Last Updated on eMC 07-03-2017 View medicine  | Pfizer 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.

Reasons for adding or updating:

  • Change to section 4.8 - Undesirable effects - how to report a side effect

Date of revision of text on the SPC:01-01-2017

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

The SPC has been updated as follows: Sec 4.8 the warnings and precautions are reordered by moving up the existing SCC information to increase its prominence in the SmPC.

Reasons for adding or updating:

  • Change to section 10 - Date of revision of the text

Date of revision of text on the SPC:01-06-2016

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

The SPC has been updated as follows: Revision date update to 06/2016 to align with the approved annex.

Reasons for adding or updating:

  • Correction of spelling/typing errors

Date of revision of text on the SPC:01-12-2015

Legal Category:POM

Black Triangle (CHM): NO

Reasons for adding or updating:

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects
  • Change to section 5.1 - Pharmacodynamic properties

Date of revision of text on the SPC:01-12-2015

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:



The SPC has been updated as follows:

Section 4.4 Special warnings and precautions for use: Subsections - Hepatic toxicity; Dermatological adverse reactions to include reactions such as ephelides, lentigo, actinic keratosis; Paediatric population to highlight a higher frequency of liver enzyme elevations that was observed in the paediatric population.

Section 4.8 Undesirable effects: updates to reflect safety and efficacy data from studies in paediatric populations.

Section 5.1 Pharmacodynamic properties: Subsection - Paediatric population.  

Reasons for adding or updating:

  • Change to section 6.6 - Special precautions for disposal and other handling

Date of revision of text on the SPC:01-07-2015

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:



The SPC has been updated as follows.

Per PRAC recommendation, a cumulative review of Pfizer’s safety database was conducted for voriconazole reports of medication error received from 01 March 2002 through 28 February 2014. Following this review and in alignment with approved labeling in the global market with regards to the reconstitution instructions for the powder for oral suspension, it was deemed appropriate to revise the current text to clearly indicate the total diluent volume should be equal to 46 mL.

Reasons for adding or updating:

  • Change to section 5.1 - Pharmacodynamic properties

Date of revision of text on the SPC:01-08-2015

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:



The SPC has been updated as follows

Following the outcome for MEA 86.1 (Rapporteur’s AR dated 30th of March 2015), the MAH was requested to update the SmPC Section 5.1 as specified as follows:

The increased resistance to C. glabrata should be reflected in the SmPC: In section 5.1 of the SmPC, under the heading “EUCAST breakpoints”. The  following change was submitted:

The sentence “However, this reduced response was not correlated with elevated MICs.” was replaced by “In vitro data showed a slight increase of resistance of C. glabrata to voriconazole.”

Reasons for adding or updating:

  • Improved presentation of SPC

Date of revision of text on the SPC:01-10-2014

Legal Category:POM

Black Triangle (CHM): NO

Reasons for adding or updating:

  • Change to section 4.8 - Undesirable effects - how to report a side effect

Date of revision of text on the SPC:01-08-2014

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:



Section 4.8 has been updated to include the change in name of the Irish Medicines Board and to include the Maltese details:

Reasons for adding or updating:

  • Change to section 4.1 - Therapeutic indications
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects
  • Change to section 5.1 - Pharmacodynamic properties

Date of revision of text on the SPC:01-06-2014

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:



Updates to Sections:

·         4.1 Therapeutic Indications has been amended to state the following:

Voriconazole, is a broad-spectrum, triazole antifungal agent and is indicated in adults and children aged 2 years and above as follows:

 

·         Treatment of invasive aspergillosis.

·         Treatment of candidaemia in non-neutropenic patients.

·         Treatment of fluconazole-resistant serious invasive Candida infections (including C. krusei).

·         Treatment of serious fungal infections caused by Scedosporium spp. and Fusarium spp.

 

VFEND should be administered primarily to patients with progressive, possibly life-threatening infections.

 

Prophylaxis of invasive fungal infections in high risk allogeneic hematopoietic stem cell transplant (HSCT) recipients.

