Pegasys 135 and 180 micrograms solution for injection in pre-filled pen

  • Name:

    Pegasys 135 and 180 micrograms solution for injection in pre-filled pen

  • Company:
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  • Active Ingredients:

    Peginterferon alfa-2a

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

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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 25 September 2019 SmPC

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No content change.

Updated on 22 March 2018 SmPC

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  • New SmPC for new product

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Updated on 22 March 2018 SmPC

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

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7.       MARKETING AUTHORISATION HOLDER

​​

Roche Registration GmbH

Emil-Barell-Strasse 1

79639 Grenzach-Wyhlen

Germany

Roche Registration Limited

6 Falcon Way

Shire Park

Welwyn Garden City

AL7 1TW

United Kingdom

​​​​​​

​​

 

10.     DATE OF REVISION OF THE TEXT

 

15 March 2018

 

 

 

Updated on 21 March 2018 PIL

Reasons for updating

  • New PIL for new product

Updated on 21 March 2018 PIL

Reasons for updating

  • Change to section 6 - marketing authorisation holder
  • Change to section 6 - date of revision

Updated on 17 November 2017 SmPC

Reasons for 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
  • Change to section 5.2 - Pharmacokinetic properties

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

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4.1     Therapeutic indications

 

Chronic hepatitis B

 

Adult patients

 

Pegasys is indicated for the treatment of hepatitis B envelope antigen (HBeAg)-positive or HBeAg-negative chronic hepatitis B (CHB) in adult patients with compensated liver disease and evidence of viral replication, increased ALTalanine aminotransferase (ALT) and histologically verified liver inflammation and/or fibrosis (see sections 4.4 and 5.1).

 

Paediatric patients 3 years of age and older

 

Pegasys is indicated for the treatment of HBeAg-positive CHB in non-cirrhotic children and adolescents 3 years of age and older with evidence of viral replication and persistently elevated serum ALT levels. With respect to the decision to initiate treatment in paediatric patients see sections 4.2, 4.4 and 5.1.

[...]

 

4.2     Posology and method of administration

 

[...]

Table 1: Dosing recommendations for combination therapy for HCVadult patients with chronic hepatitis C
[...]

Table 2: Predictive value of week 12 virological response at the recommended dosing regimen while on Pegasys combination therapy in adult patients with chronic hepatitis C
[...]

Haematological (see also Table 3)

For adults, dose reduction is recommended if the absolute neutrophil count (ANC) is 500 to < 750 cells/mm3. For patients with Absolute Neutrophil Count (ANC) < 500 cells/mm3 treatment should be suspended until ANC values return to > 1000 cells/mm3. Therapy should initially be re-instituted at 90 micrograms Pegasys and the neutrophil count monitored. Guidance for dose reduction based on ANC levels for paediatric patients is provided in Table 7.

 

Dose reduction to 90 micrograms is recommended if the platelet count is 25,000 to < 50,000 cells/mm3. Cessation of therapyTreatment discontinuation is recommended when platelet count decreases to levels < 25,000 cells/mm3.

[...]

Table 3: Dose adjustment for adverse reactionreactions in adult patients (for further guidance see also text above)

[...]

Liver function

Fluctuations in abnormalities of liver function tests are common in patients with chronic hepatitis C.CHC. Increases in ALT levels above baseline (BL) have been observed in patients treated with Pegasys, including patients with a virological response.

In chronic hepatitis CCHC clinical trials with adult patients, isolated increases in ALT ( 10x upper limit of normal [ULN,], or ≥ 2x BL for patients with a BL ALT ≥ 10x ULN) which resolved without dose-modification were observed in 8 of 451 patients treated with combination therapy. If ALT increase is progressive or persistent, the dose should be reduced initially to 135 micrograms. When increases in ALT levels are progressive despite dose reduction, or are accompanied by increased bilirubin or evidence of hepatic decompensation, therapy should be discontinued (see section 4.4). Guidance for dose reduction based on ALT levels for paediatric patients is provided in Table 7.

 

For chronic hepatitis BCHB patients, transient flares of ALT levels sometimes exceeding 10 times the upper limit of normal10x ULN are not uncommon, and may reflect immune clearance. Treatment should normally not be initiated if ALT is >10 times the upper limit of normal.10x ULN. Consideration should be given to continuing treatment with more frequent monitoring of liver function during ALT flares. If the Pegasys dose is reduced or withheld, therapy can be restored once the flare is subsiding (see section 4.4).

 

[...]

