FOI 1782 Document 1 - TGA

Type t

Australian Government Department of Health and Ageing Therapeutic Goods Administration

SA ..

Re: Special Access Scheme Approval-Adalimumab (Humira)

I refer to your request received 2151 December 2006 concerning approval to supply Adalimumab (Rumira) for use in the treatment of one of your patients.

Pursuant to Section 19(l)(a) of the Therapeutic Goods Act 1989, approval is granted for the supply of Adalimumab (Humira) for use in the treatment of your patient_ , DOB - 1963, URN - )

This approval is granted on the grounds that there is no suitable alternative therapy marketed currently in Australia. No assurance is given by the Therapeutic Goods Administration as to the quality, safety or efficacy of this drug product in the proposed usage.

All parties involved in the supply of unregistered drugs need to recognise that the practice may carry medico-legal risk and, and there may be implications regarding indemnity. The TG A does not give any assurances or indemnity in regard to the supply of unregistered drugs.

Permission is given subject to the following:

1. The approval is given for the supply of twelve (12) months therapy of the above drug at a dosage as per protocol. ·

2. This approval is valid for up to eighteen (18) months from the date of this letter or until revoked or until Adalimumab (Humira) is marketed in Australia, whichever is sooner.

3. The approval is for supply for use in the above-mentioned patient only.

4. The product is used within the context of fully informed consent. The product is currently unregistered in Australia and the proposed usage constitutes use as · an experimental drug.

5. The doctor and patient or patient's guardian accept responsibility for any adverse consequence of therapy.

6. The principles set out in the "National Statement on Ethical Conduct in Research Involving Humans" are observed

Address: PO Box 100 Woden ACT 2606 Website: www.tga.gov.au Telephone: 02 6232 8111 Facsimile: 02 6232 8112 ABN 40 939 406 804

7. Details of any suspected adverse drug reactions are reported tq the TGA.

8. The TGA is notified ofreasons for discontinuation should this.occur.

9. The Commonwealth accepts no responsibility for any defects in the product related to manufacture, distribution or directions for use, including dosage.

10. The product should be used in accordance with the treatment protocol provided to the TGA with the request.

11. This approval provides an exemption from the Therapeutic Goods legislation in order to allow supply of this unapproved product in the circumstances described. Other legislation, including any relevant State or Territory legislation, must still be complied with.

This decision is an "initial decision" within the meaning of s 60 of the Therapeutic Goods Act 1989 ("the Act11

). This means that if your interests are affected by the decision, you may seek reconsideration by the Minister. Any appeal should be made in writing within 90 days after this decision first comes fo your notice or to the notice of your company, and should be sent to the following address:

The Parliamentary Secretary to the Minister for Health and Ageing Parliament House CANBERRA ACT 2600

The letter should be headed "APPEAL UNDER S 60 OF THE THERAPEUTIC GOODS ACT 1989".

Before embarking upon this course of action you are invited to contact the initial decision maker to see whether the matter can be resolved informally.

The Parliamentary Secretary may either deal with the appeal personally, or send it to·be dealt with by one of the Minister's delegates within the Department. Should you be dissatisfied with the result of your appeal then, subject to the Administrative Appeals Tribunal Act 1975, you may appeal to the Tribunal for review of the Minister's/Delegate's decision.

Patient details

I =···~ ----------:_:_B_:= ________ 1_9_"_3_. -------'

Diagnosis j Ci""o "'"' ~. ?~.r~ a .re- j I>rev!ous SAS No. $Ed;<·~ !:. (~) ._ ___ -_r_e._r_l_~______________ (if applicable) 1e

Clinical justification for use of product 1-'~:..!..!.!cil...!......!!.~-L~~~~,;....-».i'---1.J.l..l~.t:.!.c..:;::::::::::.....::;;,p:.!-..~:S..::ii!:l.!.:~~~---l Include appratsal of

seril)J4flUS,c/pp:tient'.. l-,l~i.;..t.;..:..:;::1,.,1,.....:::;.~!..!.!,.;~ -'- w . a<; or. C{. ~ K K ~a<.

prevlo:/:::,~:~;e~c::i - - - ~----'-------w-1--c_nck--•-'-cL_ fo __ t-k __ \_"'yyr\O-'--'---,,'-l_.~;::__d._a--'-'/\.:.C.Tl_\l-J;_c__'..:.n-=c<.-=i apect.ed benef1!$frcm use of the product " -#.1s

Product ddalls Attach efficacy and stifety data to support proposed use of tlu: prodw:t and detail:, of Intended 11Jonitortng.. v,..;;/1.c,J •co111pleufor medi~inll:t only, e,~ <' •

. · Actl~e• I A-d~I, mv,.~b . I n~name I 1-lt:JM,r(;t. I ingredient ..... ------------------'· /Devicename ..... -------------'·

CompllQy/suppUer I Ahhc ff- /tt!.rftc-Jc, r '""' I (State if imported) NS W , .__ ______________________________ __,

Dose form• I f,e-4;'11~J -S;~r-:;er (;J.. f""ck.)/ Routeofadministratlon• .... I ___ .s;_c.. ____ __ ___,J

Dosage• .... l _____ w_,.,.._,__,,--___ __ Duration oftreaunent .... I __ \_2_·YY'IO __ N_~ __ s_· ___ __.I

Date of medical device pro~ure/use / f) le«se. COWl~nUl. cv.i~ /

Prescribing doctor details

Signature ·' ~ &date

'rlmedkines): 02 6232 8112 Fax (medicel devie¢S); 02 6232. 8785

Ho~tal '--I _ ------1j L---.........____ __ I

Phoncr:-:= Fuoumboc---Mail; SAS Oflii;cr, TOA, PO Boit 100, Wodc:n ACT 2606

Dear

:))ep~nt.ofU~ltb: and.t\g~tifg::•·: -;1\erapeu~~::c~o,ts:A~_m_in~~mido9:_:.; •• • • • • • • • • • • • + • • • .•,:,•. . .. .. . . . . . , .. . .. .. .

Re: ADALIMUMAB

Thank you for your letter of 2nd November 2006 in re~onse to my request for further information for supply of adalimumab for your patient- (Date of Birth: . /1969) under the SAS scheme for unregistered medications. .

I draw your attemion to the. review article which accompanied your letter1. The article notes as follows:. ·

Cwrently, ReA is better defined as an immune-mediated synovitis resulting from slow bacterial infections and showing intra-articular persistence of viable nonculturable bacteria and/or immunogenic bacterial antigens synthesized by metabolic(!,l/y active bacteria residing in the joint and/or elsewhere in the bof)y.

The article also notes ·a case of reactive arthritis secondary to HIV which resulted in sepsis and death following the use of a TNF-cx. antagonist agent.

As you have not discussed the safety of the proposed use in your letter, I request you to please comment on the safety aspect especially in regard to the risk of flare up of serious infection. I'll then submit the information I receive from you to an imernal group of senior medical officers for advice before a decision is made.

Further information about the supply of unapproved medicines can be obtained from the TGA website at htt;p://www.tga.gov.au/unapp/index.htm.