 

 

·         4.2 posology and method of administration – whereby the dosage has been revised,

·         4.4 special warnings and precautions for use – reference to prophyaxis included together with information surrounding frequency of phototoxicity.

·         4.8 undesirable effects – summary of safety profile was revised together with tablulated adverse reactions

·         5.1 pharmacodynamic properties – as been amended to include information regarding prophylaxis.

Reasons for adding or updating:

  • Change to section 4.8 - Undesirable effects
  • Improved presentation of SPC

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

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:



Section 4.8 “Undesirable effects” addition of the following:

·         “Hypertonia” as rare frequency under Nervous system disorders.

·         “atrial arrhythmia” as uncommon frequency under Cardiac disorders.

·         “Fixed drug eruption and eczema” as “uncommon frequency” under Skin and subcutaneous tissue disorders.

·         Removal of “dysgeusia” from rare frequency and added to “uncommon” frequency under Gastrointestinal disorders.

Reasons for adding or updating:

  • Change to section 4.2 - Posology and method of administration

Date of revision of text on the SPC:01-10-2013

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

Section 4.2,

Reasons for adding or updating:

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects
  • Change to section 10 - Date of revision of the text

Date of revision of text on the SPC:01-06-2013

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

Section 4.4 and Section 4.8 updated regarding phototoxicity and squamous cell carcinoma (SCC); Section 10 updated with CHMP opinion date

Reasons for adding or updating:

  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 10 - Date of revision of the text

Date of revision of text on the SPC:01-04-2013

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

Section 4.2 ‘hepatic impairment’ updated and Section 4.4 ‘monitoring of hepatic function’ updated with respect to increased LFT monitoring and the provision of further instructions to physicians in this regard.
Section 10 Change to date of revision

Reasons for adding or updating:

  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.4 - Special warnings and precautions for use

Date of revision of text on the SPC:01-05-2013

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:



Section 4.2 ‘hepatic impairment’ updated and
Section 4.4 ‘monitoring of hepatic function’ updated with respect to increased LFT monitoring and the provision of further instructions to physicians in this regard.

Reasons for adding or updating:

  • Change to section 4.4 - Special warnings and precautions for Use
  • Change to section 4.8 - Undesirable Effects
  • Change to section 9 - Date of first Authorisation/renewal of the Authorisation
  • Change to section 10 date of revision of the text
  • Introduction of new strength

Date of revision of text on the SPC:01-10-2012

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:



Section 4.4  - addition of long-term treatment and periostitis;
Section 4.8 ; periostitis added as AE;
Section 9 – date of last renewal updated;
Section 10 – date of revision updated
addition of the new presentation, 200 mg powder and solvent for solution for infusion

Reasons for adding or updating:

  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.3 - Contraindications
  • Change to section 4.4 - Special warnings and precautions for Use
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.6 - Pregnancy and Lactation
  • Change to section 5.3 - Preclinical Safety Data

Date of revision of text on the SPC:01-04-2012

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

sections 4.2, 4.4 and 4.5 updated with minor amendments for clarification
section 4.3 updated with
contraindication of co-administration with high dose efavirenz
sections 4.6 and 5.3 updated with fertility information

Reasons for adding or updating:

  • Change to section 4.2 - Posology and method of administration
  • Change to section 5.1 - Pharmacodynamic Properties
  • Change to section 5.2 - Pharmacokinetic Properties

Date of revision of text on the SPC:01-04-2012

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

SPC: Sections 4.2, 5.1 and 5.2 updated.

