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15 June 2017

An agency of the European Union

EMA/365506/2017 Human Medicines Research and Development Support

Register of deadlines to put a medicinal product on the market

In accordance with Article 33 of the Paediatric Regulation Invented Name

Pip No

Active Substance(s)

Cancidas

EMEA-000010-PIP01-07-M01 caspofungin

PegIntron ViraferonPeg

EMEA-000071-PIP01-07

Peginterferon alfa-2b

Authorised Paediatric Indication(s)

MA Date

Treatment of invasive candidiasis in adult or 24/10/2001 paediatric patients. Treatment of invasive aspergillosis in adult or paediatric patients who are refractory to or intolerant of amphotericin B, lipid formulations of amphotericin B and / or itraconazole. Refractoriness is defined as progression of infection or failure to improve after a minimum of 7 days of prior therapeutic doses of effective antifungal therapy. Empirical therapy for presumed fungal infections (such as Candida or Aspergillus) in febrile, neutropaenic adult or paediatric patients. PegIntron/ViraferonPeg is indicated in a 25/05/2000 combination regimen with ribavirin for the treatment of children 3 years of age and older and adolescents, who have chronic hepatitis C, not previously treated, without liver decompensation, and who are positive for HCV-RNA. When deciding not to defer treatment until adulthood, it is important to consider that the combination therapy induced a growth inhibition. The reversibility of growth inhibition is uncertain. The decision to treat should be made on a case by case basis (see section 4.4)."

Variation Date

Deadline to put the product on the market

Product put on the market with paediatric indication in SmPC (as declared by Company)

26/11/2008

26/11/2010

Yes

11/11/2009

11/11/2011

Yes

© European Medicines Agency, 2017. Reproduction is authorised provided the source is acknowledged.

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Invented Name

Pip No

Active Substance(s)

Authorised Paediatric Indication(s)

Rebetol

EMEA-000070-PIP01-07

ribavirin

Orencia

Variation Date

Deadline to put the product on the market

Product put on the market with paediatric indication in SmPC (as declared by Compnay)

Rebetol is indicated, in a combination 07/05/1999 regimen with peginterferon alfa-2b or interferon alfa-2b, for the treatment of children 3 years of age and older and adolescents, who have chronic hepatitis C, not previously treated, without liver decompensation, and who are positive for HCV-RNA. 3 When deciding to not to defer treatment until adulthood, it is important to consider that the combination therapy induced a growth inhibition. The reversibility of growth inhibition is uncertain. The decision to treat should be made on a case by case basis (see section 4.4).

11/11/2009

11/11/2011

Yes

EMEA-000118-PIP01-07-M01 Abatacept

Orencia in combination with methotrexate is 21/05/2007 indicated for the treatment of moderate to severe active polyarticular juvenile idiopathic arthritis (JIA) in paediatric patients 6 years of age and older who have had an insufficient response to other DMARDs including at least one TNF inhibitor.

20/01/2010

20/01/2012

Yes

Cozaar

EMEA-000008-PIP01-07

Treatment of essential hypertension in adults and children and adolescents 6-18 years of age.

23/02/2010

23/02/2010

23/02/2012

Yes

Xalatan

EMEA-000011-PIP01-07-M03 Latanoprost

Reduction of elevated intraocular pressure in 29/05/1997 paediatric patients with elevated intraocular pressure and paediatric glaucoma

15/10/2010

15/10/2012

Losartan potassium

MA Date

© European Medicines Agency, 2017. Reproduction is authorised provided the source is acknowledged.

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Invented Name

Pip No

Pediacel®

EMEA-000278-PIP01-08-M01 Purified diphtheria toxoid, Purified tetanus toxoid, Five component acellular pertussis [Purified Pertussis Toxoid (PT), Purified Filamentous Haemagglutinin (FHA), Purified Fimbriae Types 2 and 3 (FIM) and Purified Pertactin (PRN)], Inactivated poliomyelitis vaccine (Vero) – Type 1 (Mahoney), Type 2 (MEF1) and Type 3 (Saukett), Purified polyribosylribitol phosphate capsular polysaccharide of Haemophilus influenzae type b covalently bound to Tetanus protein (PRP EMEA-000331-PIP01-08-M01 Esomeprazole sodium/Esomeprazole magnesium trihydrate