I thank you and look forward to hearing from yo_u.

Yours sincerely

Drug Safety & Evaluation Branch

09 November 2006

1 Col.megna I, Cuchacovich R, Espinoza LR. Ill.A-B27-Associated Arthritis: Pathogenetic and Clinical Considerations. Clinical Microbiology Reviews; Apr. 2004, p.348-369.

Address: PO Box lOOWoden ACT2606 Website: www.tga.gov.au Telephone: 02 6232 8444 Facsimile: 02 6232 8605 ABN 40 939 406 804

T-902 P.001/001 F-510 fif r~aso P.DDZ/002 F~9B4

-,

;r s -~ :::j!''""',: ~GORY B F'.ORM i 'f''i lJ~ ""fl"!!!.-1..11'~, ~ ACCBSS SCHEME

: '~ ~• - __ :=:---- ~\\O n.EASt ltS£ Bf.ACK PBN,?,~ CUA1£.X AND COJ.0»X.ET£ AU. SEC'llONS

P,u:tent detail"-

... --.. Healthand AgedCare

=~1 l URN. DOB, Sex) _ j '----------===~-------------- - --1

J)~nosis LB ~r✓ E ff~ {T{S I l'rcvions SAS No, I --Clinical justif"!Wion ✓

. ' ft;ruscofpradaGt f)-c.-'j 1 6- 1 ,Jr:1,..R-/11 ;rt,~ ( t,/ .Pt 11 L.'M PLS .- • ' lnclw:I, llfP'aiW qf

stlritrJ,.rtJa, o/pllJIJ.r:nfs ,___L.......:.8-'-~--~----=01:...;~::;.;:;~:..:..:!:=!...-. __ i...s_~;;...:::~f...:.rt..:...:::._~..:..::O:__.::::.i;~.L..Ll~=--i IONlttia,c: deltlil ~ __ , ..

previr:iru tl'tJflrm<na f11J1i RTC 1 l ti e,.(J., r ,J ~ Los,5: 0 r- FiM~a,,/ ~dhe.n,/i#from i---........ =---------...::....i.:;;.~::;...:...::........_..:..!..._ ___ ;;___.;.,..._ _ _ ~=-=-'----1

IISltOfUleprru/1H:t !---- ------------------------,

ProdtU!C demit:s '1rlac11 eJJk:tzq onlf !ID/tey data to ~ plOJ'fJICd M:l! of tlte proriw -1 d=lk of wl!lldtttl lflorriloring n:glme •CIJ,np"'1n.f ar mt:tlldJiu onl)I.

Cotnpmty/supplh:r [ fie,~

Dasefo~• c:1,JQ~(o-#

Prucribing d~c,r ditr•lls

I i,.t:ih,e

I ?osral nddrbSS

- - -- ----

Sigoarure

J:,apo.mnerit l ---------~--

Form no. 2950 (D10SJ


- ACT ..

Re: Special Access Scheme Approval -Adalimumab (Humira)

I refer to your request received 15th June 2006 concerning approval to supply Adalimumab (Humira) for use in the treatment of one of your patients.

Pursuant to Section 19(l)(a) of the Therapeutic Goods Act 1989, approval is granted for the supply of Adalimumab (Humira) for use in the treatment of your patient -

/1956, )


All parties involved in the supply of unregistered drugs need to recognise that the practice may carry medico-legal risk and, and there may be implications regarding indemnity. The TGA does not give any assurances or indemnity in regard to the supply of unregistered drugs.

Permission is given subject to the following: '

1. The approval is given for the supply of three (3) months' therapy of the above drug at a dosage as per sponsor's protocol.

2. This approval is valid for up to six (6) months from the date of this letter or until revoked or until Adalimumab (Humira) is marketed in Australia, whichever is sooner.


4. The product is used within the context of fully informed consent. The product is currently unregistered in Australia and the proposed usage constitutes use as an experimental drug.

5. The doctor and patient or patient's guardian accepts responsibility for any adverse consequence of therapy.

Address: PO Box 100 Woden ACT 2606 Website: www.tga.gov.au Telephone: 02 6232 8111 Facsimile: 02 6232 8'!12 ABN 40 939 406 804

b3

6. The principles set out in the ''National Statement on Ethical Conduct in Research Involving Hwnans" are observed.

7. Details of any suspected adverse drug reactions are reported to the TGA.

8. The TGA is notified of reasons for discontinuation should this occur.




This decision is an "initial decision11 within the meaning of s 60 of the Therapeutic Goods Act 1989 {"the Act"). This means that if your interests are affected by the decision, you may seek reconsideration by tlie Minister. Any appeal should be made in writing within 90 days after this decision first comes to your notice or to the notice of your company, and should be sent to the following address:



Before embarking upon this course of action you are invited to contact the initial decision maker to see whether the matter can be resolved infonnally.

~

The Parliamentary ~ecretary may either deal with the appeal personally, or send it to be dealt with by one of the Minister's delegates within the Department. Should you be dissatisfied with the result of your appeal then, subject to the Administrative Appeals Tribunal Act 1975, you may appeal to the Tribunal for review of the Minister's/Delegate's decision.

Yours sincerely

DELEGATE OF THE SECRETARY

/'I June 2006

.. . l 5. JUN. _200 6 1,2: 48

Pt.EASE USE BLACK PEN. tRJN'l' CLEARLY AND COMPLETE ALL SECTIONS

DOB:

SBX:

-'"' I f\ Al>t . ~,,/ ,tis,e,i,, Previous SAS No. , /\J/A (sf applicab~) .

Clinical justification for use ofproduct ~ ~ ~ ~~~~~~ ~ ~~......:.==-~~:£:_~ ~~..[!!,.---I lllclllde apprai.1al of ..

~~ef~tien~ l..l.Q~~~ ~ ---li~ ~ ~...U:=#J~ ~ P:Jt,~__L~~-.:)!C~_tl~ conditu>n: aetail J

prevwll8 trNtmen,; and i-:-°'::.e.JU<..~ :..:.:.:.:=...:;:.......w;J..._.=;.:~~.a..:::.,,,~~=-.J..J.L..~ ~ '------l ¢Xpet;lld benefits from u.s•ofrhsp1'0dJicJ .._ __________ ___________ _,

Product details A.tJa,al, eJ/lcacy and safety data to $11J1P01't proposed use of th4 product and tkt4i/3 of intMdfld monilorirrg,. •Cmrf,lett for mdlcint.t 01:-0'·

,.:I MlALl MUIY1AB I ai::: I f-f VmrM

~--fR.AcM& -t rt Prutrr1 (~=I ....__ _____________________ ~ Dose fotm* .._4-0_ ~ _o_, 6_m_l_----J Rowe of administration* I 5 flt lo fM,-1,, nM« _s I

~" 46 -••f-1 ~ b'lif Date of medical devieeproc ._I _ __ ,---_ _____ ___.I

Dosage•

Bospitll

Postal address (hospital or private). Depanment

~mxmber

SignatUre I & d~ ,..___--' s- t{f; I (J k

.F~ (mccticines): 02 6232 8112 Fax (medical devices): 02 6232 8785 Mail: SAS Officer. TGA. PO Box 100. Wodei,. ACT 2606

Form~- 2950 (0405)

~ CT IIII

Dear-


Re: Special Access Scheme Approval- Adalimumab (Humira)


Pursuant to Section 19(1)(a) of the Therapeutic Goods Act 1989, approval is granted for the supply of Adalimumab (Humira) for use in the treatment of your patient

/1982, URN - )

This approvaj. is granted on the grounds that there is no suitable alternative therapy marketed currently in Australia. No assurance is given by the Therapeutic Goods Administration as to the quality, safety or efficacy of this drug product in the proposed usage.