Reasons for adding or updating:

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.1 - Therapeutic indications
  • Change to section 4.8 - Undesirable Effects
  • Change to section 5.1 - Pharmacodynamic Properties
  • Change to section 5.2 - Pharmacokinetic Properties
  • Change to section 6.1 - List of Excipients
  • Change to section 6. 6 - Instructions for use, handling and disposal
  • Change to section 10 date of revision of the text

Date of revision of text on the SPC:01-02-2012

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:



SPC - update of sections 2, 4.1 to 4.8, 5.1, 5.2, 6.1 to 6.6, 10

Reasons for adding or updating:

  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.8 - Undesirable Effects
  • Change to section 5.2 - Pharmacokinetic Properties
  • Change to section 6. 6 - Instructions for use, handling and disposal

Date of revision of text on the SPC:01-12-2011

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:



Sections 4.2, 4.8, 5.2 and 6.6 of the SmPC updated in order to reflect the updated information on paediatric dosing

 

Reasons for adding or updating:

  • Change to section 6. 6 - Instructions for use, handling and disposal

Date of revision of text on the SPC:01-11-2011

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

Update to section 6.6 with addition of sodium chloride as alternative reconstitution agent.

Reasons for adding or updating:

  • Change to section 4.4 - Special warnings and precautions for Use
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction

Date of revision of text on the SPC:01-08-2011

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

Update to sections 4.4 & 4.5 of the SPC

Reasons for adding or updating:

  • Correction of spelling/typing errors

Date of revision of text on the SPC:01-01-2011

Legal Category:POM

Black Triangle (CHM): NO

Reasons for adding or updating:

  • Change to section 4.4 - Special warnings and precautions for Use
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 5.1 - Pharmacodynamic Properties

Date of revision of text on the SPC:01-01-2011

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:



Revised SmPC sections

4.4, 4.5 & 5.1

 

Reasons for adding or updating:

  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.4 - Special warnings and precautions for Use
  • Change to section 4.8 - Undesirable Effects

Date of revision of text on the SPC:01-09-2010

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

update sections 4.2, 4.4 & 4.8 of the SPC.

Reasons for adding or updating:

  • Change to section 4.8 - Undesirable Effects
  • Change to section 10 date of revision of the text

Date of revision of text on the SPC:01-09-2009

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:



Section 4.8

Update to the "Paediatric Use" information in Section 4.8 of the Vfend SPC to include wording around post-marketing data that suggests there might be a higher occurrence of skin reactions (esp. erythema) in the paediatric population compared to adults.

Section 10

Update to revision date

Reasons for adding or updating:

  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 10 date of revision of the text

Date of revision of text on the SPC:02-02-2009

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:



Section 4.5 – additional wording on a drug interaction between Voriconazole and the Non-steroidal anti-inflammatory drugs (e.g. Diclofenac and Ibuprofen)

Section 10 – change to revision date

Reasons for adding or updating:

  • Change to section 9 - Date of first Authorisation/renewal of the Authorisation
  • Change to section 10 date of revision of the text

Date of revision of text on the SPC:14-10-2008

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:



Section 9 – change to:
Date of first authorisation: 21 March 2002
Date of last renewal: 21 March 2007

Section 10 – change to date of revision of text.

Reasons for adding or updating:

  • Change to section 4.4 - Special warnings and precautions for Use
  • Change to section 4.8 - Undesirable Effects

Date of revision of text on the SPC:20-06-2008

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:



Section 4.4 -   Addition of rare prolonged visual adverse events

Section 4.8 -     Additional side effects under very common and common eye disorders
                        Also reference to clinical trial studies under the visual disturbances section.

Reasons for adding or updating:

  • Improved Electronic Presentation

Reasons for adding or updating:

  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.3 - Contraindications
  • Change to section 4.4 - Special warnings and precautions for Use
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction

Date of revision of text on the SPC:01-01-2008

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

 

4.2       Posology and method of administration

Additional wording regarding co-administration of Vfend and efavirenz and dose adjustment.

4.3       Contraindications

Removal of statement regarding contraindication of Vfend with efavirenz.

 

4.4       Special warnings and precautions for use

Addition of additional wording regarding with dosing of alfentanil with Vfend.

 

4.5       Interaction with other medicinal products and other forms of interaction

Additional wording regarding interaction of alfentanil with Vfend.

 

Additional statement regarding dose adjustment with efavirenz.

