Summary of Product Characteristics
last updated on the eMC:
16/09/2011
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 16/09/2011 and displayed until Current
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Reasons for adding or updating:
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Change to section 4.8 - Undesirable Effects
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| Date of revision of text on the SPC: 24-Aug-2011 |
| Legal Category: POM |
| Black Triangle (CHM):
YES |
Free-text change information supplied by the pharmaceutical company
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To section 4.8 of the SmPC arthralgia and myalgia were added as adverse drug reactions. In addition, section 4.8 was re-structured. The adverse reactions identified from clinical studies and from post-marketing experience are presented in one table with reduced footnotes in order to present clearer safety information.
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Updated on 04/01/2011 and displayed until 16/09/2011
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Reasons for adding or updating:
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Change to section 4.4 - Special warnings and precautions for Use
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Change to section 4.8 - Undesirable Effects
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| Date of revision of text on the SPC: 26-Nov-2010 |
| Legal Category: POM |
| Black Triangle (CHM):
YES |
Free-text change information supplied by the pharmaceutical company
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To section 4.4, the following sub-section has been added on pancreatitis:
Pancreatitis
In post-marketing experience there have been spontaneously reported adverse reactions of acute pancreatitis. Patients should be informed of the characteristic symptom of acute pancreatitis: persistent, severe abdominal pain. Resolution of pancreatitis has been observed after discontinuation of sitagliptin (with or without supportive treatment), but very rare cases of necrotizing or haemorrhagic pancreatitis and/or death have been reported. If pancreatitis is suspected, Januvia and other potentially suspect medicinal products should be discontinued.
To section 4.8. "Undesirable Effects", and under the sub-section "Post marketing data", the statement on pancreatitis following has been expanded:
acute pancreatitis, including fatal and non-fatal haemorrhagic and necrotizing pancreatitis (see section 4.4);
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Updated on 18/11/2010 and displayed until 04/01/2011
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Reasons for adding or updating:
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Change to section 4.8 - Undesirable Effects
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Change to section 5.1 - Pharmacodynamic Properties
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| Date of revision of text on the SPC: 08-Nov-2010 |
| Legal Category: POM |
| Black Triangle (CHM):
YES |
Free-text change information supplied by the pharmaceutical company
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To section 4.8. "Undesirable Effects", and under the sub-section "Post marketing data", "vomiting" has been added.
To section 5.1, the last paragraph has been revised to state that the EMA has waived the obligation to submit results with Janumet in all sub-sets of the paediatric population
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Updated on 25/08/2010 and displayed until 18/11/2010
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Reasons for adding or updating:
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Change to section 4.8 - Undesirable Effects
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| Date of revision of text on the SPC: 06-Aug-2010 |
| Legal Category: POM |
| Black Triangle (CHM):
YES |
Free-text change information supplied by the pharmaceutical company
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To section 4.8. "Undesirable Effects", the following has been added in the post-marketing section in line with of adverse events reports :
"….impaired renal function, including renal failure (sometimes requiring dialysis)".
To sections 4.1 Contraindications, 4.2 Posology and method of administration, 4.5 Interactions with other medicinal products and other interactions, 4.6 Fertility, pregnancy and lactation, 4.7 Effects on ability to drive and operate machines, 4.9 overdose, 5.1 pharmacodynamics properties and 5.2 pharmacokinetic properties, editorial changes have been made in line with the latest guidance from the CHMP on drafting SmPCs.
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Updated on 27/05/2010 and displayed until 25/08/2010
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Reasons for adding or updating:
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| Date of revision of text on the SPC: |
| Legal Category: POM |
| Black Triangle (CHM):
YES |
Free-text change information supplied by the pharmaceutical company
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| None provided |
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