For children and adolescents aged 5 to 17 years with chronic hepatitis C, and having a Body Surface Area (BSA) greater than 0.7 m2, the recommended doses for Pegasys and ribavirin are provided in Table 4 and Table 5. It is recommended that Pegasys pre-filled syringes be used for paediatric patients. The Pegasys pre-filled pens do not allow for appropriate adjustment of dosing in these patients. Patients who initiate treatment prior to their 18th birthday should maintain paediatric dosing through the completion of therapy.

 

The posology of Pegasys should not be used in children with ain paediatric patients is based on the Body Surface Area (BSA) less than 0.71 as there is no available data for this subpopulation.

 

[...]

The recommended duration of therapy is 48 weeks in patients with CHB.

Before initiating therapy for CHB, persistently elevated serum ALT levels should have been documented. The response rate was lower in patients with no to minimal increase in ALT level at baseline (see Section 5.1).

[...]

For children and adolescents aged 3 to 17 years with CHB and having a BSA greater than 0.54 m2 and for children and adolescents aged 5 to 17 years with CHC and having a BSA greater than 0.71 m2, the recommended doses for Pegasys are provided in Table 4.

 

Table 4: Pegasys dosing recommendations for paediatric patients aged 5 to 17 yearswith chronic hepatitis B and chronic hepatitis C

[...]

ALT levels above upper limit of normal should repeatedly have been documented before initiating therapy for hepatitis B. The response rate was lower in patients with no to minimal increase in ALT level at baseline (see Section 5.1).

For paediatric patients, based on toxicities, up to three levels of dose modification can be made before dose interruption or discontinuation is considered (see Table 5).

 

Table 5: Pegasys dose modification recommendations in paediatric patients with chronic hepatitis B or chronic hepatitis C

[...]

Recommendations for dose modifications of Pegasys for toxicities in the CHB and CHC paediatric populations are presented in Table 6.

 

Table 6: Pegasys dose modification recommendations for toxicities in paediatric patients with chronic hepatitis B or chronic hepatitis C

[...]

Dose adjustment for adverse reactions in paediatric patients

based on toxicities (see Table 6), up to three levels of dose modification can be made before dose interruption or discontinuation is considered.

 6: Pegasys dose modification recommendations in paediatric patients

 

If toxicities occur which may be related to Pegasys and/or ribavirin administration, the dose of one or both medicinal products can be reduced. Additionally, ribavirin or Pegasys plus ribavirin combination therapy can be discontinued. It is important to note that ribavirin should never be given as monotherapy. Recommendations for dose modifications for toxicities known to have an association with Pegasys administration that are specific for the paediatric population are presented in Table 7. Unless otherwise noted, the management of all other toxicities should follow the adult recommendations.

 

Table 7: Pegasys dose modification recommendations for toxicities in paediatric patients

[...]

Table 8: Ribavirin dose modification recommendations in paediatric patients with chronic hepatitis C
[...]

4.4     Special warnings and precautions for use

[...]

 

Growth and development (children and adolescents):

 

During the course oftherapy with Pegasys plus+/-  ribavirin therapy lasting up to 48 weeks in patients aged 53 to 17 years, weight loss and growth inhibition were common (see sections 4.8 and 5.1).

 

The expected benefit of treatment should be carefully weighed against the safety findings observed for children and adolescents in the clinical trials on a case by case basis (see sections 4.8 and 5.1). It is important to consider the treatment with Pegasys +/- ribavirin the combination therapy for CHC induced a growth inhibition during treatment, the reversibility of which is uncertain.

-        It is important to consider that the combination therapy induced a growth inhibition during treatment, the reversibility of which is uncertain.

-           This risk

The risk of growth inhibition should be weighed against the disease characteristics of the child, such as evidence of disease progression (notably fibrosis), co-morbidities that may negatively influence the disease progression (such as HIV co-infection), as well as prognostic factors of response (HCV genotype and viral loadfor HBV-infection mainly HBV genotype and ALT levels; for HCV-infection mainly HCV genotype and HCV-RNA levels) (see section 5.1).

 

Whenever possible the child should be treated after the pubertal growth spurt, in order to reduce the risk of growth inhibition. There are no data on long term effects on sexual maturation.
[...]

 

Summary of the safety profile

 

Chronic hepatitis C

 

The frequency and severity of the most commonly reported adverse reactions with Pegasys are similar to those reported with interferon alfa-2a (see Table 9).The most frequently reported adverse reactions with Pegasys 180 micrograms were mostly mild to moderate in severity and were manageable without the need for modification of doses or discontinuation of therapy.

 

Chronic hepatitis B in adult patients

 

[...]