Reasons for adding or updating:

  • Change to section 4.3 - Contraindications
  • Change to section 4.4 - Special warnings and precautions for Use
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.8 - Undesirable Effects
  • Change to section 4.2 - Posology and method of administration
  • Change to section 6.2 - Incompatibilities
  • Change to section 9 - Date of first Authorisation/renewal of the Authorisation
  • Change to section 10 date of revision of the text

Date of revision of text on the SPC:01-07-2007

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

Sections:

4.3 Contraindications

Additional contraindication regarding use of voriconazole with St John’s Wort

 

4.4 Special Warnings and precautions for use

Warning regarding the monitoring of pancreatic patients especially children.

 

4.5 Interaction with other medicinal products and other forms of interaction

Interaction with St John’s Wort.

 

4.8 Undesirable effects

Additional wording regarding post-marketing reports of pancreatitis in paediatric patients.

 

 

Vfend 200 mg powder for solution for infusion ONLY

 

4.2 Posology and method of administration

Wording regarding electrolyte solutions

 

6.2 Incompatabilities

Revised wording regarding infusion of concentrated solutions of electrolytes.
 
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
Correction
 
10. DATE OF REVISION OF THE TEXT
Correction
 
 

Reasons for adding or updating:

  • Change to section 4.3 - Contraindications
  • Change to section 4.4 - Special warnings and precautions for Use
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.8 - Undesirable Effects
  • Change to section 4.2 - Posology and method of administration
  • Change to section 6.2 - Incompatibilities

Date of revision of text on the SPC:01-05-2007

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

Sections:

4.3 Contraindications

Additional contraindication regarding use of voriconazole with St John’s Wort

 

4.4 Special Warnings and precautions for use

Warning regarding the monitoring of pancreatic patients especially children.

 

4.5 Interaction with other medicinal products and other forms of interaction

Interaction with St John’s Wort.

 

4.8 Undesirable effects

Additional wording regarding post-marketing reports of pancreatitis in paediatric patients.

 

 

Vfend 200 mg powder for solution for infusion ONLY

 

4.2 Posology and method of administration

Wording regarding electrolyte solutions

 

6.2 Incompatabilities

Revised wording regarding infusion of concentrated solutions of electrolytes.

Reasons for adding or updating:

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 3 - Pharmaceutical form
  • Change to section 4.1 - Therapeutic indications
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.3 - Contraindications
  • Change to section 4.4 - Special warnings and precautions for Use
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.6 - Pregnancy and Lactation
  • Change to section 4.7 - Effects on Ability to Drive and Use Machines
  • Change to section 4.8 - Undesirable Effects
  • Change to section 5.1 - Pharmacodynamic Properties
  • Change to section 5.2 - Pharmacokinetic Properties
  • Change to section 6.1 - List of Excipients
  • Change to section 6.2 - Incompatibilities
  • Change to section 6. 3 - Shelf Life
  • Change to section 6. 4 - Special Precautions for Storage
  • Change to section 6. 5 - Nature and Contents of Container
  • Change to section 6. 6 - Instructions for use, handling and disposal
  • Change to section 9 - Date of first Authorisation/renewal of the Authorisation
  • Change to section 10 date of revision of the text

Date of revision of text on the SPC:01-05-2007

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

 

2. – Addition of excipient name and addition of reconstitution information for the “powder for solution for infusion” and “powder for oral suspension”.

3. – Simplified description for the pharmaceutical form for the “powder for solution for infusion” and the “powder for oral suspension”.

4.1 – Deleted VFEND from first sentence.

4.2 – Additional paragraph for the “powder for solution for infusion” regarding method of administration.

4.2 – Warning regarding “Use in children”

4.2 – Information about dosing in “adolescents (12 to 16 years of age)”

4.3 – Rewording of sentence regarding “hypersensitivity”

4.4 – “Cardiovascular” section – correction in spelling of “torsades”

4.4 – Addition of a title for information regarding “coadministration of voriconazole and lose dose ritonavir”

4.4 – Addition of a sodium warning for “Vfend powder for infusion”.

