safety update reports for this medicinal product are set out in the list of Union reference dates (EURD list)) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines
- Dynepo - Shire Pharmaceutical Contracts Limited
Prescription drugs listed. Manufacturer: "Shire Pharmaceutical Contracts Limited"
D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
Risk Management Plan (RMP)
E. SPECIFIC OBLIGATION TO COMPLETE
This being an approval under exceptional circumstances and pursuant to Article 14(8) of Regulation (EC) No 726/2004, the MAH shall complete, within the stated timeframe, the following measures.
1.Shire will provide an annual update of all published data concerning the efficacy and safety of anagrelide in ET patients as part of the Annual Reassessment.