All parties involved in the supply of unregistered drugs need to ·recognise that the practice may carry medico-legal risk and, and there may be implications regarding indemnity. The TGA does not give any assurances or indemnity in·regard to the supply of unregistered drugs.

Permission is given subject to the followin~:

• The approval is given for the supply of three (3) months' therapy of the above drug at a dosage as per sponsor's protocol.

• This approval is valid for up to six (6) months from the date of-this letter or until revoked or until Adalimumab. (Humira) is marketed in Australia, whichever is sooner.

• The approval is for supply for use in the above-mentioned patient only.

• The product is used within the context of fully informed consent. The product is currently unregistered in Australia and the proposed usage constitutes use as an experimental drug.

• The doctor and patient or patient's guardian accept responsibiJity'for any adverse consequence of therapy.


• The principles set out in the "National Statement on Ethical Conduct in Research Involving Humans" are observed.

• Details of any suspected adverse drug reactions are reported to the TGA.

• The TGA is notified of reasons for discontinuation should this occur.

• The Commonwealth accepts no responsibility for any defects in the product related to manufacture, distribution or directions for use, including dosage.

• The product should be used in accordance with the treatment protocol provided to the TGA with the request.

• This approval provides an exemption from the Therapeutic Goods legislation in order to allow supply of this unapproved product in the circumstances described. Other legislation, including any relevant State or Territory legislation, must still be complied with.

This decision is an "initial decision" within the meaning of s 60 of the Therapeutic Goods Act 1989 ("the Act"). This means that if your interests are affected by the decision, you may seek reconsideration by the Minister. Any appeal should be made in writing within 90 days after this decision first comes to your notice or to the notice of your company, and should be sent to the following address:




The Parliamentary Secretary may either deal with the appeal personally, or send it to be dealt with by one of the Minister's delegates within the Department. Should you be dissatisfied with the result of your appeal then, subject to the Administrative Appeals Tribunal Act 1975, you may appeal to the Tribunal for review of the Minister's/Delegate's decision.

Yours sincerely

-DELEGATE OF THE SECRETARY

q June 2006

l ACT -


Dear-

Re: Special-Access Scheme Approval -Adalimumab (H:1 tnira)

I refer to your request received 8th June 2006 concerning approval to -~upply Adalimumab (Humira) for use in the treatment of one of your patfrr ts.

Pursuant to Section 19(1)(a) of the Therap~utic Goods Act 1989, ap:1~ ~oval is_~ or the su l of Adalimum.ab (Humira) for use in the treatment of yo· .i.:·· patien~

1982,

This approv~ is granted on the grounds that there is no suitable al ten: ative thera.py mar~eted currently in Australia. No assurance is given by the There·? mtic Goods . Administration as to the quality, safety or efficacy of this drug produ:t in the proposed usage.

·All parties involved in the supply of unregistered drugs need to reco.~ 1ise that the practice may .carry medico-legal risk and, and there roay be implications rega:iing-indemnity. The TGA does not give any assurances or indemnity m· regard to the sup} .y of unregistered.

drugs.

· Pennission is given subject to the following: ·

• The approval is given for the supply of three (3) months' therai: ~ of the above drug at a dosage as.~r sponsoi:'s protocol.

• -n. • ., "'"'"'""v~l ii;: v:ilici for unto six (6) months from the date ofth s letter or until

lOf/" ~rl/~~~av l \fa t'ON I ' ~ l) ~1~ & ~ ~ AJlstralianGovernm.erit CATEGO~YB~ ~ Department of Bealdi and~ceing SPECIAL ACCESS SCHEME

Therapeutic Goods Adminisfntion

PLEASE USE BLACK PEN, PRINT CLEARLY AND COMPLETE ALL SECTIONS

Ojagnosis (,, kA l &(~ '- u.l\l"esrcm.,i11e~ ~"-fl;\tt~lo,

Product details 4ttacTi e:ffo:acy 41id safezy d~ 10 siq,p<1n proposrd TH• of the product a,,ti details oj inlmded monlloring .. •Cor,rplu, for memdne3 only.

~~:: I AJ}AL I MV MA8.

Company/supplier I Ci OB A-<-( AA(~--'( Rftl.A5 ( A (St.ate if-imported) . IT') v I' 'l "'·

Doae funn• J r 00 d I Route of admmimtioo' j S .,_ l.~u. "hi 1t ea i,s ,if" I ~ ""-• J 1 &o"::J f '1,o-J w#z.i-. ... or_ .. ,., I ikpe-,J-s"' ~~

· l\, v-rM - of medical dovice J>I'>"-· ...... I w_~ _ _ ~__.r...._p_r-ov._:tt r)-=--· _ --11 Prescribb:ig doc.tor details

Postal addre$s (hospital or private}.

Signature &date

Fax (m.edlclncs); 02 Q232 8112 Fex (medical devic:es

009 'ON

Hospital

Phone

Faxnumber

' I • • • f II

-

Officer, TGA., PO Box l 00, Woden AC'f Z606

. Form no. 2950 (0405)

56


QLD -

Dear_.

Re: Special Access Scheme Approval - Adalimumab (Humira)

I refer to your request received 30th May 2006 concerning approval to supply Adalimumab (Humira) for use in the treatment of one of your patients.

Pursuant to Section 19(1)(a) of the Therapeutic Goods Act 1989, approval is granted for the supply of Adalimumab (Humira) for use in the treatment of your patient . ( 1963,




• The approval is given for the supply of six (6) months' therapy of the above drug ata dosage as per sponsor's protocol.

• This approval is valid for up_ to twelve (12) months from the date of this letter or until revoked or until Adalimumab (Hurnira) is marketed in Australia, whichever is sooner.

• The approval is for supply for use in the above-mentioned patient only.

• The product is used withi11 the context of fully informed consent. The product is currently unregistered in Australia and the proposed usage constitutes use as an experimental drug.

• The doctor and patient or patient's guardian accept responsibility for any adverse consequence of therapy.

Address: PO Box 100 Woden ACT 2606 Website: www.tga.gov.au Telephone: 02 6232 811 1 Facsimile: 02 6232 811 2 ABN 40 939 406 804

. 5c,

• The principles set out in the "National Statement on Ethical Conduct in Research lnvoh'.ing Humans" are observed.

• Details of any suspected adverse drug reactions are reported to the TGA.