4.5 – Administrative changes

4.6 – Pregnancy – administrative change

4.7 – Additional sentence on the “effects on ability to drive and use machines”

4.8 – Re-ordering of information in the table of adverse events by system organ class and frequency.  

5.1 – Administrative changes

5.2 – Administrative changes

6.1 – Removal of the amount of sucrose for the “Powder for oral suspension”

6.2 – For the “Powder for solution for infusion”, information has been added regarding “blood products and electrolyte supplementation” and “total parenteral nutrition”

6.3 – For the “Powder for oral suspension” additional information has been added regarding the constituted suspension.

6.4 – Additional sentences regarding “storage” for the Powder for solution for infusion and the powder for oral suspension.

6.5 – Administrative changes

6.6 – More detail regarding handling and disposal

9 – New date for “date of last renewal”

10 – New date for “date of last revision of text”

Reasons for adding or updating:

  • Change to section 4.3 - Contraindications
  • Change to section 4.4 - Special warnings and precautions for Use
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction

Date of revision of text on the SPC:01-10-2006

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

sections 4.3, 4.4 and 4.5 to reflect dose adjustment of voriconazole when used with efavirenz.

Reasons for adding or updating:

  • Change to section 4.5 - Interactions with other Medicaments and other forms of Interaction

Date of revision of text on the SPC:01-05-2006

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

Reason for Submission: Change to section 4.5 - Interactions with other Medicaments and other forms of Interaction

Reasons for adding or updating:

  • Change to section 10 (date of (partial) revision of the text

Date of revision of text on the SPC:01-05-2006

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

 
Reason for Submission: Change to section 10 (date of (partial) revision of the text

Reasons for adding or updating:

  • Change to section 4.5 - Interactions with other Medicaments and other forms of Interaction

Date of revision of text on the SPC:01-05-2006

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

4.5 Interaction with other medicinal products and other forms of interaction

Reasons for adding or updating:

  • Change to section 4.4 - Special Warnings and Precautions for Use
  • Change to section 4.5 - Interactions with other Medicaments and other forms of Interaction
  • Change to section 4.2 - Posology and Method of Administration
  • Change to section 4.3 - Contra-indications
  • Change to section 4.8 - Undesirable Effects
  • Change to section 5.1 - Pharmacodynamic Properties
  • Change to section 10 (date of (partial) revision of the text

Reasons for adding or updating:

  • Change to section 4.2 - Posology and Method of Administration
  • Change to section 4.4 - Special Warnings and Precautions for Use
  • Change to section 4.8 - Undesirable Effects
  • Change to section 5.1 - Pharmacodynamic Properties
  • Change to section 5.2 - Pharmacokinetic Properties

Reasons for adding or updating:

  • Change to section 6. 3 - Shelf Life

Reasons for adding or updating:

  • Change to section 6. 3 - Shelf Life

Reasons for adding or updating:

  • Change to section 4.1 - Therapeutic Indications
  • Change to section 4.8 - Undesirable Effects
  • Change to section 5.1 - Pharmacodynamic Properties
  • Change to section 4.4 - Special Warnings and Precautions for Use

Reasons for adding or updating:

  • Change to section 4.8 - Undesirable Effects
  • Change to section 6.1 - List of Excipients

Reasons for adding or updating:

  • Change to joint SPC covering all presentations
  • Removal of Black Triangle
  • Change to section 4.8 - Undesirable Effects
  • Change to section 4.5 - Interactions with other Medicaments and other forms of Interaction
  • Change to section 4.3 - Contra-indications

Reasons for adding or updating:

  • Change to section 4.2 - Posology and Method of Administration
  • Change to section 4.4 - Special Warnings and Precautions for Use
  • Change to section 4.8 - Undesirable Effects

Reasons for adding or updating:

  • Improved Electronic Presentation

Reasons for adding or updating:

  • New SPC for new product