Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2017 Publisher: Accord Healthcare Limited, Sage House, 319 Pinner Road, North Harrow, Middlesex, HA1 4HF, United Kingdom
Mitomycin 2 mg powder for solution for injection/infusion or intravesical use.
| Pharmaceutical Form |
|---|
|
Powder for solution for injection/infusion or intravesical use. Blue-violet cake or powder. |
Each vial contains Mitomycin 2 mg.
For full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Mitomycin |
Mitomycin is an antibiotic isolated from Streptomyces caespitosus with anti-neoplastic effect. The mechanism of action is based predominantly on the alkylation of DNA (RNA to a lesser extent) with the corresponding inhibition of DNA synthesis. The degree of DNA damage correlates with the clinical effect and is lower in resistant cells than in sensitive ones. |
| List of Excipients |
|---|
|
Mannitol E421 |
Mitomycin is contained within a amber colored, type I glass vial with a bromo butyl rubber stopper and an aluminium seal.
The 2 mg vials are packaged into cartons containing 1, 5 or 10 vials.
Not all pack sizes may be marketed.
Accord Healthcare Limited, Sage House, 319 Pinner Road, North Harrow, Middlesex, HA1 4HF, United Kingdom
PL 20075/0387
Date of first authorization: 11th January 2016
| Drug | Countries | |
|---|---|---|
| MITOMYCIN | United Kingdom |
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