Chronic hepatitis C in adult patients

 

The frequency and severity of the most commonly reported adverse reactions with Pegasys are similar to those reported with interferon alfa-2a (see Table 9).The most frequently reported adverse reactions with Pegasys 180 micrograms were mostly mild to moderate in severity and were manageable without the need for modification of doses or discontinuation of therapy.

 

[...]

 

In HIV-HCV co-infected patients, the clinical adverse reaction profiles reported for Pegasys, alone or in combination with ribavirin, were similar to those observed in HCV mono-infected patients. For
[...]

Table 9: Undesirable effects reported with Pegasys monotherapy for HBVCHB or HCVCHC or in combination with ribavirin for HCVCHC patients in clinical trials and post marketing

[...]

Chronic hepatitis B

 

In a clinical trial (YV25718) with 111 paediatric patients (3 to 17 years of age) treated with Pegasys for 48 weeks, the safety profile was consistent with that seen in adults with CHB and in paediatric patients with CHC.

 

The mean changes from baseline in height and weight for age Z-scores at Week 48 of treatment in study YV25718 were -0.07 and -0.21 (n=108 and n= 106 respectively) for Pegasys-treated patients as compared to - 0.01 and -0.08 (n=47 each) in untreated patients. At Week 48 of Pegasys treatment, a height or weight percentile decrease of more than 15 percentiles on the normative growth curves was observed in 6% of patients for height and 11% of patient for weight, whereas in the untreated group it was 2% of patients for height and 9% for weight. No data is available on long-term follow-up post-treatment in these patients (see section 4.4).

 

Chronic hepatitis C

 

[...]

Growth inhibition was observed in paediatric patients (see section 4.4). Paediatric patients treated with Pegasys plus ribavirin combination therapy showed a delay in weight and height increases after 48 weeks of therapy compared with baseline. Patient ‘weight for age’ and ‘height for age’ percentiles of the normative population decreased during treatment. At the end of 2 years follow-up after treatment, most patients had returned to baseline normative growth curve percentiles for weight and height (mean weight percentile was 64% at baseline and 60% at 2 years post-treatment; mean height percentile was 54% at baseline and 56% at 2 years post-treatment). At the end of treatment, 43% of patients experienced a weight percentile decrease of 15 percentiles or more, and 25% (13 of 53) experienced a height percentile decrease of 15 percentiles or more on the normative growth curves. At 2 years post-treatment, 16% (6 of 38) of patients remained 15 percentiles or more below their baseline weight curve and 11% (4 of 38) remained 15 percentiles or more below their baseline height curve.

 

55% (21 of 38) of subjects who completed the original study enrolled in the long-term follow up extending up to 6 years post-treatment. The study demonstrated that the post-treatment recovery in growth at 2 years post-treatment was maintained to 6 years post-treatment. For a few subjects who were more than 15 percentiles below their baseline height curve at 2 years post-treatment, they either returned to baseline comparable height percentiles at 6 years post-treatment or a non-treatment related causative factor has been identified. The extent of available data is not sufficient to conclude that growth inhibition due to Pegasys exposure is always reversible.

 

[...]

United Kingdom

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Website: www.mhra.gov.uk/yellowcard or search
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[...]

5.1     Pharmacodynamic properties

 

[...]

Chronic hepatitis B

 

Study YV25718 was conducted in previously untreated paediatric patients aged 3 to 17 years (51% < 12 years old) with HBeAg positive CHB and ALT > ULN but < 10 x ULN in two blood samples taken ≥ 14 days apart during the 6 months before the first dose of study drug. Patients with cirrhosis were not enrolled in this study. A total of 151 patients without advanced fibrosis were 2:1 randomized to Pegasys (group A, n=101) or untreated control (group B, n=50), respectively. Patients with advanced fibrosis were assigned to Pegasys treatment (group C, n=10). Patients in groups A and C (n=111) were treated with Pegasys once weekly for 48 weeks according to BSA categories, whereas patients in group B were observed for a period of 48 weeks (principal observation period). Patients in group B had the choice to switch to treatment with Pegasys after Week 48 of the principal observation period. All patients were followed up for 24 weeks post-treatment (groups A and C), or post-principal observation period (group B). After the Week 24 follow-up visit, patients from group A, B and C entered a long-term follow-up period (lasting for 5 years after end of treatment). Response rates in groups A and B at the end of 24 weeks follow-up are presented in Table 22. Efficacy response in group C to Pegasys treatment was in line with that seen in group A. For paediatric patients, efficacy has not been established in HBV genotypes other than genotypes A-D.

 

Table 22: Serological, virological and biochemical responses in paediatric patients with chronic hepatitis B

[...]

Table 23: HBeAg seroconversion rates (%) by HBV genotype and baseline ALT levels
[...]