• The TGA is notified of reasons for discontinuation should this occur.

• The Commonwealth accepts no responsibility for any defects in the product related to manufacture, distribution or directions for use, including dosage.

• The product should be used in accordance with the treatment protocol provided to the TGA with the request.

• This approval provides an exemption from the Therapeutic Goods legislation in order to allow supply of this unapproved product in the circumstances described. Other legislation, including any relevant State or Territory legislation, must still be complied with.

This decision is an "initial decision11 within the meaning of s 60 of the Therapeutic Goods Act 1989 ("the Act"). This means that if your interests are affected by the decision; you may seek reconsideration by the Minister. Any appeal should be made in writing within 90 days after this decision first comes to your notice or to the notice of your company, and should be sent to the following address:



Before embarking upon this course of action you are invited to contact the initial decision maker to see whether the matter can be resolved infonnally.


Yours sincerely

- l DELEGATE OF THE SECRETARY

31st May 2006

4-9

May. 30 2006 11:48AM Pl/1

~ ;-oi);rz_qisE PRouuc~

TG/\ TIIEIIAPEU TIC IOODS ADflllllSUATIU

CATEGORY B FORM SPECIAL ACCESS SCHEME

" ..... .,.~otMllllfttf1lll'U,j"JII

PLEASE USE flt ,ACK PEN, PRINT CJ,EARLY ANn COMPLETE ALI, SECTIONS

Pat.ient tlel.aUs

Health and Aged Care

Patient detail~ (initials, TP or

URN, DOH, Sex)

Diagnosis [. C.roh~·~ Clinlonl Ju.~tlflcation

for u~c ofprnduct /,ir./uda apprail·t1/ of

seriOI/Slllt.M of pullt!J1l'S

rundilion; d,1wl previm1.v tri!CllmMIS and

e:,;p1.1cft.u /)tJntJfit,, .fmm

~~ ~~

11.1·61 uf the. prod",:t i-----

Prevlou.$ SAS No. ~-~

_Pl'_o_d0UCt de_tlt_il_l - A-Ila-,-,, "ei/foacy t:md .,afety J;,a lo supp(lr/ pmpu/ixi '11st? ()f the prod11di"°mid de14i/., ,lf i11t,·nd11a 1~1onitnri111;

regime. •C-'Jmp/etefnr nu:d/u/m:s onJy.

Active• · Trade name • [ ··-.. . . -· ~-.. .. [H". . ~--ingredient _ AdA( , __ ~u~b. /Dcviccnome -l+-uM1~ .·

Name

Po:;tal addn.:~s

Sigm1l1u-e

···~_w ..... ~'2-)°t-;~ q.~;O{~ __ ]

Routeofadminislrnfion• [ __ s( C . ~

Duration of treatment c·· ----~ Hospital

Department

!'hone

l'1uc number _____ ......_ ___ .. ,--------

Form no. 2950 (01~)

Dear-


Re: Special Access Scheme Approval -Adalimumab (Humira)


Pursuant to Section 19(l)(a) of the Therapeutic Goods Act 1989, approval is granted for the supply of Adalimumab (Humira) for use in the treatment of your patient -

/1985, I



Permission is given subject to.the following: ... 1. The approval is given for the supply of three (3) months' therapy of the above drug at

a dosage as per sponsor's protocol.

2. This approval is valid for up to six ( 6) months from the date of this letter or until revoked or until Adalimumab (Humira) is marketed in Australia, whichever is sooner.





4,-

....

6. The principles set out in the "National Statement on Ethical Conduct in Research Involving Humans" are observed.


8. The TOA is notified of reasons for discontinuation should this occur.







Before embarking upon this course of action you are invited to contact the initial decision maker to see whether the matter can be resolved informally .

The Parliamentary Secretary may either deal with the appeal personally, or send it to be dealt with by one of the Minister's delegates within the Department Should you be dissatisfied with the result of your appeal then, subject to the Administrative Appeals Tribunal Act 1975, you may appeal to the Tribunal for review of the Minister's/Delegate's decision.

Yours sincerely

- . DELEGATE OF THE SECRET ARY

If June 2006

4 b

?, 2/3

PLEASE USE BLACK PEN. PJYNT CLEARLY A.NJ> COMPLETE ALL SEC'l10NS

DOB:

SEX:

~ I :s;" (a......d,"'.J ..... el <l~ Prcviow SAS No. I (if applicable) _____ __.

Clinical justification ~ f C« foruse ofp:oduct ~~~~~:.+-~~:::!-..K:::!!.~~--=-~~...!.!.l=--~~'J!.P.~~--{ b,d,ude QJ1l)raisal of .,l ' ~

sericumus of ]JfJIJent's ~ 11{".:,....._.:.:C l\.==~===___.:::;......, .......... ..........:....,___,_~=--....1..C...:=~,__.___---1 CQndilimi; d4talJ

pm-ioustre4tmmtsand ~------- -----------------( expecled bentdft:s from IISBOfmept<XJua ..__ ______ ___ _ ________ _ _ _ ___.

Product details A.ttads sjJicacy and $0/BOI dam to SfLPport P,ropost:-d use of rh£ product an4 dltaifs of intended mo~. ~omplere for rrudtctnes onl),.

Date of medical device procedure/use

Prescriblng doctor ddails

Name

Postal address (hospital ar private).

Signature &date

I ro:: l ___ l-f_UM_f_~A __

I Routeo!acbn1Dimatio1t• I Su~~

Dlntloiioftreabneslt I ~t'M/~ j re~eb«fe I

!)epanD)elll

Phone

Fax J1U111ber

-·- --Fax (medioiues): 02 6232 8112 Fax (:medi devi<:cs). 02 6232 8785 Mail. SAS Offioet. TGA, PO Box 100, Woden ACT 2606

Fotrn no. 2950 (0405)

45

Dear

'


SA-Re: Special Access Scheme Approval - Adallmumab (Humira)

I refer to your request received 18th April 2006 concerning approval to supply Adalimumab (Humira) for use in the treatment of one of your patients.

Pursuant to Section 19(1)(a) of the Therapeutic Goods Act 1989, approval is granted for the supply of Adalimumab (Humira) for use in the treatment of your patient- DOB 111111963, URN-

This approval is granted on the grounds that there is no suitable alternative' therapy marketed currently in Australia. No assurance is given by the Therapeutic Goods Administration as to the quality, safety or efficacy of this drug product in the proposed usage.


Permission is given subject to the follovving:

1. The approval is given for the supply of six (6) months' therapy of the above drug at a dosage as per sponsor's protocol.

2. This approval is valid for up to twelve (12) months from the date of this letter or until revoked or until Adalimumab (Humira) is marketed in Australia, whichever is sooner.











This decision is an "initial decision" within the meaning of s 60 of the Therapeutic Goods Act 1989 ("the Act"). This means that. if your interests are affected by the decision, you may seek reconsideration by the Minister. Any appeal should be made in writing within 90 days after this decision first comes to your notice or to the notice of your company, and should be sent to the following address:



Before embarking upon this course of action you are invited to contact the irutial decision maker to see whether the matter can be resolved informally.

