MHRA 发布 Class 4 药品缺陷通报：Quadrant Pharmaceuticals 的 Vesomni 6 mg/0.4 mg 缓释片 EL(26)A/16

Contents

1. DMRC reference number
2. Marketing Authorisation Holder
3. Medicine Details
   1. Vesomni 6 mg/0.4 mg modified release tablets
4. Affected Lot Batch Numbers
5. Background
6. Advice for Healthcare Professionals
7. Advice for Healthcare Professionals to Provide to Patients
8. Additional information
9. Download document

DMRC reference number

DMRC-38793027

Marketing Authorisation Holder

Quadrant Pharmaceuticals Limited

Medicine Details

Vesomni 6 mg/0.4 mg modified release tablets

PLPI: 20774/2577

Active Ingredient: solifenacin succinate, tamsulosin hydrochloride

SNOMED code: 11980501000001100

GTIN: 5061052110579

Affected Lot Batch Numbers

Background

Quadrant Pharmaceuticals Limited have informed the MHRA that their parallel imported packs of Vesomni 6 mg/0.4 mg modified release tablets have been printed with the incorrect barcode/GTIN on the carton. The GTIN printed on the affected packs is the GTIN for their parallel imported Solaraze 3% Gel 2 x 25 g packs (containing diclofenac). The other product details on the carton, including the name, strength and pharmaceutical form of the medicine are correct. The quality of the tablets is not impacted by the labelling defect.

Only the specified batches of imported packs are affected.

Advice for Healthcare Professionals:

Do not to use this batch of medicine in robotic or automated dispensing or stocking systems. Carry out manual dispensing and stocking, as appropriate. Product quality of the Vesomni 6 mg/0.4 mg modified release tablets is not impacted by this issue, therefore the affected batches are not being recalled.

Advice for Healthcare Professionals to Provide to Patients:

No action is needed from patients, continue to take medication from these batches of tablets. The actions will be controlled by the healthcare professionals who prescribe or dispense the medication.

Patients who experience adverse reactions or have any questions about their medication should seek medical attention. Any suspected adverse reactions should also be reported via the MHRA Yellow Card scheme.

Additional information:

For all medical information enquiries and information on this product, please email [email protected] or telephone 01204 471269.

For stock control enquiries please email [email protected] or telephone 01204 471269.

Recipients of this Medicines Recall should bring it to the attention of relevant contacts by copy of this notice. NHS regional teams are asked to forward this to community pharmacists and dispensing general practitioners for information.

Yours faithfully

Defective Medicines Report Centre

10 South Colonnade

Canary Wharf

London

E14 4PU

Telephone +44 (0)20 3080 6574

[email protected]

Download document

Class 4 Medicines Defect Notification: Quadrant Pharmaceuticals Limited, Vesomni 6 mg/0.4 mg modified release tablets , EL(26)A/16