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Dantrium 100 mg Capsules

Last Updated on eMC 14-Dec-2016 View document  | Norgine Limited Contact details

When a pharmaceutical company changes an SPC or PIL, a new version is published on the eMC.  For each version, we show the dates it was published on the eMC and the reasons for change.

Updated on 14-Dec-2016 and displayed until Current

Reasons for adding or updating:

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.3 - Contraindications
  • Change to section 4.6 - Fertility, pregnancy and lactation
  • Change to section 4.8 - Undesirable effects - how to report a side effect
  • Change to section 10 - Date of revision of the text

Date of revision of text on the SPC: 01-Dec-2016

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

The changes to the SmPC are as follows:

Section 2 quantity of lactose monohydrate per capsule has been added

 

Section 4.3 hypersensitivity to any of the excipients

 

Section 4.6 update to pregnancy, Breast-feeding and Fertility

 

Section 4.8 aligned to QRD (frequencies listed as detailed in QRD) and additional ADRs listed under unknown: Gastrointestinal bleeding, tachycardia, Bradycardia and hepatitis

 

Section 10: Revision date

 

Updated on 31-Oct-2014 and displayed until 14-Dec-2016

Reasons for adding or updating:

  • Change to section 7 - Marketing authorisation holder
  • Change to section 8 - Marketing authorisation number(s)
  • Change to section 10 - Date of revision of the text

Date of revision of text on the SPC: 01-Sep-2014

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:



7.       MARKETING AUTHORISATION HOLDER

 

SpePharm Holding B.V.

Kingsfordweg 151

1043 GRNorgine BV.

Hogehilweg 7, 1101CA

1101CA  Amsterdam ZO

The Netherlands

 

 

8.       MARKETING AUTHORISATION NUMBER

 

PL 34413/0002

PL 20142/0014

 

 

 

 

 

9.       DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

 

25 October 1989

 

 

10.     DATE OF REVISION OF THE TEXT

 

01/2012September 2014

Updated on 23-May-2012 and displayed until 31-Oct-2014

Reasons for adding or updating:

  • Change to section 3 - Pharmaceutical form
  • Change to section 6. 5 - Nature and Contents of Container

Date of revision of text on the SPC: 01-Jan-2012

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:



3.       PHARMACEUTICAL form

 

Capsule, hard

Dantrium Capsules are presented in white-green capsules of size 1, they were previously orange-light brown

6.5         Nature and contents of container

NEW

 

Dantrium Capsules are supplied in high-density polyethylene (HDPE) bottles with HDPE caps and contained in an outer carton. One bottle contains 100 capsules.

OLD

Dantrium 100 mg capsules are supplied in high density polyethylene (HDPE) bottles with tinplate caps containing 100 capsules each and polypropylene securitainers with polyethylene caps containing 100 capsules each.

Updated on 22-Aug-2011 and displayed until 23-May-2012

Reasons for adding or updating:

  • New SPC for eMC ie an SPC for an existing product, but one that is new for the eMC

Legal Category:POM

Black Triangle (CHM): NO

Company contact details

Norgine Limited

Company image
Address

Norgine House, Widewater Place, Moorhall Road, Harefield, Middlesex, UB9 6NS

Fax

+44 (0)1895 825 865

Medical Information e-mail
Telephone

+44 (0)1895 826 600

Before you contact this company: often several companies will market medicines with the same active ingredient. Please check that this is the correct company before contacting them. Why?

Active ingredients

dantrolene sodium

Legal categories

POM - Prescription Only Medicine

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