Table 24: HBeAg seroconversion rates (%) by HBV-DNA decline from baseline to week 12 of Pegasys treatment in paediatric patients
[...]

5.2     Pharmacokinetic properties

[...]

Paediatric population

In a population pharmacokinetic study (NR16141),Pegasys pharmacokinetics have been characterized in paediatric patients with CHB (YV25718), as well as in paediatric patients with CHC (NR16141), using population pharmacokinetics.  In both studies, Pegasys apparent clearance and apparent volume of distribution were related linearly to body size ie. either BSA (NR16141) or body weight (YV25718).

 

From the YV25718 study, 31 paediatric patients 3 to 17 years of age with CHB participated in the PK sub-study and received Pegasys according to a BSA category dosing regimen. Based on the population pharmacokinetic model, the mean exposure (AUC) during the dosing interval for each BSA category was comparable with that observed in adults receiving 180 mcg fixed dosing.

 

From the NR16141study, 14 children 2 to 8 years of age with CHC received Pegasys monotherapy at a

Updated on 16 November 2017 PIL

Reasons for updating

  • Change to section 1 - what the product is used for
  • Change to section 2 - use in children and adolescents
  • Change to section 3 - use in children/adolescents
  • Change to section 4 - possible side effects

Updated on 9 June 2017 SmPC

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 10 - Date of revision of the text
  • Correction of spelling/typing errors

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

Free text change information supplied by the pharmaceutical company

4.2     Posology and method of administration

[....]

 

The recommended dosage and duration of Pegasys for both HBeAg-positive and HBeAg-negative chronic hepatitis B is 180 micrograms once weekly for 48 weeks by subcutaneous administration in the abdomen or thigh. For information on predictive values for on-treatment response, see section 5.1.

 

[....]

5.1     Pharmacodynamic properties

 

[....]

Predictability of response

 

A patient-level meta-analysis of 9 Pegasys clinical studies (n=1,423) in CHB HBeAg positive and HBeAg-negative patients demonstrated that HBsAg and HBV DNA levels at Week 12 of treatment, are predictive of final treatment outcome at Week 24 post-treatment in certain genotypes. Operating characteristics of these biomarkers are presented in Table 11. No single biomarker with a cut-off can be identified to optimizse all the operating characteristics (negative predictive value [NPV], sensitivity, specificity) and practical characteristics (simplicity, convenience). Consideration for early treatment discontinuation should be evaluated in the context of a particular clinical situation.

 

For HBeAg-positive patients with HBV genotype B and C infection, HBsAg > 20,000 IU/mL or HBV DNA > 8 log10 IU/mL at Week 12 following commencement of treatment is associated with high likelihood of failure to achieve HBeAg seroconversion and HBV-DNA <2,000 IU/mL at 24 week post-treatment (NPV > 90%). For HBV genotype A and D, subgroup size was insufficient to be analyzsed.

 

For HBeAg-negative patients with HBV genotype D infection, HBsAg > 20,000 IU/mL or HBV DNA > 6.5 log10 IU/mL at Week 12 following commencement of treatment is associated with high likelihood of failure to achieve HBV-DNA <2,000 IU/mL and ALT normalizsation at Week 24 post treatment. HBV genotype A subgroup size was insufficient to be analyzsed. No biomarker can be identified with acceptable performance for HBeAg-negative patients with HBV genotype B or C infection.

 

Other published on-treatment biomarkers that are predictive of the final outcome of Pegasys treatment may be considered.

 

Table 11: Performance of individual biomarkers at Week 12 of therapy in CHB HBeAg-positive and HBeAg-negative patients according to genotype

 

Genotype

Cut-off (IU/mL)

NPV

Sensitivity

Specificity

HBeAg-positive(a)

B

HBsAg > 20,000

0.93

0.96

0.23

HBV DNA > 8 log10

0.90

0.94

0.26

C

HBsAg > 20,000

0.96

0.97

0.22

HBV DNA > 8 log10

0.98

0.98

0.19

HBeAg-negative(a)

D

HBsAg > 20,000

0.91

0.94

0.16

HBV DNA > 6.5 log10

1.00

1.00

0.11

NPV= negative predictive value; Sensitivity = % of all responders not meeting the stopping rule; Specificity = % of all non-responders meeting stopping rule

(a)               Treatment response for HBeAg-positive patients was defined as HBeAg seroconversion (defined as loss of HBeAg and presence of anti-HBe) + HBV DNA <2,000 IU/mL at 6 months post-treatment and treatment response for HBeAg-negative patients was defined as HBV DNA < 2,000 IU/mL + ALT normalizsation at 6 months post-treatment.