The Parliamentary Secretary may either deal with the appeal personally, or send it to be dealt with by one of the Minister's delegates within the Department Should you be dissatisfied with the result of your appeal then, subject to the Administrative Appeals Tribunal Act 1975, you may appeal to the Tribunal for review of the Minister's/Delegate's decision.

Yours sincerely

-DELEGATE OF THE SECRET ARY

11 April 2006

,1 ~

~/Y fl"" 6~

... •.

~~-· .:A-ustraitaii Gov~t·ri nicnt: · · . ,,1.ffl) ~~,..~'6,wl~..., ....... ~~ ...........

. ..

CATEGORY B FORM SPECIAL ACCESS SCHEME llttijj~'-i! .. "'1l :nu.pnrcm~utut'livt~lth .iutd Agl•inu

.T.h~r.a)t(\ntlc-Go~di.Adm)AlstrRftOll . . .

PLEASE USE BLACK PEN. J>RlNT CLEARLY AND COMPLETE ALL SECTIONS

DOB: - 19h 3. MRN: SEX: -

agnos s .• • . A __ 0 - · r(.'(l~-

Dl I

I

Cir,:.. t... " r !) , r-~ c~ .re-

I Previous SAS No.

(if applicable)

--------------------J Clinical justification

for use of product 1---1-=~LLL-'-'-'~--1.,;~~=~,::;;_~__.....u....i-"L~i..:...;.;=:.._.r,~!....._..1,e~=!...!.!..Jt...;..::::l:---I Include app,alsa/ of

S{:riousness of patient's e,. Y\ k.. f-eGI\ · condttlon: ®tall fl. , . 1. , . h J .J .1.. r,Lt , L •

previous treatmantstmd I \i ~~ \C H'T\c'I.IO, ~ ctl.) ~ r onr>e ~ IU ,~n.,vna)'lt~d 01\:n 11Jfo( expected benejilsfrom . . , • \ . • I.

use of the prodUCI I tee~ ) OY' ;,_h · - rr-o.: h \ a . tJ ... ' ~ ro~ - . , cw.d.. tb {;,I:) nhl..U~ .ti_ I~

Product details Attach t1/Jloacy mtd w/ety data tQ suppor1 proposed use of the produa/ a,,d detaifa of tmendea monllortng.. wi/1..o J I •Complete for medicine$ only. Ght'-'uj (I ,

Active• I Ing.red lent !rd~l,mv~ I m~~C:::: I ll<lm,~ev j

Company/supplier I ./1/o/,,o ff fw.rftfA.iot·i<>-- I (State if imported) NS' /JV .

~ - ----Dose form"' I Pre~ll~J i«;v-ct] er ( ;J.. po-<.lc.)I Route of adthinlstratlon,.. J ..... ___ s_·_c:.... _______ _,

Dosage"' L.l ____ 4-0 __ Mij__,_ ____ ___..; Dul'ation of treatment j ._ __ \_2_ rn __ o_f'\_-_\'h._ S_· _ __ _

Date of medical device procedure/use I (> le(St! ~~hU. ~ ] Prescribing doctor detans

Nome I /!.,, Sw,~•

Postal address (hospital or private).

Signature & date

Fax (m.edici.nes): 02 6232 8112

this add ~s.

PoGtC1Jde ■•

l

Phone

Fax number


Drug: Adalimurnab Patient: - DOB - /1952 Supplier: Unknown Dosage: As per protocol Duration:3 months Dose Form: Injection

Patient category ~-

THERAPEUTIC GOODS ACT 1989, S.19 EXEMTIONS FOR SPECIAL AND EXPERIMENTAL USES

26/12/2005

APPROVAL TO SUPPLY UNDER THE SPECIAL ACCESS SCHEME

Concerning your application to use the above drug in the treatment of the above pat i ent on the grounds that there is no alternative therapy currently supplied in Australia, I, the medi cally qualified person named below, hereby provide a formal Notification of Approval. The proposed clinical use of this drug must be regarded both medico-legally and ethically as experimental. No assurance can be given as to the quality, ·safety and efficacy in the proposed usage. Your co-operation is required concerning sound data management.

Permission is given for the use of the drug in the above patient for the above duration subject to the following conditions: -

1. The doctor and patient, patient's parent or guardian accept responsibi lity for any adverse consequences of therapy;

2. The principl es set out in the Nation~l Health and Medi cal Research Counci l's 'Statement on Human Experimentation' is observed;

3. Details of any suspected adverse drug reactions are to be reported to the Australia Drug Evaluation Committee;

4. The TGA be notified of reasons for discontinuation should this occur;

5. On completion of the treatment a detailed patient profile, before and after treatment, is to be submitted to the supplier of this product;

6. On completion of the treatment all remaining supplies of the above product be returned to the supplier;

7 . The company supplying the drug accepts responsibility for any defects in the drug related to manufacture, distribution or directions for use including dosage.

8. Special Conditions: Nil

Drug Safety and Evaluat i on Branch Doctor: Please· forward a copy to your Chief Pharmacist


4/

SAS Number

Drug {Active Ingredient)

Drug (Trade Name)

Company Name

Hospital Name

Section/Department

Postal Address

Patient's initials

Dosage

Duration

Diagnosis

Previous/Current Therapy & other Comments

Monitoring

Special conditions

Change details

Approval YES

Delegate's Signature

Evaluation Unit [£] Doctor

µ v /q r () A-Tel. No.

Date of birth Patient ID -------·----

t-OA-tc}: s / c ~ Dosage form I i 7AJ . s/c_ i 2 /~2- y 3k ~ Route of I <:>/ L

administration

C-r R ~ ,t ~ ?cli-f :_;

Date '------------'

~~- Australia11 Government ~ Department or Health and Ageing

Therapeutic Goods Adminhtration


.PU:ASI!'. USE BLACK PE'N, rJUNT Cl$ARLY AND COMPLETE ALI. SECTIONS

Patient detlt.ih

I Patirnt • s i, i tial,c

MR.N:

DOB:

$EX:

J .Previous SAS No. ~ ~ (ifapplic.:1ble) L _ _]

Product details Attach epi<xicy ,1nd safety ,JUU:"7u IIUJJJ)OJ'f *Completefr,r mi:diciJ1cs only.

Active* I j 4A .. ingredient tt-0,., ,_r M. UM l'}-8

C<.1mptmy/suppHer I ~ 'A-v~,.✓,,,11,,.,. , ) pf I... I (St.ate i f imported) ._ _____ '--_'_· _, _ ,.._,~_ . ....., _ :+ _ ___ · ___________ _

J>ose form" L.,-~_..j...._ _______ _,J Route of administration* I ~~J

Dosage• ~I -4-0~ b'uj eCNt-~ Ourati~n of tret1tment IT~ Cuu1wl'yj

Date ofmcuici1I device proccdurc/u~ '--I ___ _ _ ] P1·es~ribing doetor details

HospiUll

Po.~! address (hospital or pri~ate). Dcpartmem

Slgnarure I .. !)?>,/~1 &date I

'----==;;:;::;:;========----------------......J .Fox (mcdlcmcs): 02 6232 81 l 2 Fax (medical dcvie<::;): 02 6232 8785 Mail: SAS Officer, TGA. f>O Sox 100, Woden ACr 2606

Form no. 2950 (0405)

- VIC III

DearDr-



I refer to your request received 23rd December 2005 concerning approval to supply Adalimumab (Humira) for use in the treatment of one of your patients.

