MHRA 通报 Advanz Pharma 对 Mynzepli 40 mg/mL 预充式注射器注射液实施 2 类召回 EL(26)A/44

Contents

1. DMRC reference number
2. Marketing Authorisation Holder
3. Medicine Details
   1. Mynzepli 40 mg/mL solution for injection in pre-filled syringe
4. Affected Lot Batch Numbers
5. Background
6. Advice for Healthcare Professionals
7. Advice for Patients
8. Additional information
9. Download document

DMRC reference number

DMRC - 41252013

Marketing Authorisation Holder

Advanz Pharma Limited

Medicine Details

Mynzepli 40 mg/mL solution for injection in pre-filled syringe

PL: 56734/0022

Active Ingredient: aflibercept

SNOMED code: 45567511000001107

GTIN: 05021691005605

Affected Lot Batch Numbers

Background

Advanz Pharma Limited are recalling the specified batches of Mynzepli 40 mg/mL solution for injection in pre-filled syringe as a precautionary measure because a small variation in the size of the finger grip could affect how the medicine is administered and potentially pose a risk to patient safety. The finger grip/flange provides a platform/surface for better grip of the syringe. It allows the user to securely hold the pre-filled syringe while applying pressure to the plunger rod during product administration.

Advice for Healthcare Professionals:

Stop supplying the above batches immediately. Quarantine all remaining stock and return it to your supplier using your supplier’s approved process.

Advanz Pharma have confirmed that other unaffected batches of Mynzepli 40 mg/mL solution for injection in pre-filled syringe are currently available for distribution.

Advice for Patients:

This is a Pharmacy and Wholesaler level recall, therefore no further action is required by patients.

This product is only administered by a qualified healthcare professional experienced in administering intravitreal injections.

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

Additional information:

For all enquiries and information on this product, please email [email protected], or telephone +44 (0) 208 588 9131.

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 2 Medicines Recall: Advanz Pharma Limited, Mynzepli 40 mg/mL solution for injection in pre-filled syringe, EL(26)A/44