- Approval Id
- 4b2616fcd235660d
- Drug Approval Emc Name
- Agomelatine Zentiva 25 mg film-coated tablets
- Drug Name
- Agomelatine Zentiva 25 mg film-coated tablets
- Company Address
- First Floor, Andrews House, College Road, Guildford, Surrey, GU1 4QB, UK
- Company Website
- https://www.zentiva.co.uk/contact/mi-form
- Company Medical Info Direct Line
- +44 (0)800 090 2408
- Company Medical Info Email
- UKMedInfo@zentiva.com
- Company Customer Care Direct Line
- +44 (0)844 8793 188
- Atc Code
- N06AX22
- Legal Category
- Prescription only medicine
- Authorisation Holder
- Zentiva Pharma UK Limited
12 New Fetter Lane
London
EC4A 1JP
United Kingdom
- Authorisation Number
- PL 17780/0809
- Authorisation Date
- 08/06/2018 / 12/10/2022
- Instruction Authorisation Holder
- Zentiva Pharma UK Limited
12 New Fetter Lane
London
EC4A 1JP
United Kingdom
- Instruction Authorisation Number
- PL 17780/0809
- Instruction Authorisation Date
- 08/06/2018 / 12/10/2022
- Instruction Composition
- Each film-coated tablet contains 44.74 mg of agomelatine-citric acid co-crystal, equivalent to 25 mg of agomelatine.
For the full list of excipients, see section 6.1.
- Instruction Dosage Form
- Film-coated tablet
Yellow, oblong, biconvex film-coated tablets 9x4.5 mm.
- Instruction Content
- ## Composition
Each film-coated tablet contains 44.74 mg of agomelatine-citric acid co-crystal, equivalent to 25 mg of agomelatine.
For the full list of excipients, see section 6.1.
## Pharmaceutical Form
Film-coated tablet
Yellow, oblong, biconvex film-coated tablets 9x4.5 mm.
- Company Detail Path
- /organization/sanofi-ilac-sanayi-ve-ticaret-anonim-sirketi