Pursuant to Section 19(1)(a) of the Therapeutic Goods Act 1989, approval is granted for the supply of Adalimumab (Humira) for use in the treatment of your patient■ (DOB - /1952)




1. The approval is given for the supply of three (3) months' therapy of the above drug at a dosage of 40mg, every 2 weeks, subcutaneous injection.

2. This approval is valid for up to six (6) months from the date of this letter or until revoked or until Adalimumab (Humira) is marketed in Australia, whichever is sooner.







8. The TGA is notified ofreasons for discontinuation should this occur.

9. The Commonwealth accepts no responsibility for any defocts in the product related to manufacture, distribution or directions for use, including dosage.

I 0. The product should be used in accordance with the treatment protocol provided to the TGA with the request.




The letter should be headed "APPEAL UNDER S 60 OF THE THERAPEUTIC GOODS ACT 198911

•


The Parliamentary Secretary may either deal with the appeal personally, or. send it to be dealt with by one of the Minister's delegates within the Department. Should you be dissatisfied with the result of your appeal then, subject to the Administrative Appeals Tribunal Act 1975, you may appeal to the Tribunal for review of the Minister's/Delegate's decision.

Yours sincerely

➔ Januazy 2006

6: 2005 -12-23 18:32

Australian NON DATABASE P&QDJ&~ FORM

Department of Health and Ageing 'fhera~utic Goods Administration

-SPECJAL.A~ SCHEME

PLEA~m l!SF. BLACK PEN, PRJNT CL~ARLY AND COMPLETE ,~LI.. SECTIONS

Patient details

Pa\ieot's.initi~

'MRN:

po,...ed)

DOB:

SEX;

suppiicr ~~TT

.- ----------

P 1/1 ],~

I _I

! ~-------JI Rooteof a<bn;n;,:ration• [ .wJ.. ~ I Dosage• r: 40 ':'j ~ s{iw0'.§ .... ,fonnf troa~nt I ~ ,,._.;-11v) (tW~

] rei1cribing doctor details ..

Postal address (hospital or ptivare). The , _p,ova I lone, wHI ho m,ilc<l JO :his cddres,~ Departmen

Phone

- F.ix number

Signa~ure &dare I . . .

Fax (medicines): 02 6232 8 I 12 Fox AS. omceI, TOA, PO Box 100, Woder. ACT 2606

Dear


D-Re: Special Access Scheme Approval - Adalimumab (Humira)

I refer to your request received 14th December 2005 concerning approval to supply Adalimumab (Humira) for use in the treatment of one of your patients.

Pursuant to Section 19(1)(a) of the Therapeutic Goods Act 1989, approval is granted for the supply of Adalimumab (Hurnil'a) for use in the treatment of your patient- (DOB - /1962) UR: -




1. The approval is given for the supply of twelve (12) months' therapy of the above drug at a dosage of 40mg, every 2 weeks, subcutaneous injection.

2. This approval is valid for up to twelve ( 12) months from the date of this letter or until revoked or until Adalimumab (Humira) is marketed in Australia, whichever is sooner.




6. The principles set out in the ''National Statement on Ethical Conduct in Research Involving Humans" are observed.

Address: PO Box 100 Woden A.CT 2606 Website: www.tga.gov.au TP.IP.nhone: 02 6232 8111 Facsimile: 02 6232 8112 ABN 40 939 406 804








The letter should be headed t•APPEAL UNDER S 60 OF THE THERAPEUTIC GOODS ACT 1989".


The Parliamentary Secretary may either deal with the appeal personally, or send it to be dealt with by one of the Ministerts delegates within the Department. Should you be dissatisfied with the result of your•appeal then, subject to the Administrative Appeals Tribunal Act 1975, you may appeal to the Tribunal for review of the Minister's/Delegate's decision.

Yours sincerely


)r6 December 2005

14- DEC-2005 21:50 - P . 01 .ZS (v

~

TG/\ TRIIAIEUrIC HODS AIMINlfTBATtD•

--t "f AX A 6 P L 'j f' Lf-Asr

CATEGORY B FORM ''-t SPECIAL ACCESS-SCHEME ~ J

--· Health and PLEASE US& BLACK PEN. PRINT CLEARLY .AND COMPLETE ALL SECTIONS AgedCare

Patient details

Patient details (initials, ID or

URN, DOB, Sex)

Clinical justification "O R. •. for use of product ,__r __ -..:+__..;;;'----"';..._--+-...:........:::....:.....:,,,.._ _ _____,\ -"'tJ"---''--'t>_ A_l_..,,,_\_M __ u_M_ A_'\:;-=-----1

In.elude appraisal of ~ -f C) .A-i A 7' rl serioumess of p otienJ's ~ ~.:_~~.::.;:!..:.....:..::::._.!...!::::--L~~~'..C:::=i...::-u~--=---=-~l;..k.::'.:-"l~ :..:.l!,,L!..J::::::..:.....::.~ '.l__..J-

ct,,td[Jion; detail previous treat111cnt:t and i--,:~---.!:O:W..J~<...!.:::::.- ~:::.l.l..:...:..::==w.a.w;_~~~.u::::!_ __ .,,,.....:::::;;.~-......::::::::......~

expected ~nefits from

ureoftheprodud. 1---- - - - - - ---------- ----- --------l

Product details ANach efficacy and safery d'11a to support p roposed us.r of the product and details of inJended monitoring regime. •Compktefor medicines only.

PrC$crihing doctor details

lnino. S

: ~;-~

Name I r Hospital , - .

Department

• br,4+!

IJ-..L/

Signature

Form no. 2950 (0105)

TOTAL P.01

Dear



I refer to your request received 13th December 2005 concerning approval to supply adalimumab (Humira) for use in the treatment of one of your patients.

Pursuant to Section 19(1)(a) of the Therapeutic Goods Act 1989, approval is granted for the supply of Adalimumab (Humira) for use in the treatment of your patientllll(DOB ~ /1985)UR: -


All parties involved in the supply of unregistered drugs need to recognise that the practice may carry medico-legal risk and, and there may be implications regarding indemnity. The TOA does not give any assurances or indemnity in regard to the supply of unregistered drugs.

Permission is given s~bject to the following:

I. The approval is given for the supply of twelve (12) months' therapy of the above drug at a dosage of 40mg, every 2 weeks, subcutaneous injection.

2. This approval is valid for up to twelve (12) months from the date of this letter or until revoked or until adalimumab (Humira) is marketed in Australia, whichever is sooner.




