Eviplera 200 mg/25 mg/245 mg film-coated tablets

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 29/07/19

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Summary of Product Characteristics last updated on medicines.ie: 29/7/2019

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Gilead Sciences Ltd

Gilead Sciences Ltd

Company Products

Medicine NameActive Ingredients
Medicine Name AmBisome (Liposomal Amphotericin) Active Ingredients Amphotericin B
Medicine Name Atripla 600 mg/200 mg/245 mg film- coated tablets Active Ingredients Efavirenz, Emtricitabine, Tenofovir disoproxil fumarate
Medicine Name Biktarvy 50 mg/200 mg/25 mg film-coated tablets Active Ingredients Emtricitabine, Tenofovir alafenamide fumarate, Bictegravir sodium
Medicine Name Cayston 75 mg powder and solvent for nebuliser solution Active Ingredients Aztreonam lysine
Medicine Name Descovy 200 mg/10 mg film-coated tablets Active Ingredients Emtricitabine, Tenofovir alafenamide fumarate
Medicine Name Descovy 200 mg/25 mg film-coated tablets Active Ingredients Emtricitabine, Tenofovir alafenamide fumarate
Medicine Name Emtriva 10 mg/ml oral solution Active Ingredients Emtricitabine
Medicine Name Emtriva 200 mg hard capsules Active Ingredients Emtricitabine
Medicine Name Epclusa 400 mg/100 mg film coated tablets. Active Ingredients Sofosbuvir, Velpatasvir
Medicine Name Eviplera 200 mg/25 mg/245 mg film-coated tablets Active Ingredients Emtricitabine, Rilpivirine Hydrochloride, Tenofovir disoproxil fumarate
Medicine Name Genvoya 150mg/150mg/200mg/10mg film coated tablets Active Ingredients Cobicistat, Elvitegravir, Emtricitabine, Tenofovir alafenamide fumarate
Medicine Name Harvoni 90 mg/400 mg film-coated tablets Active Ingredients Ledipasvir, Sofosbuvir
Medicine Name Hepsera 10 mg tablets Active Ingredients Adefovir dipivoxil
Medicine Name Odefsey 200 mg/25 mg/25 mg film-coated tablets Active Ingredients Emtricitabine, Rilpivirine Hydrochloride, Tenofovir alafenamide fumarate
Medicine Name Sovaldi 400 mg film coated tablets Active Ingredients Sofosbuvir
Medicine Name Stribild 150 mg/150 mg/200 mg/245 mg film coated tablets Active Ingredients Cobicistat, Elvitegravir, Emtricitabine, Tenofovir disoproxil fumarate
Medicine Name Truvada film-coated tablets Active Ingredients Emtricitabine, Tenofovir disoproxil fumarate
Medicine Name Tybost 150mg film coated tablets Active Ingredients Cobicistat
Medicine Name Vemlidy 25 mg film coated tablets Active Ingredients Tenofovir alafenamide fumarate
Medicine Name Viread 245 mg film-coated tablets Active Ingredients Tenofovir disoproxil fumarate
Medicine Name Vosevi 400 mg/100 mg/100 mg film coated tablets Active Ingredients Sofosbuvir, Velpatasvir, Voxilaprevir
Medicine Name YESCARTA (axicabtagene ciloleucel) Active Ingredients Axicabtagene Ciloleucel
Medicine Name Zydelig (idelalisib) 100mg Active Ingredients Idelalisib
Medicine Name Zydelig (idelalisib) 150mg Active Ingredients Idelalisib
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When a pharmaceutical company changes any document, a new version is published on medicines.ie. For each version, we show the dates it was published on medicines.ie and the reasons for change.

Updated on 29 July 2019 PIL

Reasons for updating

  • Change to section 6 - date of revision

Updated on 29 July 2019 SmPC

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.9 - Overdose
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

Update to section 4.9 to remove recommendation to use oral activated charcoal in the event of an overdose with rilpivirine.

