521 08 flecainide acetate 200mg capsules (Tambocor XL)
Attn: Newsdesks
Health Correspondents
SMC ISSUES ADVICE ON NEW DRUGS
The Scottish Medicines Consortium (SMC) today (Monday) accepted the following new drug through its abbreviated submission process (the abbreviated submissions process is used for new formulations at same or lesser cost, and new tablet strength or size):
- flecainide capsules (Tambocor XL) for the treatment of AV nodal reciprocating tachycardia, arrhythmias associated with Wolff-Parkinson-White Syndrome and similar conditions with accessory pathways; paroxysmal atrial fibrillation in patients with disabling symptoms when treatment need has been established and in the absence of left ventricular dysfunction
Notes for editors – Glossary:
- Tachycardia - Abnormal fast rhythm of the heart.
- Wolff-Parkinson-White Syndrome - A condition in which an additional pathway allows the electrical signal to travel too quickly to the lower chambers of the heart causing a fast heartbeat.
- Paroxysmal atrial fibrillation – A condition that affects the heart, causing an irregular pulse that comes and goes.
Notes for editors – About SMC:
1. The SMC advises NHS Boards and Area Drug and Therapeutic Committees (ADTCs) in Scotland about the use of all newly licensed medicines, all new formulations of existing medicines and any major new indications for established products. It does this after new medicines have been licensed by the Medicines and Healthcare products Regulatory Agency (MHRA) / European Medicines Evaluation Agency (EMEA).
2. The SMC process encourages pharmaceutical manufacturers to make a submission before a product is launched. The aim is to issue advice as soon as possible after the launch of a product.
3. Membership of the SMC has been derived from NHS Boards across Scotland. Membership is wide ranging across multi-disciplines of NHS Scotland and also includes members of the Association of British Pharmaceutical Industry (ABPI), and patient and voluntary group representatives.
4. This advice represents the views of the Scottish Medicines Consortium and was arrived at after careful consideration of the available evidence. Health professionals are expected to take due account of this recommendation when exercising their clinical judgement. This recommendation does not, however, override the individual responsibility of health professionals to make appropriate decisions in the circumstances of the individual patient, in consultation with the patient and/or guardian or carer.
For further information, contact Stephen Ferguson on 07779 320 689.