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Merck Serono
Bedfont Cross, Stanwell Road, Feltham, Middlesex, TW14 8NX, UK
Telephone: +44 (0)208 818 7200
Fax: +44 (0)208 818 7267
Medical Information Direct Line: +44 (0)208 818 7373
Medical Information e-mail: medinfo.uk@merckserono.net
Medical Information Fax: +44 (0)208 818 7274

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?
Summary of Product Characteristics last updated on the eMC: 20/04/2010
SPC Nutrizym 22

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 20/04/2010 and displayed until Current
Reasons for adding or updating:
  • Change to section 6. 3 - Shelf Life
Date of revision of text on the SPC:   17-Apr-2010
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Change to Section 6.3 - Shelf Life  from

2 Years
to
18 months
Updated on 21/01/2010 and displayed until 20/04/2010
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-Jan-2010
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Change to Section 7: MA Holder from

E Merck Ltd to Merck Serono Ltd

Change to Section 8: MA Number from

PL 0493/0158

to
PL 11648/0078

Change to section 10: Date of Revision of text to reflect date of approval of variation to change ownership from:

22 October 2008 to 01 January 2010
Updated on 22/10/2008 and displayed until 21/01/2010
Reasons for adding or updating:
  • Change to section 4.6 - Pregnancy and Lactation
  • Change to section 7 - Marketing Authorisation Holder
Date of revision of text on the SPC:   22-Oct-2008
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
changed  to section 7 - MA Holder Address to:

7 MARKETING AUTHORISATION HOLDER


E. Merck Ltd

Bedfont Cross, Stanwell Road

Feltham, Middlesex,

TW14 8NX, UK

Changed to section 4.6 to include the additional wording in bold:

4.6       Pregnancy and lactation

 

Safety has not been established and animal toxicological studies are lacking, therefore Nutrizym 22 should not be used in pregnancy and lactation unless clearly necessary, but if required should be used in doses sufficient to provide adequate nutritional status.

 

Refer to section 4.8 for the potential side - effects of high doses of pancreatic enzymes in patients with cystic fibrosis.
Updated on 02/09/2002 and displayed until 22/10/2008
Reasons for adding or updating:
  • Change to section 4.8 - Undesirable Effects
Updated on 03/07/2001 and displayed until 02/09/2002
Reasons for adding or updating:
  • No reasons supplied
Updated on 03/07/2000 and displayed until 03/07/2001
Reasons for adding or updating:
  • No reasons supplied
Updated on 06/09/1999 and displayed until 03/07/2000
Reasons for adding or updating:
  • No reasons supplied

Active Ingredients/Generics

 
  pancreatin