The opportunity was taken to make administrative changes to update the lactose wording to align with excipients guidance and updates to section 5.1 to reflect the full waiver fo the PIP

Updated on 31 October 2018 SmPC

Reasons for updating

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

Legal category: Product subject to medical prescription which may not be renewed (A)

Updated on 29 August 2018 PIL

Reasons for updating

  • Change to section 2 - interactions with other medicines, food or drink

Updated on 29 August 2018 SmPC

Reasons for 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

Legal category: Product subject to medical prescription which may not be renewed (A)

Updated on 5 June 2018 SmPC

Reasons for updating

  • Change to section 7 - Marketing authorisation holder

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

Approval of MA Transfer application changing the Eviplera MA Holder (MAH) from Gilead Sciences International Ltd., Cambridge - UK (GSIL; ‘transferor’) to Gilead Sciences Ireland UC, Cork - Ireland (GSIUC; ‘transferee’) as a result of ‘BREXIT’. The full details of the new MAH is:

 

Gilead Sciences Ireland UC

Carrigtohill

County Cork, T45 DP77

Ireland

Updated on 5 June 2018 PIL

Reasons for updating

  • Change to section 6 - marketing authorisation holder

Updated on 3 January 2018 SmPC

Reasons for updating

  • New SmPC for new product

Legal category: Product subject to medical prescription which may not be renewed (A)

Updated on 3 January 2018 SmPC

Reasons for 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 4.6 - Pregnancy and lactation
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

$0$0Updatesto section 4.2 (Posology and method of administration), 4.4 (Specialwarnings and precautions for use), 4.6 (Fertility, pregnancy andlactation), 5.1 (Pharmacodynamic properties) 5.2 (Pharmacokineticproperties) in line with Study TMC114HIV3015, additional pregnancydata.$0$0

Updated on 2 January 2018 PIL

Reasons for updating

  • New PIL for new product

Updated on 2 January 2018 PIL

Reasons for updating

  • Change to section 2 - pregnancy, breast feeding and fertility
  • Change to section 6 - date of revision

Updated on 23 October 2017 SmPC

Reasons for 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

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

$0$0Updatesto section 4.5: deletion of telaprevir DDI due to the withdrawal oftelaprevir from the EU. $0$0Updatesto section 4.5: with simeprevir DDI (no interaction) per CCDS$0$0

Updated on 19 October 2017 PIL

Reasons for updating

  • Change to section 6 - date of revision
  • Change to other sources of information section

Updated on 6 June 2017 SmPC

Reasons for updating

  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.8 - Undesirable effects

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

Variation to update the product information (PI) annexes of the TDF- and TAF-containing products with data from Studies GS-US-342-1167/1326, two drug-drug interaction studies between Epclusa (sofosbuvir/velpatasvir; SOF/VEL) and HIV antiretroviral regimens. Sections 4.4 and 4.5 of the Summary of Product Characteristics (SmPC) and Section 2 of the Patient Information Leaflet (PIL) have been updated for Viread (all strengths), Truvada, Stribild and Atripla. Section 4.5 of the SmPC has been updated for Eviplera, Genvoya, Descovy and Odefsey.

 

Note, an administrative edit has been done in Section 4.8 of the SmPC for Viread for all strengths, Stribild, Atripla and Eviplera (not required for Truvada). This administrative update was required to align with the table ‘Tabulated summary of AR associated with ‘XXX’ based on clinical study and post marketing experience’.

 

We took the opportunity of this application to submit minor linguistics amendments

Updated on 5 August 2016 SmPC

Reasons for updating

  • Removal of black triangle
  • 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 4.9 - Overdose
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 5.3 - Preclinical safety data
  • Change to section 6.1 - List of excipients
  • Change to section 9 - Date of renewal of authorisation
  • Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