Sortis and associated names, As well as: Lipitor, Tahor, Xarator, Zarator, Liprimar, Totalip, Torvast, Cardyl

EMEA-000073-PIP01-07

Atorvastatin is indicated as an adjunct to diet for reduction of elevated total cholesterol, apolipoprotein B, and triglycerides in patients with primary hypercholesterolaemia including familial hypercholesterolaemia (heterozygous variant) or combined (mixed) hyperlipidaemia (Corresponding to Types IIa and IIb of the Fredrickson classification) when response to diet and other nonpharmacological measures is inadequate. Atorvastatin is also indicated to reduce totalC and LDL-C in patients with homozygous familial hypercholesterolaemia as an adjunct to other lipid-lowering treatments (e.g. LDL apheresis) or if such treatments are unavailable.

Diovan

EMEA-000005-PIP01-07-M01 valsartan

Nexium and associated names

Active Substance(s)

Atorvastatin calcium (trihydrate)

Authorised Paediatric Indication(s)

Variation Date

Deadline to put the product on the market

Product put on the market with paediatric indication in SmPC (as declared by Compnay)

Pediacel is indicated for primary and booster 03/12/2010 vaccination against diphtheria, tetanus, pertussis, poliomyelitis and invasive Haemophilus influenzae type b disease in infants and children from the age of 6 weeks up to the fourth birthday. Pediacel should be used in accordance with applicable official recommendations.

03/12/2010

03/12/2012

Yes

Children and adolescents with duodenal ulcers caused by H. Pylori infection.

15/04/2011

15/04/2013

Yes

03/08/2010 05/05/2011

05/05/2013

Yes

11/05/2011

11/05/2013

Yes

Treatment of hypertension in children and adolescents 6 - 18 years of age.

MA Date

09/12/2000

12/05/2010

© European Medicines Agency, 2017. Reproduction is authorised provided the source is acknowledged.

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Invented Name

Pip No

Active Substance(s)

Viramune

EMEA-000391-PIP01-08-M01 Nevirapine

Gardasil

Authorised Paediatric Indication(s)

MA Date

Variation Date

Deadline to put the product on the market

Product put on the market with paediatric indication in SmPC (as declared by Compnay)

Tablets and oral suspension: Viramune is 05/02/1998 indicated in combination with other antiretroviral medicinal products for the treatment of HIV-1-infected adults, adolescents, and children of any age (see section 4.4). prolonged-release tablets: Viramune is indicated in combination with other antiretroviral medicinal products for the treatment of HIV-1-infected adolescents and children three years and above and able to swallow tablets (see section 4.2 and 4.4).

05/09/2011

05/09/2013

Yes

EMEA-000375-PIP01-08-M02 Human Papillomavirus type 6 L1 protein / Human Papillomavirus type 11 L1 protein / Human Papillomavirus type 16 L1 protein / Human Papillomavirus type 18 L1 protein

Prevention of premalignant genital lesions (cervical, vulvar, vaginal, anal, perineal, perianal, penile), cervical, anal, perineal, and perianal cancer, and external genital warts (condyloma acuminata) causally related to Human Papillomavirus (HPV) types 6, 11, 16 and 18 in males.

20/09/2006

16/11/2011

16/11/2013

Yes

Remicade

EMEA-000549-PIP01-09-M01 infliximab

21/02/2012

21/02/2014

Yes

RotaTeq

EMEA-000967-PIP01-10-M01 rotavirus type P1A[8]/rotavirus type G3/rotavirus type G1/rotavirus type G4/rotavirus type G2

Extension of indication for the treatment of 13/08/1999 severely active ulcerative colitis, in paediatric patients aged 6 to 17 years, who have had an inadequate response to conventional therapy including corticosteroids and 6-MP or AZA, or who are intolerant to or have medical contraindications for such therapies. Sections 4.1, 4.2, 4.4, 4.8, 5.1 and 5.2 of the SmPC have been updated accordingly as well as Annex II and IIIB. The MAH also took the opportunity to update the list of local representatives for Belgium, Estonia, Lithuania, Hungary and Portugal in Annex IIIB To extend the upper limit of the 27/06/2006 administration of the third dose of vaccine from up to 26 weeks to up to 32 weeks of age. In addition, the MAH took the opportunity to update the list of local representatives in the Package Leaflet and to amend the section on Braille in the Labelling in line with current guidance.