6. The principles set out in the ' 'National Statement on Ethical Conduct in Research Involving Humans" are observed.

Address: PO Box 100 Woden ACf 2606 Website: www.tga.gov.au -r,.J.,nh""". O? 1.? 1? Sl11 l J;',.,,1: imilP.· O? r'>?1?. Rl 1?. ARN 40 QJQ 406 804


8. The TGA is notified ofreasons for discontinuation should this occur.


10. The product should be used in accordance with the treatment protocol provided to the TGA w~th the request.

11. This approval provides an exemption from the Therapeutic Goods legislation in order to allow supply of this unapproved product in the circumstances described. Other legislation, including any relevant State or Territory legislation, must stilJ be complied with.






Yours sincerely

DELEGAT SECRETARY

/ ~ December 2005

13-DEC-05 9:05

1HfRA1EIITIC ·l:DDDS . . .. -

'!"Jfa·•~•1s1•~t,oi

PLEASE USE BLACK PEN, PRINT CLEARLY AND COMPLETE ALL SECTIONS

Patient details

Patie:nt:detailli (initial~ ID or

URN, DOB, Sex) '::t)o ,, ' l({.~ ,r: -·--

--· Health and Agectcare

Product details .tttxzch l!'jficacy and safety darr,f'to supporr proposed use of tT1e product and derafls oftnm:ded montt.orlng regime. •Complete for medicine., Qn{y.

. Acti~e• I ,A "t) A L \ t-,.,\ lA_ M A 3 .. I ~e name I \--\ \J\. N\ \ R J,\ I ingredient .__ ------------~-'. /Device name 1... ~-----------'·

, eom...,,..,,,,,., I A~bo--'tl I ~ '----~-----------------'

'A p, ~,. ..... I l;o; ( M, ..... \ \,/\0c\. 1/ -- ofadmi,;,oadon' L-l _s_c__. __ ~ __ ,,, _ ___.I

-· 11.t;o; i"'°'"'~ i~ ~.,...,,,,. .. I \ 1-. ~4-t-•- ,__f

Hospit.al

Dq,iutment

.. , .

JI IYJW Phone

Fax number

Form no. 2950 (0105)

TOTAL P.01

Dear

Australian Government D"epartment of Health and Ageing Therapeutic Goods Administration


I refer to your request received 19th October 2005 concerning approval to supply Adalimumab (Humira for use in the treatment of one of your patients.

Pursuant to Section 19(1)(a) of the T.herapeutic Goods Act 1989, approval is granted for the supply of Adalimumab (Humira) for use in the treatment of your patient ~ OB 111111962) UR- . .


All parties involved in the supply of unregistered drugs need to recognise that .the practice may carry medico-legal risk and, and there may be implications regarding indemnity. The TGA does not give any assurances or indemnity in regard to the supply of unregistered drugs.


1. The approval is given for the supply of three (3) months' therapy of the above drug at a dosage of 40mg, every 2 weeks, subcutaneous injection.

2. This approval is valid for up to six (6) months from the date of this letter or until revoked or until Adalimumab (Humira) is marketed in Australia, whichever is sooner. •


4. The product is used within the context of fully infonned consent. The product is currently unregistered in Australia and the proposed usage constitutes use as an experimental drug.


6.. The principles set out in the "National Statement on Ethical Conduct in · Research Involving Humans" are observed.



8. The TGA is notified of reasons for. discontinuation should this occur.

9. The Commo~wealth accepts no responsibility for any defects in the product related to manufacture, distribution or directions for use, including dosage.



This decision is an "initial decision" within the meaning ofs 60 of the Therapeutic Goods Act 1989 ("the Act"). This means that if your interests are affected by the decision, you may seek reconsideration by the Minister. Any appeal should be made in writing within 90 days after this d.ecision first comes to your notice or to the notice of your company, and should b~ sent to the following address:


The letter should be headed "APPEAL UNDER S 60 OF THE THERAPEUTIC GOODS f.\CT 1989".



Yours sincerely

DELEGATEOFTHESECRETARY

( ~} October 2005

0 t 18 2005 04:44PM P2 C '

TG/\ TIIEIAPEU BOHS A••t•ISTIA110.

CATEGORY B FORM SPECIAL ACCESS SCHEMt

PLEASE USE JILACK PEN. fRINl' CLEARLr AND COMPLETE ALL SECTIONS

P11deot details

Piitient decalls (initials, ID or

URN. DOB, Sex)

/

l' ---Healthand AgedCare

0aanoau / Ffs Ufi''j GroL ~ J):f ~ Provious SAS No. ,_/ ______ ~ Clinical justification ~

fur use of product ~~:!::::::::.l..!..~=..__:_..::...__..:.......:·~.:....=:..::t.v-:~~~~~~....1.:~~~~------- ---I l11dude apprrzisol of

.tertour1t~ofpat1ent's W~Jn;~~L5]~~~~~:._J:V.~~~~k____:~~-:::p_~~:::.....-J condition; utall

prev/0119 treamwitsahd ~~::.!.::.::..__-f:L~~~2--Q~O.SL~~~~~..:C~-(?.:J~~::::::....---l Dpected bowjia.fro,n

use oft"4produa J...4~~~c::5i~~~~~~~

Product details Attach qftcocy tmd ~ty data to ICIIJ1PD'f pro~d use of tire prod11~t a"d dfdail.1 of i.,,teruud m4,rflorlllg r,111-. ~'11!Plett: for medtcinl!3 * ·

. Acci~e• f Ab.AL-\fv\,V-./v\A,Ss, mgnd1mt L. _ ______ _______ __,

Postal address

Company/supplier I A 1::::, ~o Tl

Signature

Hospital

Department

DearD~


Re: Special Access Scheme Approval - Adalimumab

I refer to your request received 4 August 2004 concerning approval to supply Adalimumab for use in the treatment of one of your patients.

Pursuant to Section 19(I)(a) of the Therapeutic Goods Act 1989, approval is granted for the supply of Adalimumab for use in the treatment of your patient- DOB . 1990).

This approval is granted on the grounds that there is no suitable alternative therapy marketed currently in Australia. No assurance is given by the Therapeutic Goods Administration as to the quality, safety or efficacy of this therapeutic good as defined in the Act, in the proposed usage.

All parties involved in the supply of unregistered dru~ need to recognise that the practice may carry medico-legal risk and, and there may be implications regarding indemnity. The TGA does not give any assurances or indemnity in regard to the supply of unregistered drugs.


1. The approval is given for the suppt of up to six (6) months' therapy of the above drug at a dosage of 24mg/m BSA subcutaneously every 2 weeks

2. Doses are to be given in a suitably equipped medical facility under the supervision of medical personnel trained in resuscitation, until such time as it is clear that the patient is not at risk of anaphylaxis.

3. This approval is valid for up to twelve (12) months from the date of this letter.


5. The product is used within the context of fully informed consent. The proposed usage is not in accordance with the conditions of registration of Adalimumab and constitutes use as an experimental drug.