$0·Renewalapproved with unlimited validity. $0$0·Renewalrequires no amendments to the terms of the Community Marketing Authorisation.$0$0·Basedon the review of quality, safety and efficacy data, including all variationsintroduced since the Marketing Authorisation was granted, the risk-benefitbalance of Eviplera remains unchanged.$0$0·Renewalapproved with updates to the Eviplera product information (in particular toSmPC sections 4.1, 4.4, 4.5, 4.6, 4.7, 4.8, 4.9, 5.3, 9; Annex IIIa[label/carton] and; Annex IIIb [PIL] sections 1-4). Gilead also took thisopportunity to implement EU QRD template updates and other administrativeupdates throughout the Eviplera product information.$0$0 $0$0Furthermore, this approval alsoincludes the endorsement to removethe black triangle’ status fromEviplera which means that additional safety monitoring of Eviplera is no longerrequired.$0

Updated on 29 July 2016 PIL

Reasons for updating

  • Change of trade or active ingredient name
  • Change to warnings or special precautions for use
  • Change of contraindications
  • Change to instructions about missed dose
  • Change to side-effects
  • Change to date of revision
  • Change to marketing authorisation holder
  • Addition of information on alternative format leaflets
  • Removal of black triangle

Updated on 17 May 2016 SmPC

Reasons for 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 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company



·         Section 4.4

 

o    Revise the HIV class label wording on mitochondrial dysfunction following the review of existing data on mitochondrial toxicity including the Mitochondrial Toxicity in Children (MITOC) Study

o    The PILs were also updated accordingly

 

·         Sections 4.4 and 4.5  

o     Addition of a warning update to the safety information with the potential drug interaction of ledipasvir/sofosbuvir (LDV/SOF), as well as that of LDV and SOF as single agents with tenofovir disoproxil fumarate

o    The PILs were also updated accordingly

 

 

 

 

 

 

 

Updated on 13 May 2016 PIL

Reasons for updating

  • Change to side-effects
  • Change to information about pregnancy or lactation
  • Change to date of revision
  • Change to MA holder contact details

Updated on 15 February 2016 SmPC

Reasons for 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

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

Sections 4.4 & 4.8:

- Update to delete previous lipodystrophy class labelling text and, to add new class labelling regarding weight and metabolic parameters (blood lipids and glucose).

Section 10:

- Change to the date of revision to January 2016.

Updated on 12 February 2016 PIL

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to side-effects
  • Change to date of revision

Updated on 28 January 2016 SmPC

Reasons for updating

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

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

Section 4.4:

- Inclusion to state that the most pronounced decreases in bone mineral density were seen in patients treated with tenofovir DF as part of a regimen containing a boosted protease inhibitor, and also to advise that alternative treatment regimens should be considered for patients with osteoporosis that are at a high risk for fractures, in line with HIV European guidelines.

Section 10:

- Change to the date of revision to December 2015.

Updated on 6 November 2015 SmPC

Reasons for 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

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

• Section 4.4: Addition of the warning regarding the cases of severe skin reactions
• Section 4.8: Inclusion of the warning regarding the severe skin reactions to the tabulated summary of adverse reactions
• Section 10: Change to the date of revision to September 2015

Updated on 5 November 2015 PIL

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to side-effects
  • Change to date of revision

Updated on 24 June 2015 SmPC

Reasons for 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

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

Sections 4.4 & 4.8:

- Removal of the warnings related to lactic acidosis

Section 10:

- Change to the date of revision to May 2015

Updated on 22 June 2015 PIL

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to date of revision

Updated on 13 March 2015 PIL

Reasons for updating

  • Change to date of revision
  • Change to name of manufacturer

Updated on 22 September 2014 SmPC

Reasons for updating

  • Change to section 6.3 - Shelf life
  • Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

• Section 6.3: Shelf life extension of Eviplera tablets from 2 years to 3 years
• Section 10: Change to the date of revision to September 2014

Updated on 3 September 2014 SmPC

Reasons for 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

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

Section 4.4 of the SmPC:

- Addition of safety information on the risk of renal injury in patients with risk factors for renal dysfunction after co-administration of non-steroidal anti-inflammatory drugs (NSAIDs) with tenofovir.
- Change of wording around the monitoring of renal function “In patients at risk for renal impairment consideration should be given to a more frequent monitoring of renal function is required.”/ “Interrupting treatment with Eviplera should also be considered in case of progressive decline of renal function when no other cause has been identified.”

