Imatinib 400mg Capsules (3 x 10) PL 36390/0180 : Company-led Drug Alert
Cipla (EU) Limited has informed MHRA that there is an error on the Patient Information Leaflet (PIL) for the above product: the dosage information for the indication CML is incorrect
Product information
CLDA number
CLDA (18)A/08
MDR number
MDR 43-09/18
Company name
Cipla (EU) Ltd
Product description
Imatinib 400mg Capsules (3 x 10) PL 36390/0180
Batch number/expiry
| Batch Number | Expiry Date |
| GJ80583 | April 2020 |
Brief description of the problem
Cipla (EU) Limited has informed MHRA that there is an error on the Patient Information Leaflet (PIL) for the above product: the dosage information for the indication CML is incorrect
Action
Pharmacists are asked to remove the defective PIL from affected cartons before dispensing and provide a copy of the correct PIL
Please ensure that existing patients are taking the correct dose and provide a copy of the correct PIL if necessary.
Company contact for medical information enquiries:
Cipla (EU) Ltd
Tel: 07826544512 or 07876612672
Published 21 September 2018