7. The principles set out in the ''National Statement on Ethical Conduct in Research Involving Humans" are observed.

Address: PO Box 100 Woden ACT 2606 Website: www.tga.gov.au. Telephone: 02 6232 8111 Facsimile: 02 6232 8112 ABN 40 939 406 804

8. Details of any suspected adverse drug reactions are reported to the TGA


1 O The Commonwealth accepts no responsibility for any defects -in the product related to manufacture, distribution or directions for use, including dosage.

11. The product should be used in accordance with the trea.tpient protocol provided to the TGA with the request.

This decision is an "initial decision" within the meaning of s .60 of the Therapeutic Goods Act 1989 ("the Act") . This means that if your i~erests are affected by the decision, you may seek reconsideration by the Minister. Any appeal should be made in writing within 90 days after this decision first comes to your notice or to the notice of your company, and should be sent to the following address:



Before embarking upon this course of action you are invited to contact the initial decision maker to see whether the matt~r can be resolved informally.


Yours sincerely


I I August 2004

I ~ 001 /0 04

.. ~ , Australian Government ~ Department of Health and Ageing

Therapeutic Goods Admin1stration


PLEASE USE BLACK PEN, PRJN'l' CJ&ARLY AND COM Pl.ET\! ALL SECTIONS

Patient deta.ils

I ••• ,,,,,. ;.;,;,,., • - MRN:

DOB:

SEX;

Diagnosis I 'JU \)~ c....,L r-0<.,A..A c. · I Previous SAS No- I .._ __ _ _ _.Q,/......__4-u __ ~{~-h~f _______ __,, (ifapplicable) '----------J

Product details A1tach efficacy and safety dttJa Jo suppon pro'f'l)sed use of the product and derails of inlenaed monitoring .. *Complote for medicines 011/y.

Active• I A ~ v1A LIM 4-l, ingredient '------------------'

Trade n\\me l /Device name

Company/supplier I f\s~.,,.- I (State ifimponed) ._ ____________________ ________ __._

Dose fom1* I ~C. ~ o- I Route of administration• I ~ C::.. I ~ - ..___ __ ___.

.go~age• k~4 ~ Durarionoftreatmenc ._I __ l.;2 __ ~ ____ · _ _ __.I

v+ ...,_., /f"..·).. aji e of medical device procedure/use ----- --- - -----

Prescribing doctor details

Name Hospital

Postal address (hospital or private). ' ' . Oepa.mienr

Phone

Fax number

(i' f I ~• I , 4 ~~,t~ '7]

T G /\ THERAPEUTIC IIOODS ADMINIS TRATIDH

~~) PO Box 100 Woden ACT 2606 Australia 'Telephone: (02) 6232 8444 Facsimile: (02) 6232 8241

Comlo'.r.-.lll!DtP•l'fi«lld

Health and Ageing

Dear

Re: Adalimumab

I refer to your request received 8 July 2002 concerning approval to supply Adalimumab .for use in the treatment of one of your patients.

Pursuant to Section 19(l)(a) of the Therapeutic Goods Act 1989, approval is granted for the supply of Adalimumab for use in the treatment of your patient i-. (DOB- /1979).


All parties involved in the supply of unregistered drugs need to recognise that the practice may carry medico-legal risk and, in the case of a major company, there may be implications for the company's indemnity. The TGA does not give any assurances or indemnity in regard to the supply of unregistered drugs.


l . The approval is given for the supply ofup to six (6) months' therapy of the above drug at a dosage as per manufacturer's instructions.

2. This approval is valid for up to twelve (12) months from the date of this letter or until revoked or until Adalimumab is marketed in Australia, wpichever is sooner.

3. The approval is for supply for use in the above mentioned patient only.

4. The product is used within the context of fully informed consent. The product is currently unregistered in Australia and the proposed usage constitutes use as an experimental drug. -


6. The principles set out in the "National Statement on Ethical Conduct in Research Involving Humans'' are observed.



9. The Commonwealth accepts no responsibility for any defects in the product related to manufacture, distribution or directions for us, including dosage.


(9

This decision is an "initial decision" within the meaning of s 60 of the Therapeutic Goods Act 1989 ("the Act11

). This means that if your interests are affected by the decision, you may seek reconsideration by the Minister. Any appeal should be made in writing within 90 days after this decision first comes to your notice or to the notice of your company, and should be sent to the following address:

The Parliamentary Secretary to the Minister for Health and Aged Care Parliament House CANBERRA ACT 2600

The lett~r sh9uld be headed "APPEAL U1'U)ER S 60 OF THE THERAPEUTIC GOODS ACT 1989".


The Parli~entary Secretary may either deal with the appeal personally, or send it to be dealt with by one of the Minister's delegates within the Department. Should you be dissatisfied with the result of your appeal then, subject to the Administrative Appeals Tribunal Act 1975, you may appeal to the Tribunal for review of the Minister's/Delegate's decision.

tS July2002

... ..... , .... . , ... - .... £ ..... ,._ -- ·-·- ..... ._. .......... _.__. _______ ._(~•~• ' --·- -~~ TG/\

TIIIU HUrll: UIHU ADMIIIJTUTIDN

~003

---HeaJthand "PLEASE USE BLACK PEN, PRINT CU~ARLY A.ND COMPLETE ALL SECTIONS l Agedcara

Pctlent details (lniria.15, 10 or

tJR.N. DOB, Sex) I I

Clinical jwrtification ~ cv~~ l'R-a ~-s s, ✓c t; o/ ,-J o V I ;, .J I for use ofprodm:t

/,.elude appralsal of ·U rJ '-- cn,-1 ~'I,..(.. .. ~ (.,.(_ s I ,,..I &- c.. e, ,,...J.; ~ n ~ ,t-c_

.tdl'ibu.r1te.s., of patienl's t:Ufldlr/01t; dd,oll ..,-Z-kr-1< .A- ('' ;-J /,,_f (... i..<.,<.. J I ,.-4 (... ),·J--r;~ 1-t~, /"7,rlt:-

pnNiCRts ln-atmt!Nrl and tJJtpiu::ud lutneflt!I from 0 (l,<-<. f- 5 ' N~ ! /J.+"r, e,,-..rr )~,-~ )'T,t?-Jetl.~ ~ ofmt! prodW!t

.,.. ,rJ l-1...,~ ,f-t~ .

Product detalh .4lla,·I, rJ]it:(l,:Y and SQj'et}• data ta :mpport proposed uw l)ftlt., p roduc.1 am/ d~toih nf ir,16'. drtd mcmitori11g ref ime. • Comp.k.te f or rr.cdicinas ""ly.

~;:~ I /.\) 1t.__, >"\ u >1A ~ l )1 €~) Tr~de name I I /Devx:e zumM: .__ --- --- ---------'·

Company/~upplicr I .4 -~ I!, ,rr"r

Dose form•

Prescribing doctor deta.111

Pom.l addnw;i

-

Route ofadnunistnlt:ion* I ~ -6 <:. £..< ~..=i,,..J ,

Duration of treatment I l'N)t:-.4,.....# · I

I Fbrm no. 2950 (010!J)

- ,

Documents

FOI 1782 Document 1 - TGA