Section 4.8 of the SmPC:

- Addition of information about proximal renal tubulopathy.

Section 10 of the SmPC:

- Change to the date of revision to July 2014.

Updated on 28 August 2014 PIL

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to date of revision

Updated on 8 August 2014 SmPC

Reasons for updating

  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 7 - Marketing authorisation holder
  • Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

- Section 5.1: Addition of the tenofovir resistance-associated substitution K70E, and the combination of L100I+K103N as a rilpivirine resistance-associated substitution to the list of exclusion mutations for Eviplera
- Section 7: To correct an error in the Marketing Authorisation Holder name (Limited changed to Ltd)
- Section 10: Change to the date of revision to June 2014

Updated on 4 August 2014 PIL

Reasons for updating

  • Change to date of revision
  • Change to marketing authorisation holder

Updated on 7 April 2014 SmPC

Reasons for updating

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

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

·         Update to section 4.4 of the SmPC “Special warnings and precautions for use” to revise the wording regarding the risk of sexual transmission of HIV infection following CHMP request adopted in December 2013.

Updated on 2 April 2014 PIL

Reasons for updating

  • Change to, or new use for medicine

Updated on 4 February 2014 SmPC

Reasons for 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

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

·         Update to section 4.5 - information that rilpivirine is an in-vitro inhibitor of the transporter MATE-2K with an IC50 of <2.7 nm and the clinical implication is unknown

 

·         Update to section 4.5 - information on interaction between rifapentin and rilpivirin (co-administration contra indicated)

 

·         Update to section 4.5 - information on interaction between rilpivirine and metformin (no dose adjustment is required)

 

·         Change to the date of revision in section 10

Updated on 30 January 2014 PIL

Reasons for updating

  • Change of contraindications
  • Change to date of revision

Updated on 11 December 2013 SmPC

Reasons for 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 5.2 - Pharmacokinetic properties
  • Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company


·         The Eviplera indication has been amended in section 4.1 to


"Eviplera is indicated for the treatment of adults infected with human immunodeficiency virus type 1 (HIV-1) without known mutations associated with resistance to the non-nucleoside reverse transcriptase inhibitor (NNRTI) class, tenofovir or emtricitabine, and with a viral load ≤100,000 HIV-1 RNA copies/mL (see sections 4.2, 4.4 and 5.1).


As with other antiretroviral medicinal products, genotypic resistance testing and/or historical resistance data should guide the use of Eviplera (see sections 4.4 and 5.1)."

·         The appropriate sections of the SmPC (sections 4.8, 5.1 & 5.2) have been updated to include data from the two switch studies (GS-US-264-0106 & GS-US-264-0111)

 

·         Change to the date of revision in section 10

Updated on 6 December 2013 PIL

Reasons for updating

  • Change to, or new use for medicine
  • Change to date of revision

Updated on 6 November 2013 SmPC

Reasons for updating

  • Addition of black triangle
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.3 - Contraindications
  • 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

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

  • Addition of the black triangle with a specific statement.
  • Update to sections 4.2, 4.3 and 4.5 of the Eviplera SmPC: rifabutin is no longer contraindicated with Eviplera, a dose adjustment is however required

Updated on 25 October 2013 PIL

Reasons for updating

  • Change to, or new use for medicine
  • Change to warnings or special precautions for use
  • Change to MA holder contact details
  • Addition of black triangle

Updated on 24 June 2013 SmPC

Reasons for 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

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company


- Sections 4.4 and 4.8 of the SPC have been updated to include the below wording:

 

·         “Autoimmune disorders (such as Graves’ disease) have also been reported to occur in the setting of immune reactivation; however, the reported time to onset is more variable and these events can occur many months after initiation of treatment”

 

- Additional changes to sections 4.4 and 4.8 are as follows:

 

  • Expression of combination antiretroviral therapy (CART) was amended throughout sections 4.4 and 4.8 of the SPC