 

 

[....]

 

The virological responses of HCV monoinfected patients treated with Pegasys and ribavirin combination therapy in relation to genotype and pre-treatment viral load and in relation to genotype, pre-treatment viral load and rapid virological response at week 4 are summarised in Table 134 and Table 145, respectively. The results of study NV15942 provide the rationale for recommending treatment regimens based on genotype, baseline viral load and virological response at week 4 (see Tables 1, 134 and 154).

[....]

10.     DATE OF REVISION OF THE TEXT

 

5 May 2017

 

 

Updated on 6 June 2017 SmPC

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • 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

4.2     Posology and method of administration

 [....]

 

The recommended dosage and duration of Pegasys for both HBeAg-positive and HBeAg-negative chronic hepatitis B is 180 micrograms once weekly for 48 weeks by subcutaneous administration in the abdomen or thigh. For information on predictive values for on-treatment response, see section 5.1.

 

[.....]

5.1     Pharmacodynamic properties

 

[.....]

Predictability of response

 

A patient-level meta-analysis of 9 Pegasys clinical studies (n=1,423) in CHB HBeAg positive and HBeAg-negative patients demonstrated that HBsAg and HBV DNA levels at Week 12 of treatment, are predictive of final treatment outcome at Week 24 post-treatment in certain genotypes. Operating characteristics of these biomarkers are presented in Table 11. No single biomarker with a cut-off can be identified to optimizse all the operating characteristics (negative predictive value [NPV], sensitivity, specificity) and practical characteristics (simplicity, convenience). Consideration for early treatment discontinuation should be evaluated in the context of a particular clinical situation.

 

For HBeAg-positive patients with HBV genotype B and C infection, HBsAg > 20,000 IU/mL or HBV DNA > 8 log10 IU/mL at Week 12 following commencement of treatment is associated with high likelihood of failure to achieve HBeAg seroconversion and HBV-DNA <2,000 IU/mL at 24 week post-treatment (NPV > 90%). For HBV genotype A and D, subgroup size was insufficient to be analyzsed.

 

For HBeAg-negative patients with HBV genotype D infection, HBsAg > 20,000 IU/mL or HBV DNA > 6.5 log10 IU/mL at Week 12 following commencement of treatment is associated with high likelihood of failure to achieve HBV-DNA <2,000 IU/mL and ALT normalizsation at Week 24 post treatment. HBV genotype A subgroup size was insufficient to be analyzsed. No biomarker can be identified with acceptable performance for HBeAg-negative patients with HBV genotype B or C infection.

 

Other published on-treatment biomarkers that are predictive of the final outcome of Pegasys treatment may be considered.

 

Table 11: Performance of individual biomarkers at Week 12 of therapy in CHB HBeAg-positive and HBeAg-negative patients according to genotype

 

Genotype

Cut-off (IU/mL)

NPV

Sensitivity

Specificity

HBeAg-positive(a)

B

HBsAg > 20,000

0.93

0.96

0.23

HBV DNA > 8 log10

0.90

0.94

0.26

C

HBsAg > 20,000

0.96

0.97

0.22

HBV DNA > 8 log10

0.98

0.98

0.19

HBeAg-negative(a)

D

HBsAg > 20,000

0.91

0.94

0.16

HBV DNA > 6.5 log10

1.00

1.00

0.11

NPV= negative predictive value; Sensitivity = % of all responders not meeting the stopping rule; Specificity = % of all non-responders meeting stopping rule

(a)               Treatment response for HBeAg-positive patients was defined as HBeAg seroconversion (defined as loss of HBeAg and presence of anti-HBe) + HBV DNA <2,000 IU/mL at 6 months post-treatment and treatment response for HBeAg-negative patients was defined as HBV DNA < 2,000 IU/mL + ALT normalizsation at 6 months post-treatment.

 

 

[....]

 

10.     DATE OF REVISION OF THE TEXT

 

5 May 2017

 

 

Updated on 19 October 2016 SmPC

Reasons for updating

  • Addition of joint SPC covering all presentations

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None provided

Updated on 18 October 2016 PIL

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  • Addition of joint PIL covering all presentations

Updated on 10 September 2015 PIL

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Updated on 21 November 2014 PIL

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Updated on 1 May 2014 PIL

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Updated on 28 April 2014 PIL

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Updated on 22 November 2013 PIL

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Updated on 9 October 2013 PIL

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Updated on 19 March 2013 PIL

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Updated on 22 December 2011 PIL

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Updated on 30 November 2011 PIL

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  • New PIL for medicines.ie