28 September 2017 EMA/639158/2017 Human Medicines Evaluation Division

List of nationally authorised medicinal products

Active substance: amitriptyline hydrochloride / chlordiazepoxide

Procedure no.: PSUSA/00000171/201702

30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom Telephone +44 (0)20 3660 6000 Facsimile +44 (0)20 3660 5525 Send a question via our website www.ema.europa.eu/contact

An agency of the European Union

© European Medicines Agency, 2017. Reproduction is authorised provided the source is acknowledged.

Product Name (in authorisation country)

MRP/DCP Authorisation number

National Authorisation Number

MAH of product in the member state

Member State where product is authorised

Limbitrol 12,5 mg/5 mg

not available

5236

MEDA OY

FI

not available

021462066

MEDA PHARMA S.P.A.

IT

not available

021462078

MEDA PHARMA S.P.A.

IT

not available

5236

MEDA OY

FI

hårda kapslar Limbitryl 12.5 mg/5 mg capsule rigide Limbitryl 25 mg/10 mg capsule rigide Limbitrol 12,5/5 mg kovat kapselit

List of nationally authorised medicinal products EMA/639158/2017

Page 2/2