 

Section 10

 

- Change to date of revision to May 2013

Updated on 21 June 2013 PIL

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to date of revision

Updated on 2 April 2013 SmPC

Reasons for updating

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

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

Changes to:

4.5     Interaction with other medicinal products and other forms of interaction

 

P‑glycoprotein substrates: Rilpivirine inhibits P‑glycoprotein in vitro (IC50 is 9.2 μM).  In a clinical study rilpivirine did not significantly affect the pharmacokinetics of digoxin.  However, it may not be completely excluded that rilpivirine can increase the exposure to other drugs transported by P‑glycoprotein that are more sensitive to intestinal P‑glycoprotein inhibition (e.g. dabigatran etexilate).

 

 

Please see page 15; Table 1  of the SPC: ANTIARRHYTHMICS

 

 

10. Date of Revision - 02/2013

Updated on 27 March 2013 PIL

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to date of revision

Updated on 25 February 2013 SmPC

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

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

SPC

 

Update of section 4.2:

 

  • The recommended dose of Eviplera is one tablet, taken orally, once daily.  Eviplera must be taken with food

 

  • ‘meal’ replaced with the word ‘food’ throughout the document

 

 

Update of section 5.2:

 

  • following results of clinical study GS-US-264-0112 “A Phase 1 Study to Determine the Effect of Food on the Pharmacokinetics of Emtricitabine/Rilpivirine/Tenofovir DF Single Tablet Regimen”

 

The administration of Eviplera to healthy adult subjects with either a light meal (390 kcal) or a standard meal (540 kcal) resulted in increased exposures of rilpivirine and tenofovir relative to fasting conditions.  The Cmax and AUC of rilpivirine increased by 34% and 9% (light meal) and 26% and 16% (standard meal), respectively.  The Cmax and AUC for tenofovir increased by 12% and 28% (light meal) and 32% and 38% (standard meal), respectively.  Emtricitabine exposures were not affected by food. 

 

Update of section 10:

 

  • update to date of revision to January 2013

Updated on 22 February 2013 PIL

Reasons for updating

  • Change to, or new use for medicine
  • Change to date of revision

Updated on 31 January 2013 SmPC

Reasons for updating

  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company



Section 5.1:
Update to include Y188L as a rilpivirine resistance- associated mutation (RAM)

Section 10: Date changed for the revision of the text to December 2012

Updated on 10 January 2013 SmPC

Reasons for 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

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company


Section 4.5: Update to the interaction table to include information following the results of the rilpivirine- telaprevir study

Section 10: Date changed for the revision of the text to November 2012

Updated on 12 November 2012 SmPC

Reasons for updating

  • Change to section 4.1 - Therapeutic indications
  • 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 5.1 - Pharmacodynamic properties
  • Change to section 6.1 - List of excipients
  • Change to section 9 - Date of renewal of authorisation
  • Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

Updates/amendments to Section:

 

4.1 – Removal of paragraph describing the design of the registration study

 

4.4 – Information to reflect the 96 weeks data of the TMC278-C209 and TMC278-C215 trials

 

4.5 – Update to Table 1: interaction with raltegravir.

 

4.8 - Update to Table 2: tabulated summary of adverse reactions – inclusion of RPV related reactions and Information to reflect the 96 weeks data of the TMC278-C209 and TMC278-C215 trials.

 

5.1 - Information to reflect the 96 weeks data of the TMC278-C209 and TMC278-C215 trials and the 240-week data of the TMC278-C204 trial.

 

6.1 - to correct a minor typographical error in the number associated with magnesium stearate

 

9 - To include the date of the first marketing authorisation.

 

10 – Update to date of revision

Updated on 5 November 2012 PIL

Reasons for updating

  • Change to storage instructions
  • Change to side-effects
  • Change to date of revision
  • Change to MA holder contact details

Updated on 3 August 2012 SmPC

Reasons for updating

  • New SPC for new product

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

None provided

Updated on 1 December 2011 PIL

Reasons for updating

  • New PIL for new product