21/02/2012

21/02/2014

Yes

© European Medicines Agency, 2017. Reproduction is authorised provided the source is acknowledged.

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Invented Name

Pip No

Active Substance(s)

Enbrel

EMEA-000299-PIP01-08-M03 Etanercept

Glivec

EMEA-000463-PIP01-08-M03 Imatinib mesilate

Authorised Paediatric Indication(s)

MA Date

Variation Date

Deadline to put the product on the market

Product put on the market with paediatric indication in SmPC (as declared by Compnay)

Juvenile idiopathic arthritis Treatment of 03/02/2000 polyarthritis (rheumatoid factor positive or negative) and extended oligoarthritis in children and adolescents from the age of 2 years who have had an inadequate response to, or who have proved intolerant of, methotrexate. Treatment of psoriatic arthritis in adolescents from the age of 12 years who have had an inadequate response to, or who have proved intolerant of, methotrexate. Treatment of enthesitisrelated arthritis in adolescents from the age of 12 years who have had an inadequate response to, or who have proved intolerant of, conventional therapy. Enbrel has not been studied in children aged less than 2 years. Psoriatic arthritis Treatment of active and progressive psoriatic arthritis in adults when the response to previous diseasemodifying antirheumatic drug therapy has been inadequate. Enbrel has been shown to improve physical function in patients with psoriatic arthritis, and to reduce the rate of progression of peripheral joint damage as measured by X-ray in patients with polyarticular symmetrical subtypes of the disease. Paediatric plaque psoriasis Treatment of chronic severe plaque psoriasis in children and adolescents from the age of 6 years who are inadequately controlled by, or are intolerant to, other systemic therapies or phototherapies.

31/07/2012

31/07/2014

Yes

Treatment of paediatric patients with newly 07/11/2001 diagnosed Philadelphia chromosome positive acute lymphoblastic leukaemia (Ph+ALL) integrated with chemotherapy.

27/06/2013

27/06/2015

Yes

© European Medicines Agency, 2017. Reproduction is authorised provided the source is acknowledged.

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Invented Name

Pip No

Active Substance(s)

Ezetrol®, Ezetimibe MSD- EMEA-000007-PIP01-07-M02 ezetimibe SP® and associated names, Viemm® and associated names, Zient® and associated names

Authorised Paediatric Indication(s)

MA Date

Children and adolescents ≥ 10 years 17/10/2002 (pubertal status: boys Tanner Stage II and above and girls who are at least one year post-menarche): No dosage adjustment is required (see section 5.2). The clinical experience in paediatric and adolescent patients (aged 10-17 years old) is, however, limited. When Ezetrol is administered with simvastatina statin, the dosage instructions for simvathe statin, in adolescents children should be consulted. Children >6 and < 61010 years: There is limited data on safety and efficacy in this age group. Ezetrol is not recommended for use in children below age 10 6 due to insufficient data on safety and efficacy (see section s 5.1 and 5.2). Children <6 years: There is no available data on use of Ezetrol in this age group.

Variation Date

Deadline to put the product on the market

Product put on the market with paediatric indication in SmPC (as declared by Compnay)

30/07/2013

30/07/2015

Yes

Prezista

EMEA-000038-PIP01-07-M03 Darunavir (as ethanolate) Prezista, co-administered with low dose ritonavir is indicated in combination with other antiretroviral medicinal products for the treatment of human immunodeficiency virus (HIV-1) infection in adult and paediatric patients from the age of 3 years and at least 15 kg body weight (see section 4.2). In deciding to initiate treatment with Prezista co-administered with low dose ritonavir, careful consideration should be given to the treatment history of the individual patient and the patterns of mutations associated with different agents. Genotypic or phenotypic testing (when available) and treatment history should guide the use of Prezista

12/02/2007

19/09/2013

19/09/2015

Yes

Invega®

EMEA-000014-PIP01-07-M06 paliperidone palmitate/paliperidone

25/06/2007

23/05/2014

23/05/2016

Yes

Invega is indicated for the treatment of schizophrenia in adults and in adolescents 15 years and older.

© European Medicines Agency, 2017. Reproduction is authorised provided the source is acknowledged.

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Invented Name

Pip No

Active Substance(s)

Baraclude

EMEA-000339-PIP02-09-M03 entecavir monohydrate

Travatan

Authorised Paediatric Indication(s)

MA Date

Variation Date

Deadline to put the product on the market

Product put on the market with paediatric indication in SmPC (as declared by Compnay)

Baraclude is also indicated for the treatment 26/06/2006 of chronic HBV infection in nucleoside naive paediatric patients from 2 to < 18 years of age with compensated liver disease who have evidence of active viral replication and persistently elevated serum ALT levels, or histological evidence of moderate to severe inflammation and/or fibrosis.

22/08/2014

22/08/2016

Yes

EMEA-001271-PIP01-12-M01 travoprost

Decrease of elevated intraocular pressure in 27/11/2001 paediatric patients aged 2 months to < 18 years with ocular hypertension or paediatric glaucoma (see section 5.1).

19/12/2014

19/12/2016

Yes

Emend

EMEA-000144-PIP01-07-M05 aprepitant

Prevention of nausea and vomiting associated with highly and moderately emetogenic cancer chemotherapy in children, toddlers and infants from the age of 6 months to less than 12 years.

11/11/2003

17/12/2015

17/12/2017

Yes

Revolade

EMEA-000170-PIP01-07-M03 Eltrombopag (olamine)

Revolade is indicated for chronic immune 11/03/2010 (idiopathic) thrombocytopenic purpura (ITP) patients aged 1 year and above who are refractory to other treatments (e.g. corticosteroids, immunoglobulins) (see sections 4.2 and 5.1)

04/04/2016

04/04/2018

HyQvia

EMEA-000872-PIP01-10-M03 Human normal immunoglobulin

Replacement therapy in adults, children and 16/05/2013 adolescents (0-18 years) (≥ 18 years) in: • Primary immunodeficiency syndromes with impaired antibody production (see section 4.4). • Hypogammaglobulinaemia and recurrent bacterial infections in patients with chronic lymphocytic leukaemia (CLL), in whom prophylactic antibiotics have failed or are contra-indicated. • Hypogammaglobulinaemia and recurrent bacterial infections in multiple myeloma (MM) patients. • Hypogammaglobulinaemia in patients pre- and post-allogeneic hematopoietic stem cell transplantation (HSCT).”

01/06/2016

01/06/2018

© European Medicines Agency, 2017. Reproduction is authorised provided the source is acknowledged.

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Invented Name

Pip No

Active Substance(s)

Simponi

EMEA-000265-PIP01-08-M04 golimumab

Ryzodeg

Caprelsa

Authorised Paediatric Indication(s)

MA Date

Variation Date

Deadline to put the product on the market

Simponi in combination with MTX is 01/10/2009 indicated for the treatment of polyarticular juvenile idiopathic arthritis in children with a body weight of at least 40 kg, who have responded inadequately to previous therapy with MTX.

24/06/2016

24/06/2018

EMEA-000479-PIP01-08-M03 insulin degludec/insulin aspart

Treatment of diabetes mellitus in adults, adolescents and children from the age of 2 years

21/01/2013

22/07/2016

22/07/2018

EMEA-000052-PIP01-07-M03 Vandetanib

Caprelsa is indicated for the treatment of aggressive and symptomatic medullary thyroid cancer (MTC) in patients with unresectable locally advanced or metastatic disease. Caprelsa is indicated in adults, children and adolescents aged 5 years and older. For patients in whom re-arrangedduring-transfection(RET) mutation is not known or is negative, a possible lower benefit should be taken into account before individual treatment decision.

17/02/2012

16/12/2016

16/12/2018

© European Medicines Agency, 2017. Reproduction is authorised provided the source is acknowledged.

Product put on the market with paediatric indication in SmPC (as declared by Compnay)

Yes

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